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目的:系统评价阿托伐他汀仿制药和原研药的疗效与安全性,为临床选择提供循证参考。方法:计算机检索PubMed、EMBase、Cochrane图书馆、中国期刊全文数据库、万方数据库、中文科技期刊数据库和中国生物医学文献数据库,纳入比较仿制阿托伐他汀(试验组)和原研阿托伐他汀(对照组)疗效与安全性的随机对照试验(RCT)。由两位研究员根据纳入和排除标准独立进行文献筛选、资料提取并评价质量后,采用Rev Man 5.3统计软件进行Meta分析。结果:纳入16项RCT,共2 077例患者。Meta分析结果显示,与对照组比较,试验组在降低总胆固醇(TC)[MD=-0.06,95%CI(-0.14, 0.01),P=0.11]、三酰甘油(TG)[MD=-0.00,95%CI(-0.08, 0.08),P=0.99]、低密度脂蛋白胆固醇(LDL-C)[MD=-0.07,95%CI(-0.16, 0.01),P=0.09],升高高密度脂蛋白胆固醇(HDL-C)[MD=-0.00,95%CI(-0.03,0.03),P=0.96]和发生主要心血管事件(MACE)[OR=1.18,95%CI(0.71,1.97),P=0.52]等方面的差异均无统计学意义;安全性方面,试验组在导致丙氨酸转氨酶(ALT)升高[OR=1.08,95%CI(0.51,2.30),P=0.83]、肌肉疼痛发生率[OR=2.46,95%CI(0.70,8.65),P=0.16]和胃肠道不良反应发生率[OR=1.11,95%CI(0.64,1.95),P=0.71]方面与对照组比较亦无显著性差异。 结论:阿托伐他汀的仿制药和原研药均能有效降低血脂水平,且安全性相似。
OBJECTIVE: To systematically review the efficacy and safety of the generic and original preparation of atorvastatin, and provide evidence-based reference for clinical treatment. METHODS: Retrieved from PubMed, EMBase, Cochrane Library, CJFD, Wanfang Database, VIP and CBM, related randomized controlled trials (RCT) about generic preparation of atorvastatin (test group) versus original preparation of atorvastatin (control group) were collected. Meta-analysis was performed by using Rev Man 5.3 software after data extract and quality evaluation. RESULTS: Totally 16 RCTs were included, involving 2 077 patients. Results of Meta-analysis showed, compared with control group, there were no significant differences in reducing total cholesterol (TC) [MD=-0.06,95%CI(-0.14,0.01),P=0.11], triglyceride (TG) [MD=-0.00,95%CI(-0.08,0.08),P=0.99], low-density lipoprotein cholesterol (LDL-C) [MD=-0.07,95%CI(-0.16,0.01),P=0.09], increasing high-density lipoprotein cholesterol (HDL-C) [MD=-0.00,95% CI(-0.03,0.03),P=0.96] and the incidence of major adverse cardiac events (MACE) [OR=1.18,95%CI(0.71,1.97),P=0.52] in test group; in terms of safety, compared with control group, there were no significant differences in the resulting in alanine aminotransferase (ALT) increased [OR=1.08,95%CI(0.51,2.30),P=0.83], the incidences of myalgia [OR=2.46,95%CI(0.70,8.65),P=0.16] and gastrointestinal adverse reactions [OR=1.11,95%CI(0.64,1.95),P=0.71]. CONCLUSIONS: Both the generic and original preparation of atorvastatin can effectively reduce blood lipid levels, with similar safety.
阿托伐他汀仿制药原研药Meta分析系统评价
atorvastatinGeneric preparationOriginal preparationMeta-analysisSystematic review
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