硫酸氢氯吡格雷片仿制药对比原研药治疗冠心病的疗效、安全性与经济性的系统评价
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篇名: 硫酸氢氯吡格雷片仿制药对比原研药治疗冠心病的疗效、安全性与经济性的系统评价
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摘要: 目的:系统评价硫酸氢氯吡格雷片仿制药对比原研药治疗冠心病的疗效、安全性与经济性,为临床治疗提供循证参考。 方法:计算机检索PubMed、Embase、Medline、Cochrane图书馆、中国生物医学文献数据库、中国期刊全文数据库、维普网和万方数据,检索时限均为2008年1月-2018年3月,收集硫酸氢氯吡格雷片仿制药(试验组)对比原研药(对照组)治疗冠心病疗效(血小板聚集率、临床有效率)、安全性(主要心血管不良事件发生率、不良反应发生率)和经济性的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取和质量评价后,采用RevMan 5.3统计软件进行Meta分析。结果:共纳入26项RCT,合计3 058例患者。Meta分析结果显示,两组患者血小板聚集率变化值[WMD=0.58,95%CI(-0.35,1.51),P=0.22]、临床疗效[OR=0.83,95%CI(0.46,1.50),P=0.54]、主要心血管不良事件发生率[OR=0.97,95%CI(0.63,1.47),P=0.87]与不良反应发生率[OR=1.15,95%CI(0.78,1.70),P=0.49]比较,差异均无统计学意义。在成本-效果比上,试验组较对照组具有明显优势(仿制药A、B与原研药临床疗效的成本-效果比分别为3 014.70、2 417.41、5 692.98;主要心血管不良事件的成本-效果比分别为3 006.21、2 410.66、5 760.24)。结论:硫酸氢氯吡格雷片仿制药与原研药的疗效、安全性均相当,且仿制药具有明显经济学优势。
ABSTRACT: OBJECTIVE: To systematically evaluate the efficacy, safety and economy of generic Clopidogrel hydrogen sulphate tablets versus original drug in the treatment of coronary heart disease (CHD), and to provide evidence-based reference for clinical treatment. METHODS: Retrieved from PubMed, Embase, Medline, Cochrane Library, CBM, CJFD, VIP and Wanfang database, randomized controlled trials (RCTs) about the efficacy (platelet aggregation rate, clinical response rate), safety (incidence of main cardiac adverse event, incidence of ADR) and economy of generic Clopidogrel hydrogen sulphate tablets (trial group) versus original drug (control group) in the treatment of CHD were collected from Jan. 2008-Mar. 2018. After quality evaluation and information extraction of clinical studies which met inclusion criteria, RevMan 5.3 statistical software was used for Meta-analysis. RESULTS: Totally 26 RCTs were enrolled, involving 3 058 patients. Results of Meta-analysis showed there were no statistical significance in the change of platelet aggregation rate [WMD=0.58,95%CI(-0.35,1.51),P=0.22], clinical response rate [OR=0.83,95%CI(0.46,1.50),P=0.54], the incidence of main cardiac adverse event [OR=0.97,95%CI(0.63,1.47),P=0.87] or the incidence of ADR [OR=1.15,95%CI(0.78,1.70),P=0.49] between 2 groups. The cost-effectiveness ratio of trial group had obvious advantages, compared with control group (cost-effectiveness ratio of generic drug A and B with original drug for clinical efficacy were 3 014.70,  2 417.41, 5 692.98; cost-effectiveness ratio of main cardiac adverse events were 3 006.21, 2 410.66,      5 760.24). CONCLUSIONS: Therapeutic efficacy and safety of generic Clopidogrel hydrogen sulphate tablets are similar to those of original drug, but generic drug has obvious economy advantage.
期刊: 2018年第29卷第21期
作者: 边妍,潘芸芸,陈吉生
AUTHORS: BIAN Yan,PAN Yunyun,CHEN Jisheng
关键字: 氯吡格雷;仿制药;波立维;冠心病;疗效;安全性;经济性;Meta分析
KEYWORDS: Clopidogrel; Generic drug; Plavix; Coronary heart disease; Efficacy; Safety; Economy; Meta-analysis
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