最新刊期
卷 34 ， 期 2 ， 2023
- 摘要：OBJECTIVETo provide reference for better implementation of the priority review system for generic drugs of encouraged generic drug catalogues.METHODSBased on literature research， practical status of the priority review system for generic drugs in two batches of encouraged generic drug catalogues in China was analyzed， and the problems existing in the application of the system were compared to propose corresponding solutions. RESULTS &CONCLUSIONSChina has issued two batches of encouraged generic drug catalogues， and there were 49 varieties of generic drugs included in the catalogues. In the implementation of the priority review system for generic drugs of encouraged generic drug catalogues， there were some problems in legislation， incentive system for the first generic drug， post-marketing re-evaluation system， and cross-departmental coordination and linkage mechanism. It is suggested to strengthen legislation， improve the “first generic market exclusivity period” system， perfect the post-marketing re-evaluation system and form a normalized cross-departmental coordination mechanism so as to ensure the safety， effectiveness and accessibility of generic drugs in China.关键词：encouraged generic drug catalogues;priority review system;improvement countermeasures
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发布时间：2023-02-22 - 摘要：OBJECTIVETo identify the demand levels and specific connotations of pharmaceutical care in social pharmacy based on Kano theory， and to provide suggestions for the optimization of pharmaceutical care in Chinese social pharmacy.METHODSUsing Kano theory as the analysis framework， the needs of consumer for different levels of pharmaceutical care in social pharmacy were identified through literature combing. The ideas and suggestions were proposed for the optimization of pharmaceutical care in Chinese social pharmacy based on the content and characteristics of different levels of needs. RESULTS &CONCLUSIONSThe demands for pharmaceutical care in Chinese social pharmacy were divided into three levels， among which the basic demand included ensuring the accessibility， safety and effectiveness of drugs； the expectation demand included personalized medication guidance and management， convenient and efficient medication purchasing services triggered by consumer upgrading； the charming demand included health services and management， professional and high-quality service experience. Social pharmacies should take drug security as the core， achieve high quality and good price， and fully meet basic demand； take patient medication management as the grip， conduct double-drive professional services and model innovation to fully respond to expectation demand； take public health as the goal， broaden service content and experience value， and meet the charming demand of consumer at the right time.关键词：pharmaceutical care;service optimization;Kano theory
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the role of phosphatidylinositol-3-kinase （PI3K） on sunitinib-induced myocardial systolic dysfunction.METHODSUsing human-induced pluripotent stem cell-derived cardiomyocytes （hiPSC-CMS） as objects， the contractile force of cardiomyocytes was measured by CardioExcyte 96 system， and IC50 of sunitinib was calculated after hiPSC-CMS were treated with sunitinib at different concentrations [0 （control）， 0.5， 1， 3， 5， 10 μmol/L] for 24 hours. The effects of sunitinib （3.14 μmol/L） on the contractile frequency of cardiomyocytes， calcium transient amplitude and calcium transient recovery time course， mRNA expression of myocardial injury markers atrial natriuretic peptide （ANP）， brain natriuretic peptide （BNP） and β-myosin heavy chain （β-MHC） were detected. PI3K activator 3，4，5-triphosphate phos-phatidylinositol （PIP3， 1 μmol/L） and sunitinib were used to intervene in hiPSC-CMs jointly， so as to investigate the role of PI3K in the myocardial systolic dysfunction induced by sunitinib.RESULTSSunitinib inhibited the contractile force of hiPSC-CMs in a concentration-dependent manner. IC50 of sunitinib was 3.14 μmol/L. After intervention with 3.14 μmol/L sunitinib， the contractile frequency of hiPSC-CMs and calcium transient amplitude were decreased significantly （P＜0.05 or P＜0.01）； the duration of calcium transient recovery was prolonged significantly （P＜0.05）， and mRNA expressions of ANP， BNP and β-MHC were significantly increased （P＜0.01）. After PI3K was activated with PIP3， the contractile force of hiPSC-CMs was increased significantly （P＜0.01）.CONCLUSIONSActivating PI3K activity is a potential molecular mechanism to improve myocardial toxicity induced by sunitinib.关键词：systolic dysfunction;cardiotoxicity;phosphatidylinositol-3-kinase;human induced pluripotent stem cell-derived cardiomyocytes
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the toxic mechanism of Mahuang xixin fuzi decoction （MXF） on normal mice.METHODSTotally 48 SPF grade BABL/C mice were randomly divided into blank group， MXF low-dose， medium-dose and high-dose groups， with 12 mice in each group. MXF low-dose， medium-dose and high-dose groups were given drug intragastrically at the dose of 11.262， 33.786， 45.050 g/kg， respectively. Blank group was administered with equal volume of normal saline， once a day， for consecutive 7 d. The body weight， anal temperature and survival rate were recorded， organ index and serum biochemical factors were detected. After the last administration， fecal samples of mice were collected and detected by UHPLC-QE/MS.RESULTSCompared with blank group， the body weight was decreased significantly from the 3rd to the 5th day after administration in MXF medium-dose group， and from the 2nd to the 7th day after administration in MXF high-dose group significantly （P＜0.05）. There was no significant difference in anal temperature among the treatment groups； the average survival rates of MXF medium-dose and high-dose groups were 58.33% and 50.00%， respectively. Compared with blank group， there were significant difference in the indexes of spleen， lung， thymus， adrenal gland and creatine kinase in MXF low-dose， medium-dose and high-dose groups， the testis index in MXF low-dose and high-dose groups， the creatine kinase isoenzyme/creatine kinase ratio in MXF low-dose group， the α-hydroxybutyrate dehydrogenase， lactate dehydrogenase and alkaline phosphatase in MXF medium-dose group， the urine and cystatin C in MXF medium-dose and high-dose groups （P＜0.05）. The fecal metabonomic analysis showed that 19 biomarkers such as phenylpyruvate， L-tyrosine， phosphatidylcholine， glycerol 3-phosphate in MXF low-dose， medium-dose and high-dose groups were significantly different from those in the blank group.CONCLUSIONSWhen MXF reaches a certain dose， it will have adverse effects on the body weight， multiple organs and serum biochemical indicators of mice， thus showing a certain toxic effect. Its mechanism may be related to disrupting the intestinal flora metabolism， causing inflammatory reaction and immune disorders.关键词：toxic effects;fecal metabolomics
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发布时间：2023-02-22 - 摘要：OBJECTIVETo prepare the nanoporous flower-shaped lactose （FL）-loaded curcumin （Cur） solid lipid nanoparticles （SLN） inhalation powder （Cur-SLN-FL）， and to investigate its inhibition effect on LPS-induced apoptosis of BEAS-2B cells.METHODSUsing different kinds （lactose， sucrose， mannitol， trehalose） and different amounts （2%， 3%， 5%） of freeze-dried protectants as objects， the suspension of Cur-SLN was micronized by freeze-drying technology into lyophilized powder， which was then mixed with FL and sieved by a 200-mesh sieve to obtain Cur-SLN-FL. The physicochemical properties of Cur-SLN-FL was characterized by scanning electron microscopy and laser particle size analyzer. Using BEAS-2B cells cultured in vitro as objects， LPS-induced apoptosis and the changes of mitochondrial membrane potential after treatment of Cur-SLN-FL were detected by Annexin Ⅴ/PI double staining method and JC-1 kit.RESULTSWith 3% trehalose as Cur-SLN freeze-dried protective agent， the freeze-dried powder obtained was compact and full in shape， did not shrink and collapse， and was uniform in color and light-yellow powder， which could be completely dissolved in 30 s. When FL and Cur-SLN freeze-dried powder were mixed at a ratio of 1∶2， it had a higher deposition rate of secondary distribution [（40.92±0.02）%]. SEM results showed that Cur-SLN-FL had a flower-shaped appearance with an average particle size of （4.95±0.57） μm and an aerodynamic particle size of （4.03±0.40） μm. The critical relative humidity of Cur-SLN-FL was about 54%， and the evacuation rate was （90.34 ± 1.21）%； the quantity of fine particles that could be inhaled by Cur-SLN-FL in the 2-7 receiving discs was （47.5±0.7）%， and the measured aerodynamic particle size was （4.33±0.08） μm. The LD50 of Cur-SLN-FL to BEAS-2B cells was 5.809 mg/mL. The apoptosis rate of model cells was significantly reduced after treatment of Cur-SLN-FL， and the mitochondrial membrane potential was significantly increased （P＜0.05）.CONCLUSIONSThe preparation process of Cur-SLN-FL is simple and feasible. Cur-SLN-FL can improve LPS-induced apoptosis of BEAS-2B cells， and this effect is related to the regulation of mitochondrial membrane potential.关键词：flower-shaped lactose;solid lipid nanoparticles;dry powder inhalers;apoptosis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo study the effects of Wubao capsule on airway inflammation in asthmatic model mice by regulating upstream and downstream cytokines of type Ⅱ innate lymphoid cells （ILC2s）.METHODSTotally 40 female BABL/c mice were randomly divided into normal group， model group， positive control group （dexamethasone 1 mg/kg）， Wubao capsule low-dose and high-dose groups （0.5， 1 g/kg）， with 8 mice in each group. Asthma models were induced by ovalbumin （OVA） sensitization and nebulization. Each group was given normal saline or drug intragastrically for 7 consecutive days. The contents of IgE and OVA-IgE in serum， the contents of interleukin 5 （IL-5）， IL-9， IL-13， IL-25， IL-33， thymic stromal lymphopoietin （TSLP） and mucin 5AC （MUC5AC） in bronchoalveolar lavage fluid （BALF） were determined by ELISA. HE staining was used to observe the pathological changes of lung tissues in mice. PAS staining was used to observe the changes of goblet cell proliferation in each group. The number of ILC2s in lung tissue was determined by flow cytometry （except for Wubao capsule low-dose group）.RESULTSCompared with model group， the contents of IgE and OVA-IgE in serum and the contents of IL-5， IL-9， IL-13， IL-25， IL-33， TSLP and MUC5AC in BALF were significantly reduced in Wubao capsule high-dose and low-dose groups （P＜0.01）. The infiltration of inflammatory cells and the thickening of basement membrane in lung tissue was alleviated to varying degrees， and the proliferation of goblet cells was inhibited； the number of ILC2s in lung tissues of mice in Wubao capsule high-dose group was significantly reduced （P＜0.01）.CONCLUSIONSWubao capsule could effectively reduce the number of ILC2s in lung tissue， the contents of upstream and downstream cytokines of ILC2s in BALF of asthmatic model mice， so as to inhibit the airway inflammation and improve asthma.关键词：type Ⅱ innate lymphoid cells;asthma;airway inflammation
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the mechanism of Tingli dazao xiefei decoction on ventricular remodeling in model rats with heart failure after myocardial infarction.METHODSThe rat model of heart failure after myocardial infarction was established by ligation of anterior descending branch of left coronary artery， which was divided into 8 groups： sham operation group， model group， A779 group （1 mg/kg）， A779 （1 mg/kg）+Tingli dazao xiefei decoction equivalent-dose group （0.8 g/kg）， A779 （1 mg/kg）+Tingli dazao xiefei decoction high-dose group （1.6 g/kg）， Tingli dazao xiefei decoction equivalent-dose group （0.8 g/kg）， Tingli dazao xiefei decoction high-dose group （1.6 g/kg） and losartan potassium group （10 mg/kg）. Each group was given equal volume of distilled water or corresponding drugs intragastrically for 4 weeks. Masson staining was used to determine the distribution of collagen fibers in rat myocardium. The content of hydroxyproline （Hyp） in myocardium was determined by alkaline hydrolyzation. The expressions of type Ⅰ and Ⅲ collagen （COLⅠ， COLⅢ）in myocardium were detected by immunohisto-chemistry. Myocardial fibrosis-related indexes such as matrix metalloproteinase-2 （MMP-2）， MMP-9， tissue inhibitor of metalloproteinase-1 （TIMP-1） and soluble suppression of tumorigenicity-2 （sST-2） were detected by ELISA. The protein expressions of angiotensin converting enzyme 2-angiotensin-（1-7）-Mas [ACE2-Ang-（1-7）-Mas] axis were detected by Western blot.RESULTSCompared with sham operation group， myocardial cells in model group and A779 group were disordered， collagen fiber deposition was significantly increased and myocardial fibrosis was obvious； the Hyp content and MMP-2， MMP-9， sST-2 levels were increased， and COL Ⅰ and COL Ⅲ positive expressions were significantly enhanced； TIMP-1 level， protein expressions of ACE2， Ang-（1-7） and Mas were significantly decreased （P＜0.05）. Compared with model group， above indexes of Tingli dazao xiefei decoction equivalent-dose and high-dose groups were improved to different extents. Compared with A779 group， A779+Tingli dazao xiefei decoction equivalent-dose and A779+high-dose groups could improve myocardial arrangement and collagen distribution， reduce the Hyp content and MMP-2， MMP-9 levels， reduce positive expressions of COL Ⅰ and COL Ⅲ （P＜0.05）， but couldn’t improve Ang-（1-7） and Mas protein expression.CONCLUSIONSTingli dazao xiefei decoction can improve ventricular remodeling in myocardial failure model rats after myocardial infarction by improving the expression of ACE2-Ang-（1-7）-Mas axis proteins.关键词：heart failure;ventricular remodeling;ACE2-Ang-（1-7）-Mas axis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo prepare spider fibroin membrane loaded with Periplaneta americana extract， and investigate its characterization， in vitro drug release property and cytotoxicity.METHODSUsing natural spider silk collected from Chilobrachys guangxiensis as raw material， P. americana extract as model drug， the drug-loaded spider fibroin membrane （hereinafter referred to as drug-loaded membrane） was prepared by solvent casting method. The material matrix spider fibroin membrane without P. americana extract （hereinafter referred to as blank membrane） was prepared with same method. The membrane structure was characterized by static water contact angle， Fourier infrared chromatography， X-ray diffraction and scanning electron microscopy from different angles； drug release characteristics in artificial saliva were simulated in vitro to evaluate the drug sustained-release performance. MTT assay was adopted to validate the cytotoxicity of drug-loaded membrane.RESULTSThe drug-loaded membrane was prepared， and the static water contact angle was less than 90°， which was less than that of blank membrane. The drug-loaded membrane showed the characteristic absorption peak to polypeptide of P. americana extract at 1 500-1 700 cm－1. X-ray diffraction and scanning electron microscopy also proved that the drug was successfully loaded into the pellicle. The release time of the pellicle in artificial saliva was more than 200 min. The MTT test results showed that the cell proliferation rates of blank membrane and drug-loaded membrane were 84.6% and 79.4% （both greater than 70%）， respectively， without significant potential cytotoxicity.CONCLUSIONSDrug-loaded membrane prepared with natural spider silk has a certain sustained-release effect in artificial saliva， which can be further developed as a drug sustained-release carrier with excellent biological characteristics and biocompatibility.关键词：oral pellicles;natural spider silk;Chilobrachys guangxiensis;spider fibroin membrane;drug sustained-release;content determination;cytotoxicity
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发布时间：2023-02-22 - 摘要：OBJECTIVETo evaluate the cost-effectiveness of denosumab and teriparatide in the treatment of postmenopausal osteoporosis in Chinese women， and provide reference for relevant decision-making.METHODSFrom the perspective of health system in China， Excel 2003 was used to establish Markov model， and cost-utility analysis was used to evaluate the cost-effectiveness of denosumab or teriparatide combined with Calcium carbonate D3 tablets in the treatment of postmenopausal osteoporosis in Chinese women. Pharmacotherapy effects were obtained with network meta-analysis， and cost and health utility value data were obtained from published literature. The model cycle was 1 year， and the simulation time limit was the patient’s lifetime. Univariate sensitivity analysis and probabilistic sensitivity analysis were used to evaluate the effects of model parameter changes on the robustness of the results. Through scenario analysis， the cost-effectiveness of domestic drug cost used as drug cost of terlipatide group was discussed； the influence of residual effects of teriparatide on the results and the cost-effectiveness of sequential use of desumamab after terlipatide withdrawal were also discussed.RESULTSThe effect of denosumab regimen was better than that of terlipatide regimen [13.24 quality-adjusted life years （QALYs） vs. 12.96 QALYs]， with lower cost （51 224.64 yuan vs. 167 102.67 yuan）， denosumab regimen was the absolutely superior regimen. The results of single factor sensitivity analysis showed that the cost and discount rate of Terlipatide injection had greater impact on the results. The results of probability sensitivity analysis showed that when three times of China’s per capita gross domestic product （GDP） in 2021 was used as the threshold of willingness to pay， the probability of cost-effectiveness of denosumab regimen was 93.5%. The results of scenario analysis showed that， whether the drug cost of terlipatide regimen which was replaced by domestic drugs， or the residual effect of terlipatide was considered， or desulmonab was used sequentially after two years of terlipide treatment， denosumab regimen was always the absolute advantage regimen.CONCLUSIONSDenosumab combined with Calcium carbonate D3 tablets is more cost-effective than teriparatide combined with Calcium carbonate D3 tablets in the treatment of postmenopausal osteoporosis in Chinese women.关键词：teriparatide;Chinese women;postmenopausal osteoporosis;cost-utility analysis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo discuss medical insurance access and pricing methods for multi-indication drugs.METHODSThe access situation of multi-indication drugs in China’s medical insurance negotiation over the years was sorted out. Referring to the economic theory of value-based pricing and the relevant experience of other countries， five applicable pricing methods of 3 categories for multi-indication drug in China were summarized. Taking ceftazidime-avibactam（CAZ-AVI） as an example， cost-utility analyses were performed for different indications， and appropriate pricing methods were applied. RESULTS &CONCLUSIONSAll multi-indication drugs in China adopted a single pricing method. The pricing methods that could be explored include product-based pricing， such as single pricing based on the lower-value indication or mixed/weighted single pricing； indication-based pricing， such as developing a new agreement for single pricing under different discounts and listing with different brands and pricing of the same medicine for different indications； and compensation for access restrictions. Each method has its advantages and limitations. The case of CAZ-AVI showed that it is necessary to estimate the value of each indication for multi-indication drugs， and comprehensively consider appropriate access conditions and pricing methods based on value. Although single pricing is simple to operate， it is different to reflect the value entirely. The indication-based pricing and compensation for access restrictions all depend on the information collection system and the cooperation of multiple departments. China is supposed to carry out the value-based pricing of multi-indication drugs and constantly explore reasonable access methods to improve overall social welfare.关键词：value-based pricing;pricing methods;medical insurance access
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发布时间：2023-02-22 - 摘要：OBJECTIVETo analyze the risk of adverse drug reaction of ustekinumab， so as to provide reference for rational drug use in clinic.METHODSThe adverse events （AE） reports related to ustekinumab included in the FDA public data program（OpenFDA） database were analyzed after marketing （from September 25th 2009 to December 30th 2021）. The risk signals were mined for top 100 AE by the method of reporting odds ratio （ROR） and proportional reporting ratio （PRR）.RESULTSA total of 62 356 AE reports related to ustekinumab were retrieved， male patients （51.79%） were more than female patients （39.51%）. Results of ROR method and PRR method showed that 31 suspicious signals were mined， mainly infections and infectious diseases （9 kinds）， general disorders and administration site conditions （5 kinds）， skin and subcutaneous tissue disorders diseases （4 kinds）， musculoskeletal and connective tissue disorders （4 kinds）， etc. Fourteen suspicious signals were not included in the instructions， such as hepatic enzyme increase， basal cell carcinoma， pericarditis， pemphigus， hair loss， synovitis， glossodynia， etc.CONCLUSIONSDuring clinical dosing of ustekinumab， in addition to ADR mentioned in package inserts， great attention should be paid to the patient’s liver function， skin status， hair loss and cardiovascular-related risks，which is helpful to discover AE early and ensure the safety medication of patients.关键词：OpenFDA;adverse events;data mining
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the appropriate dosing regimen of meropenem in the elderly with renal insufficiency.METHODSThe meropenem population pharmacokinetics of the two-compartment model of elderly patients were applied for Monte Carlo simulation. The model included the effect of renal function on the parameters. The designed dosages were 0.5， 1， 2 g； the administration modes included intravenous injection （lasting for 6 min） and intravenous drip （0.5， 3 h）； the administration frequencies were q12 h， q8 h. A total of 18 dosing regimens were designed. The probability of target attainment of %fT＞4MIC≥40% and Cmin≤27.5 mg/L were calculated respectively to optimize the dosing regimen.RESULTSFor elderly patients with creatinine clearance （CLcr） ≤40 mL/min， when the minimum inhibitory concentration （MIC） was equaled to 1 mg/L， the suggested dosing regimens were “0.5 g， intravenous drip 0.5 h， q12 h” “1 g， intravenous injection， q12 h”. When the MIC was equaled to 2 mg/L， the suggested dosing regimens were “0.5 g， intravenous injection， q8 h” “1 g， intravenous drip 0.5 h， q12 h”. When the MIC was equaled to 4， 8 mg/L， the suggested dosing regimens were “1 g （or 2 g）， intravenous injection， q8 h”. For elderly patients with CLcr equal to 50 mL/min， when the MIC was equaled to 1 mg/L， the suggested dosing regimens were “0.5 g， intravenous injection， q8 h”“1 g， intravenous injection， q12 h”. When the MIC was equal to 2， 4， 8 mg/L，the suggested dosing regimens were“0.5 g （or 1 g， or 2 g）， intravenous drip for 0.5 h， q8 h”. The appropriate dosing regimens of all the above protocols were above 96.6%. In the dosing regimen of “2 g，intravenous injection or intravenous drip 0.5 h， q8 h”， Cmin＞27.5 mg/L occurred in 40 times among the 1 000 times of simulation， indicating adverse reactions of the nervous system may occur.CONCLUSIONSFor the elderly patients with renal insufficiency， the dosing regimen of meropenem should be adjusted accordingly with CLcr＝40 mL/min as the boundary， and the toxicity of nervous system should be considered at the same time.关键词：Monte Carlo simulation;two-compartment;renal insufficiency;elderly patients;neurotoxicity
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the relationship between the ANKK1 rs1800497 polymorphism and atypical antipsychotic drug-induced metabolic syndrome （MS）.METHODSTotally 94 patients with schizophrenia were included， and ANKK1 rs1800497 genotypes of patients were detected by micro-fluorescence immunoassay； social demographic information， clinical characteristics and other data were collected. The χ2 test was used to compare the correlation between the sex of patients and the occurrence of MS， and the correlation between gene polymorphism and the occurrence of MS and its risk factors.RESULTSTotally 94 patients included 24 cases （25.53%） of GG， 51 cases （54.26%） of GA and 19 cases of AA （20.21%）. Among them， there were 45 cases （47.87%） of MS， and the incidence of MS in male was higher than that in female （P＜0.05）. Genotype analysis showed that ANKK1 rs1800497 polymorphism was not associated with MS （P＝0.452）. ANKK1 rs1800497 A allele was significantly associated with hyperglycemia （χ2＝4.379， P＝0.036）， while it was not related to abdominal obesity， hypertension， high level of TG and low level of HDL-C （P＞0.05）， suggesting that for patients with schizophrenia， allele A was a relative risk factor for inducing hyperglycemia [OR＝2.008，95%CI（1.039， 3.881）].CONCLUSIONSANKK1 rs1800497 polymorphism has no correlation with the induction of MS by atypical antipsychotics， while the schizophrenia patients with A allele are more likely to induce hyperglycemia. The incidence of MS in male patients is significantly higher than that in female patients.关键词：metabolic syndrome;gene polymorphism;schizophrenia;atypical antipsychotics
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发布时间：2023-02-22 - 摘要：OBJECTIVETo compare the efficacy， safety and economics of bid-winning and original Moxifloxacin hydrochloride tablets in the treatment of outpatient community-acquired pneumonia （CAP）.METHODSA retrospective cohort study was conducted to screen and include CAP outpatients during the period of January to December 2021 in Lianyungang First People’s Hospital. They were divided into generic drug group （1 058 cases） and bid-winning drug group （1 121 cases） according to the drug source. Two groups were respectively given original and bid-winning Moxifloxacin hydrochloride tablets， 0.4 g each time， once a day. The efficacy indexes （clinical effective rate， remission time， treatment course， revisiting rate） and safety indexes （allergy， nervous system symptoms， etc.） were compared between the two groups； and the influence factors of clinical treatment failure were analyzed with multi-factor modified Poisson regression model. The economic indicators of the two drugs [quantity， consumption sum， defined daily doses （DDDs）， defined daily dose cost （DDDc）， price ratio， replacement rate] were compared.RESULTSThere were no significant differences in the clinical effective rate， treatment course， revisiting rate， the incidence of nervous system symptoms and Q-T interval prolongation between the two groups （P＞0.05）. The remission time of original drug group was significantly shorter than that of bid-winning drug group， and the incidence of total adverse drug reaction， allergy reaction， gastrointestinal symptom reaction and hyperglycemia were significantly lower than those in bid-winning drug group（P＜0.05）. Multivariate Poisson regression analysis showed that bid-winning drug did not increase the risk of clinical treatment failure in CAP outpatients [RR＝1.132， 95%CI （0.883， 1.542）， P＝0.327]. However， antibiotic exposure history， more than 2 items of abnormal clinical manifestations and auxiliary examination all increased the risk of clinical treatment failure （P＜0.05）. Compared with before the implementation of centralized volume-based procurement policy， the quantity and DDDs of Moxifloxacin hydrochloride tablets increased significantly， while the consumption sum decreased significantly， DDDc of bid-winning drug decreased significantly， the price ratio of it to original drug decreased to 0.117， and the replacement rate increased to 69.44% after the implementation of centralized volume-based procurement policy.CONCLUSIONSCompared with original drug， bid-winning Moxifloxacin hydrochloride tablet shows reliable efficacy and obvious price advantage in the treatment of outpatient CAP， but the incidence of adverse drug reactions is higher.关键词：outpatient;moxifloxacin hydrochloride;generic drug;original drug;centralized volume-based procurement
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发布时间：2023-02-22 - 摘要：OBJECTIVETo compare the efficacy and safety of levetiracetam versus valproic acid in the treatment of pediatric epilepsy， and to provide evidence-based reference.METHODSThe databases including CNKI， VIP， China Biomedical Literature Database， Wanfang data， PubMed， Embase and Cochrane Library were searched for the RCTs about levetiracetam （trial group） and valproic acid （control group） were collected from the inception to October 1st， 2021. After literature screening and data extraction， the quality of included literature was evaluated using the bias risk assessment tool recommended by Cochrane system evaluator manual 5.1.0 and RevMan 5.3 software were used for meta-analysis， sensitivity analysis and bias risk analysis.RESULTSA total of 33 RCTs were included， involving 3 116 patients in total. The results of the meta-analysis showed that the effective rate of trial group was significantly higher than control group [RR＝1.06， 95%CI （1.02， 1.11）， P＝0.003]. The subgroup analysis according to different courses of treatment showed that there was no statistical significance in the effective rate between 2 groups after 1 and 3 months of treatment （P＞0.05）； after 6 months of treatment， the effective rate of trial group was significantly higher than that of control group （P＜0.05）. The incidence of adverse drug reaction in trial group was significantly lower than control group [RR＝0.50， 95%CI （0.41， 0.61）， P＜0.000 01]； among specific adverse drug reactions， the incidence of nausea and vomiting in trial group was significantly lower than control group （P＜0.05）； but there was no statistical significance in the incidence of rash， drowsiness， abnormal mood， loss of appetite， dizziness or headache （P＞0.05）. Results of sensitivity analysis showed that study results were stable and reliable. Results of publication bias analysis showed that there was little possibility of publication bias in this study.CONCLUSIONSThe short-term efficacy （1， 3 months） of LEV is similar to that of VPA in the treatment of pediatric epilepsy， but long-term efficacy （6 months） of LEV is better than that of VPA； moreover， LEV shows better safety in digestive system.关键词：levetiracetam;valproic acid;meta-analysis;efficacy;safety
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发布时间：2023-02-22 - 摘要：With the increasing aging of our population， the incidence of drug-related problems among elderly patients in the community is gradually increasing. Drug-related problems can lead to an increased incidence of adverse health outcomes such as falls and frailty in elderly patients in the community. Medication review is one of the effective means of addressing drug-related problems. The medication review models in Europe and the United States have been developed for decades to address drug-related problems； medication review model in the United Kingdom focuses on the management of drug therapy for elderly patients in aged care facilities， while the medication review models in the United States and Australia have a broader scope（covering all elderly patients in the community）， and the frequency of medication reviews in the United States and Australia are clearer and more standardized. Compared with the above countries， China’s medication review model has a late start. Our country can learn from the advanced experience of the United Kingdom， the United States， Australia and other countries， actively explore and build a drug review model suitable for China’s national conditions， so as to improve the health level of elderly patients in the community and save social public medical resources.关键词：elderly;drug-related problems
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发布时间：2023-02-22 - 摘要：OBJECTIVETo provide a method to reduce environmental residues for pharmacy intravenous admixture service （PIVAS）， and ensure the occupational health of medical staff.METHODSThe residues of 15 cytotoxic antineoplastic drugs such as gemcitabine were detected by UPLC-Q-Orbitrap-HRMS. The cleaning process was optimized with the residual quantity as the index. Nitrogen blowing method was used for alcohol volatilization experiment. CCK-8 assay was used to detect the effect of chlorine-containing disinfectant on the toxicity of cytotoxic antitumor drugs.RESULTSThe linear range of 15 cytotoxic antineoplastic drugs such as gemcitabine were 0.5-1 000 ng/mL. RSDs of intra-day and intra-day precision were no higher than 20.00%. Six drugs including gemcitabine， isocyclophosphamide and cyclophosphamide were detected in the PIVAS environment of our hospital， and the residue of cyclophosphamide was relatively high. The optimal cleaning procedure was cleaning once with water + cleaning once with 1 000 mg/L chlorine-containing disinfectant + cleaning once with 75% alcohol， wiping with dry gauze method. The results of alcohol volatilization test showed that there was no significant difference in drug residues between control group and 75% alcohol group （P＞0.05）. The results of CCK-8 test showed that compared with control group， the survival rates of the cells treated with 15 cytotoxic antineoplastic drugs were decreased significantly （P＜0.01）； the survival rates of the cells treated with 15 cytotoxic antineoplastic drugs+chlorine-containing disinfectant were significantly higher than those treated with 15 cytotoxic antineoplastic drugs （P＜0.01）.CONCLUSIONSA method for the simultaneous determination for residues of 15 cytotoxic antineoplastic drugs such as gemcitabine in PIVAS is successfully established； the optimal cleaning procedure can significantly reduce the residues of drugs， the use of chlorine-containing disinfectant can significantly reduce the toxicity of drug， and the residual drugs will not cause secondary contamination of the operating area with alcohol volatilization.关键词：UPLC-Q-Orbitrap-HRMS;cytotoxic antineoplastic drugs;environmental residues detection;environmental residues clean
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发布时间：2023-02-22 - 摘要：OBJECTIVETo provide reference for the management of antithrombotic therapy in thrombocytopenia patients with atrial fibrillation and atherosclerosis.METHODSThe clinical pharmacist participated in the treatment of a thrombocytopenia patient with atrial fibrillation and atherosclerosis， and analyzed the causes of thrombocytopenia according to the patient’s medical history and laboratory examination results. At the same time， the risk of thrombosis-bleeding was evaluated according to the relevant guidelines， and the clinicians were assisted in formulating individual antithrombotic therapy plan and pharmaceutical care plan for the patient. The literature on antithrombotic therapy related to thrombocytopenia was collected and analyzed by retrieving CNKI.RESULTSThrombocytopenia was considered as primary thrombocytopenia in this patient， and the main risk of bleeding was age ≥65 years old， bleeding tendency， and combined use of antithrombotic drugs. After the clinical pharmacist assessed the risk of thrombosis and bleeding， the clinician was recommended to give full dose of Bemiheparin sodium injection + Dronedarone hydrochloride tablets + Metoprolol succinate sustained-release tablets. In view of thrombocytopenia， the clinician gave Compound zaofan pill， Caffeic acid tablet and Sheng xuexiaoban capsule， but the patient developed diarrhea after the medication. The clinical pharmacist suggested stopping Sheng xuexiaoban capsule， and the clinician adopted the clinical pharmacist’s suggestion. When the patient was discharged from hospital， the clinical pharmacist suggested that the antithrombotic therapy plan for discharge was anticoagulation alone or selective anticoagulation. The clinician chose selective anticoagulation treatment considering that the patient’s current thrombocytopenia， urinary occult blood （+） and fecal occult blood were weakly positive， and ordered the patient to take Metoprolol succinate sustained-release tablets + Atorvastatin calcium tablets at discharge. Literature analysis showed that the causes of thrombocytopenia of patients with thromboembolism mainly included heparin induced-thrombocytopenia， immune thrombocytopenia， etc. All patients were improved after symptomatic treatment.CONCLUSIONSBy participating in the management of antithrombotic therapy for the thrombocytopenia patient with atrial fibrillation and atherosclerosis， clinical pharmacists can help effectively control the patient’s condition and ensure the safety and effectiveness of drug use.关键词：atherosclerosis;thrombocytopenia;antithrombotic therapy;pharmaceutical care
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发布时间：2023-02-22 - 摘要：OBJECTIVETo explore the effects of intensive pharmaceutical intervention led by clinical pharmacists on hypertension patients with medium and high risk of ischemic stroke.METHODSThe hypertension outpatients with medium and high risk of ischemic stroke， who were assessed by the modified Framingham stroke scale in Zhengzhou People’s Hospital from Oct. 2019 to Apr. 2020， were randomly divided into control group and intervention group， with 200 cases in each group. Patients in the control group received conventional treatment without pharmaceutical intervention； on the basis of conventional treatment， patients in the intervention group received 12-month intensive pharmaceutical intervention （grading management of compliance+regular follow-up， involving medication education and guidance， blood glucose， blood pressure， blood lipid management and healthy life guidance） provided by clinical pharmacists. The blood glucose indexes， blood lipid indexes， blood pressure compliance rate， medication compliance， 10-year stroke risk and stroke incidence were compared between two groups at baseline and 12 months after enrollment.RESULTSAfter 12 months of enrollment， the level of low-density lipoprotein cholesterol （LDL-C） in intervention group was significantly lower than that in the same group at baseline， and the levels of fasting blood glucose， glycosylated hemoglobin， total cholesterol and LDL-C in intervention group were significantly lower than those in control group at the same time points （P＜0.05 or P＜0.01）. The compliance rate of blood pressure and medication compliance in intervention group were significantly higher or better than those in control group （P＜0.01）. There were 12 and 15 patients in control group and intervention group turned into low-risk ones respectively， and the proportion of high-risk patients in intervention group was significantly lower than that in control group（P＜0.01）， while the proportion of medium-risk patients was significantly higher than that in control group（P＜0.05）； the incidence of stroke in intervention group was significantly lower than that in control group （1.0% vs. 4.5%， P＜0.05）.CONCLUSIONSThe pharmaceutical intensive intervention led by clinical pharmacists can reduce blood glucose and blood lipid levels of hypertensive outpatients， improve their blood pressure compliance rate and medication compliance， and help reduce the risk of stroke.关键词：intensive pharmaceutical intervention;hypertension;risk of stroke;outpatient patients
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发布时间：2023-02-22 - 摘要：The traditional intravenous infusion configuration in medical institutions has the shortcomings of long time and low efficiency， and it is difficult to ensure that the dispensed liquid medicine is not contaminated. At the same time， medical staff may be exposed to risks such as cytotoxic drugs due to lack of protection. To solve the defects and deficiencies in intravenous infusion configuration， the “Dolphin 7” pharmacy intravenous compounding robots are introduced in our hospital， cluster management platform is constructed based on data middle platform service exchange system； mini-intelligent PIVAS module is designed and constructed. The mode can reduce the workload of medical staff， save medical construction and labor costs， also help to promote and deepen the construction of intelligent hospitals.关键词：mini-intelligent PIVAS;modularization
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发布时间：2023-02-22 - 摘要：This paper reports the clinical pharmacist participated in the diagnosis and treatment of a patient with acanthoma caused by nivolumab. This patient developed acanthoma 2 weeks after medication， involving scalp， neck， trunk， back of hand， sole of foot and other parts， with moderate pruritus. The clinical pharmacist determined it as “yes” according to the causality evaluation method of adverse reactions. After reviewing the literature， clinical pharmacists found that acanthoma caused by immune checkpoint inhibitors was more commonly seen in male elderly patients with malignant melanoma， and mainly involved the trunk， extremities and hands. Under the general principle of considering the effectiveness， safety， economy and accessibility of therapeutic drugs， the clinical pharmacist finally decided to give the patient a comprehensive treatment scheme of Halometasone cream for external use + oral administration of Retinoic acid capsules + oral administration of Ebastine tablets after discussion with the doctor， with maximum respect for the patient’s wishes，and continued to use navulizumab for immunotherapy. At the same time， pharmaceutical care and psychological counseling were conducted by clinical pharmacist. Finally， the patient successfully completed the treatment， and the acanthoma gradually subsided after the end of navulizumab treatment. The diagnosis and treatment process of this patient indicated that the participation of clinical pharmacists is helpful to improve the continuity and safety of immunotherapy.关键词：acanthoma;cutaneous immune-related adverse events;clinical pharmacist;prognosis
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发布时间：2023-02-22 - 摘要：OBJECTIVETo construct the evaluation index system for scientific research ability of hospital pharmacists， and provide reference for the improvement of hospital pharmacists’ scientific research ability and the formulation of relevant scientific research policies.METHODSThe relevant indexes of scientific research evaluation of hospital pharmacists were extracted by literature analysis， and consultation questionnaire was designed according to Likert grade 5 scoring method. Delphi method was used to conduct two rounds of questionnaire consultation for 28 experts， and the weight of each index was determined by analytic hierarchy process. The reliability and validity of index system were analyzed by questionnaire survey.RESULTSAfter two rounds of expert correspondence， evaluation index system for scientific research ability of hospital pharmacists was finally determined from three core dimensions： basic scientific research ability， scientific research achievements and transformation ability， academic influence and personnel training （including 11 sub-dimensions and 34 measurement items）. The weight value of each dimension index was determined. The result of reliability and validity analysis confirmed the scientific rationality of the index system.CONCLUSIONSThe established evaluation index system for scientific research ability of hospital pharmacists is innovative， comprehensive and scientific. The index system model can provide reference for the improvement of hospital pharmacists’ scientific research ability and the formulation of relevant scientific research policies.关键词：scientific research ability;Delphi method;analytic hierarchy process;reliability and validity test
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发布时间：2023-02-22 - 摘要：Artemisinin is a sesquiterpene lactone containing a peroxide group isolated from the plant Artemisia annua. It has antimalarial activity and is effective for the treatment of malaria. With the deepening of research on artemisinin， the pharmacological effects of artemisinin and its derivatives in other systems have gradually become a research hotspot. This article reviews the research progress of artemisinin and its derivatives in the prevention and treatment of cardiovascular diseases. Artemisinin and its derivatives in the prevention and treatment of cardiovascular disease have shown anti-atherosclerosis， lipid-lowering， inhibition of vascular remodeling， reducing vascular pressure， improving ventricular remodeling， anti-arrhythmia， protection of vascular endothelium， prevention and treatment of diabetic cardiovascular complications and protection of myocardial cells and other pharmacological effects. It provides a new treatment strategy for common cardiovascular diseases such as hypertension， arrhythmia， coronary heart disease complications after stent implantation， hyperlipidemia， etc. However， there are few studies on the antiplatelet aggregation and antithrombotic effects of artemisinin and its derivatives， the molecular mechanisms behind many pharmacological effects have not yet been clarified， and there is little clinical application. A large number of basic studies and clinical trials are still needed to answer these questions.关键词：derivatives;cardiovascular disease;pharmacological effect
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发布时间：2023-02-22 - 摘要：In recent years， neurotoxicity caused by traditional Chinese medicine （TCM） has frequently occurred and has become one of the important factors restricting the development and application of TCM. TCM contains active components and its dosage-effect relationship is the key to determine its pharmacological activity and toxic effects. Among them， the endogenous toxic components include alkaloids， glycosides， diterpenoids， animal and plant toxic proteins and heavy metals， and so on； exogenous toxic components mainly refer to some harmful elements and pesticide residues during the cultivation， processing， transportation and storage of medicinal materials that are not synthesized by themselves. Effect on the processes such as oxidative stress， inflammation， ion exchange， and energy metabolism may be important mechanisms of TCM-induced neurotoxicity. Neural cells， myelin cells， axons and neurotransmitter systems are common targets of TCM-induced neurotoxicity. In the future， we can use modern research methods and big data mining means to establish a safety evaluation mode of “toxic symptoms-poisoning dose-toxic original agent-detoxification scheme” with the basic component group of toxic substances as the core， so as to provide support for development and clinical intervention of neurotoxic traditional Chinese medicine.关键词：neurotoxicity;material basis;mechanism of action;target;toxic component
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发布时间：2023-02-22
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