作　　者： (）;

机构地区： 广州中医药大学针灸康复临床医学院

出　　处： 《中国医院药学杂志》 2019年第11期1158-1165,共8页

摘　　要： 目的:系统评价六味地黄丸(汤)联合二甲双胍治疗2型糖尿病的有效性和安全性,为其临床应用提供依据。方法:系统检索中国期刊全文数据库(CNKI)、万方数据库(WanFang Data)、维普(VIP)、中国生物医学文献数据库(CBM)、PubMed、Embase、Cochrane Library,收集六味地黄丸(汤)联合二甲双胍治疗2型糖尿病的临床随机对照试验(RCT),检索时限均为建库至2018年9月,采用Cochrane风险评价表评价其研究质量,由2位研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险,提取资料后通过RevMan 5.3.3软件进行Meta分析,Stata 12.0软件进行发表偏倚检验,TSA v 0.9软件进行试验序贯分析。结果:共纳入20个RCT包括2 018例患者。Meta分析结果显示:与对照组相比,试验组患者的有效率更高[RR=1.20,95%CI(1.13,1.28),P<0.000 01],甘油三酯[MD=-0.35,95%CI(-0.42,-0.28),P<0.000 01]、糖化血红蛋白[MD=-0.77,95%CI(-1.03,-0.51),P<0.000 01]、低密度脂蛋白[MD=-1.12,95%CI(-1.20,-1.04),P<0.000 01]、血糖[MD=-1.17,95%CI(-1.57,-0.77),P<0.000 01]、空腹血糖[MD=-1.24,95%CI(-1.53,-0.94),P<0.000 01]、中医症状评分[MD=-0.83,95%CI(-1.13,-0.52),P<0.000 01]的降低均优于对照组,六味地黄丸汤剂联合二甲双胍对高密度脂蛋白的增高[MD=0.27,95%CI(0.11,0.43),P=0.000 8]、对总胆固醇的降低[MD=-1.34,95%CI(-1.42,-1.27),P<0.000 01]优于对照组。Egger检验提示可能存在发表偏倚,试验序贯分析提示六味地黄丸(汤)联合二甲双胍治疗2型糖尿病证据确切。结论:六味地黄丸(汤)联合二甲双胍治疗2型糖尿病疗效显著,且不良反应少,但纳入研究质量偏低,未来需要更严谨更大样本的研究以证实此结论。 OBJECTIVE To systematically evaluate the efficacy and safety of Liuwei Dihuang Pills(Tang) combined with metformin in the treatment of 2 diabetes and to provide the basis for its clinical application. METHODS CNKI, WanFang Data database, VIP, CBM, PubMed, Embase and Cochrane Library from their inception to September, 2018 were systematically searched. Randomized controlled trials(RCTs) in which Liuwei Dihuang Pills combined with metformin in the treatment of type 2 diabetes were included. Cochrane risk evaluation was used to evaluate the quality of studies. Two investigators independently screened the literature, extracted the data and evaluated the risk of bias of the included studies RevMan 5.3.3 software was used to perform the Meta Analysis. Stata 12.0 software was adopted to test publication bias and TSA 0.9 software was used for the trial sequential analysis(TSA).RESULTS 20 RCTs involving 2018 participants were included. Meta analysis results showed that Liuwei Dihuang Pills combined with metformin can increase the total efficacy compared with the control groups [RR=1.20,95%CI(1.13,1.28),P< 0.000 01]. Meanwhile, it could decrease triglyceride [MD=-0.35, 95% CI(-0.42,-0.28),P<0.000 01], glycosylated hemoglobin [MD=-0.77, 95% CI(-1.03,-0.51), P<0.000 01], low density lipoprotein [MD=-1.12, 95% CI(-1.20,-1.04),P<0.000 01], blood glucose [MD=-1.17, 95% CI(-1.57,-0.77), P<0.000 01] and TCM symptom score [MD=-1.24, 95% CI(-1.53,-0.94),P<0.000 01]. When Liuwei Dihuang Pills was in the decoction form, it could increase high density lipoprotein [MD=0.27,95%CI(0.11,0.43), P=0.000 8] and decrease the total cholesterol [MD=-1.34,95%CI(-1.42,-1.27), P< 0.000 01] compared with the control groups. The result of Egger’s test showed that a publication bias might exist. The trial sequential analysis(TSA) that there was definite evidence for the treatment of type 2 diabetes with Liuwei Dihuang Pills(Tang) in combination with metformin. CONCLUSION Liuwei Dihuang Pills combined with metformin in the treatment of type 2 diabet

关 键 词： 六味地黄丸 汤 二甲双胍 型糖尿病 分析 试验序贯分析

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