阿托伐他汀仿制药和原研药疗效与安全性的系统评价

发布时间：2018-10-11 13:37

【摘要】：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Pub Med、EMBase、Cochrane图书馆、相关期刊论文、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。
[Abstract]:Objective: to evaluate the efficacy and safety of Atto vastatin for clinical selection. Methods: Pub Med,EMBase,Cochrane library, full text database of Chinese periodicals, Wanfang database, Chinese sci-tech journal database and Chinese biomedical literature database were searched by computer. A randomized controlled trial (RCT).) was conducted to compare the efficacy and safety of Atto vastatin (trial group) and Atto vastatin (control group). According to the inclusion and exclusion criteria, the two researchers independently sifted the literature, extracted the data and evaluated the quality, and then analyzed the data with Rev Man 5.3 statistical software. Results: a total of 2 077 patients with 16 items of RCT, were included. The results of Meta analysis showed that, compared with the control group, 璇曢獙缁勫湪闄嶄綆鎬昏儐鍥洪唶(TC)[MD=-0.06,95%CI(-0.14,0.01),P=0.11],涓夐叞鐢樻补(TG)[MD=-0.00,95%CI(-0.08,0.08),P=0.99],浣庡瘑搴﹁剛铔嬬櫧鑳嗗浐閱，

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