【摘要】：目的:系統(tǒng)評(píng)價(jià)阿托伐他汀仿制藥和原研藥的療效與安全性,為臨床選擇提供循證參考。方法:計(jì)算機(jī)檢索Pub Med、EMBase、Cochrane圖書館、相關(guān)期刊論文、萬(wàn)方數(shù)據(jù)庫(kù)、中文科技期刊數(shù)據(jù)庫(kù)和中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù),納入比較仿制阿托伐他汀(試驗(yàn)組)和原研阿托伐他汀(對(duì)照組)療效與安全性的隨機(jī)對(duì)照試驗(yàn)(RCT)。由兩位研究員根據(jù)納入和排除標(biāo)準(zhǔn)獨(dú)立進(jìn)行文獻(xiàn)篩選、資料提取并評(píng)價(jià)質(zhì)量后,采用Rev Man 5.3統(tǒng)計(jì)軟件進(jìn)行Meta分析。結(jié)果:納入16項(xiàng)RCT,共2 077例患者。Meta分析結(jié)果顯示,與對(duì)照組比較,試驗(yàn)組在降低總膽固醇(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]、低密度脂蛋白膽固醇(LDL-C)[MD=-0.07,95%CI(-0.16,0.01),P=0.09],升高高密度脂蛋白膽固醇(HDL-C)[MD=-0.00,95%CI(-0.03,0.03),P=0.96]和發(fā)生主要心血管事件(MACE)[OR=1.18,95%CI(0.71,1.97),P=0.52]等方面的差異均無(wú)統(tǒng)計(jì)學(xué)意義;安全性方面,試驗(yàn)組在導(dǎo)致丙氨酸轉(zhuǎn)氨酶(ALT)升高[OR=1.08,95%CI(0.51,2.30),P=0.83]、肌肉疼痛發(fā)生率[OR=2.46,95%CI(0.70,8.65),P=0.16]和胃腸道不良反應(yīng)發(fā)生率[OR=1.11,95%CI(0.64,1.95),P=0.71]方面與對(duì)照組比較亦無(wú)顯著性差異。結(jié)論:阿托伐他汀的仿制藥和原研藥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, 璇曢獙緇勫湪闄嶄綆鎬昏儐鍥洪唶(TC)[MD=-0.06,95%CI(-0.14,0.01),P=0.11],涓夐叞鐢樻補(bǔ)(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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