最新刊期
卷 32 ， 期 24 ， 2021
- 摘要：OBJECTIVE：To provid e reference for the optimization and improvement of centralized volume-based procurement policy of drugs in China. METHODS ：Six provinces ，i.e. Hebei ，Jiangsu，Hainan，Henan，Jiangxi and Yunnan ，were randomly selected nationwide by random sampling to summarize and analyze the information of drug network withdrawal from Jan. 1st，2018 to Nov. 30th，2020. RESULTS & CONCLUSIONS ：Jiangsu province had the largest number of withdrawn products from the network，being 6 331；Yunnan province had the smallest ，being 101. Product price was the leading factor for drug network withdrawal，accounting for 89.12％；the second factor was product quality ，accounting for 7.06％；the third factor was the product supply，accounting for 2.91％. At present ，there were many problems in drug network withdrawal in China ，such as inconsistent withdrawal regulations in different regions ，unclear subjects of withdrawal behavior ，difficulty in sharing information of purchasing platforms in different regions ，unreasonable bidding rules of online drugs ，etc. Some suggestions are put forward to promote standardization of drug network withdrawal ，promote information sharing among provincial platforms ，actively develop drug price monitoring，support enterprises to make reasonable pricing based on cost ，strengthen departmental linkage and guarantee of drug supply so as to improve centralized volume-based procurement policy of drugs.关键词：Drug;Drug network withdrawal;Centralized volume-based procurement policy;Supply guarantee
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To p rovide reference for improving the level of technological innovation and promoting the high-quality development of pharmaceutical industry in Fujian province. METHODS ：A total of 452 people were interviewed by relevant departments of pharmaceutical industry ，industry associations ，pharmaceutical enterprises and some consumers in Fujian province. After sorting out the interview data ，based on the theory of causal loop diagram and problem basic model methods ，the key variables and problem basic models affecting the technological innovation system of pharmaceutical industry in Fujian province were investigated . The leverage solutions and suggestions were put forward. RESULTS & CONCLUSIONS：The scientific and technological innovation environment ，managers’innovative ideas ，scientific and technological innovation motivation ，enterprise profits，product’s market competitiveness ，social organizations of pharmaceutical industry ，and industrialization of scientific and technological innovation achievements in the technological innovation system of pharmaceutical industry in Fujian province were closely related to the technological improvement of pharmaceutical industry in Fujian province. There were basic modes of “the rich getting richer ”for the technological innovation system of pharmaceutical industry in Fujian province ，i.e. the investment of external resources on scientific and technological innovation of pharmaceutical enterprises was mostly concentrated in the pharmaceutical enterprises above designated size. At the same time ，due to the lack of industry-research-university interaction and the unsmooth achievement transformation channel ，some small and medium-sized pharmaceutical enterprises with the potential of scientific and technological innovation or with traditional advantages may form the problem basic model “to attend to trifles and neglect the essentials”. It is suggested that the subjects related to pharmaceutical industry should give full play to the role of various scientific and technological platforms ，strengthen the attention and support to innovative small and medium-sized pharmaceutical enterprises ， create and optimize the financial service environment for scientific and technological innovation of pharmaceutical enterprises ，and support pharmaceutical enterprises with innovation power and potential to carry out technological innovation projects.关键词：Pharmaceutical industry;Technological innovation;Causal loop diagram;Problem basic model analysis;Fujian
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To learn from the experience of foreign listed chimeric antigen receptor T lymphocyte （CAR-T） products in signing risk sharing agreements in medical insurance access ，so as to provide references for relevant decisions of medical insurance departments in China. METHODS ：Taking 9 risk sharing agreements of CAR-T products marketed in the United Kingdom，France，Italy and Germany as samples ，the international experience of medical insurance payment of CAR-T products were analyzed from six dimensions ，such as agreement types ，monitoring indicators ，data collection metho ds，agreement periods ， payment conditions and payment methods. Some suggestions were put forward for the medical insurance access of these products in China. RESULTS & CONCLUSIONS ：Four sample countries generally signed risk sharing agreements of medical insurance access （financial agreement and performance-based agreement ）with pharmaceutical enterprises ；the indicators such as progressive disease and progression-free survival were collected by using data collection system or clinical research data ，so as to monitor the efficacy and safety of CAR-T products. The agreement periods and payment conditions were determined according to different agreement types；“medical insurance advance payment ”or“pharmaceutical enterprise advance payment ”combined with “staged payments ” were adopted for risk control. Solving the risk of medical insurance funds caused by “efficacy uncertainty ”is the core issue of CAR-T product access. The induction of risk sharing agreements may be the way to solve this problem ，and the scientific design of the various elements of risk sharing agreements is a prerequisite to ensure that the agreement is operational.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To ex plore the effects of solamargine on the growth and apoptosis of human hepatocarcinoma cells HepG2 and its underlying mechanism. METHODS ：The effects of 0（blank group ）-12 μmol/L solamargine treatment of 24，48 h on survival rate of HepG 2 cells were investigated. The effects of 0（blank group ），6 μmol/L solamargine treatment of 10 days on cell clone formation were also investigated. The effects of 0（blank group ），4，6，8 μmol/L solamargine for 24 h on the apoptotic rate of cells，mRNA expression of Bcl- 2，Bax and caspase- 3， protein expression of Bcl- 2 and cleaved caspase- 3 as well as ratio of p-AMPKα to AMPKα were all tested. The effects of AMPK inhibitor as compound C on the protein expression of AMPKα and Bcl- 2 in cells were investigated after treated with 6 μmol/L solamargine for 24 h. RESULTS ：Compared with 020-39318678。E-mail：wujingjing6028@gzucm.edu.cn blank group ，1-12 μ mol/L solamargine for 24，48 h could significantly decrease the survival rates of cells （P＜0.05）in a concentration-dependent manner ；IC50 of them were 8.310 and 7.996 μmol/L，respectively；the rate of cell clone formation was decreased significantly after treated with 6 μmol/L solamargine for 10 days（P＜0.05）. The apoptotic rate of HepG 2 cells，mRNA expression of Bax and caspase- 3，protein expression of cleaved caspase-3（except for 8 μmol/L）as well as ratio of p-AMPKα to AMPKα（except for 8 μmol/L）were all increased significantly after treated with 6，8 μmol/L solamargine（P＜0.05）；mRNA and protein expression of Bcl- 2 were decreased significantly （P＜ 0.05）；the changes of some indexes were in a concentration-dependent manner. The compound C could inhibit protein expression of AMPKα，and reverse the inhibitory effect of solamargine on Bcl- 2 protein. CONCLUSIONS ：Solamargine can inhibit the proliferation of HepG 2 cells and induce apoptosis ，the mechanism of which may be associated with activating AMPK signaling pathway.关键词：Solamargine;Human hepatocarcinoma cells HepG 2;Growth;Apoptosis;AMPK signaling pathway
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish a method for the simultaneous determination of eight constituents ，such as scopolin ， scopoletin，chlorogenic acid ，cryptochlorogenic acid ，neochlorogenic acid ，isochlorogenic acid A ，isochlorogenic acid B ，and isochlorogenic acid C ，in different medicinal parts （stems，twigs and leaves ）of Porana racemosa ，and to compare the contents of eight constituents . METHODS ：HPLC method was adopted. The determination was performed on Agilent TC-C 18 column with mobile phase consisted of acetonitrile- 0.1％ phosphate acid （gradient elution ） at the flow rate of 1.0 mL/min. The column temperature was 30 ℃，and the detection wavelength was set at 345 nm. The sample size was 10 μL. The contents of above constituents in stems ，twigs and leaves of P. racemosa were compared ，and the principal component analysis was carried out by Markerlynx XS software. RESULTS ：The linear range of scopolin ，scopoletin，chlorogenic acid ，cryptochlorogenic acid ， neochlorogenic acid ，isochlorogenic acid A ，isochlorogenic acid B ，and isochlorogenic acid C were 0.076 4- 7.64，0.062 8-6.28， 0.090 8-9.08，0.080 0-8.00，0.057 6-5.76，0.094 4-9.44，0.086 0-8.60，0.078 8-7.88 mg/L，respectively（all r＞0.999）. RSDs of precision，stability（24 h）and reproducibility tests were all lower than 2.0％. The average recoveries were 99.71％（RSD＝1.36％， n＝6），100.39％（RSD＝1.76％，n＝6），99.20％（RSD＝1.75％，n＝6），100.04％（RSD＝2.63％，n＝6），98.57％（RSD＝1.99％， n＝6），99.68％（RSD＝1.84％，n＝6），99.90％（RSD＝1.88％，n＝6），99.76％（RSD＝1.47％，n＝6），respectively. The average contents of above eight constituents were 9.725 3，1.286 5，7.271 3，1.347 6，0.997 7，0.710 9，0.656 3，0.364 7 mg/g in stems ； those were 0.690 3，0.411 7，4.394 3，0.639 6，0.531 3，1.392 7，0.989 1，1.129 2 mg/g in twigs ；those were 1.195 1，0.691 1， 27.952 9，6.173 4，1.405 1，0.549 7，0.288 8，0.794 2 mg/g in leaves ，respectively. The results of principal component analysis showed that different parts of P. racemosa could be divided into 3 categories. Among them ，most of the stems ofP. racemosa gathered in the first quadrant of score plot ，all the twigs gathered in the third quadrant ， and all the leaves 分m gathered in the fourth quadrant. CONCLUSIONS ：Established method is simple and reproducible ，and can be used for the determination of 8 constituents in different medicinal parts of P. racemosa. The average contents of neochlorogenic acid ，chlorogenic acid and cryptochlorogenic acid in the leaves of P. racemosa are relatively high ；the contents of isochlorogenic acid B ，isochlorogenic acid A and isochlorogenic acid C in the twigs are relatively high；the average contents of scopolin and scopoletin in the stems are also relatively high.关键词：Porana racemosa;Stems;Twigs;Leaves;Content determination;HPLC
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the repa ir effect and mechanism of Taohong siwu decoction on rotator cuff injury in rabbits. METHODS：New Zealand rabbits were randomly divided into blank control group ，model group ，Taohong siwu decoction low-dose，medium-dose and high-dose groups （2.75，5.5，11 g/kg），and Taohong siwu decoction+LY 294002 group [ 5.5 g/kg Taohong siwu decoction+ 6.4 μg/kg LY294002（pathway inhibitor ）]，with 11 rabbits in each group. Except for blank control group ， other groups underwent right subscapularis muscle detachment to establish rotator cuff injury model. After modeling ，blank control group and model group were given normal saline intragastrically ；Taohong siwu decoction groups were given relevant medicine intragastrically；Taohong siwu decoction+LY 294002 group was given Taohong siwu decoction intragastrically ，and then injected with LY 294002 at the ear edge ，once a day ，for 12 weeks. After last intragastric administration （injection），the pathological changes of tendon-bone interface was observed ；the levels of TNF-α，IL-10 and IL- 6 in serum were detected ；mRNA and protein expressions of PI 3K，Akt and mTOR in tendon-bone interface were detected ；the expression of autophagy related protein （Beclin1， LC3Ⅱ）were detected. RESULTS ：Compared with blank control group ，the tendon-bone interface was uneven and the intima was swollen in model group. Serum levels of TNF-α and IL-6，mRNA and protein expressions of PI 3K，Akt and mTOR in tendon-bone interface were increased significantly （P＜0.05 or P＜0.01），while the level of IL- 10 and protein expression of Beclin 1 and LC 3Ⅱ were decreased significantly （P＜0.01）. Compared with model group ，the tendon-bone interface of rabbits in Taohong siwu decoction low-dose and medium-dose groups still had certain intimal damage ，while the tendon-bone interface of rabbits in high-dose group was smooth and flat without an obvious intimal tear ；the levels of most indexes in serum and tendon-bone interface of rabbits were significantly reversed in each dose group （P＜0.05 or P＜0.01）. Swollen tendon-bone interface and obvious intimal tear were obse rved in Taohong siwu decoction + LY group；compared with model group ，there w as no significant difference in above indexes of serum and tendon-bone interface （P＞0.05）. CONCLUSIONS ：Taohong siwu decoction may repair the rotator cuff injury of rabbits ，the mechanism of which may be associated with inhibiting PI3K/Akt/mTOR signaling pathway，activating autophagy and inhibiting inflammatory response.关键词：Taohong siwu decoction;Rotator cuff injury;PI3K/Akt/mTOR signaling pathway;Autophagy;Rabbit
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To prepare chelerythrine nanoparticles（CHE-NPs），optimize their formulation ，and evaluate its drug release behavior in vitro and its inhibitory effect on melanoma. METHODS ：Using methoxy polyethylene glycol-poly （lactic-co- glycolic acid ）（mPEG-PLGA）as carrier ，CHE-NPs were prepared by the nano-precipitation method. HPLC method and dialysis bag method were used to determine entrapment efficiency and drug loading. The formulation of CHE-NPs was optimized by Box-Behnken response surface design using overall desirability （OD）of them as dependent variables ，CHE dosage ，mPEG-PLGA concentration and poloxamer 188（F68）concentration as independent variables. The particle size and Zeta potential of CHE-NPs prepared by the optimal formulation were detected ；the characteristics of drug release in vitro were investigated ；the effects of CHE and CHE-NPs on survival rate of mice B 16 melanoma cells were compared ，and median inhibition concentrations （IC50）of them were calculated. RESULTS ：The optimal formulation included CHE of 2 mg，mPEG-PLGA of 13 mg/mL，F68 of 1.8％. Average entrapment efficiency rate of CHE-NPs prepared by the optimal formulation was （80.18±1.11）％，average drug loading was （11.36±0.28）％，average OD value was 0.96±0.04 [the relative deviation from predicted value （0.90）of OD was 6.67％]； particle size was （113.1±1.40）nm，and Zeta potential was （－21.6±0.29）mV；polydispersity index was 0.07±0.01（n＝3）； accumulative release rates of CHE control and CHE-NPs were 90.87％ and 68.68％ within 8 h，and drug release behavior in vitro of the latter was in accordance with Weibull kinetic model. Inhibitory effect of CHE-NPs on B 16 melanoma cells was significantly stronger than that of CHE ；the 24 h IC 50 of CHE-NPs and CHEwere 69.35 and 107.36 μg/mL，respectively. CONCLUSIONS ：The prepared CHE-NPs show good sustained-effect and high capacity of drug loading ，and strengthen the inhibitory effect of CHE on melanoma.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To investigate the potential mechanism of Salvia miltiorrhiza in the treatment of postoperative abdominal adhesion （PAA）. METHODS ：Active components and target genes of S. miltiorrhiza were retrieved from TCMSP database，SwissADME database ，Perl database ，UniProt database and other databases. GeneCards ，OMIM and PubMed database were used to retrieve target genes related to PAA. Venn diagram was drawn by using mapping tool of bioinformatic online database so as to screen the intersecting targets of active component-PAA. STRING platform was adopted to establish target network related to active component-PAA and protein-protein interaction （PPI）network of intersecting targets ，etc.，and to screen hub genes. Gene ontology（GO）and Kyoto Encyclopedia of Genes and Genom es（KEGG）pathway enrichment were carried out by using R 3.6.1 software. Using the protein encoded by hub gene as receptor and tanshinone Ⅱ A as ligand ，the molecular docking was carried out with AutoDock 1.5.6 tool. RESULTS ：A total of 38 active components of S. miltiorrhiza with high gastrointestinal absorption and their corresponding 72 targets，755 PAA-related target genes were identified. Results of Venn diagram showed that there were 33 intersecting targets of active components of chuqi90@163.com S. miltiorrhiza with PAA. Tanshinone ⅡA，dihydrotanshinolac- tone and other components may be important nodes of the target network related to active component-PAA. FOS，APP，ACHE， CASP3 and PTGS2 may be the hub genes in PPI network of intersecting targets. Results of GO enrichment showed that the intersecting targets were mainly concentrated in adrenergic receptor activity ，catecholamine binding ，G protein-coupled amine receptor activity and so on ；KEGG pathway enrichment analysis showed that the intersecting targets were mainly enriched in neuroactive ligand-receptor interaction ，cGMP-PKG signaling pathway ，endocrine resistance ，EGFR-tyrosine kinase inhibitor resistance and calcium signaling pathway.Molecular docking analysis showed that tanshinone ⅡA could form hydrogen bonds with many amino acid residues such as VAL- 580 of proto oncogenes c-Fos ，amyloid precursor protein ，acetylcholinesterase，caspase 3 and prostaglandin G/H synthase 2. CONCLUSIONS ：The active components of S. miltiorrhiza play a role in the treatment of PAA by directly or indirectly acting on neuroactive ligand-receptor interaction ，cGMP-PKG signaling pathway ，endocrine resistance ， EGFR-tyrosine kinase inhibitor resistance resistance and calcium signaling pathway.关键词：Postoperative abdominal adhesion;Salvia miltiorrhiza;Network pharmacology;Molecular docking
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To compare the methods for the con tent determination of polysaccharide and reducing sugar in Polygonatum cyrtonema， and to optimize the wine-steaming technology of P. cyrtonema . METHODS ： The contents of polysaccharide in P. cyrtonema were determined by anthrone-sulfuric acid method and phenol-sulfuric acid method. The contents of reducing sugar in P. cyrtonema were determined by anthrone-sulfuric acid method ， phenol-sulfuric acid method and 3， 5-dinitrosalicylic acid （DNS）method，respectively. Taking appearance and property scores of processed products ，the contents of polysaccharide，reducing sugar and total sugar as indicators ，the amount of alcohol added ，steaming time and moistening time as factors，the wine-steaming technology of P. cyrtonema was optimized by Latin square design. The contents of polysaccharide ， reducing sugar and total sugar were compared before and after steaming. RESULTS ：The linear ranges of polysaccharide and reducing sugar obtained by anthrone-sulfuric acid method were both 0.006 6-0.033 mg/mL（R2＝0.999 9）. RSDs of precision ， stability（90 min）and reproducibility tests were all lower than 3％ and 2％，respectively. Average recoveries were 99.75％（RSD＝ 0.48％，n＝6）and 103.40％（RSD＝1.25％，n＝6），respectively. The linear ranges of polysaccharide and reducing sugar obtained by phenol-sulfuric acid method were both 0.002 5-0.025 mg/mL（R2＝0.999 2）. RSDs of precision ，stability （90 min） and reproducibility tests were all lower than 5％ and 6％，respectively. Average recoveries were 112.80％（RSD＝2.36％，n＝6）and 99.20％（RSD＝3.47％，n＝6）. The linear range of reducing sugar obtained by DNS method was 0.01-0.18 mg/mL（R2＝0.999 9）. RSDs of precision ，stability（90 min）and reproducibility tests were all lower than 2％. Average recoveries was 96.95％（RSD＝ 1.19％，n＝6）. The optimal wine-steaming technology of P. cyrtonema included the amount of alcohol added of 20％，moistening time of 2 h and steaming time of 7 h. RSDs of average contents of polysaccharide ，reducing sugar and total sugar in wine-steamed products were all lower than 3％ in 3 times of validation tests （n＝3）. The average contents of polysaccharide ，reducing sugar and total sugar in 4 batches of P. cyrtonema were 16.3％，11.2％ and 27.4％；those of 4 batches of wine-steamed products were 3.4％， 61.0％ and 64.4％，respectively. CONCLUSIONS ：The anthrone- ） sulfuric acid method is the best for the determination of poly- saccharide in P. cyrtonema ；DNS method is the best for the pandongmei1228@126.com determination of reducing sugar in P. cyrtonema. The content ofpolysaccharide in wine-steamed products is decreased signifi- cantly，while the contents of reducing sugar and total sugar are increased significantly.关键词：Polygonatum cyrtonema;Polysaccharide;Reducing sugar;Content determination;Optimization of wine-steaming
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To study the effects of sulforaphane on the prolifera tion and apoptosis of human renal tubular epithelial cells HK- 2 induced by high glucose ，and to investigate its mechanism primarily. METHODS ：HK-2 cells were divided into normal group ，high glucose group ，irbesartan group （positive control ，1 μmol/L），sulforaphane low ，medium and high concentration groups （10，20，40 μmol/L）. The cells in normal group were cultured in DMEM medium for 96 hours. T he cells in other groups were cultured in high glucose DMEM medium （containing 40 mmol/L glucose ）for 48 hours. After inducing cell injury，the cells were added with corresponding drugs for 48 hours. Survival rate and apoptotic rate of cells were detected. mRNA expression of cyclin D 1，caspase-3，Bcl-2 and Bax as well as protein expression of p-mTOR ，p-AMPK，p-Akt and p-PI 3K were also determined. In addition ，HK-2 cells were divided into normal group ，high glucose group ，sulforaphane high concentration group（40 μmol/L），acardicin group （AMPK agonist ，1 mmol/L），sulforaphane high concentration+compound C group （sulforaphane 40 μmol/L+AMPK inhibitor compound C 40 μmol/L），perifoxine group （Akt inhibitor ，19.95 μmol/L）、sulforaphane high concentration+SC 79 group（sulforaphane 40 μmol/L+Akt agonist SC79 4 μmol/L）. After cultured with the same method ， protein expression of p-mTOR ，p-AMPK，p-Akt and p-PI 3K were detected in HK- 2 cells. RESULTS ：Compared with normal group，survival rate of HK- 2 cells，mRNA expression of cyclin D 1 and Bcl- 2 as well as protein expression of p-AMPK were decreased significantly in high glucose group （P＜0.05）；apoptotic rate ，mRNA expression of caspase- 3 and Bax ，protein expression of p-mTOR ，p-Akt and p-PI 3K in HK- 2 cells were increased significantly （P＜0.05）. Compared with high glucose group，above indexes of sulforaphane low ，medium and high concentration groups ，irbesartan group were all improved significantly （P＜0.05）；the improvement of above indexes in sulforaphane medium and high concentration groups were significantly better those of sulforaphane low concentration group （P＜0.05）. There was no significant difference in above indexes between sulforaphane high concentration group and irbesartan group （P＞0.05）. Compared with sulforaphane high concentration group，there were no significant difference in the protein expression of p-AMPK ，p-mTOR in acardicin group and p-mTOR ，p-Akt and p-PI 3K in perifoxine group （P＞0.05）；the protein expression of p-AMPK in sulforaphane high concentration+compound C group was decreased significantly （P＜0.05），while the protein expression of p-mTOR was increased significantly （P＜0.05）；the protein expression of p-mTOR 、p-Akt、p-PI3K in sulforaphane high concentration+SC 79 group were increased significantly （P＜ 0.05）. CONCLUSIONS ：Sulforaphane can promote the proliferation of renal tubular epithelial cells and inhibit its apoptosis ；its mechanism may be associated with up-regulating the expression of p-AMPK and down-regulating the expression of p-mTOR ，p-Akt and p-PI 3K.关键词：Sulforaphane;High glucose;Human renal tubular epithelial cells;PI3K/Akt signaling pathway;AMPK/mTOR
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To establish the fingerprint of wine-processed Schisandra chinensis ，and to conduct cluster analysis and principal component analysis. METHODS ：HPLC method was adopted. The determination was performed on Diamonsil C 18（2） column with mobile phased consisted of methanol-water （gradient elution ）at the flow rate of 1 mL/min. The detection wavelength was set at 250 nm，and the column temperature was 30 ℃；the injection volume was 10 μL. With schisandrol A as the reference peak，HPLC fingerprints of 15 batches of samples were drawn and their similarity were evaluated with Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition）. The common peaks were determined. Cluster analysis and principal component analysis were performed by using SPSS 22.0 statistical software. RESULTS ：There were 20 common peaks in 15 batches of samples ，and the similarities were 0.983-0.999；a total of 8 common peaks were identified ，namely 5-hydroxymethyl furfural，schisandrol A ，schisandrol B ，schisantherin A ，schisantherin B ，deoxyschizandrin，γ-schizandrin，pseudo-γ-schizandrin. The results of cluster analysis showed that 15 batches of wine-processed S. chinensis could be clustered into 4 categories. Among them，S1-S4 and S 14 were clustered into one category ，S9-S11 were clustered into one category ，S5，S7-S8，S12-S13 were clustered into one category ，and S 6 and S 15 were clustered into one category. The results of principal component analysis showed that the cumulative variance contribution rate of first four principal component s was 85.381％；the classification results were basically consistent with the results of cluster analysis. Compared with S. chinensis ，5-hydroxymethyl furfural was newly found in S. chinensis after wine-processing ，with high content ；but there was no significant difference in the other chromatographic peaks. CONCLUSIONS：The established HPLC fingerprint is simple and easy to operate ，combined with cluster analysis and principal component analysis ，can be used for quality control of wine-processed S. chinensis decoction pieces.关键词：Wine-processed Schisandra chinensis;HPLC;Fingerprint;Cluster analysis;Principal component analysis
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To evaluate the economy performance of dexamethasone （DXM）combined with rituximab （RTX） for the first-line treatment of chronic primary immune thrombocytopenia （ITP）in adults. METHODS ：From the perspective of China ’s medical and health system ，Markov model for eight states was constructed with a period of 4 weeks and a time limit of 20 years， using DXM regimen as control. The cost-utility of DXM+RTX regimen for the treatment of chronic ITP in adults were evaluated. The parameters of clinical efficacy and utility value were derived from own published literature ；cost parameters were from the MENET website and the official websites of local health committees and medical insurance bureaus ；one-way sensitivity analysis ， probability sensitivity analysis and scenario analysis were performed to observe the uncertainty of model and data source. RESULTS：The average cost of DXM+RTX regimen was 51 064 dollars and that of DXM regimen was 50 455 dollars. Compared with DXM regimen ，DXM+RTX regimen yielded an additional 0.14 QALYs for each patient ；the incremental cost-effectiveness ratio（ICER）was 4 356 dollars/QALY，and was lower than the willingness-to-pay threshold of China ’s per capita gross domestic product（GDP）in 2020. In the one-way sensitivity analysis ，the cost of drugs was the main driver in the model. Probability sensitivity analysis demonstrated that DXM+RTX regimen had 57.5％-61.0％ probability of being cost-effective at a willingness- to-pay threshold of 1-3 times per capita GDP in 2020. The results of scenario analysis showed that DXM+RTX regimen would have obvious long-term benefits ，and the utility value had little impact on the conclusion. CONCLUSIONS ：DXM + RTX is more economical than DXM in the treatment of chronic ITP in adults ，but the results have the uncertainty.关键词：Pharmacoeconomic evaluation;Primary immune throm bocytopenia;Rituximab;Dexamethasone;First-line
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To analyze the clinical manifestations and characteristics of adverse drug reactions （ADR）induced by EGFR-TKI，and to provide reference for safe use of drugs in clinic. METHODS ：The relevant data of EGFR-TKI-induced ADR reports which were reported to Shandong ADR Monitoring Center from January 2018 to December 2020 were summarized ，and analyzed statistically in respects of age ，gender，drug variety ，ADR classification ，usage and dosage ，occurrence time ，involved organs/systems，clinical manifestations and prognosis of patients. RESULTS & CONCLUSIONS ：A total of 120 ADR reports induced by EGFR-TKI were included ，involving 120 patients. Among 120 patients，the female （60.83％）was more than the male （39.17％），and the age was mainly 50-79 years old （79.16％）. A total of 5 drugs including gefitinib ，ositinib，afatinib，ektinib and erlotinib were involved. ADR occurred in 72，11，15，6 and 16 patients using the above drugs respectively ；the main ADR was general ADR （70.83％），followed by severe ADR （22.50％），new general ADR （5.00％）and new severe ADR （1.67％）. All patients were given drugs orally ，off-label use was found in 2 patients who used ektinib ，and the rest met the medication requirements of the drug instructions. ADR occurred in 61 patients（50.83％）within 1 month after medication ，34 patients （28.33％）within 1-3 months after medication ，25 patients（20.83％）within 4-12 months after medication ，and no ADR occurred after 12 months. ADR of organs/systems involved were mainly the lesion of skin and its appendant injury，gastrointestinal system injury and hepatobiliary system injury. The main clinical manifestations were rash ，diarrhea and abnormal liver function ；in addition，some patients developed severe or new severe ADR such as interstitial pneumonia ，bone marrow suppression ，tongue swelling and cerebral infarction. Totally 102 patients recovered or improved after drug withdrawal or symptomatic treatment ，12 patients had unknown outcome ，and 6 patients did not improve. It is suggested that pharmaceutical care should be strengthened within 1 month after EGFR-TKI administration ，so as to guard against the occurrence of new and serve ADR and ensure the safety of clinical medication.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To prov ide referen ce for clinical safe and rational use of belimumab by mining the risk signals of adverse drug event （ADE）. METHODS ：ADE reports related to belimumab were collected from FDA adverse event reporting system（FAERS）from the first quarter of 2015 to the first quarter of 2021. The reporting odds ratio （ROR）method and the Medicines and Healthcare Products Regulatory Agency （MHRA）method were adopted to mine the ADE risk signals related to belimumab，setting the threshold as the number of reports ＞3 and the lower limit of 95％ CI ＞1（ROR method ）and the proportional reporting ratio （PRR）＞2，and χ2 ＞4（MHRA method ）. ADEs were counted and classified by using the preferred system organ class （SOC）and preferred term （PT）of Medical Dictionary for Regulatory Activities （MedDRA）. RESULTS & CONCLUSIONS：A total of 3 529 ADE reports with belimumab as the primary suspicious drug were screened ，in which female patients（90.31％）were much more than male patients （6.15％）；age distribution was concentrated in 18-59 years old （41.80％）. There were 1 234 cases（34.97％）of severe ADE reports ，mainly involving hospital or prolonged hospital stay. Most of the reporters were consumers or other non-medical professionals （81.84％）. North America reported the most （70.39％）and the main reporting country was the United States （2 029 reports）. A total of 180 PTs were mined from 3 529 reports，in addition to PTs associated with primary disease （systemic lupus erythematosus ，pain，arthralgia，pyrexia，weight decreased ，swelling，oropharyngeal pain ， etc.），PTs related to medication error （product dose omission ，inappropriate schedule of product administration ，underdose， product availability issue ，etc.）and PTs related to infection （influenza，urinary tract infection ，infection，sinusitis，etc.）were reported in a large number of cases. Twenty-six SOCs were involved ，the top 10 SOC in ADE reports were all kinds of injuries ， poisoning and surgical complications （2 225 reports），infections and infectious diseases （1 247 reports），general disorders and administration site conditions （1 196 reports），musculoskeletal and connective tissue disorders （1 195 reports），surgical and medical procedures（515 reports），etc. PTs in SOC in the first place （all kinds of injuries ，poisoning and surgical complications ）of ADE reports were all related to medication error ；herpes zoster ，kidney infection and cellulitis in SOC in the second place （infections and infectious diseases ）of ADE reports were not included in the drug instruction of belimumab ；most PTs in SOCs such as various nervous system diseases ，immune system diseases ，mental diseases ，benign，malignant and unknown tumors （including cystic and polypoid）which were taken attention in clinic were not included in the drug instruction of belimumab. It is suggested to avoid medication errors as far as possible in clinical use of belimumab ，and to guard against adverse reactions such as herpes zoster ， kidney infection ，cellulitis and various nervous system diseases ，immune system diseases and mental diseases. In addition ，the patients with malignant tumor or related history should use belizumab carefully.
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To conduct reevaluation of systematic review/Meta-ana lysis on the efficacy and safety of selegiline in the treatment of Parkinson ’s disease （PD）. METHODS ：Retrieved from PubMed ，Embase，Cochrane L ibrary，CNKI，Wanfang database as well as official websites of domestic and foreign health technology assessment institutions ，based on manual retrieval and review of references ，systematic review/Meta-analysis on selegiline alone or combined with other anti-PD drugs （trial group ） versus placebo or blank control or other anti-PD drugs （control group ）were collected. The time limit was from database inception to November 2020. After literature screening and data extraction ，PRISMA statement was adopted to evaluate the quality of the included reports. AMSTAR 2 scale was used to evaluate the methodological quality ，and GRADE method was adopted to evaluate the evidence quality ，the outcome indicators of the included studies were summarised and analyzed. RESULTS ：A total of 12 systematic reviews/Meta-analysis were included ，involving 4 systematic reviews and 8 Meta-analysis；there were 31 outcome indexes in total. PRISMA scores of them ranged from 16.5 to 27.0，including 15.0 to 21.0 for 2 literatures（16.67％）and 22.0 to 27.0 for 10 literatures（83.33％）. Results of AMSTAR 2 scale showed that the methodological qualities of 2 literatures were classed as high quality ，3 as low quality and 7 as very low quality. Results of GRADE evidence quality evaluation showed that 1 evidence quality was high-level ，3 were medium-level ，5 were low-level ，21 were very low-level ，and 1 was no evaluable . The main factors leading to the degradation were bias risk （87.10％），publication bias （77.42％），inaccuracy （51.61％）and incon sistency（41.94％）. In terms of therapeutic efficacy ，compared with control group ，selegiline could improve the total score of UPDRS ，UPDRS Ⅰ score，UPDRS Ⅱ score，UPDRS Ⅲ score and Webster score in patients with Parkinson ’s disease，either monotherapy or in combination with other anti-PD drugs （P＜0.05）. In terms of safety ，there was no significant difference in the incidence of adverse events or mortality between 2 groups（P＞0.05），but the rate of withdrawal due to adverse events was higher（P＜0.05）. CONCLUSIONS ：Selegiline is effective and safe in the treatment of Parkinson ’s disease ，but current methodological quality and evidence quality of included systematic reviews /Meta-analysis are low，which requires further standardization of research methods.关键词：Selegiline;Parkinson’s disease;Reevaluation of systematic review;Efficacy;Safety
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发布时间：2022-06-21 - 摘要：OBJECTIVE：To prov ide a reference for the diagnosis and treatment of invasive fungal infection in children. METHODS：Four male children with invasive fungal infection in critical condition ，aged from 3 months to 17 years，were treated in our hospital. The types of diseases included pneumonia ，endocarditis，meningitis and pulmonary infection. The pathogens involved Trichosporon asahii ，Candida portugal ，Malassezia globosa ，Pichia guilliermondii ，Alternaria alternate and Candida krusei. Clinical pharmacists comprehensively followed up the treatment and reviewed the literature to assist doctors in formulating treatment plans. They provided Fluconazole sodium chloride injection （6 mg/kg，ivgtt，qd），Caspofungin acetate for injection （loading dose 32 mg，maintenance dose 25 mg，ivgtt，qd），Fluconazole capsules （400 mg，p.o.，qd）and Voriconazole for injection（200 mg，i.v.，q12 h）+Capofungin acetate for injection （loading dose 70 mg，maintenance dose 50 mg，i.v.，qd）and other symptomatic treatment ，and closely monitored the changes of relevant indicators and the occurrence of ADR during the treatment of children. RESULTS ：The doctor adopted the clinical pharmacist ’s suggestion ，three cases were relieved and one was not cured. No serious ADR was found. CONCLUSIONS ：Once similar infections are found in clinic ，timely targeted treatment should be given in combination with the types of pathogens and drug resistance characteristics ，so as to effectively control the disease. The real cases provided in this article can provide evidence for the treatment of children with fungal infection.关键词：Invasive fungal in fection;Case analysis;Children;Literature review
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发布时间：2022-06-21 -
Enlightenment of Efficiency Frontier Approach on the Methods of Pharmacoeconomic Evaluation in China
摘要：OBJECTIVE：To p rovide reference for pharmacoecono mic study in China. METHODS ：The key steps in the operation process of efficiency frontier approach （EFA）were analyzed ；the similarities and differences of EFA with cost-utility analysis（CUA）and cost-effectiveness analysis （CEA）were compared on the basis of case demonstration ；the enlightenment of EFA to pharmacoeconomic evaluation and related decision-making in China were puts forward combined with the practice of China. RESULTS & CONCLUSIONS ：The research framework of EFA could be roughly divided into 5 parts：cost calculation ，benefit definition，model establishment ，incremental analysis and sensitivity analysis. Benefit indicators were the measurement indicators of health output in EFA ，including clinical indicators and comprehensive indicators ，among which comprehensive indicators were more widely used. When constructing the efficiency frontier ，the benefit of the intervention measures was generally taken as the ordinate and the cost of the intervention measures as the abscissa. The cost-benefit coordinate points of each alternative intervention measure in a specific disease field constituted the cost-benefit plane frontier. Researchers conducted economic evaluation by judging the relative position between each alternative intervention measure and the efficiency frontier. Thewillingness to pay threshold was numerically equal to the reciprocal of the ray slope outside the efficiency frontier. Generally speaking ，EFA was similar to CUA and CEA. All of them needed to clarify the cost and health output ，model analysis ， data source and uncertainty analysis ；however，EFA was different from CUA and CEA in intervention measures and control selection，expression form of evaluation results ，willingness to pay threshold ，etc. It is suggested that the payers in China can consider using EFA to calculate the willingness to pay threshold of specific disease areas to ensure the accessibility of some drugs in short supply ；establish a health insurance database of specific diseases to standardize the data quality and form a clear evaluation standard at the same time ，or combine a variety of pharmacoeconomic evaluation methods to enrich the application materials so as to ensure both clinical value and economy of the intervention measure.关键词：Efficiency frontier approach;Pharmacoeconomics;Evaluation method;Enlightenment- 62
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发布时间：2022-06-21
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