最新刊期
卷 33 ， 期 15 ， 2022
- 摘要：Comprehensive clinical evaluation of drugs is an important technical tool to promote the return of drugs to clinical value. Under the background of normalization and institutionalization of centralized drug volume-based procurement ，it is very crucial to actively organize and carry out comprehensive clinical evaluation of drugs. As of March 2022，there are 5 lipid-lowing drugs that have been included in the centralized drug volume-based procurement of the state and Shandong Province. In order to actively promote the medical institutions to develop the comprehensive clinical evaluation of lipid-lowing drugs standardly ，led by the Shandong Provincial Hospital Affiliated to Shandong First Medical University ，supported by Shandong Hospital Association ，and 19 third grade class A hospitals in Shandong Province jointly participated ，Using Delphi method ，through three rounds of expert opinion investigation and extensive discussion ，Expert Consensus on the Comprehensive Clinical Evaluation of Lipid-lowering Drugs under the Centralized Drug Volume-based Procurement Policy in Shandong Province was developed. The expert consensus adopted the percentage system for quantitative evaluation. The comprehensive clinical evaluation on 15 lipid-lowing drugs involved in centralized drug volume-based procurement in Shandong Province was implemented from eight dimensions including pharmaceutical characteristics ，effectiveness，safety，economy，suitability，accessibility，innovation and other attributes ，and different recommendation levels were formed according to the scores. The development of this consensus will help medical institutions to reasonably allocate and use lipid-lowering drugs in the context of centralized drug volume-based procurement ，so as to better satisfy the national policy needs and continuously improve the quality of pharmaceutical services.
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发布时间：2022-11-09 - 摘要：OBJECTIVE To provide reference for developing pharmacovigilance and constructing an active surveillance system with extensive participation of pharmaceutical enterprises in China. METHODS Retrieving the literature and data from databases such as CNKI ，PubMed，and the official website of observational medical outcomes partnership （OMOP），the mechanism of pharmaceutical enterprises ’participation and its operation mode were investigated ，while specific path and code of conduct for pharmaceutical enterprises to participate in active surveillance system were analyzed. Finally ，the corresponding suggestions were put forward according to the actual situation of China. RESULTS & CONCLUSIONS Pharmaceutical enterprises in OMOP participated in project construction and operation through public private partnership （PPP）mechanism，and played the role of project funding ，project governance and project research. Pharmaceutical enterprises participating in OMOP need to carry out activities in accordance with the code of conduct of extensive cooperation ，transparency and openness and the protection of patient privacy. In the future practice of active surveillance system in China ，it is necessary to promote the relevant legislation of active monitoring system ，emphasize the responsibility of active surveillance of pharmaceutical enterprises ，establish a PPP mechanism of industry-university-research integration ，form a good governance ecology and strengthen the protection of patients ’privacy.
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发布时间：2022-11-09 - 摘要：OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.关键词：Drug Administration Law;drug standard;drug registration standard;expression;provisions;Chinese herbal pieces
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发布时间：2022-11-09 - 摘要：OBJECTIVE To explore wheth er there is a relationship between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence. METHODS By searching for medical damage liability disputes related to off-label drug use up to 2021 on pkulaw.cn ，documents were extracted to record objective factors ，subjective factors and judgment results ；whether there was evidence-based evidence was judged according to Off-label Drug Use List and Evidence-based Evaluation Standards for Off-label Drug Use of Guangdong Pharmaceutical Association ；univariate analysis was adopted to test the relationship between the judgment results and evidence-based evidence. RESULTS A total of 57 cases were included. Cases mainly occurred in the eastern China （63.2％）and tertiary hospitals （64.9％），the main appraisal agency was the appraisal center or institute（61.4％），and the most common type of off-label drug use was overdose drug use （45.6％）. Among the judgment results ， 23 cases（40.4％）of off-label drug use had a causal relationship with medical damage ，most of the responsibility of doctors was secondary responsibility （28.1％），and the actual compensation amount of the most cases were less than 100，000 yuan（54.4％）. There were 25 cases（43.9％）with evidence-based evidence. Univariate analysis found that for off-label drug use the claim amount of the case with evidence-based evidence was significantly higher than that of the case without evidence-based evidence （P＝ 0.040），and there was no significant correlation between evidence-based evidence and the actual compensation amount of the case （P＝0.741），causality determination （P＝0.256），liability type （P＝0.598）or appraisal agency （P≥0.260）. CONCLUSIONS There is no significant correlation between the judgment results of medical damage liability disputes related to off-label drug use and evidence-based evidence ，indicating that there may be certain differences between judicial trials and medical science. The off-label drug use should be regulated by establishing a complete off-label drug use management system and standardizing informed consent procedure for off-label drug use. 1610307322@pku.edu.cn
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发布时间：2022-11-09 - 摘要：OBJEC TIVE To evaluate the efficiency of drug safet y supervision in China after issuing a series of new policies in 2018，and to provide the suggestions for optimizing the construction of drug safety supervision system in China and narrowing regional differences. METHODS The panel data of input-output indexes of 18 provinces in 7 administrative regions were collected from the official website of provincial drug regulatory departments ，the open platform of budget and final accounts and the official website of National Bureau of Statistics. Data envelopment analysis （DEA）model and Malmquist index were adopted to conduct an empirical analysis on the efficiency of drug safety supervision in China during 2019-2020. RESULTS & CONCLUSIONS DEA analysis showed that during 2019-2020，the overall technical efficiency （TE）of drug safety supervision in China was lower than 1.000，which didn ’t meet effective DEA. Only Liaoning ，Guangdong and Guangxi had TE of 1.000，indicating significant differences in efficiency of drug safety supervision in different regions. The results of Malmquist index analysis showed that the overall efficiency of drug safety regulation in China was declining ，among which insufficient regulatory capacity supported by technology and large loss of professional personnel were the main factors ，and the improvement of drug regulatory departments ’ management and supervision level could ensure the improvement of overall regulatory efficiency. The current scale of drug supervision in nearly half of provinces （8/18）was close to the optimal state. It is necessary to strengthen the infrastructure construction and pay attention to the training of professional talents to optimize the drug regulatory team ；strengthen the innovation of supervision technology and improve the construction of technological support system ；rationally allocate regulatory resources and balance regional regulation according to local conditions to improve the construction of drug safety supervision system in China.关键词：drug safety supervision;efficiency;data envelopment analysis;Malmquist index;input-output
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发布时间：2022-11-09 - 摘要：OBJECTIVE To study the effects of Wenyang huazhuo tongluo formula conta ined serum on the expression and methylation of retinoic acid related nuclear orphan receptor （RORγt），and to explore the mechanism of its regulation of Th 17 cell proliferation in the treatment of scleroderma. METHODS Wistar rats were given 15，30，60 g/（kg·d）Wenyang huazhuo tongluo formula intragastrically to prepare different doses of drug-contained serum ，and peripheral blood of scleroderma patients were collected to sort Th 17 cells. Using blank serum as blank control ，methyltransferase inhibitor decitabine （DCA）as positive control ， Th17 cells were treated with different concentrations of drug-contained serum ，and then the proliferation of Th 17 cells was detected by CCK- 8；mRNA expressions of RORγt and IL-17 were detected by qRT-PCR ，and the protein expression of RORγt was detected by Western blot assay ；the protein expression of IL- 17 in the cell supernatant was detected by ELISA ，and the methylation level of RORγt gene promoter was detected by methylation-specific PCR. The transcriptional activity of RORγt gene promoter was detected by dual-luciferase assay. RESULTS Compared with blank control ，Wenyang huazhuo tongluo formula contained serum and DCA could inhibit the proliferation of Th 17 cells（P＜0.05），reduced the mRNA and protein expressions of RORγt and IL-17，enhanced the methylation level of RORγt gene promoter and attenuated ， the transcription activity of RORγt gene promoter. Except for mRNA expression of Th 17 and the methylation level of RORγt gene promoter in drug-contained serum low-dose group ，there were statistical significance in above indexes of other groups（P＜0.05）. CONCLUSIONS Wenyang huazhuo tongluo formula can promote the methylation lev el of RORγt gene，and inhibit the expression of RORγt and the secretion of IL-17，so as to inhibit the proliferation of Th 17 cells.关键词：scleroderma;Wenyang huazhuo tongluo formula;drug-contained serum;RORγt;methylation;Th17 cell
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发布时间：2022-11-09 - 摘要：OBJECTIVE To explore the the reg ulation of intestinal flora and effects of Qingjie huagong decoction on intestinal mucosal barrier in severe acute pancreatitis （SAP）mode rats . METHODS SAP rat model was induced by intraperitoneal injection of caerulein and lipopolysaccharide.The survival state of rats in each group were observed.The levels of serum amylase ，interleukin 10（IL-10），IL-18 and IL- 1β in serum were all detected. The pathological changes of pancreatic and small intestinal tissue were observed. The expressions of Occludin，ZO-1 and HMGB1 were detected in small intestinal tissue of rats. The structure and relative abundance of intestinal microflora in rats were detected by 16S rRNA high throughput sequencing. RESULTS After the intervention of Qingjie huagong decoction ，abdominal distension symptoms of SAP model rats were significantly relieved ，and their mental state recovered better ；the levels of serum amylase and IL- 18 in serum were decreased significantly （P＜0.05），while the level of IL- 10 was increased significantly （P＜0.05）. The necrotic area of pancreatic tissue and the infiltration of inflammatory cells were reduced ， the degree of intestinal epithelial cell structural disorder was alleviated ，and the shedding of intestinal mucosal epithelium was reduced.The protein expression of HMGB 1 in small intestinal tissue was decreased significantly （P＜0.05），and the protein expression of Occludin and ZO- 1 were increased significantly . Results of 16S rRNA high throughput sequencing showed that Qingjie huagong decoction could increased the relative abundance of probiotics such as Bacteroidea and Lactobacillus in rat intestine ，reduced the colonization of harmful bacteria such as Firmicutes. CONCLUSIONS Qingjie huagong decoction can improve the intestinal barrier by up-regulating the expression of Occludin and ZO- 1 in small intestinal tissue and down-regulating the protein expression of HMGB 1. It can also adjust the relative abundances of different flora to protect the intestinal tract.关键词：severe acute pancreatitis;Qingjie huagong decoction;Intestinal flora;intestinal mucosal barrier
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发布时间：2022-11-09 -
Evaluation of the quality of different germplasms of Rehmannia glutinosa based on iridoid glycosides
摘要：OBJECTIVE To evaluate the quality of different germplasms of Rehmannia glutinosa based on iridoid glycosides. METHODS The contents of total iridoid glycosides ，catalpol，rehmaionoside D ，rehmaionoside A ，and leonuride in 18 batches of R. glutinosa from 6 germplasms（85-5，JinJiu，BX，BJ-1，Shandong，QH-1）were determined by ultraviolet spectrophotometry and high performance liquid chromatography. After normalization of the above content determination results ，the quality of different germplasm of R. glutinosa were evaluated by multiple statistical methods such as cluster analysis ，factor comprehensive analysis and partial least squares discriminant analysis （PLS-DA）. RESULTS Among 6 germplasms of R. glutinosa ，the content of total iridoid glycosides in R. glutinosa 85-5 was the highest ，and the content of catalpol in R. glutinosa BX was the highest ；the contents of rehmannioside D and rehmannioside A in R. glutinosa JinJiu were the highest ，and the content of leonuride in R. glutinosa BX was the highest. Cluster analysis showed that R. glutinosa JinJiu were clustered into one category ，R. glutinosa BX clustered into one category ，R. glutinosa Shandong and R. glutinosa BJ-1 were clustered into one category ，and R. glutinosa QH-1 and 85-5 were clustered into one category. Through factor comprehensive analysis ，there were differences in the quality of different germplasms of R. glutinosa . The comprehensive score of R. glutinosa BX，Shandong，85-5，BJ-1，QH-1，JinJiu were 2.283 9，1.689 1，1.664 8， 1.503 3，1.469 0，1.214 6，respectively. PLS-DA showed that variable importance projection value of total iridoid glycosides ， catalpol and leonuride were all higher than 1. CONCLUSIONS The quality difference of R. glutinosa from different germplasms may be caused by total iridoid glycosides ，catalpol and leonuride.关键词：Rehmannia glutinosa;germplasms;iridoid glycosides;multivariate statistics;Quality evaluation- 12
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发布时间：2022-11-09 - 摘要：OBJECTIVE To develop an HPLC method for the simultaneous dete rmination of morroniside ，loganin，paeoniflorin， salvianolic acid B and icariin in Shenfukang Ⅱ capsule. METHODS The determination was performed on Agilent 5 TC-C18 column with mobile phase consisted of acetonitrile- 0.1％ phosphate acid （gradient elution ）at the flow rate of 1 mL/min. The column temperature was 30 ℃，and detection wavelength was set at 240 nm. The sample size was 10 μL. RESULTS The linear range of morroniside，loganin，paeoniflorin，salvianolic acid B and icariin were 4.80-240.00，4.84-242.00，7.00-350.00，4.72-236.00 and 5.18-259.00 μg/mL（r≥0.999 8），respectively. RSDs of precision ，stability and reproducibility tests were all lower than 3％（n＝6）. Average recoveries were 97.22％-101.36％ with the RSDs of 1.19％-2.43％（n＝6）. The contents of above 5 components in 5 batches of samples were 2.019 3-2.360 0，1.624 2-1.847 1，5.637 7-6.828 0，5.015 9-5.717 0 and 1.208 8-1.754 6 mg/g，respectively. CONCLUSIONS The method is simple ，accurate and reproducible. It can improve the quality control level of Shenfukang Ⅱ capsule.
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发布时间：2022-11-09 - 摘要：OBJECTIVE To know about the development trend of small nucleic acid drugs in the world ，to provide reference for the research and development of small nucleic acid drug in China. METHODS By searching the academic literature and patents related to small nucleic acid drugs through the Web of Science literature database and PatSnap patent database from Jan. 1980 to Dec. 2021，research and development situation of small nucleic acid drugs were revealed comprehensively by analyzing research enthusiasm，R&D countries ，R&D institutions and technical topics of small nucleic acid drugs. RESULTS & CONCLUSIONS A total of 59 819 documents and 37 645 patent groups were included. The global trend of small nucleic acid drug literature publication and patent application could be divided into three stages. From 2003 to 2021，the research enthusiasm for small nucleic acid drugs continued to increase. The United States ，China，Japan and Germany were the main research and development countries for small nucleic acid drugs. The number of document publications （25 703，15 927 papers）and patent applications （14 240、8 937 groups） in the United States and China were ahead of other countries ，and the research and development activities were relatively strong. Moreover，the number of document publications and patent applications in China in this field had grown rapidly in recent years. The R&D institution with the largest number of publications was the University of California （2 499 papers），the R&D institution with the largest number of patent applications was the American Ionis Corporation （1 378 groups），and the Chinese Academy of Sciences （1 580 papers）had been shortlisted among the top 10 document producing institutions in the world. However ，our country ’s research and development in this field are mostly based on basic research ，and the research on industrial application is slightly insufficient. The research focus in the field of small nucleic acid drugs mainly focuses on nucleic acid sequences and their modification and improvement and drug loading technology. RNA interference technology has gradually become a hot technology for small nucleic acid drugs.关键词：small nucleic acid drugs;research development of drug;patents;RNA interference technology
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发布时间：2022-11-09 - 摘要：OBJECTIVE To investigate th e intervention effect of Jinkui shenqi pills on renal fibrosis （RF）model rats and its mechanism based on transforming growth factor β1/Smads（TGF-β1/Smads）and TGF-β1/extracellular signal regulated kinase （ERK） signaling pathway. METHODS Male SD rats were given adenine suspension （250 mg/kg）to induce RF model. After modeling ， they were randomly divided into model group ，Colchicine tablet group （positive control ，0.45 mg/kg）and Jinkui shenqi pills low-dose，medium-dose and high-dose groups （0.5，1，2 g/kg），with 10 rats in each group. Other 10 healthy rats were selected as normal group. The rats in administration groups were given the corresponding drugs intragastrically ；normal group and model group were given 0.1％ sodium carboxymethyl cellulose solution ，once a day ，for consecutive 30 d. After last medication ，the serum levels of creatinine （Cr）and blood urea nitrogen （BUN），renal weight and body weight were detected. The ratio of BUN/Cr and renal coefficient were calculated. The pathological morphology of renal tissue in rats were observed. The protein and mRNA expressions of TGF-β1，Smad2，Smad3，ERK1 and ERK 2 were detected. RESULTS Compared with normal group ，serum levels of Cr and BUN and renal coefficient were all increased significantly in model group （P＜0.05），while the ratio of BUN/Cr was decreased significantly （P＜0.05）. The volume of the kidney was significantly increased ，and the surface was seriously granulated. Mesangial hyperplasia ，dilation or atrophy of renal tubules ，accompanied by large-area collagen deposition，could be found. Protein and mRNA expressions of TGF-β 1，Smad2，Smad3，ERK1 and ERK 2 were increased significantly in renal tissue （P＜0.05）. Compared with model group ，above indexes of Jinkui shenqi pills groups were all reversed significantly （P＜0.05）；dilation or atrophy of renal tubules was relieved ，and collagen deposition was reduced to different extents. CONCLUSIONS Jinkui shenqi pills can improve renal function of RF model rats ，the mechanism of which may be associated with inhibiting TGF-β1/Smads and TGF-β1/ERK signaling pathway.关键词：Jinkui shenqi pills;renal fibrosis;TGF-β1/Smads signaling pathway;TGF-β1/ERK signaling pathway;Mechanism
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发布时间：2022-11-09 - 摘要：OBJECTIVE From the perspective o f China ’s h ealth service system ，to ev aluate the cost-effectiveness of sintilimab combined with chemotherapy in the first-line treatment of advanced or recurrent non-small cell lung cancer （NSCLC），so as to provide reference for the selection of clinical medication plan and medical and health decision-making. METHODS Based on the ORIENT-11 study data ，a partitioned survival model was established ，and the model period was 21 days to simulate the death of 99％ of the patients. Using quality-adjusted life years （QALY）as an output indicator ，the cost-effectiveness of sintilimab combined with chemotherapy （trial group ）versus chemotherapy alone （control group ）in the first-line treatment of advanced or recurrent NSCLC was evaluated. Cost and utility were discounted using 5％ discount rate ；sensitivity analysis and scenario analysis were used to verify the robustness of the underlying analysis results. RESULTS Under the premise that 3 times of the per capita gross domestic product （GDP）of China in 2020 was used as the threshold of willingness-to-pay （WTP），the patients in the trial group obtained more utility （0.482 QALY）and also spent nearly twice as much as the control group. The incremental cost-effectiveness ratio（ICER）was 334 974.41 yuan/QALY. Univariate sensitivity analysis showed that progression-free survival status utility value ， pemetrexed price ，utility discount rate ，cost discount rate and sintilimab price had a greater impact on ICER. The results of probability sensitivity analysis showed that when the WTP threshold was 3 times of China ’s per capita GDP in 2020，the probability of the trial group ’s plan being cost-effective was 6.5％. The results of the scenario analysis verified the robustness of the underlying analysis results. CONCLUSIONS On the premise of taking 3 times of China ’s per capita GDP in 2020 as the WTP threshold ， sintilimab combined with chemotherapy is not cost-effective for first-line treatment of advanced or recurrent NSCLC compared with chemotherapy alone.
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发布时间：2022-11-09 - 摘要：OB JECTIVE To evaluate the cost-effectiveness of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer from the perspective of the Chinese health care system. METHODS A Markov model was developed by using updated four-year survival data from the PACIFIC trial in May 2021 and relevant literature. The cost-effectiveness of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer was evaluated by using quality-adjusted life years （QALYs）as health output index with 20-year simulation time frame and a 2-week cycling period. The costs and health output were discounted using discount rate of 5％；one-way sensitivity analysis and probabilistic sensitivity analysis were used to examine the robustness of the model simulation results. RESULTS The results of the base analysis showed that compared with placebo group ，durvalumab resulted in 0.73 QALYs at an incremental cost of 1 076 062.86 yuan and an incremental cost-utility ratio （ICER）of 1 467 546.54 yuan/QALY，which was much higher than 3-fold per capita gross domestic products （GDP）in 2020（217 713 yuan）as willingness-to-pay （WTP）threshold. The results of one-way sensitivity analysis showed that the price of durvalumab and discount rate had a great impact on ICER. Probabilistic sensitivity analysis showed no cost-effective advantage for durvalumab when the WTP threshold was three times of GDP per capita in 2020 （217 713 yuan）. CONCLUSIONS From the perspective of Chinese health care system ，there is no cost-effective advantage to the use of durvalumab for consolidation therapy after chemoradiotherapy for unresectable stage Ⅲ non-small cell lung cancer when the WTP threshold was three times of GDP per capita in 2020.关键词：durvalumab;non-small cell lung cancer;consolidation therapy;Pharmacoeconomics;Cost-utility analysis
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发布时间：2022-11-09 -
Adverse drug event signal mining of semaglutide based on FDA Adverse Event Reporting System database
摘要：OBJECTIVE To exc avate the adverse drug event （ADE）signals of semaglutide and provide reference for its clinical rational use. METHODS The proportional unbalance method was used to mine the signals of all semaglutide ADE reports from FDA Adverse Event Reporting System （FAERS）up to September 2021. The basic situations of the reported cases were analyzed. The corresponding system organ classification （SOC）was mapped and compared with the adverse drug reactions recorded in the drug instructions. Preferred terms （PT）of patients with different indications were analyzed. RESULTS A total of 6 661 semaglutide ADE reports were extracted and 194 valid signals were mined. Among 6 661 cases of ADE ，the proportion of men （43.40％）was lower than women （52.65％）；the age was mainly distributed in ＞40-65 years old （29.00％）and ＞65 years old （22.61％）；the reporting country was mainly the United States （83.88％）；the report year was mainly concentrated in 2021 （40.88％），with an increasing trend year by year ；the main outcome was hospitalization or prolonged hospitalization in serious ADE reports （17.78％）. Semaglutide ADE signal was mapped to the main SOC ，mainly including gastrointestinal diseases ，various injuries，poisoning and operation complications ，metabolic and nutritional diseases ，various examinations. The screening criteria were based on the report odds ratio ＞10 or ADE reported cases ＞50，and 48 new potential adverse drug reactions were added to the drug description. Among the indications with the top two reported cases （type 2 diabetes and obesity ，overweight，weight control），the frequency of gastrointestinal system related ADE reports represented by nausea ，vomiting and diarrhea was higher ， which was similar to the drug instructions. CONCLUSIONS This study supplemented 48 new potential adverse drug reactions based on the drug instructions of semaglutide. At present ，it can be considered that semaglutide is safe.关键词：semaglutide;FDA Adverse Event Reporting System;adverse drug events;Signal mining;proportional unbalance- 29
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发布时间：2022-11-09 - 摘要：OBJECTIVE To conduct a c omprehensive clinical evaluation method of Chinese patent medicine ，and to provide reference for rational clinical drug use. METHODS Taking the top 10 Chinese patent medicine injections for promoting blood circulation and removing stasis in Shandong province from 2016 to 2020 collected by the National Rational Drug Use Monitoring Network as an example ，the method combining health technology assessment with objective judgement analysis is used to construct the comprehensive evaluation index system ；based on evidence-based medical evidence and pharmacoeconomic model ，the safety ， effectiveness and economy of the drug were evaluated comprehensively ，and the scores were quantified. RESULTS & CONCLUSIONS The final scores of the 10 kinds of Chinese patent medicine injections were between 26 and 37 scores. Safflower yellow for injection scored the highest score in the treatment of cerebral infarction and angina pectoris of coronary heart disease ， while Ginkgo diterpene lactone meglumine injection and Shuxuening injection had the highest scores in the treatment of coronary heart disease. The clinical comprehensive evaluation method of Chinese patent medicine based on evidence-based medical evidence and pharmacoeconomic model can clarify the comprehensive value of Chinese patent medicine in clinic ，promote rational drug use in clinic ，and provide basis for the next adjustment of medical insurance catalogue and essential medicine catalogue ，decision-making of centralized procurement of related drugs.
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发布时间：2022-11-09 - 摘要：OBJECTIVE To summarize the research status and development trend of pharmacy intravenous admixture service in China in recent 20 years. METHODS Related literatures of pharmacy intravenous admixture service were retrieved from CNKI ， VIP and Wanfang database. The journal source ，authors and keywords were visualized by NoteExpress and CiteSpace 5.8.R1 software. RESULTS Totally 4 128 literature were included ，and the most literature were published in Strait Pharmaceutical Journal （198 pieces）. The configuration service of intravenous administration and the role of clinical pharmacists was cited the most frequently（104 times）；the author cooperation network analysis of literature showed that the author with the largest number of papers in the research field of pharmacy intravenous admixture service was Zhang Xiaoxia （31 pieces）. The top 20 key words showed that the research contents of pharmacy intravenous admixture service mainly focused on the rational drug use ， pharmaceutical care ，quality control ，management mode and other related fields. CONCLUSIONS In recent 20 years，more and more attention has been paid to the research of pharmacy intravenous admixture service. Establishing standard management mode ， strengthening laboratory quality control and implementing occupational exposure prevention and control programs are important means to improve the quality of finished infusion products and ensure clinical rational drug use ，and lay a foundation for the healthy development of pharmacy intravenous admixture service. Emphasizing the core of pharmaceutical care ，simplifying management mode and establishing standard management mechanism are the research hotspots in this field in the future.关键词：Pharmacy intravenous admixture service;Bibliometrics;visual analysis;CiteSpace
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发布时间：2022-11-09 - 摘要：OBJECTIVE To provide reference for improving the continuing education management for licensed pharmacists in China. METHODS By searching related policies ，notices and documents of continuing education of licensed pharmacists in various provinces in China ，the retrieval time limit was from the implementation of the licensed pharmacist qualification access system in 1994 to December 31，2021. The organizational structure ，implementation status and problems of continuing education management for licensed pharmacists in 31 provinces were analyzed to put forward the suggestions. RESULTS & CONCLUSIONS At present ， the management subjects of continuing education for licensed pharmacists in China at the national level are still unclear ，and the management subjects of continuing education at the local level are mostly provincial drug administration and （licensed）pharmacist association，and some are pharmaceutical societies ，so the management system needs to be straightened out. At present ，most provinces have selected teaching institutions through public bidding ，basically realize the separation of discipline ，but the openness and transparency of selection standards need to be strengthened. In addition ，there are still some problems ，such as teaching content and methods need to be enriched and optimized ，and insufficient funds guarantee in most areas. It is suggested to clarify the division of responsibilities for the continuing education management of licensed pharmacists in China ，improve the management of teaching institutions ，enrich the teaching contents and forms of continuing education of licensed pharmacists ，and ensure the management funds of continuing education of licensed pharmacists.关键词：Licensed pharmacist;Continuing education;management system;teaching management
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发布时间：2022-11-09 -
Cultivation of prescription-auditing pharmacists’ability in prescription pre-audit and case analysis
摘要：OBJECTIVE To summariz e the expe rience of the ability training of prescription-auditing pharmacists in prescription pre-audit，and introduce the typical cases of the prescription-auditing pharmacists participating in the drug intervention. METHODS From October ，2020 to October ，2021，under the audit mode of “prescription pre-audit system+prescription-auditing pharmacists ” adopted by Yuxi People ’s Hospital （hereinafter referred to as “the hospital ”），the abilities of prescription-auditing pharmacists were cultivated from the aspects of training in pharmaceutical related professional knowledge ，training in the use of Chinese and English medical retrieval tools ，databases and websites ，and clinical thinking and communication ability ；through the construction of ability evaluation form of prescription-auditing pharmacists ，their abilities were assessed. RESULTS & CONCLUSIONS After one year ’s ability training ，the rational rate of prescription （doctor’s order ），the proportion of doctors ’active revision of problem prescription （doctor’s order ）and the doctor ’s acceptance rate of intervention by prescription-auditing pharmacists showed an upward trend ，the average time of irrational prescription （doctor’s order ）by prescription-auditing pharmacists showed a shortening trend ，and the intervention rate of prescription （doctor’s order ）showed a downward trend. In addition to the publication of papers （belonging to the bonus item ），the average score of the ability evaluation form of prescription-auditing pharmacists had significantly increased ， from 45.2 in October 2020 to 97.6 in October 2021.- 190
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发布时间：2022-11-09 - 摘要：OBJECTIVE To explore the research sta tus，hotspots and frontier trends in the field of domestic evidence-based traditional Chinese medicine ，and to provide reference for the development of this field. METHODS Retrieved from CJFD ，VIP and Wanfang database ，CiteSpace software and bibliometrics method were used to statistically analyze the annual quantity of documents published ，authors，institutions，and keywords ，etc. RESULTS A total of 3 154 papers were included in this study ，and the annual number of papers presented an overall upward trend. The author with the highest number of papers was Liu Jianping ， who published 106 papers and was closely connected with other authors. China Academy of Chinese Medical Sciences ，Beijing University of Chinese Medicine and Tianjin University of Chinese Medicine were highly productive institutions ，with more than 100 articles published each and a relatively wide range of cooperation. Evidence-based medicine ，Traditional Chinese Medicine ， evaluation，evidence-based nursing ，review，medical education ，clinical research and other high-frequency keywords （frequency of more than 100 times each ）formed hot topics of research. CONCLUSIONS The research of evidence-based traditional Chinese medicine in China has been paid more and more attention ；“evidence-based medicine ”“traditional Chinese medicine ” “evidence-based nursing ”and“clinical research ”are the research hotspots.关键词：evidence-based medicine;traditional Chinese medicine;bibliometrics
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发布时间：2022-11-09 - 摘要：OBJECTIVE To stud y the s patial distribution and spatial aggregation of pharmacist resources at provincial level in China from 2010 to 2020，and to provide reference for the optimal configuration of pharmacist resources. METHODS Taking the 2011 China Health Statistics Yearbook ，2016 China Health and Family Planning Statistics Yearbook ，2021 China Health Statistics Yearbook and China Statistical Yearbook as data sources ，the spatial distribution of the number of pharmacists per capita in each province in China was described ，and the current situation of pharmacist resource spatial aggregation were analyzed by using global spatial autocorrelation and local spatial autocorrelation methods. RESULTS In 2020，the number of pharmacists per capita in China had certain differences among provinces ，with the highest in Beijing reaching 6.9 people/10 000 people，and the lowest in Hebei at 2.7 people/10 000 people. From 2010 to 2020，the number of pharmacists per capita in all provinces had increased ，with the largest increase in Guizhou （50.6％）and the smallest increase in Liaoning （3.1％）. Results of the global spatial autocorrelation showed that the clustering degree of pharmacist resource allocation per capita decreased gradually from 2010 to 2014. Spatial aggregation of pharmacist resource allocation per capita increased to certain extent from 2016 to 2019，and remained stable in 2020. Results of local spatial autocorrelation showed that Sichuan ，Yunnan and Guizhou presented a low-low aggregation pattern in 2010，while Tianjin presented a high-high aggregation pattern ；in 2015，Sichuan and Yunnan presented a low-low aggregation pattern ，while Tianjin presented a high-high aggregation pattern ；in 2020，Shandong presented a low-low aggregation pattern ，while Tianjin presented a high-high aggregation pattern. CONCLUSIONS From 2010 to 2020，there was a spatial clustering phenomenon in the allocation of pharmacist source per capita at the provincial level in China ，and pharmacist resources are correspondingly concentrated in the Beijing ，Shanghai，Guangzhou and Shenzhen and the economically developed Yangtze River Delta region.关键词：Pharmacist;resource allocation;spatial statistical techniques;spatial aggregation
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发布时间：2022-11-09 - 摘要：OBJE CTIVE To explore the rational application and management of antibiotics in burn department of our hospital based on disease diagnosis related groups （DRGs）. METHODS Patients discharged from the burn department of our hospital from July 2020 to June 2021 were selected as the research objects to collect DRG data. The overall application of antibiotics in DRG group with more than 10 cases were analyzed ，and the application of antibiotics in typical disease groups were evaluated horizontally and vertically. RESULTS Among 3 732 discharged cases in the burn department of our hospital ，a total of 3 515 cases were included in 66 DRG groups ，21 DRG groups of which were included in the study. Among 21 DRG groups ，the maximum antibiotics use density （AUD）of antibiotics was 102.20 DDDs/（100 person·d）in AH 11 group，the utilization ratio of antibiotics was 100％，and the combined use rate of antibiotics was 81.82％；case-mix index （CMI）value was 11.49. The minimum AUD was 1.01 DDDs/（100 person·d）in XR 19 group，the utilization ratio of antibiotics was 5.06％，and the combined use rate of antibiotics was 0；CMI value was 0.81. Within the same core group ，AUD increased with the increase of CMI. The horizontal comparison and analysis of WB 11 group showed that there was a large gap in AUD among different physicians. The vertical comparison of AUD in WB11 group showed relatively small changes over time. CONCLUSIONS The horizontal and vertical evaluation of antibiotics based on DRGs can provide new clues for the control of antibiotics and help to realize the fine specialized management of antibiotics.关键词：disease diagnosis related groups;Antibiotics;fine management;burn department;Rational drug use
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发布时间：2022-11-09 - 摘要：Malaria is a serio us and life-threatening infectious disease that has a profound impact on human life. Artemisinin is still the first-line drug for clinical antimalarial treatment recommended by the World Health Organization. The antimalarial activity of artemisinin is mainly reflected in the peroxide bridge structure. Artemisinin-based combination therapy （ACT）is the first-line treatment for malaria in many countries. ACT mainly include artemether-lumefantrine ，artesunate-amodiaquine and dihydroartemisinin- piperaquine，etc. Compared with artemisinin monotherapy ，ACT has the advantages of shortening the length of hospital stay ， speeding up parasite clearance ，and saving economic costs ，etc. However ，there are still problems such as drug resistance. This article reviews the application status ，advantages and disadvantages of ACT at home and abroad in recent years ，in order to provide ideas for the subsequent screening of long-acting adjuvant antimalarial drugs in ACT and to solve the problem of drug resistance.关键词：artemisinin;artemisinin-based compounds;combination therapy;malaria
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发布时间：2022-11-09 - 摘要：Euryale f erox is the dry and mature seed kernel of Euryale ferox Salisb.，the effect of raw E. ferox is mainly to astringe spontaneous emission or leukorrhea ，while the effect of fried E. ferox is mainly to tonify the spleen and stomach. Therefore ， processing has an important impact on the effect of E. ferox . The author summarizes the processing evolution ，chemical composition ， pharmacological action and quality control of E. ferox by consulting past materia medica monographs and related research papers. The results show that the processing methods of E. ferox in the past include cleansing ，medicinal juice ，frying and steaming ；modern processing methods mainly continue to use cleansing and frying ，among which frying can be divided into stir-frying and bran-frying. E. ferox mainly contains polyphenols ，flavonoids，sterols and other components ，with antioxidant ，antibacterial，hypoglycemic and other pharmacological effects. At present ，scholars have established a variety of fingerprints to control the quality of E. ferox . Naringin，total amino acids and other components may be the differential components that affect the quality of E. ferox ，while the contents of heavy metals and sulfur dioxide are important indicators that affect the safety of E. ferox ，and α-tocopherol and gallic acid may be the quality markers of E. ferox . Later ，according to the basic properties of raw and processed products of E. ferox ， pharmaceutical analysis methods can be used to comprehensively investigate the differences and change rules of chemical components in E. ferox before and after processing. The pharmacodynamic effects of E. ferox before and after processing can be evaluated by in vivo and in vitro models，so as to provide references for the inheritance of processing technology ，the formulation of processing standards and clinical application of E. ferox .关键词：Euryale ferox;Processing;historical evolution;Chemical composition;pharmacological effects;quality contr ol
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发布时间：2022-11-09 - 摘要：Glioma is a malignant tumor with extremely high rates of recurrence. Clinically ，with the prolongation of the use of chemotherapy drugs ，the drug resistance of glioma cells to chemotherapy drugs is also increasing ，which eventually leads to poor prognosis and shortens overall survival time of patients. It is well known that the development of drug resistance involves multiple mechanisms，including drug transport metabolism ，apoptosis，DNA damage repair ，autophagy，variation of cancer stem cells and epithelial mesenchymal transition. Abnormal expression of circular RNA （circRNA），a novel RNA molecule with unique stability and tissue specificity ，has been shown by more and more evidence to play a crucial regulatory role in the development of drug resistance in glioma. This paper systematically reviews the mechanism of multiple drug resistance in glioma ，and focuses on the role and molecular mechanism of circRNA regulating temozolomide-resistance in glioma. At the same time ，the potential function of circRNA as a new therapeutic target is prospected ，in order to provide an objective theoretical basis for the development of new therapeutic methods.关键词：circular RNA;glioma;chemotherapy resistance;Mechanism
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发布时间：2022-11-09
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