最新刊期
卷 34 ， 期 10 ， 2023
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Framework design of WHO and typical national essential medicine lists and its implications for China
摘要：OBJECTIVETo sort out the common presentation forms and components of the framework of domestic and foreign essential medicine lists （EMLs）， in order to provide reference for optimizing the framework of the Chinese EML.METHODSThe latest edition of the EMLs of WHO， China， South Africa， India， Malaysia and other typical countries were compared， and the similarities and differences of the presentation form and constituent elements of the list framework were analyzed. RESULTS & CONCLUSIONSThe common presentation forms of WHO and typical countries’ EMLs included version， classifications and symbols， of which management ideas， functions， and implementation difficulties varied； common framework elements included target population， hospital levels， drug use conditions， core and supplementary lists and procurement priority. Through comparison， it was found that the information covered by the Chinese EML was relatively thin， and the framework design had not yet fully played the ideal role in guiding clinical rational drug use and optimizing the allocation of health resources， and there was still some room for improvement. It is recommended that China clarify the characteristics and roles of different presentation forms of the EML， and reasonably set the EML framework based on national conditions and development needs； the multi-dimensional drug information should be supplemented， such as clinical use， economy， and policy attributes of drugs in the EML， to ensure the rational use of essential drugs； it is also necessary to add “the level of hospitals” in the framework of the EML， refine the management requirements for the allocation and use of essential medicine， and optimize the resource allocation of hospitals.关键词：essential medicine list;structure;rational use of drug;health resource allocation;international experience- 56
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发布时间：2023-05-25 - 摘要：OBJECTIVETo provide reference for the subsequent landing of national medical insurance negotiated drugs （referred to as “national negotiated drugs”） at the provincial level.METHODSBy reviewing the data publicly released by the official websites of National Healthcare Security Administration and the Healthcare Security Administration of Zhejiang Province， combined with policy documents， the descriptive analysis was conducted on the number of tertiary medical institutions， the actual allocation of national negotiated drugs， the availability rate of national negotiated drugs， the allocation rate of national negotiated drug varieties， and the allocation rate of medical institutions of various cities in Zhejiang province. The Spearman rank correlation test was used to analyze the correlation between the number of types of national negotiated drugs equipped in tertiary medical institutions in Zhejiang province and the per capita disposable income， the number of tertiary medical institutions equipped with national negotiated drugs， and the implementation time of disease diagnosis-related grouping （DRG） of various cities in Zhejiang province.RESULTSAs of the first quarter of 2022， 135 tertiary medical institutions in Zhejiang province were equipped with a total of 261 types of national negotiated drugs， accounting for 94.91% of the 2021 edition of the National Negotiated Drugs Catalogue （275 types）. The allocation rates of Goserelin acetate sustained-release implant， Sacubitril valsartan sodium tablets， Alteplase for injection and other varieties were at high level， and the types of national negotiated drugs equipped were highly coincident with the top 10 causes of death with disease of urban and rural residents in Zhejiang province. The tertiary medical institutions in Hangzhou had the most types of national negotiated drugs， with 230 types， while Quzhou had the lowest， with only 34 types； allocation rate of national negotiated drugs in medical institutions of Zhoushan was the highest （100%）， while that of Lishui was the lowest （57.14%）. The types of national negotiated drugs equipped were positively correlated with per capita disposable income in various cities and the number of tertiary medical institutions equipped with national negotiated drugs （P＜0.01）， and there was no significant correlation with the length of implementation of DRG （P＞0.05）.CONCLUSIONSThe landing of national negotiated drugs in Zhejiang province is generally good， with a high rate of equipping tertiary medical institutions with national negotiated drugs and a high rate of equipping drug varieties. Therefore， it is recommended that the provincial implementation of national negotiated drugs should be multi-faceted， and policy-making departments should adopt a dual-channel of “unbundling” and “driving” to smooth the drug chain into hospitals. The health insurance sector should improve the “dual channel” management mechanism to share the pressure on hospitals to use drugs. At the same time， it should also improve the multi-level medical security system and raise the level of reimbursement of medical insurance for national negotiated drugs.关键词：landing practice;dual-channel;Zhejiang;DRG
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发布时间：2023-05-25 - 摘要：OBJECTIVETo explore standardized evaluation process for clinical comprehensive evaluation of blood lipid-regulating drugs and perform rapid assessment of clinical comprehensive evaluation of blood lipid-regulating drugs with different mechanisms so as to provide reference for the drug catalogue selection and rational drug use of medical institutions.METHODSReferring to guidelines and consensus such as the guideline for the management of comprehensive clinical evaluation of drugs， the methods such as literature research， expert interviews， and Delphi expert consultation were used to establish a multi-dimensional and multi-criteria clinical comprehensive evaluation index system and quantitative scoring table for blood lipid-regulating drugs around the two main lines of technical evaluation and policy evaluation. Then 13 blood lipid-regulating drugs with different mechanisms in 21 third-grade class-A medical institutions from five provinces and regions of Northwest China were scored from both technical and policy dimensions to form a comprehensive evaluation result.RESULTSThe clinical comprehensive evaluation index system and corresponding rapid evaluation quantitative scoring table were constructed for blood lipid-regulating drugs in the five northwest provinces and regions. The technical evaluation section included 6 primary indicators， 13 secondary indicators， and 34 tertiary indicators， totaling 110 points. The policy evaluation section included 4 primary indicators and 6 secondary indicators， with a total score of 40 points （30 points for some drugs） and a total score of 150 points （or 140 points）. The scoring results showed that the highest score was atorvastatin， followed by rosuvastatin and simvastatin.CONCLUSIONSStatins are still the cornerstone of drug therapy for patients with dyslipidemia； the rapid evaluation quantitative scoring table constructed in this study is comprehensive， systematic and operable. The evaluation process in this study can provide empirical references for other groups to exploring the standardized path and quality control mechanism of clinical comprehensive evaluation of drugs.关键词：evaluation mechanism;quality control;index system;rapid evaluation;blood lipid-regulating drugs
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发布时间：2023-05-25 - 摘要：OBJECTIVETo explore the construction of a new scientific management model for temporary drug purchase，and to provide a reference for hospitals to improve the level of rational drug use.METHODSGuided by clinical diagnosis and treatment needs and patient medication safety， our hospital carried out the whole process management practice of temporarily purchased drugs by optimizing the review process， creating a review team， formulating pre-audit and post follow-up evaluation standards based on comprehensive drug evaluation， and evaluated the practice effect through the number of temporary purchase applications， implementation rate， drug structure optimization and other indicators.RESULTSSince January 2021， our hospital had implemented a new mode of temporary drug purchase management. By December 2022， clinical pharmacists had reviewed 111 temporary drug procurement applications， effectively intercepted 13 irrational drug use applications （11.71%）， reduced the overall implementation rate of temporary drug procurement by 8.36%，and proposed five batches of drug structure optimization suggestions； 24 drugs were successively introduced such as camrelizumab，sorafenib，busulfan. After optimizing the management mode，the number of temporary drug procurement applications decreased by more than half from 133 in 2019 and 138 in 2020 to 66 in 2021 and 45 in 2022.CONCLUSIONSThe model is helpful to optimize the hospital drug catalog， strengthen rational drug use，ensure the safety of patients’ drug use， and fully reflects the professional value of clinical pharmacists in hospital pharmacy management and rational drug use.关键词：comprehensive evaluation of drugs;catalog optimization;rational drug use;clinical pharmacist
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发布时间：2023-05-25 - 摘要：OBJECTIVETo investigate whether matrine exerts improvement effect on experimental autoimmune encephalomyelitis （EAE） mice by regulating ferroptosis pathway.METHODSTotally 30 female C57BL/6 mice were randomly assigned into normal group， model group and matrine group， with 10 mice in each group. Model group and matrine group were given antigen emulsion containing inactivated Mycobacterium tuberculosis and MOG35-55 to induce EAE model. Matrine group was injected with Matrine injection （50 mg/kg） intraperitoneally since the 7th day after immunization； normal group and model group were given constant volume of normal saline intraperitoneally， once a day， since 18th day after immunization. The neurofunctional score of mice was recorded， and hematoxylin and eosin staining and Luxol fast blue staining were used to observe inflammatory cell infiltration and demyelination in spinal cord tissue. The quantitative reverse transcription PCR and Western blot assay were performed to determine the mRNA expressions of transferrin receptor 1 （TFR1）， nuclear receptor coactivator 4 （NCOA4） and hephaestin （Heph）， and the protein expressions of system Xc－ （xCT） and glutathione peroxidase 4 （GPx4）.RESULTSCompared with normal group， accumulative neurofunctional score was significantly increased in model group （P＜0.01）； inflammatory cell infiltration and demyelination were obvious in spinal cord tissue， and related scores were increased significantly （P＜0.01）. The mRNA expressions of TFR1 and NCOA4 in myelin tissue were up-regulated significantly， while the mRNA expression of Heph and the protein expressions of xCT and GPx4 were down-regulated significantly （P＜0.05 or P＜0.01）. Compared with model group， above indexes of matrine group were all improved significantly （P＜0.05 or P＜0.01）.CONCLUSIONSMatrine can improve EAE mice， the mechanism of which may be associated with regulating iron metabolism pathway and xCT/GPx4 pathway in ferroptosis.关键词：experimental autoimmune encephalomyelitis;iron metabolism;xCT/GPx4 pathway;mice
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发布时间：2023-05-25 - 摘要：OBJECTIVETo investigate the improvement effect and mechanism of different extracts from Tylophora yunnanensis on non-alcoholic steatohepatitis （NASH）.METHODSNormal human liver LO2 cells were induced to steatosis by free fatty acid， then were divided into normal group， model group， silybin group （100 μmol/mL）， T. yunnanensis ethanol extracts （TYS） group （50 μg/mL）， T. yunnanensis ethyl acetate extracts （TYSA） group （50 μg/mL）， and T. yunnanensis n-butanol extracts （TYSB） group （50 μg/mL）. After 24 hours of drug intervention， the deposition of lipid droplets was observed in LO2 cells in each group. The contents of total cholesterol （TC）， triacylglycerol （TG）， malondialdehyde （MDA） and glutathione （GSH）， the activities of aspartate transaminase （AST）， alanine transaminase （ALT） and superoxide dismutase （SOD）， the mRNA expressions of Kelch-like ECH-associated protein 1 （Keap1）， nuclear factor E2-related factor 2 （Nrf2） and heme oxygenase 1 （HO-1） were detected. NASH rat model was induced by a high-fat diet， and then divided into normal group， model group， silybin group （12.6 mg/kg）， TYS group （80 mg/kg）， TYSA group （80 mg/kg） and TYSB group （80 mg/kg）， with six rats in each group. The liver indexes of rats in each group were calculated after 6 weeks of drug intervention. The liver histopathological changes were observed， and the contents of TC， TG， HDL-C and LDL-C， AST and ALT activities in serum， the contents of MDA and GSH， SOD activities in liver tissue were detected.RESULTSCompared with model group， TYS， TYSA and TYSB could reduce lipid droplet deposition， intracellular TC， TG and MDA contents， AST and ALT activities， and increase SOD activity， GSH content， and Keap1， Nrf2， HO-1 mRNA expression levels in LO2 cells after steatosis to varying degrees， with some differences being statistically significant （P＜0.05）. They also significantly improved liver injury in NASH model rats， reduced their liver indexes， TC， TG， LDL-C and MDA contents， AST and ALT activities， and increased HDL-C （except for TYS and TYSB）， GSH contents and SOD activity， with TYSA having the most significant effect （P＜0.05）.CONCLUSIONSTYS， TYSA and TYSB have a certain improvement effect on NASH， among which TYSA has the most obvious effect. Its mechanism of action may be related to upregulating the Keap1/Nrf2/HO-1 signaling pathway and inhibiting oxidative stress关键词：non-alcoholic steatohepatitis;free fatty acids;normal liver cells LO2;liver function;antioxidant activity;rat
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发布时间：2023-05-25 - 摘要：OBJECTIVETo study the inhibitory effects and possible mechanism of naringenin on the activation of hepatic stellate cells.METHODSUsing human hepatocytes LO2 as reference， based on drug intervention concentration screened by MTT assay， the effects of naringenin （Western blot assay and trypan blue staining test in 10， 20， 40 μmol/L， immunofluorescence assay in 40 μmol/L） on the expressions of liver fibrosis markers protein （collagen Ⅰ， α-SMA） and mRNA （α1-pro collagen Ⅰ， α-SMA） in human hepatic stellate cells LX2， and the expressions of cell apoptosis and apoptosis-related proteins （Bcl-2， Bax， cleaved caspase-3） were investigated. The apoptosis agents （Z-VAD-FMK， FMK）， ferroptosis pathway inhibitor ferrostatin-1， and programmed death pathway inhibitor necrostatin-1 were used to verify the mechanism of the above effects.RESULTSThe naringenin could significantly down-regulate protein expressions of collagen Ⅰ （except for naringenin 10 μmol/L） and α-SMA， mRNA expressions of α1-pro collagen Ⅰ （except for naringenin 10 μmol/L） and α-SMA （P＜0.05）； it also induced LX2 cell apoptosis and increased its apoptotic ratio， down-regulated the protein expression of Bcl-2 while up-regulated the protein expressions of Bax （except for naringenin 10 μmol/L） and cleaved caspase-3 （except for naringenin 10 μmol/L）. FMK could reverse above effects of naringenin on LX2 cells （P＜0.05）.CONCLUSIONSNaringenin can inhibit the activation of hepatic stellate cells LX2 through activating the cell apoptosis signal， which plays ameliorative role in liver fibrosis.关键词：hepatic stellate cells;liver fibrosis;cell apoptosis signal
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发布时间：2023-05-25 - 摘要：OBJECTIVETo investigate the effects of astilbin （AST） on myocardial ischemia-reperfusion injury （MIRI） in rats and its potential mechanism.METHODSSD male rats were randomly divided into sham operation group， model group， positive control group （Compound Salvia miltiorrhiza tablets， 240 mg/kg）， AST low-dose and high-dose groups （30， 90 mg/kg）， and high-dose of AST+hypoxia-inducible factor-1α（HIF-1α） inhibitor group （AST 90 mg/kg+2ME2 15 mg/kg）， with 25 rats in each group. Except for sham operation group， MIRI model was induced in other groups， and then given relevant drug or normal saline intragastrically or intraperitoneally， for consecutive 28 d. Serum contents of cardiac troponin I （cTnI） and creatine kinase isoenzyme （CK-MB） were detected； volume ratio of myocardial infarction was measured； the pathological changes of myocardium， the apoptotic rate of myocardial cells and ultrastructure of mitochondria in myocardial tissue were all observed. The contents of tumor necrosis factor α （TNF-α）， interleukin 6 （IL-6） and malondialdehyde （MDA）， the activity of superoxide dismutase （SOD）， the expressions of HIF-1α， adenovirus E1B interacting protein 3 （BNIP3） and myosin-like Bcl-2 interacting protein （Beclin1） were determined in myocardium. The ratio of microtubule-associated protein light chain 3 （LC3） Ⅱ to Ⅰ （LC3Ⅱ/Ⅰ） in rat myocardium was calculated.RESULTSCompared with model group， no obvious swelling was found in the myocardial tissue of rats in positive control group， AST low-dose and high-dose groups， and the myocardial fibers were arranged regularly； the volume ratio of myocardial infarction， the contents of cTnI， CK-MB， TNF-α， IL-6 and MDA， the apoptotic rate were decreased significantly （P＜0.05）， while SOD activity， protein expressions of HIF-1α， BNIP3 and Beclin1， LC3Ⅱ/Ⅰ were increased significantly （P＜0.05）. HIF-1α inhibitor could significantly weaken the improvement effect of AST on the above indicators in MIRI model rats （P＜0.05）.CONCLUSIONSAST enhances mitochondrial autophagy by activating HIF-1α/BNIP3 signaling pathway， thereby reducing MIRI in rats.关键词：myocardial ischemia-reperfusion injury;hypoxia-inducible factor-1α;B-cell lymphoma-2/adenovirus E1B interacting protein 3;autophagy
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发布时间：2023-05-25 - 摘要：OBJECTIVETo establish the method for content determination of related substances in Oxcarbazepine tablets.METHODSUltra-high performance liquid chromatography （UPLC） method was adopted and the separation was performed on ZORBAX Eclipse Plus C18 column with mobile phase consisted of acetonitrile-0.01 mol/L ammonium acetate solution （pH6.0） （gradient elution） at the flow rate of 0.5 mL/min. The detection wavelength was 230 nm and column temperature was set at 35 ℃. The sample size was 10 μL.RESULTSThe linear ranges of oxcarbazepine and impurity A， B， C， D， E， I， K， L and N were 0.192-1.440， 1.019-7.639， 0.208-1.559， 0.230-1.727， 0.389-2.915， 0.182-1.364， 0.393-2.945， 0.199-1.493， 0.199-1.490 and 0.200-1.503 μg/mL， respectively （all r＞0.999）. The detection limits were 0.046， 0.037， 0.049， 0.027， 0.077， 0.040， 0.114， 0.054， 0.055 and 0.039 μg/mL. The quantitation limits were 0.152， 0.122， 0.162， 0.090， 0.258， 0.132， 0.380， 0.181， 0.185 and 0.130 μg/mL. RSDs of precision， repeatability， stability （24 h） and durability tests were all lower than 5.0%. The average recoveries were 92.8%-105.6% （RSD≤3.0%， n＝9）. Only impurity K and unknown impurity were detected in the original preparation sample， with a total content of 0.078% to 0.083%； impurities A， B， D， I and unknown impurity were detected in the generic preparations produced by domestic enterprise Ⅰ， with a total content of 0.147% to 0.163%； impurities A， B， I and unknown impurity were detected in the generic preparations produced by domestic enterprise Ⅱ， with a total content of 0.085% to 0.161%.CONCLUSIONSThe established method is rapid， sensitive， accurate， stable and durable. It can be used for the content determination of 9 known impurities in Oxcarbazepine tablets.关键词：UPLC;related substance;content determination
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发布时间：2023-05-25 - 摘要：OBJECTIVETo study protective effect and potential mechanism of Modified yupingfeng nasal spray （YPF+） on nasal mucosal injury in allergic rhinitis （AR） model rats.METHODSAR model was induced by ovalbumin （OVA） and randomly divided into model group， YPF+group （50 µg/side，twice a day）， positive control group （Mometasone furoate aqueous nasal spray， 50 µg/side，once a day）； the blank group was set up， with 10 rats in each group. Administration groups were given relevant medicine， and blank group and model group were given equivalent normal saline for consecutive 4 weeks. Thirty minutes after last medication， the behavioral scores of rats were recorded， and the pathological changes of their nasal mucosa tissue were observed. The level of reactive oxygen species （ROS） in nasal mucosa tissue was detected. The protein and mRNA expressions of nucleotide-binding oligomerization domain-like receptor protein 3 （NLRP3），caspase-1，gasdermin D （GSDMD） were detected； the contents of interleukin-1β （IL-1β） and IL-18 in serum were also determined.RESULTSCompared with blank group， in model group， the nasal mucosa tissue structure was disordered， inflammatory cells infiltrated seriously， and lamina propria vascular dilation was visible； its behavioral score and pathological score， the level of ROS， protein and mRNA expressions of NLRP3， caspase-1 and GSDMD， serum contents of IL-1β and IL-18 in nasal mucosa tissue were increased significantly （P＜0.05）. Compared with model group， the symptoms of nasal mucosal injury in rats of each drug group were improved to varying degrees， and the above indicators were significantly reduced （P＜0.05）.CONCLUSIONSYPF+ may improve nasal mucosal injury of rats， relieve AR symptoms such as sneezing， itchy nose， runny nose， the mechanism of which may be associated with reducing the production of ROS in nasal mucosa and downregulating NLRP3/caspase-1/GSDMD pathway.关键词：allergic rhinitis;NLRP3/caspase-1/GSDMD pathway;reactive oxygen species
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发布时间：2023-05-25 - 摘要：OBJECTIVETo investigate the effects of Angelica sinensis polysaccharide on the apoptosis of cardiomyocytes in diabetic KK-Ay mice.METHODSKK-Ay mice were randomly divided into model group， metformin group （200 mg/kg） and A. sinensis polysaccharide high-dose， medium-dose and low-dose groups （400， 200 and 100 mg/kg）； C57BL/6J mice were included in blank group， with 8 mice in each group. Each group was given relevant medicine intragastrically or normal saline， once a day， for consecutive 4 weeks. After the final administration， the levels of fasting glucose， total cholesterol （TC）， low-density lipoprotein cholesterol （LDL-C） and insulin （INS） were detected； the protein expressions of B-cell lymphoma 2 （Bcl-2）， cleaved-caspase-3， apoptosis signal-regulated kinase 1 （ASK1）， phosphorylated c-Jun N-terminal kinase （p-JNK）， phosphorylated inositol-requiring enzyme 1α （p-IRE1α） in myocardium， and apoptosis in cardiomyocytes were also detected.RESULTSCompared with model group， the fasting glucose， TC and LDL-C content， apoptotic rate of cardiomyocyte， protein expressions of p-JNK and p-IRE1α， ASK1， cleaved-caspase-3 were significantly lower in the metformin group and A. sinensis polysaccharide medium-dose， high-dose groups； INS level and relative expression of Bcl-2 protein were significantly increased （P＜0.05 or P＜0.01）.CONCLUSIONSA. sinensis polysaccharide can improve the levels of blood glucose and blood lipid and inhibit cardiomyocyte apoptosis in diabetic KK-Ay mice， and the mechanism may be related to the inhibition of IRE1/ASK1/JNK signaling pathway.关键词：diabetic cardiomyopathy;KK-Ay mice;apoptosis;IRE1/ASK1/JNK signaling pathway
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发布时间：2023-05-25 - 摘要：OBJECTIVETo explore the regulatory effects of baicalin on the proliferation and migration of human periodontal ligament stem cells （hPDLSCs） induced by lipopolysaccharide （LPS） and Janus protein tyrosine kinase 2 （JAK2）/signal transduction and transcription activator 3 （STAT3） signaling pathways.METHODShPDLSCs were divided into control group， LPS group， different concentration baicalin groups （0.1， 1 and 10 mg/L）. ELISA method and CCK-8 assay were used to determine the contents of cell inflammatory factors [interleukin 6 （IL-6）， IL-1β and tumor necrosis factor-α （TNF-α）] and cell viability， so as to screen the optimal concentration of baicalin for follow-up pathway validation experiments. The cells were then divided into control group， LPS group， optimal baicalin concentration group and inhibitor group （10 μg/mL LPS+1 mg/L baicalin +3 μmol/L JAK2/STAT3 pathway inhibitor AG490）. After treated for 24 h， the proliferation rate of hPDLSCs， apoptosis rate， migration rate， invasion cell number， mRNA and protein expressions of Cyclin D1 and caspase-3， the expression of JAK2/STAT3 pathway-related proteins were all detected.RESULTSAccording to cell inflammatory factors and cell viability， 1 mg/L was selected as the optimal concentration of baicalin. Compared with control group， cell proliferation rate， migration rate， invasion cell number， Cyclin D1 mRNA and protein expression were significantly decreased in LPS group， while cell apoptosis rate， caspase-3 mRNA and protein expression， p-JAK2 and p-STAT3 protein expression were significantly increased （P＜0.05）. After treated with 1 mg/L baicalin， the above indexes were reversed significantly （P＜0.05）. The improvement of above indexes in the inhibitor group was more obvious （P＜0.05）.CONCLUSIONSBaicalin can promote the proliferation， migration and invasion of LPS-induced hPDLSCs and inhibit their apoptosis and inflammation by blocking the JAK2/STAT3 pathway.关键词：baicalin;periodontal ligament stem cells;Janus protein tyrosine kinase 2/signal transduction and transcription activator 3 signaling pathway;proliferation;migration
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发布时间：2023-05-25 - 摘要：OBJECTIVETo establish the fingerprint of Qiguiling mixture and the method for the content determination of 4 kinds of active components such as calycosin-7-glucoside， so as to control the quality of Qiguiling mixture.METHODSThe fingerprints of 12 batches of Qiguiling mixture were established by HPLC. SPSS 25.0 software was used for cluster analysis and principal component analysis， and SIMCA 14.1 software was used for orthogonal partial least squares-discriminant analysis. The variable importance in projection （VIP） value greater than 1.0 was used as the index to screen the differential components. The contents of calycosin-7-glucoside， glycyrrhizin and glycyrrhizic acid were calculated by the quantitative analysis of multi-components by single marker （QAMS） with hesperidin as the internal reference， and the results were compared with external standard method.RESULTSIn the fingerprints of 12 batches of samples， 17 common peaks were identified， and the similarities were more than 0.940. A total of 4 common peaks were identified， which were calycosin-7-glucoside （peak 6）， glycyrrhizin （peak 8）， hesperidin （peak 12）， and glycyrrhizic acid （peak 17）. The 12 batches of samples could be clustered into two categories， S4， S7-S9 and S11-S12 were clustered into one category， and the other batches of samples were clustered into one category. The cumulative variance contribution rate of the six principal components was 85.840%， and VIP values of peaks 15， 14， 4， 8 （glycyrrhizin） and 9 were all greater than 1.0. The relative error between the results of QAMS and external standard method was less than 5% （n＝3） for the contents of calycosin-7-glucoside， glycyrrhizin and glycyrrhizic acid.CONCLUSIONSEstablished HPLC fingerprint and content determination method in this study can be used for quality control of Qigiling mixture. Five components such as glycyrrhizin are the differential components.关键词：fingerprint;HPLC;quantitative analysis of multi-components by single marker;content determination;quality control
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发布时间：2023-05-25 - 摘要：OBJECTIVETo compare the efficacy and safety of icotinib and gefitinib in the treatment of epidermal growth factor receptor （EGFR）-mutated advanced non-small cell lung cancer （NSCLC）.METHODSThe data of 146 patients with EGFR-mutant advanced NSCLC of our Hospital from December 2015 to September 2021 were retrospectively analyzed and divided into the gefitinib group （73 cases） and the icotinib group （73 cases） according to the drug use. Patients in the gefitinib group were given 0.25 g of gefitinib tablets once a day orally by single drug or combined with conventional chemotherapy， while patients in the icotinib group were given 125 mg of icotinib hydrochloride tablets three times a day orally by single drug or combined with conventional chemotherapy. Short-term efficacy， progression-free survival （PFS） were observed； Cox regression model was used to analyze the factors affecting the prognosis of patients； the occurrence of ADR were observed in the two groups.RESULTSThere was no statistically significant difference in the objective remission rate， disease control rate， and the incidence of grade 1-2 and grade 3-4 adverse drug reactions between the two groups （P＞0.05）； median PFS was significantly better in the icotinib group than in the gefitinib group （P＝0.048）. Results of subgroup analysis based on patients basic information showed that compared with the gefitinib group， PFS of female [HR＝0.57，95%CI（0.34，0.96），P＝0.031] and non-brain metastatic patients [HR＝0.58，95%CI（0.36，0.91），P＝0.017] in icotinib group were prolonged significantly. Results of regression model analysis showed that EGFR19 exon Del mutation [HR＝0.50， 95%CI（0.25，1.00）， P＝0.049]， EGFR21 exon L858R mutation [HR＝0.44， 95%CI（0.21，0.89）， P＝0.022] and icotinib treatment [HR＝0.65， 95%CI （0.44，0.96）， P＝0.030] were influential factors for prognosis.CONCLUSIONSThe short-term efficacy and safety of icotinib and gefitinib in the treatment of EGFR-mutant advanced NSCLC are comparable， but icotinib can significantly prolong the patients’ PFS； EGFR19 exon Del， EGFR21 exon L858R mutations and icotinib treatment are factors affecting patients’ prognosis.关键词：icotinib;EGFR mutation;advanced non-small cell lung cancer;efficacy;safety
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发布时间：2023-05-25 - 摘要：OBJECTIVETo analyze the clinical manifestations and characteristics of adverse drug reactions （ADR） caused by cefotaxime sodium in Shandong province， and to explore the effects of skin test before medication of cefotaxime sodium on serious ADR， so as to provide reference for safe drug use in clinic.METHODSThe relevant data of cefotaxime sodium-induced ADR reported by Shandong Province ADR Monitoring Center during December 2019 to December 2021 were collected from National ADR Monitoring System. The ADR classification， age， gender， ADR occurrence time， route of administration， history of allergy， primary diseases， ADR systems/organs involved， clinical manifestations， outcome， skin test or not before medication were statistically analyzed.RESULTSA total of 1 057 ADR reports caused by cefotaxime sodium were included. Among them， there were 867 patients （82.02%） with general ADR and 190 patients （17.98%） with serious ADR. The majority were ＜11 years old （40.30%）. The main route of administration was intravenous drip （96.69%）. A total of 1 033 patients （97.73%） developed ADR 30 min to 24 h after medication. A total of 814 patients （77.01%） had no history of allergy. The primary diseases were respiratory system infection （56.58%）. Main systems/organs involved in ADR were skin and its appendants， digestive system and respiratory system， and its clinical manifestations were rash， pruritus， nausea， vomiting， chest tightness， etc. After withdrawal or symptomatic treatment， 1 050 patients （99.34%） were cured or improved. Before the use of cefotaxime sodium， 850 patients underwent skin test （151 patients occurred serious ADR）； there was no statistical significance in the incidence of serious ADR， compared with the incidence of serious ADR in 207 patients without skin test （39 patients occurred serious ADR） （P＝0.718）.CONCLUSIONSADR caused by cefotaxime sodium is mainly seen in patients ＜11 years old， mostly occurring 30 min to 24 h after intravenous drip； skin test before medication of cefotaxime sodium cannot reduce the risk of serious ADR. Before using cefotaxime sodium in clinical practice， patients should be asked about their allergy and medication history in detail. During use， it is important to focus on the patient’s condition within 24 h after medication to prevent serious ADR and ensure the safety of clinical medication.关键词：adverse drug reactions;safety of drug use;Shandong province;skin test
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发布时间：2023-05-25 - 摘要：OBJECTIVETo explore the effects of posaconazole combined with proton pump inhibitors （PPI） on the blood concentration and the risk of invasive fungal disease （IFD） in patients with malignant hematological disorder.METHODSIn accordance with the random number table method， 40 patients with malignant hematological disorders who were admitted to the hematology department of our hospital between December 2020 and December 2021 were chosen and divided into control group （20 cases） and observation group （20 cases）. The control group received Posaconazole oral suspension alone， while the observation group received Posaconazole oral suspension combined with PPI. The incidence of IFD， attainment rate of blood concentration， the time from the start of prophylaxis to IFD onset， the fatality associated with IFD， treatment of infected patients， and blood concentrations of posaconazole on 7th， 14th， 21st， and 28th day after posaconazole application were compared between 2 groups； the occurrence of adverse events during drug administration in the two groups was recorded.RESULTSThe study was stopped because 2 patients in the observation group and 9 patients in the control group received hospital departures after taking posaconazole for fewer than 7 days. The incidence of IFD in the observation group was significantly higher than control group， and the attainment rate of blood concentration in the observation group was significantly lower than control group （P＜0.05）. There was no significant difference in the time from the start of prophylaxis to IFD onset， the fatality associated with IFD， treatment of infected patients and the incidence of adverse events （P＞0.05）. The blood concentration of posaconazole in the observation group was significantly lower than control group on 7th day of medication （P＜0.05）； there was no significant in blood concentration of posaconazole between 2 groups on the 14th day of medication （P＞0.05）.CONCLUSIONSPosaconazole combined with PPI can reduce the blood concentration of patients with malignant hematological disorders， increase the risk of IFD. Clinical practice should try to avoid the combination of the two or use them under the guidance of therapeutic drug monitoring.关键词：proton pump inhibitors;blood concentration;invasive fungal disease;rational drug use
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发布时间：2023-05-25 - 摘要：OBJECTIVETo evaluate the clinical efficacy and safety of XELOX chemotherapy （oxaliplatin+capecitabine） combined with antiangiogenic agent （apatinib） and immunotherapy （camrelizumab） in patients with inoperable metastatic colorectal cancer （CRC）of microsatellite stable （MSS） type.METHODSClinical medical records of 40 patients with inoperable metastatic CRC of MSS type treated in Lishui People’s Hospital from January 2020 to January 2021 were retrospectively collected. According to the treatment plan， the patients were divided into control group （20 cases） and observation group （20 cases）. Control group was given XELOX+apatinib regimen， while observation group was given XELOX+apatinib+camrelizumab regimen. Every 3 weeks was a treatment cycle， and the treatment lasted for 2 consecutive cycles. The objective response rate （ORR）， disease control rate （DCR）， progression-free survival （PFS）， overall survival （OS） and adverse events （AEs） were recorded for all patients.RESULTSThe ORR and DCR of observation group were 65.0% and 85.0%， respectively； and the ORR and DCR of control group were 35.0% and 75.0%， respectively， with no statistical significance between 2 groups （P＞0.05）. The median PFS of observation group and control groups were 16.0 months and 8.0 months， respectively； and the median OS were 19.0 months and 12.5 months， respectively， with statistical significance between 2 groups （P＜0.05）. Each patient in both groups had at least one AEs， and the incidences of reactive skin capillary hyperplasia and hyperthyroidism in observation group （40.0%， 20.0%） were significantly higher than those in control group （both were 0） （P＜0.05）. The incidence of nausea and vomiting in control group （90%） was significantly higher than observation group （10%） （P＜0.05）. There were 14 cases （70.0%） of patients with grade 3 or above AEs in observation group， and only 5 cases （25.0%） in control group， with statistical significance between 2 groups （P＜0.05）. However， no severe AEs that could not be tolerated or fatal occurred in the two groups， which could be alleviated after drug withdrawal or treatment.CONCLUSIONSThe efficacy of XELOX chemotherapy combined with apatinib and camrelizumab in inoperable metastatic CRC patients of MSS type is comparable to that of XELOX chemotherapy combined with apatinib， but it has certain advantages in ORR， PFS and OS， and controllable safety.关键词：microsatellite stable type;meta-static colorectal cancer;chemotherapy;immunotherapy;antiangiogenic agent
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发布时间：2023-05-25 - 摘要：OBJECTIVETo evaluate the effectiveness， safety and economics of Aidi injection combined with first-line chemotherapy for non-small cell lung cancer （NSCLC）， and to provide evidence-based reference for clinical drug use and decision.METHODSRetrieved from PubMed， Embase， the Cochrane Library， CNKI， Wanfang databases， VIP and Health Technology Assessment （HTA） related websites， HTA reports， systematic evaluation/meta-analysis and economic evaluations about Aidi injection combined with first-line chemotherapy for NSCLC were collected from the inception to Aug. 2022. After data extraction and quality evaluation， descriptive analysis was performed for the results of included studies.RESULTSA total of 16 pieces of literature were included， involving 1 piece of systematic review， 13 pieces of meta-analysis， 2 pieces of pharmacoeconomic studies. Compared with first-line chemotherapy， Aidi injection combined with first-line chemotherapy could improve response rate and disease control rate， prolonged survival time， improved survival quality， reduced the incidence of nausea and vomiting， leukocytopenia and thrombocytopenia， and improved immune function， but had controversial effects on liver and kidney function. With the payment threshold set by 3 times the national per capita GDP in 2019， Aidi injection combined with first-line chemotherapy had a more economical probability.CONCLUSIONSAidi injection combined with first-line chemotherapy for NSCLC has good efficacy and safety， and has certain economic benefits. However， given the limited pharmacoeconomic studies included， the economic conclusions obtained need to be carefully interpreted.关键词：chemotherapy;non-small cell lung cancer;rapid health technology assessment;pharmacoeconomic
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发布时间：2023-05-25 - 摘要：OBJECTIVETo systematically evaluate the efficacy and safety of prophylactic use of low-dose hydrocortisone （HC） for the prevention and treatment of bronchopulmonary dysplasia （BPD）， and to provide evidence-based reference for clinical treatment.METHODSPubMed， Embase， Web of Science， Cochrane Library， CJFD， VIP and Wanfang databases were searched by computer； randomized controlled trials （RCT） about prophylactic use of low-dose HC （trial group） versus placebo or dopamine （control group） in very premature infants were collected from the establishment of the database to Jun. 2022. The quality of the included literature was evaluated by using bias risk assessment tool recommended by Cochrane system evaluator’s manual （version 6.2） after screening the literature and extracting the data. Meta-analysis， sensitivity analysis and publication bias analysis were carried out with RevMan 5.3 statistical software.RESULTSA total of 1 437 very premature infants were included in 9 RCTs. Meta-analysis showed that the incidence of BPD [OR＝0.75， 95%CI（0.58，0.95）， P＝0.02] and fatality [OR＝0.72， 95%CI （0.54，0.97）， P＝0.03] in trial group were significantly lower than control group； the survival rate without BPD [OR＝1.36， 95%CI （1.06，1.74）， P＝0.02]， the incidences of gastrointestinal perforation [OR＝2.23， 95%CI （1.31，3.78）， P＝0.003] and sepsis [OR＝1.27， 95%CI （1.01，1.60）， P＝0.04] in trial group were all significantly higher than control group. There was no significant difference in the incidence of necrotizing enterocolitis， paraventricular leukomalacia， intraventricular hemorrhage， patent ductus arteriosus， hyperglycemia， pneumothorax， retinopathy of premature infants between the two groups （P＞0.05）. Results of sensitivity analysis showed that study results were robust. Results of publication bias analysis showed that there was little possibility of publication bias in this study.CONCLUSIONSThe early prophylactic use of low-dose HC can reduce BPD in very premature infants， reduce fatality， and improve the survival rate without BPD， but we should pay attention to gastrointestinal perforation and sepsis.关键词：hydrocortisone;bronchopulmonary dysplasia;efficacy;safety;meta-analysis
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发布时间：2023-05-25 - 摘要：OBJECTIVETo explore and establish a long-term mechanism for rational control of intravenous fluids in hospitals.METHODSOn the basis of the establishment of rules and regulations， through the exploration and implementation of the core technical strategy of “six-step method”， a new mode of intravenous infusion control was established. The contents of the “six-step method” were as follows： the first step was to sort out the diseases that did not require intravenous infusion； the second step was to sort out the alternative drugs/dosage forms； the third step was to sort out the alternative routes of infusion； the fourth step was to develop drug specifications； the fifth step was to explore the personalized medication needs of clinical departments； the sixth step was to develop a department-specific integrated infusion regimen. The utilization rate of intravenous fluids in inpatients and the average daily amount of intravenous fluids per bed in inpatients were used as the main indicators to evaluate the control effect.RESULTSThe comparison of the average values of three months before and after the implementation of the “six-step” management mode in the department of thoracic surgery of our hospital showed that after management and control， the average utilization rate of intravenous fluids in inpatients decreased by 1.74%， the average daily use of intravenous fluids in inpatients per bed decreased by 0.30 bags/bottle， and the per capita use of infusion drugs under key control gradually decreased.CONCLUSIONSThe “six-step” management mode can reduce the utilization rate of intravenous fluids in inpatients， and this management mode is practical and feasible.关键词：infusion management;medication specifications
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发布时间：2023-05-25 - 摘要：OBJECTIVETo provide reference for the diagnosis and treatment of Stevens-Johnson syndrome caused by rebamipide， and to explore the predisposing factors of Stevens-Johnson syndrome.METHODSClinical pharmacists analyzed the treatment process of a patient with gastrointestinal diseases and evaluated the correlation between the drug used and adverse reactions， in order to determine the suspected allergenic drug causing Stevens-Johnson syndrome. The predisposing factors of patients with Stevens-Johnson syndrome were explored. RESULTS & CONCLUSIONSThe suspected allergenic drugs that caused the patient to develop Stevens-Johnson syndrome included Ilaprazole enteric-coated tablets， Rebamipide tablets and Kangfuxin liquid. In summary， the suspect drug was identified as Rebamipide tablets according to the causality evaluation method of the National Center for Adverse Drug Reaction Monitoring， Naranjo’s scoring method and the algorithm of drug causality for epidermal necrolysis scoring criteria. Hypoproteinemia， competitive binding of plasma proteins between drugs， advanced age， bacterial and viral infections were the predisposing factors of Stevens-Johnson syndrome. Therefore， before using rebamipide in clinical practice， it is necessary to inquire about the patient’s allergy history in detail. During the use process， it is necessary to strengthen the patient’s medication monitoring and be alert to the occurrence of serious adverse reactions. If any abnormalities are found， the medication should be stopped immediately and symptomatic treatment should be given as soon as possible to ensure the safety and effectiveness of the patient’s medication.关键词：Stevens-Johnson syndrome;adverse drug reaction
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发布时间：2023-05-25 - 摘要：OBJECTIVETo provide reference for the construction of intelligent pharmacy and quality control of each link in medical institutions.METHODSThe problems， difficulties， and risk points in the links of prescription extraction， allocation， drug resource utilization， prescription and child information verification in pediatric outpatient and emergency pharmacy of our hospital were sorted out to put forward the solutions. The pediatric outpatient and emergency intelligent pharmacy service system of our hospital was established， and its effectiveness was analyzed. RESULTS & CONCLUSIONSIn response to the risk points of drug accumulation， dispensing errors， being prone to complaints or disputes， safety hazards in dispensing， and pharmacist’s incorrect operation in various stages such as payment， taking medicine and dispensing， pediatric outpatient and emergency intelligent pharmacy service system was established in our hospital by adding intelligent queuing links， enabling “QR codes”， introducing devices such as rapid dispensing machines， intelligent drug racks， and intelligent dismantling machines. After using the system， the average outpatient dispensing speed increased from 37.55 s/piece to 16.97 s/piece （direct delivery prescriptions） and 27.10 s/piece （non-direct delivery prescriptions）， and the average emergency dispensing speed increased from 26.98 s/piece to 19.61 s/piece （P＜0.01）. The walking distance for pharmacists to dispense prescriptions had decreased from 4-16 m/piece to 2-5 m/piece， and the inventory rate had shortened from 2.0-2.2 h/time to 1.5-1.7 h/time. The rate of dispensing error decreased from 0.003% to 0 （P＜0.01）. At the same time， the improvement of pharmaceutical service quality has been demonstrated in terms of shortening the waiting time of family members of child， precise drug supplement and helping family members understand medication information. The application of the system can further promote pediatric outpatient and emergency pharmacy services in our hospital.关键词：outpatient and emergency pharmacy;intelligent pharmacy service system;establishment;application effectiveness
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发布时间：2023-05-25 - 摘要：Exosome is a kind of vesicle secreted by a variety of cells with lipid bilayer membrane structure， which has good biocompatibility， high targeting and high stability， and is a natural nanoscale drug carrier with great development potential in drug delivery system. In this paper， exosomes and their properties， exosome drug delivery pathways and methods， the design strategy of engineered exosome drug delivery systems for targeted disease therapy， and the application of exosome drug delivery systems in the treatment of a variety of diseases were reviewed. Exosome drug delivery pathways could be divided into two categories： exogenous and endogenous. Common exosome drug delivery methods included electroporation， co-incubation， and ultrasound. Engineered exosome drug delivery system can further improve drug loading and enhance drug targeting. The main way of engineering is to modify exosome surface through genetic engineering technology， physical modification， chemical modification， etc. Exosome drug delivery system provides a new idea for targeted therapy of arthritis， tumor， brain and other diseases.关键词：drug loading system;surface modification;targeted therapy
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发布时间：2023-05-25 - 摘要：Gliomas are commonly central nervous system tumors. The conventional treatment is surgical resection combined with chemoradiotherapy， but glioma patients often have a poor prognosis. Therefore， there is an urgent need to identify new potential targets in gliomas and develop more effective treatments. Valproic acid has the properties of histone deacetylase inhibitor， which has been proven to have inhibitory effects on various tumors. It is confirmed that valproic acid could promote apoptosis and cell arrest of glioma cells， inhibit cell invasion and glioma stem cells， increase the sensitivity of glioma cells to radiotherapy and chemotherapy by regulating ERK/Akt signaling pathway， Akt/mTOR signaling pathway， and regulating expression levels of RECK， MGMT， Nrf2， PON2， Smad4， GSK3β and other proteins. In addition， valproic acid can also enhance the effectiveness of anticancer drugs by inhibiting the growth of glioma stem cells and inducing their differentiation. In conclusion， valproic acid can inhibit glioma through multiple targeted actions， and may become a new targeted drug for the treatment of glioma.关键词：glioma;cell apoptosis;histone deacetylase inhibitor
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发布时间：2023-05-25
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