最新刊期
卷 33 ， 期 22 ， 2022
- 摘要：OBJECTIVETo provide reference for improving the management of rare diseases in China.METHODSThrough consulting the comprehensive plan for rare disease management in South Korea and relevant laws and regulations， typical prevention and treatment practices and guarantee measures for rare diseases in South Korea were summarized， and suggestions on improving the management of rare diseases in China were put forward based on the actual situation in China. RESULTS &CONCLUSIONSSouth Korea has established a relatively complete prevention and guarantee system of rare diseases through dynamic supplementary rare disease list， differentiated rare disease cost assistance programs， and patient organizations providing supplementary social security. Our country can optimize the management of rare diseases from 4 aspects： establishing a programmatic action plan for rare disease management， improving the selection procedure of rare disease catalogue， exploring the establishment of rare disease subsidy strategies and supporting the development of rare disease patient organization.关键词：South Korea;prevention and treatment;guarantee;orphan drug;China
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发布时间：2023-02-22 - 摘要：OBJECTIVETo compare the antibacterial drugs between the 2021 edition of WHO Model List of Essential Medicines for Children （WHO EMLc） and the 2018 edition of National Essential Medicines List of China （NEML）， and provide reference for the drug selection of Chinese essential medicine list for children.METHODSBy means of descriptive analysis， the similarities and differences in classification methods， special markers， the varieties， dosage forms and specifications were compared between WHO EMLc and NEML.RESULTSWHO EMLc had strict limits and classifications on the antibacterial drugs， marked the age and weight of children who were restricted to use， and focused on the drug resistances and safety in children. In terms of varieties， there were 51 kinds of antibacterial drugs in NEML and 62 in WHO EMLc； 36 kinds of antibacterial drugs were both included in NEML and WHO EMLc； some antibacterial drugs， such as cloxacillin， procaine penicillin and ceftazidime avibactam， were listed in WHO EMLc but not in NEML. In terms of dosage forms， the dosage forms of antibacterial drugs included in WHO EMLc were more abundant and flexible， such as oral liquids， powder for oral liquids and scored tablets which were not included in NEML， and could improve the compliance of children’s medication and the accuracy of dosage. In terms of specifications， the total numbers of the specifications of antibacterial drugs both included in the two lists were close， but the specifications of some drugs included in NEML were more abundant， and the minimum specifications included in NEML were smaller. Although some of the unique antibacterial drugs included in WHO EMLc were listed in China， they could not be used in children due to the lack of drug data on children in China， such as clofazimine， bedaquinoline and delamanid.CONCLUSIONSThe antibacterial drugs included in NEML can not fully meet the medication needs of children in China. WHO EMLc has certain advantage and rationality as a special list for children. The relevant departments in China can learn from the excellent experience of WHO EMLc， improve the information of pediatric medication of NEML and launch Chinese Essential Medicine List for Children as soon as possible.关键词：National Essential Medicines List of China;children;antibacterial drug
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发布时间：2023-02-22 - 摘要：OBJECTIVETo obtain mitochondria targeting compounds from Gastrodia elata， and to study the neuroprotective activities of these compounds.METHODSThe mitochondria was extracted from cerebral tissue of rats. The purity of mitochondria was evaluated with Janus green staining and neutral red staining. The activity of purified mitochondria was evaluated. The purified mitochondria was included in the control group，and the inactivated mitochondria was included in the experimental group. The ratio of the difference between the peak areas of the control group and the experimental group to the peak areas of control group（ΔP） was determined and calculated to verify the feasibility of the method for obtaining the mitochondria targeting compounds. The mitochondria targeting compounds from G. elata were obtained by ultrafiltration centrifugation-high performance liquid chromatography （HPLC） and identified， and the effects of the compounds on the acitivities of mitochondria were also detected. The neuroprotective activities of the compounds with better activities were studied with hypoxia glucose deprivation/reoxygenation （OGD/R） damaged HT22 cells.RESULTSThe extracted mitochondria possessed high purity and activity. Results of feasibility validation showed that ultrafiltration centrifugation-HPLC method had recognition and separation function， and could be used to obtain compounds with mitochondria targeting function. Two mitochondria targeting compounds （p-hydroxybenzyl alcohol and p-hydroxybenzaldehyde） were obtained from G. elata； these 2 compounds could improve the activities of mitochondria in vitro， and p-hydroxybenzyl alcohol had higher activity. Results of cell experiment showed that pretreatment with p-hydroxybenzyl alcohol （25， 50， 100 μmol/L） had little effect on the survival rate of HT22 cells. Compared with the model group， p-hydroxybenzyl alcohol could reduce cell mortality of OGD/R damaged cells， improve cell morphology， increase the levels of ATP and MMP， and reduced LDH and ROS levels and MPTP openness；most of the differences were statistically significant （P＜0.05）.CONCLUSIONSTwo brain mitochondria targeting compounds （p-hydroxybenzyl alcohol and p-hydroxybenzaldehyde） are obtained from G. elata，among which p-hydroxybenzyl alcohol has a significant protective effect against OGD/R-induced neuronal injury， possibly through mitochondria targeting therapy.关键词：brain mitochondria;ultrafil-tration centrifutgation;HPLC;targeted therapy;neuroprotec-tion
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the “property-effect” correlation material basis of the classic famous prescription Taohe chengqi decoction in removing blood stasis and purging heat.METHODSThe rat model of blood storage syndrome was established to investigate the effects of Taohe chengqi decoction （17.29 g/kg） and its property grouping components [bitter-cold property group （Rhei Radix et Rhizoma+Natrii Sulfas） 9.43 g/kg， pungent-warm property group （Cinnamomi Ramulus+Persicae Semen） 4.71 g/kg， sweet-flat property group （Glycyrrhizae Radix et Rhizoma） 3.14 g/kg] on coagulation indexes （prothrombin time， prothrombin activity， activated partial thrombin time， fibrinogen， thrombin time and endothelin-1） and inflammation indicators （C-reactive protein， tumor necrosis factor-α and superoxide dismutase） in rats. On the basis of determining the dominant property groups， ultra-performance liquid chromatography-quadrupole-orbitrap high-resolution mass spectrometry was used to identify the components. The molecular docking was performed， and the components with binding energy ≤－5.0 kcal/mol were selected as the basis of “property-effect” correlation material basis.RESULTSTaohe chengqi decoction total prescription group and pungent-warm property group could significantly improve the coagulation indexes of model rats （P＜0.05 or P＜0.01）， and the total prescription group and bitter-cold property group could significantly improve the inflammation indexes of model rats （P＜0.05 or P＜0.01）. The pungent-warm property group was the dominant property group for removing blood stasis，and the bitter-cold property group was the dominant property group for purging heat. Thirty-two and thirty-five components were identified from the pungent-warm property group and bitter-cold property group，respectively. With binding energy ≤－5.0 kcal/mol， there were 10 components （abscisic acid， 3，4-dihydroxypheny-lethanol， procyanidin B1， etc.） in the pungent-warm property group and 13 components （baicalein， aloe-emodin， demethylwedelolactone， etc.） in the bitter-cold property group.CONCLUSIONSTaohe chengqi decoction has the effect of removing blood stasis and purging heat， and its material basis comes from pungent-warm property group （Cinnamomi Ramulus， Persicae Semen） and bitter-cold property group （Rhei Radix et Rhizoma， Natrii Sulfas） respectively.关键词：blood storage syndrome;medical property;coagulation index;inflammatory indicator;material basis;rats
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the discrimination of processing degree of Zingiber officinale charcoal and the correlation between color and component content based on machine vision system， and provide reference for quality evaluation and processing degree control of Z. officinale charcoal.METHODSHigh-performance liquid chromatography method was used to determine the contents of 5 components in Z. officinale charcoal and its different processed products， such as 6-gingerol， 8-gingerol， 10-gingerol， 6-shogaol， gingerone. Machine vision system was used to obtain the image of the decoction pieces and extract the color features of the decoction pieces in RGB， L*a*b* and HSV color spaces. Machine learning methods， such as principal component analysis （PCA）， linear discriminant analysis （LDA）， partial least squares-discriminant analysis （PLS-DA） and support vector machine （SVM）， were used to establish qualitative identification model for Z. officinale charcoal processed products of different processing degree. The correlation between the color eigenvalues and the contents of measured 5 components were analyzed， and the color-component content prediction model was established.RESULTSWith the deepening of processing， gingerone was produced after processing and the content firstly increased and then decreased， and the content of gingerone in standard carbon was the highest； the contents of 6-gingerol， 8-gingerol and 10-gingerol decreased gradually； the content of 6-shogaol increased firstly and then decreased. The prediction accuracy of qualitative discriminant model， which was established on the basis of objective quantization of image and color combined with LDA and SVM of supervised discriminant pattern recognition method， reached 100% in cross-validation training and 95.83% in the external validation. Content prediction model of 5 components was established on the basis of objective quantization of image and color combined with SVM， the RPD values were all greater than 2， the R2P and R2C values of gingerone were 0.633 9 and 0.683 3， and the values of other components were all greater than 0.75， indicating SVM had good prediction ability for the contents of 4 components except for gingerone.CONCLUSIONSThe machine vision system is excellent for the discrimination of the processing degree of Z. officinale charcoal and the content prediction， which can provide a reference for the quality control of Z. officinale charcoal decoction pieces and the judgment of the processing degree.关键词：machine vision;machine learning;quality evaluation;processing degree
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the effects of osthole （OST） on renal interstitial fibrosis in diabetic nephropathy （DN） model mice.METHODSThe diabetic mice model was established by the tail vein injection of streptozotocin once， and the DN model was established by feeding for 12 weeks after successful modeling of diabetes. Diabetic model mice were randomly divided into model group， low-dose， moderate-dose， high-dose groups （20， 40， 80 mg/kg） of OST， with 10 mice in each group. After successful modeling of diabetes， the mice were given corresponding drugs or solvent （model group） intragastrically， once a day， for consecutive 12 weeks， and the normal control group was set up at the same time. After the last administration， the levels of fasting blood glucose， 24 h urinary protein， serum creatinine （Scr） and blood urea nitrogen were tested in each group. Masson staining was used to observe the deposition of collagen fibers in renal interstitium； the expressions of E-cadherin and vimentin in renal cortex were detected by immunohistochemical staining. The protein expressions of follistatin-like protein 1 （Fstl1） and Snail family transcriptional repressor 1 （Snail1）， the phosphorylation of protein kinase B （Akt） （calculated by p-Akt/Akt） in the renal cortex were detected by Western blot.RESULTSCompared with normal control group， the levels of fasting blood glucose， 24 h urinary protein， Scr and blood urea nitrogen， collagen fiber deposition ratio of renal interstitium， the expression of vimentin， protein expressions of Fstl1 and Snail1， p-Akt/Akt in renal cortex were increased significantly （P＜0.01）， as well as the expression of E-cadherin was decreased significantly （P＜0.01）. Compared with model group， above indexes of OST groups were reversed significantly （P＜0.05 or P＜0.01）.CONCLUSIONSPreventive use of OST can effectively reduce fasting blood glucose level， protect renal function and inhibit epithelial-mesenchymal transition of DN model mice， and delay the progression of renal interstitial fibrosis ， the mechanism of which may be associated with the suppression of Fstl1/Akt/Snail1 signaling pathway.关键词：diabetic nephropathy;interstitial fibrosis;follistatin-like protein 1;protein kinase B;Snail family transcriptional repressor 1;mice
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the effects of different drying methods on the index components in wine-processed Cornus officinalis so as to optimize drying method.METHODSAfter processed with wine， C. officinalis decoction pieces were dried with different drying methods （blast drying， far infrared drying， microwave drying， freeze drying， sun drying， shade drying and combined drying）. The contents of 5 components such as gallic acid in wine-processed C. officinalis were determined by high-performance liquid chromatography. The contents of total flavonoids in wine-processed C. officinalis were determined by chromogenic method. Analytic hierarchy process was used to evaluate the effects of different drying methods on the contents of components in C. officinalis.RESULTSThe contents of gallic acid， 5-hydroxymethylfurfural， monoside， loganin， cornuside and total flavonoids in 22 batches of wine-processed C. officinalis were 1.043 8-1.563 8， 0.648 5-2.358 8， 5.031 0-10.305 7， 6.681 2-7.534 2， 0.986 5-1.148 8 and 33.657 2-50.741 5 mg/g， respectively. The comprehensive scoring results of analytic hierarchy process showed that the comprehensive score of each component in C. officinalis dried by microwave at 75 ℃ was higher， followed by blast drying at 60 ℃ and far infrared drying at 60 ℃.CONCLUSIONSThe wine-processed C. officinalis could be dried by microwave drying at 75 ℃， blast drying at 60 ℃ or far infrared drying at 60 ℃.关键词：drying method;content determination;comprehensive evaluation
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the efficacy of sinapine thiocyanate dissoluble microneedle （ST-DMN） for acupoint administration against bronchial asthma （BA）.METHODSThe network pharmacology and molecular docking techniques were used to screen the core targets of sinapine thiocyanate （ST） against BA， and the pharmacodynamics of the top 3 core targets was studied. Firstly， ST-DMN was prepared （drug loading of ST was 1 mg/tablet）； secondly， 30 rats were divided into blank control group， model control group， blank microneedle group， Sinapine powder plaster group （positive control group） and ST-DMN group. Except for the blank control group， rats of other groups were sensitized with 10% ovalbumin （containing aluminum hydroxide adjuvant） and nebulized with 1% ovalbumin to induce the BA model. After modeling， blank control group did not receive any intervention； normal saline was applied to the Feishu acupoint and Dazhui acupoint of the rats in the model control group， while the blank microneedle group， Sinapine powder plaster group and ST-DMN group were given blank microneedle， Sinapis alba powder （plaster， 1.5 g） and ST-DMN （3 tablets at 2 acupoints） at same acupoint， once a day， for 28 consecutive days. After administration， the general symptoms were observed and the body mass of the rats was measured. The pathological changes of lung tissues in rats was observed； the levels of prostaglandin endoperoxide synthase 2 （PTGS2）， matrix metalloproteinase-9 （MMP-9） and interleukin-2 （IL-2） in serum， bronchoalveolar lavage fluid （BALF） and lung tissues were determined.RESULTSResults of network pharmacology and molecular docking showed that the key targets of ST against BA were identified as PTGS2， MMP-9， IL-2， epidermal growth factor receptor， heat shock protein90AA1， etc. Pharmacodynamic experiments showed that compared with model control group， relieved cough， restored hair color， sensitive behavior， stable respiration and increased body weight were all found in ST-DMN group； the histopathological changes as the structure of lung tissue， infiltration of alveolar epithelial cells and pulmonary interstitial inflammatory cells were improved to different extent； the levels of PTGS2， MMP-9 and IL-2 in serum， BALF and lung tissue were significantly reduced （P＜0.05 or P＜0.01）.CONCLUSIONSThe anti-BA effect of ST-DMN acupoint administration is good， the mechanism of which may be associated with decreasing the levels of PTGS2， MMP-9 and IL-2 in serum， BALF and lung tissue.关键词：dissoluble microneedle;acupoint administration;bronchial asthma;target;pharmacodynamics
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发布时间：2023-02-22 - 摘要：OBJECTIVETo optimize the extraction and separation process of chebulagic acid and chebulinic acid from Terminalia chebula.METHODSBased on single factor experiment， with particle size， liquid-solid ratio， extraction time and extraction times as factors， using the contents of chebulagic acid and chebulinic acid as indexes， orthogonal experiment was designed to optimize the extraction process of chebulagic acid and chebulinic acid. Taking sample concentration， elution solvent and the ratio of eighteen-group bonded silicone reverse phase （ODS） to the amount of raw medicine as factors， the separation processes of chebulagic acid and chebulinic acid were optimized.RESULTSThe optimal extraction process of chebulagic acid and chebulinic acid included ethanol volume fraction of 70%， ultrasonic extraction， particle size of 120 mesh， liquid-solid ratio of 25∶1 （mL/g）， extraction time of 20 min， and extracting for 2 times. After 3 experiments， the average comprehensive score was 99.33 （RSD＝0.68%， n＝3）， and the average contents of chebulagic acid and chebulinic acid were 107.05 and 58.32 mg/g， respectively. The optimal separation process of the two components included the concentration of sample loading solution was 0.5 g/mL （1 mL was equivalent to 0.5 g of medicinal materials）， the ratio of ODS to the amount of raw medicine was 10∶1.5 （g/g）， methanol-water （1∶4， V/V） eluted chebulagic acid， methanol-water （3∶7， V/V） eluted chebulinic acid. After 3 experiments， the average total yields of the two components were 53.33%， 39.23%. After recrystallization， the purity of both components was 100%.CONCLUSIONSEstablished extraction and separation process of chebulagic acid and chebulinic acid is simple and feasible.关键词：chebulinic acid;extraction process;separation process
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the chemical composition difference of Paeonia lactiflora before and after being processed with wine and its analgesic effect.METHODSUPLC-Q-TOF-MS was used to analyze the chemical composition of P. lactiflora before and after being processed with wine. Wister rats were randomly divided into blank group， model group， positive control group （ibuprofen 0.072 mg/g） and P. lactiflora low-dose and high-dose groups （0.005， 0.01 mg/g， by raw material） and P. lactiflora stir-baked with wine low-dose and high-dose groups （0.005， 0.01 mg/g， by raw material）， with 6 rats in each group； the dysmenorrhea model of rats was induced by estradiol benzoate combined with oxytocin； the incubation period of body twisting in rats was recorded after the last medication； the contents of prostaglandin F2α（PGF2α）， progesterone， nitric oxide （NO） and β-endorphin in uterine tissue homogenate were detected.RESULTSSame 60 chemical compositions were identified in both positive and negative ion modes of P. lactiflora and P. lactiflora stir-baked with wine. The contents of 7 compositions， such as linalool， pedunculagin and syringic acid， were increased after stir-baked with wine， but the contents of other compositions were decreased. Compared with model group， the incubation period of body twisting in all administration groups （except for P. lactiflora low-dose group） was significantly prolonged （P＜0.05）； PGF2α in uterine tissue homogenate （except for P. lactiflora low-dose group） was significantly decreased； the contents of progesterone （except for P. lactiflora low-dose and high-dose groups）， NO （except for P. lactiflora low-dose and high-dose groups） and β-endorphin were significantly increased （P＜0.05）.CONCLUSIONSThe analgesic effect of P. lactiflora stir-baked with wine on dysmenorrhea model rats is better than that of P. lactiflora， which may be related to the increase of 7 compositions such as linalool， pedunculagin and syringic acid after stir-baked with wine.关键词：stir-baked with wine;chemical composition;UPLC-Q-TOF-MS;analgesic effect
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish a quantitative analysis method for the quality control components in Tenghuang jiangu capsules， and predict the possible action mechanism of the quality control components.METHODSSeven key quality control components in Tenghuang jiangu capsules were quantitatively analyzed by UHPLC-Q-Orbitrap HRMS. The “component-target” network was constructed based on network pharmacology， and the Kyoto Encyclopedia of Genes and Genomes （KEGG） pathway enrichment analysis and gene ontology （GO） function enrichment analysis were further conducted to find the key signaling pathways.RESULTSThe average contents of succinic acid， hyperoside， gallic acid， kaempferol， naringin， naringenin and protocatechuic acid in 20 batches of Tenghuang jiangu capsules were 520.92， 67.67， 129.48， 4.74， 397.45， 5.66 and 376.62 μg/g， respectively. The results of network pharmacology showed that the 62 key target genes of the quality control components of the drug included AKT1， TNF， VEGFA， MMP9， PTGS2， etc. They were mainly enriched in cytokine receptor interaction， nuclear factor， tumor necrosis factor， interleukin 17， rheumatoid arthritis， Toll-like receptor and other signal pathways， involving inflammatory reaction， signal transduction， protein phosphorylation and other biological processes， kytoplasm， cell membrane and other cell components， as well as enzyme activity， energy activity and other molecular functions.CONCLUSIONSThe established UHPLC-Q-Orbitrap HRMS method can be used for the quantitative analysis of the quality control components of Tenghuang jiangu capsule. Its quality control components may be mapped to inflammatory pathways related to bone diseases such as rheumatoid arthritis and Toll-like receptors through AKT1， TNF， VEGFA and other key targets， so as to play a therapeutic role.关键词：quality control components;content determination;network pharmacology;mechanism
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发布时间：2023-02-22 - 摘要：OBJECTIVETo optimize the drying methods of Compound Scutellaria baicalensis extract powder.METHODSCompound S. baicalensis extract powder was prepared by atmospheric pressure drying， decompression drying and spray drying respectively， and high-performance liquid chromatography （HPLC） fingerprint of the extract powder was established. The physical fingerprint of the extract powder was established by 13 secondary indexes， such as particle size， particle size distribution and bulk density. HPLC fingerprints and physical fingerprints of 3 kinds of extract powders were compared by similarity evaluation method； through the conversion of the secondary indexes， five primary indexes of homogeneity， stacking， compressibility， fluidity and stability were calculated， and the physical properties of 3 kinds of extract powder were evaluated. The compressibility parameters of 3 kinds of extract powder such as index of parameter （IP）， index of parametric profile （IPP） and index of good compression （IGC） were calculated by the secondary index to evaluate the compression formability of the powder.RESULTSThe similarity means of HPLC fingerprint of the extract powder obtained by atmospheric pressure drying， decompression drying and spray drying were 0.74， 0.90 and 0.94， respectively， and the similarity means of physical fingerprint were 0.74， 0.83 and 0.92， respectively. The overall similarity of spray drying extract powder was higher. The results of physical fingerprint analysis showed that the physical properties of the extract powder obtained by different drying methods were different. The 3 kinds of extract powder showed poor stability but good stacking. The homogenity and compressibility of extract powder by spray drying and decompression drying were better than those by atmospheric pressure drying， but the fluidity was worse than that by atmospheric pressure drying. The results of further compression formability analysis showed that the IP of spray drying extract powder was 0.54， IPP was 5.23， IGG was 5.03， and the spray drying extract powder could be directly pressed after adding a small amount of lubricant.CONCLUSIONSThere are differences in HPLC and physical fingerprints of Compound S. baicalensis extract powder obtained by different drying methods. The spray drying extract powder possesses better overall quality， which is more suitable for the drying of Compound S. baicalensis extract powder.关键词：extract powder;HPLC fingerprint;physical fingerprint;drying method;powder property;formability
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发布时间：2023-02-22 - 摘要：OBJECTIVETo establish the fingerprint of Pulan liyan mixture， and content determination method of 8 components such as chlorogenic acid so as to evaluate the quality of Pulan liyan mixture.METHODSUsing baicalin as reference peak， high-performance liquid chromatography （HPLC） fingerprints of 11 batches of Pulan liyan mixture were established by the Chromatographic Fingerprint Similarity Evaluation System of TCM （2012 edition） for similarity evaluation and identifying the common peaks. Cluster analysis， principal component analysis and orthogonal partial least squares-discriminant analysis of those samples were performed with SPSS 20.0 software and SIMCA 14.1 software. The variable importance projection （VIP） value greater than 1 was used as the index to screen the markers affecting the quality of Pulan liyan mixture； the contents of 8 components such as chlorogenic acid were determined by the same HPLC method.RESULTSTotally 20 common peaks in the fingerprints of 11 batches of Pulan liyan mixture was established， and the similarities were 0.973-0.994. The 8 peaks were identified， which were chlorogenic acid， caffeic acid， loganin， cichoric acid， styroside B， baicalin， melaleucalycin A-7-O-β-D-glucuronic acid and wogonin. The results of cluster analysis showed that the 11 batches of samples were divided into two categories， S3， S10 and S11 were grouped into one category， and the other batches of samples were grouped into one category. The results of principal component analysis showed that the cumulative variance contribution rate of the first four principal components was 95.546%， and the classification results were consistent with the cluster analysis results. The results of orthogonal partial least squares-discriminant analysis showed that 15， 14 （baicalin）， 10， 18 （wogonin）， 11， 17 （laminarin A-7-O-β-D-glucuronic acid）， 4， 20， 16， 12， 7 and 19 peaks had VIP values greater than 1. The contents of chlorogenic acid， caffeic acid， loganin， cichoric acid， styroside B， baicalin， melaleucalycin A-7-O-β-D-glucuronic acid and wogonin were 0.287-1.021， 0.163-0.485， 0.735-3.641， 0.587-4.012， 1.920-9.063， 37.443-115.974， 3.623-13.942 and 7.135-18.736 mg/g， respectively.CONCLUSIONSThe established HPLC fingerprint and the determination method of 8 components such as chlorogenic acid could be used for the quality evaluation of Pulan liyan mixture. The 12 components， such as baicalin， wogonoside， melaleucalycin A-7-O-β-D-glucuronic acid， may be the markers affecting the quality of Pulan liyan mixture.关键词：fingerprint;content determination;high-performance liquid chromatography;chemical pattern recognition analysis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo mine the risk signals of linaclotide， so as to provide evidence for clinically safe drug use.METHODSOpenVigil 2.1 data platform was used to obtain the adverse drug event （ADE） report data of linaclotide from August 30， 2012 to December 31， 2021 in the database of FDA adverse event reporting system （FAERS）. The reporting odds ratio （ROR） and proportional report ratio （PRR） of the proportional imbalance method were used to mine the data of ADE reports. The mined risk signals were statistically classified and described by the preferred system organ class （SOC） and preferred term （PT） stated in the Medical Dictionary for Regulatory Activities （23.1 edition）.RESULTSThere were 17 590 ADE reports related to linaclotide， including 5 494 reports of severe ADE， accounting for about 31.23%. A total of 120 risk signals were detected. According to the frequency of occurrence， top 10 risk signals （measured by PT） were diarrhea， ineffective drugs， off-label drug use， abdominal distension， abdominal pain， improper administration time， epigastric pain， flatulence， product storage error and intentional misuse of products. According to the signal intensity， the increase of dihydrotestosterone （ROR was 271.258， PRR was 271.131） ranked the first， and two signals such as the increase of dihydrotestosterone and the compression of intervertebral disc were not mentioned in the drug instructions. The SOC of risk signals obtained by two sorting methods mainly included various examinations， gastrointestinal diseases， systemic diseases and various reactions at the administration site.CONCLUSIONSIn clinical application of linaclotide， in addition to the adverse drug reactions mentioned in the drug instructions， close attention should be paid to safety risks such as increase of dihydrotestosterone and the compression of intervertebral disc， which are not mentioned in the instructions， so as to guarantee the safety of drug use.关键词：FDA adverse event reporting system;risk signal;reporting odds ratio;proportional report ratio
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发布时间：2023-02-22 - 摘要：OBJECTIVETo observe the efficacy and safety of albumin-bound paclitaxel in the treatment of advanced non-small cell lung cancer （NSCLC）.METHODSClinical data of patients with advanced NSCLC treated in our hospital from January 2018 to December 2021 were selected. According to their chemotherapy regimen，they were divided into albumin-bound paclitaxel group and paclitaxel group， with 100 patients in each group. Both groups received chemotherapy regimen containing Paclitaxel for injection （albumin-bound） or Paclitaxel injection for at least 2 cycles （every 21 days as a cycle）. The progression-free survival （PFS） and efficacy of the two groups were compared，and the occurrence of toxic and side effects were recorded.RESULTSThe patients in albumin-bound paclitaxel group completed 430 cycles of chemotherapy， with an average of 4.3 cycles； patients in paclitaxel group completed 476 cycles of chemotherapy， with an average of 4.8 cycles. The median PFS （4.0 months） and the response rate （13.00%） of albumin-bound paclitaxel group were not significantly different from those of paclitaxel group （4.0 months，9.00%） （P＞0.05）. The disease control rate （99.00%） was significantly higher than that in paclitaxel group （89.00%）， and the incidences of leukopenia， neutropenia， thrombocytopenia，anemia， sensory neuropathy， fatigue，nausea and vomiting，joint myalgia in albumin-bound paclitaxel group were significantly lower than those in paclitaxel group （P＜0.05）.CONCLUSIONSAlbumin-bound paclitaxel is effective in the treatment of advanced NSCLC， and it can better control the progression of the disease and is safer than ordinary paclitaxel.关键词：paclitaxel;non-small cell lung cancer;efficacy;safety
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发布时间：2023-02-22 - 摘要：OBJECTIVETo provide a reference for the safety of guselkumab in clinical use.METHODSThe reporting odds ratio and the Bayesian confidence propagation neural network were used to mine the data of adverse drug events （ADE） related to guselkumab in FAERS database from the fourth quarter of 2017 to the second quarter of 2022. RESULTS &CONCLUSIONSA total of 29 951 ADE reports related to guselkumab were screened， involving 197 （3 871 cases） ADE signals and 21 system organs. The major ADE signals of guselkumab manifested as infectious and invasive diseases， systemic disease and various reactions at the site of administration， and skin and subcutaneous tissue diseases， which were basically consistent with the instructions. The new ADE signals were found， such as neoplasm of orbit， gallbladder adenocarcinoma， sweat gland disorder， decreased blood uric acid， eyelid retraction， angioimmunoblastic T-cell lymphoma， nonalcoholic fatty liver disease， hyperplastic cholecystopathy， tracheomalacia， inner ear disorder， etc. And the severe ADE signals included severe infections in various parts of the body， liver and gallbladder diseases， tumor， etc.关键词：adverse drug events;adverse drug reaction;data mining
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发布时间：2023-02-22 - 摘要：OBJECTIVETo monitor the occurrence of tenofovir disoproxil fumarate （TDF）-induced kidney injury and investigate the risk factors， and provide reference for rational use of TDF in clinic.METHODSThe information of inpatients with hepatitis B was collected by China Hospital Pharmacovigilance System （CHPS） from the Second People’s Hospital of Lanzhou during Jan. 1st， 2019 to Dec. 31st 2021. The search criteria were set according to kidney injury criteria， and suspected TDF-induced kidney injury cases were actively monitored； then the clinical pharmacist confirmed the positive patients with TDF-induced kidney injury one by one and calculated the incidence of TDF-induced renal injury； the risk factors for TDF-induced kidney injury in real world were explored by collecting and analyzing the correlation of basic data of patients， main indexes of liver and kidney function， complications and combined use of drugs with TDF-induced renal indexes.RESULTSTotally 1 226 inpatients with hepatitis B using TDF were included. Through active monitoring of CHPS， 160 suspected patients with TDF-induced kidney injury were found， and 64 positive patients were finally confirmed manually. The incidence of TDF-induced kidney injury was 5.22%. Compared with pre-medication， the levels of serum creatinine and cystatin C， the proportion of patients with urinary protein 2+ and above were increased significantly after medication （P＜0.001）， glomerular filtration rate and blood phosphorus level were reduced significantly （P＜0.001） and other indicators had no statistical difference. Treatment time for more than 36 months， disease progresses to decompensated cirrhosis， and concomitant use of more than 10 kinds of drugs were significantly correlated with TDF-related kidney injury （P＜0.05 or P＜0.012 5）.CONCLUSIONSThe active monitoring scheme of TDF-induced kidney injury established by CHPS has the characteristics of time-saving， labor-saving and high efficiency； based on real-world evidence， it is imperative to strengthen monitoring kidney function of patients when using TDF， especially when the patient has been on medication for a long time， in decompensated cirrhosis and combination of multiple drugs， and thus， we can identify earlier and avoid adverse effects in high-risk patients effectively.关键词：kidney injury;China Hospital Pharmacovigilance System;active monitoring;adverse drug reaction;real world
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the factors influencing the failure of tigecycline in the treatment of multidrug-resistant Acinetobacter baumannii （MDRAb） pneumonia， and to provide a basis for the rational use of tigecycline.METHODSThe information of patients with MDRAb pneumonia who were treated with tigecycline in the ICU of our hospital during Aug. 2020-Jun. 2022 were collected retrospectively. The patients were divided into treatment failure group and treatment success group according to the curative effect. The basic information， acute physiology and chronic health evaluation Ⅱ （APACHE-Ⅱ） score， laboratory indicators， and medication-related information were recorded and compared between 2 groups. Logistic regression analysis was conducted for analyzing the influential factors inducing the failure of tigecycline in the treatment of MDRAb pneumonia.RESULTSA total of 102 cases of MDRAb pneumonia received tigecycline therapy， with 71 in the treatment success group and 31 in the treatment failure group. Compared with the treatment success group， the patients in the treatment failure group had higher APACHE Ⅱ score （P＜0.05）， and more cases with abnormal coagulation function and comorbidities ≥2 types （P＜0.05）. After the treatment of tigecycline， procalcitonin level of the treatment failure group was significantly higher than that of the treatment success group （P＜0.05）. Logistic regression analysis showed that the independent risk factors for the failure of tigecycline in the treatment of MDRAb pneumonia included abnormal coagulation function and APACHE-Ⅱ score ≥20 （P＜0.05）； doubling the first dose was a protective factor （P＜0.05）.CONCLUSIONSIn patients with MDRAb pneumonia with APACHE-Ⅱ score ≥20 and abnormal coagulation function， tigecycline therapy is more likely to fail； doubling the first dose of tigecycline has better efficacy in the treatment of MDRAb pneumonia.关键词：multidrug-resistant Acinetobacter baumannii;pneumonia;treatment failure;influential factor
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发布时间：2023-02-22 - 摘要：OBJECTIVETo systematically evaluate the efficacy and safety of transcatheter arterial chemoembolization （TACE） combined with local ablation in the treatment of unresectable primary liver cancer （PLC）， and to provide evidence-based reference for rational clinical treatment.METHODSRetrieved from CNKI， Wanfang Data， VIP， PubMed， Embase， Cochrane Library， ClinicalTrials， Web of Science， Ovid and SinoMed， randomized controlled trial （RCT） about TACE combined with local ablation （trial group） versus TACE （control group） were collected. After screening the literature and extracting the data， the bias risk assessment tool recommended by the Cochrane System Evaluator Manual 5.1.0 was used to evaluate the quality of the included literature； Stata14.0 software was used for meta-analysis.RESULTSA total of 39 RCTs were included， including 2 294 patients， involving 6 interventions， i.e. TACE， TACE + radiofrequency ablation （RFA）， TACE + microwave ablation （MWA）， TACE + absolute ethanol injection （PEI）， TACE + cryoablation （CRA）， TACE + high-intensity ultrasound focused ablation （HIFU）， and 4 chemotherapeutic drugs， i.e. platinum， anthracycline， pyrimidine analogues， and polypeptides. The results of meta-analysis showed that in terms of objective remission rate， TACE+RFA， TACE+HIFU and TACE+MWA were higher； in terms of 1-year survival rate， TACE+PEI， TACE+HIFU and TACE+MWA were higher； in terms of 2-year survival rate， TACE+HIFU， TACE+MWA and TACE+PEI were higher； in terms of 3-year survival rate， TACE+HIFU， TACE+PEI and TACE+RFA were higher； in terms of security， TACE+MWA， TACE+RFA and TACE were higher； there was no significant difference in the efficacy of 4 chemotherapeutic drugs in TACE+MWA （P＞0.05）.CONCLUSIONSFor patients with unresectable PLC， TACE+MWA has good efficacy and safety， which is the best combination； the 4 chemotherapeutic drugs in TACE+MWA are all effective， and suitable chemotherapeutic drugs can be selected individually.关键词：unresectable;transcatheter arterial chemoembolization;local ablation;meta-analysis;efficacy;safety
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发布时间：2023-02-22 - 摘要：OBJECTIVETo compare the effectiveness，safety and economy of bovine pulmonary surfactant （PS） and porcine PS in the treatment of preterm neonates with respiratory distress syndrome （RDS）.METHODSRetrieved from PubMed，Embase，Cochrane Library，CNKI，SinoMed，Wanfang and health technology assessment （HTA） organization websites and relevant database，HTA report，systematic review/meta-analysis and pharmacoeconomic study about bovine PS versus porcine PS in the treatment of preterm neonates with RDS were included from the inception to Feb 2022. Data extraction and quality evaluation were carried out for the included literature，and then research results were summarized and analyzed descriptively.RESULTSA total of 1 HTA report，6 systematic reviews/meta-analyses，and 6 pharmacoeconomic studies were included. There appeared to be no significant differences between bovine PS and porcine PS in terms of time staying in neonatal intensive care unit and extra-pulmonary outcomes. In terms of PS re-treatment，blood gas index，total effective rate and the incidence of patent ductus arteriosus，porcine PS was superior to bovine PS. Results from other indicators，such as mortality， the incidence of bronchopulmonary dysplasia，air leakage syndrome，pulmonary hemorrhage，were still controversial. In terms of economy，there was no statistical difference in average hospital charges and administration cost per dose between two groups （P＞0.05）； compared with porcine PS，mean wastage cost per dose of bovine PS was higher （P＜0.001），and 24 h treatment cost of bovine PS was lower （P＜0.05）； the results of average medication cost were controversial.CONCLUSIONSThe effectiveness， safety and economy of bovine PS are found to be similar or inferior to porcine PS. It is not certain whether the inferiority has clinical significance.关键词：preterm neonate;respiratory distress syndrome;effectiveness;safety;economy;rapid health technology assessment
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the influential factors for the collaboration between clinical pharmacists and physicians， and provide reference for improving the collaboration between clinical pharmacists and physicians in China.METHODSThe published literature about influential factors for the collaboration between pharmacists and physicians from various countries was collected from Chinese and English databases； the division methods of influential factors for the collaboration were summarized； then the influential factors and possible mechanisms were summarized referring to the collaborative working relationship model， and the integrity and applicability of existing influential factors in Chinese health system were discussed. RESULTS &CONCLUSIONSFinally， a total of 27 pieces of literature were included and all in English. Different studies had different ways of classifying the influential factors. There were three main classifications： the perspective of the collaboration subject， the progress stage of collaboration/external and internal factors， existing collaboration conceptual model and measurement tool structure. By summarizing the existing literature， it can be obtained that there are influential factors and specific connotation for the collaboration between clinical pharmacists and physicians in China based on three dimensions of the characteristics of individual， context and exchange. In addition， the personnel situation and social publicity with Chinese characteristics can also be taken into consideration.关键词：physician;collaboration;influential factors;collaborative working relationship model
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发布时间：2023-02-22 - 摘要：OBJECTIVETo improve the utilization rate of intravenous infusion in inpatients and enhance the level of rational drug use.METHODSPDCA cycle method was used to formulate and implement countermeasures from the aspects of institution， system， person and management. The utilization rate of intravenous infusion and the average daily number of bags （bottles） per bed for intravenous infusion were used as indicators to evaluate the implementation effect of PDCA.RESULTSThe utilization rate of intravenous infusion decreased from （92.58±0.11）% 3 months before PDCA cycle to （89.72±0.62）% 3 months after PDCA cycle， and the average daily number of bags （bottles） per bed from intravenous infusion decreased from 5.20±0.09 to 4.64±0.24 （P＜0.05）. The utilization rate of intravenous infusion decreased from 92.55% 6 months before PDCA cycle to 89.98% 6 months after PDCA cycle （P＜0.05）； but average daily number of bags （bottles） per bed for intravenous infusion decreased from 5.36±0.26 6 months before PDCA cycle to 4.97±0.39 6 months after PDCA cycle， without statistical significance （P＞0.05）.CONCLUSIONSPDCA cycle method can effectively reduce the utilization rate and average daily number of bags （bottles） per bed for intravenous infusion in the inpatients and improve the level of rational drug use.关键词：inpatient;intravenous infusion;rational drug use
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发布时间：2023-02-22 - 摘要：OBJECTIVETo investigate the effectiveness of clinical pharmacists’ participation in the refined pharmaceutical management for inpatients of oncology center based on diagnosis related groups （DRG）.METHODSPatients who entered DRG and stayed in hospital for less than 60 days in oncology center of Daping Hospital， Army Medical University were selected as the research objects to analyze the changes of DRG indicators and related hospitalization indicators before the intervention of clinical pharmacists’ participation in the refined pharmaceutical management （Jan.-Dec. 2019）， the first year after the intervention （Jan.-Dec. 2020）， and the second year after the intervention （Jan.-Dec. 2021）； the key DRG groups were selected from the oncology center according to DRG enrollment and disease diagnosis and treatment methods， and related hospitalization indicators before and after the intervention and rational drug use after intervention were analyzed.RESULTSCompared with before intervention， in the first and second years after the intervention， the number of DRG groups increased to 157 and 184， and the case mix index increased significantly （P＜0.05）， while cost consumption index， time consumption index， average hospital stay and average hospitalization expense per time were decreased or shortened significantly （P＜0.05）； drug cost per time was increased significantly （P＜0.05）， and there were no low-risk deaths and severe adverse drug reactions. Among the 4 key DRG groups， the average hospital stay in RE19 disease group and RU29 disease group in the first and second year after intervention and those of RU14 disease group in the first year after intervention were significantly lower than before （P＜0.05）； the average hospitalization expense per time of RE19 disease group in the first and second year after intervention and those of RU14 disease group， RV19 disease group and RU29 disease group in the second year after intervention were significantly lower than before （P＜0.05）； drug cost per time of RU14 disease group in the second year after intervention was significantly lower than before， while those of RE19 disease group and RU29 disease group in the first and second year after intervention were significantly higher than before （P＜0.05）. There was some irrational drug use in the DRG disease groups with a significant increase in the drug cost per time after the intervention， such as inappropriate selection of drugs， inappropriate usage and dosage， off-label drug use， etc.CONCLUSIONSIn the context of DRG， after the clinical pharmacists participated in the refined pharmaceutical management， the overall diagnosis and treatment service capacity of oncology center are improved， the efficiency of diagnosis and treatment are improved， and there are no low-risk deaths and severe adverse drug reactions， which promote the management of rational drug use in medical institutions.关键词：clinical pharmacist;refined pharmaceutical management;oncology center;effectiveness
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发布时间：2023-02-22 - 摘要：OBJECTIVETo provide reference for improving the working efficiency of prescription review for pharmacists and ensuring the safe use of parenteral nutrition solution in patients.METHODSThe review module of parenteral nutrition prescription was developed with the pharmacy intravenous admixture services（PIVAS） MATE system. According to the instructions and relevant information of parenteral nutrition solution， the parameters to the review module for parenteral nutrition solution prescriptions were assigned， thresholds and calculation formulas were set， and the prescription was automatically determined by the system. The type and quantity of the inappropriate prescriptions of parenteral nutrition solution in our hospital from January to August 2020 and from January to August 2022 were counted， and the review efficiency of inappropriate prescriptions was compared before and after the application of the review module of parenteral nutrition solution prescription.RESULTSThe module realized the informatized review of basic attribute parameters and custom parameters of parenteral nutrition solution prescription， such as ion concentration， ratio of heat to nitrogen， ratio of sugar to lipid， glucose concentration， ratio of sugar to insulin， maximum dosage of compound preparation， necessary drug collocation， incompatibility， repeated drug use， age limit， etc. The module also shortened the review time greatly. It took about 33 minutes for two pharmacists to review 100 prescriptions， and only took 6 seconds after the module went online. Compared with January to August in 2020， the average approval rate of inappropriate prescriptions for parenteral nutrition solution increased from 0.582% to 1.416% during the corresponding period in 2022 （P＜0.05）.CONCLUSIONSThe review module of parenteral nutrition solution prescription established by parameter assignment method in our hospital can greatly reduce the phenomenon of missed and wrong review by pharmacists， reduce the risk of parenteral nutrition solution dispensing， reduces the work pressure of pharmacists reviewing prescriptions， and ensures the drug safety of patients.关键词：prescription review;parameter assignment method;work efficiency;rational drug use
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发布时间：2023-02-22 - 摘要：Volatile oil microemulsion gel of traditional Chinese medicine has the dual characteristics of microemulsion and gel， which can improve the solubility and stability of drugs， promote drug absorption and achieve long-term sustained release effect. In recent years， it has been widely used in clinical diseases such as internal medicine， gynecology and pediatrics. In this paper， the characteristics， prescription design， molding process and quality evaluation of volatile oil microemulsion gel of traditional Chinese medicine were reviewed by searching relevant literature. The results showed that the volatile oil microemulsion gel had the characteristics of improving the stability of the drug， increasing the transdermal penetration of the drug， strong adhesion， easy to wash， convenient preparation， etc. The prescription design consists of oil phase， surfactant， cosurfactant and gel matrix. The molding process includes the molding process of microemulsion and the molding process of gel， and the formation of microemulsion mainly uses the pseudo-ternary phase diagram method. The quality evaluation can be divided into 2 parts： volatile oil of traditional Chinese medicine and microemulsion gel. The quality evaluation of volatile oil can be studied qualitatively and quantitatively. Microemulsion gel should meet the relevant requirements and be tested for in vitro release and transdermal absorption.关键词：microemulsion gel;formulation design;molding process;quality evaluation
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发布时间：2023-02-22
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