| 引用本文:陈宇1，陈小愚1，苏冠旬1，王世东2，肖永华2.六味地黄丸及其类方联合二甲双胍治疗2型糖尿病疗效的Meta分析[J].世界中医药,2023,(07):. |
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| 六味地黄丸及其类方联合二甲双胍治疗2型糖尿病疗效的Meta分析 |
| Meta-analysis of the Therapeutic Effect of Liuwei Dihuang Pills and Its Analogues Combined with Metformin in the Treatment of Type 2 Diabetes Mellitus |
| 投稿时间：2021-07-22 |
| DOI：10.3969/j.issn.1673-7202.2023.07.017 |
| 中文关键词: Meta分析 系统评价 2型糖尿病 六味地黄丸 二甲双胍 随机对照试验 中西医结合疗法 类方 |
| English Keywords:Meta-analysis Systematic evaluation Type 2 diabetes mellitus Liuwei Dihuang Pills Metformin Randomized controlled trial Integrated traditional Chinese and western medicine therapy Analogous prescriptions |
| 基金项目:国家重点研发计划项目（2018YFC1704402）——阴虚证辨证标准的系统研究 |
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| 中文摘要: |
| 目的：系统评价六味地黄丸及其类方联合二甲双胍治疗2型糖尿病（T2DM）的有效性和安全性，为临床应用提供依据。方法：系统检索国家知识基础设施数据库（CNKI）、中国学术期刊数据库(CSPD)、中文科技期刊数据库(CCD)、中国生物医学文献数据库(CBM)、PubMed、Embase、Web of Science、EIsevier，收集六味地黄丸及其类方联合二甲双胍治疗T2DM的临床随机对照试验（RCT）。采用Cochrane风险评价表评价文献的研究质量，RevMan 5.3.3软件进行Meta分析。结果：共纳入37个RCT包括4 101例患者。Meta分析显示：观察组患者的总有效率（OR=6.07,95%CI为4.70~-7.83,P<0.000 01）、对空腹血糖（FBG,MD=-1.59,95%CI为-1.82~-1.36，P<0.000 01）、餐后2 h血糖（2 h PBG,MD=-1.61，95%CI为-1.89~-1.34，P<0.000 01）、糖化血红蛋白（HbA1c,MD=-1.13，95%CI为-1.32~-0.93，P<0.000 01）、血清总胆固醇（TC,MD=-0.57，95%CI为-0.89~-0.25，P<0.000 5）、三酰甘油（TG,MD=-0.39，95%CI为-0.58~-0.19，P<0.000 01）、低密度脂蛋白（LDL,MD=0.24，95%CI为0.12~0.35，P<0.000 1）、胰岛素抵抗指数（MOHA-IR,MD=-1.11，95%CI为-1.57~-0.64），P<0.000 01)、空腹胰岛素水平(FINS,MD=-5.97，95%CI为-7.90~-4.04，P<0.000 01）的降低和对高密度脂蛋白（HDL-C）的升高均优于对照组（MD=0.24，95%CI为0.12~0.35，P<0.000 1）。亚组分析显示，六味地黄丸类方各组对FBG、2 h PBG、HbA1c、TC、LDL-C、MOHA-IR、FINS的降低也优于对照组。结论：六味地黄丸及其类方联合二甲双胍治疗2型糖尿病疗效显著，不良反应少。目前整体研究质量偏低，未来需要设计更严谨、更大样本研究证实相关结论。 |
| English Summary: |
| To systematically evaluate the therapeutic effect and safety of Liuwei Dihuang Pills and its analogous prescriptions combined with metformin in the treatment of type 2 diabetes mellitus(T2DM) and provide a basis for clinical application.Methods:China National Knowledge Infrastructure(CNKI)，China Science Periodical Database(CSPD)，Chinese Citation Database(CCD)，China Biology Medicine(CBM)，PubMed，Embase，Web of Science，and Elsevier were searched for the randomized controlled trials(RCTs) on the treatment of T2DM with Liuwei Dihuang Pills and its analogous prescriptions.The Cochrane risk of bias assessment tool was employed to evaluate the quality of the RCTs，and RevMan 5.3.3 was used for meta-analysis.Results:A total of 37 RCTs involving 4 101 patients were included in this study.Meta-analysis showed that the observation group outperformed the control group in increasing the total effective rate(OR=6.07，95%CI 4.70 to -7.83，P<0.000 01)，fasting blood glucose(FBG，MD=-1.59，95%CI -1.82 to -1.36，P<0.000 01)，2 h postprandial blood glucose(2h PBG，MD=-1.61，95%CI -1.89 to -1.34)，P<0.000 01)，glycosylated hemoglobin(HbA1c，MD=-1.13，95%CI -1.32 to -0.93)，P<0.000 01)，total cholesterol(TC，MD=-0.57，95%CI -0.89 to -0.25，P<0.000 5)，triglycerides(TG，MD=-0.39，95%CI -0.58 to -0.19，P<0.000 01)，low-density lipoprotein cholesterol(LDL-C，MD=0.24，95%CI 0.12 to 0.35，P<0.000 1)，Homeostatic Model Assessment for Insulin Resistance(HOMA-IR，MD=-1.11，95%CI -1.57 to -0.64，P<0.000 01)，and fasting insulin(FINS，MD=-5.97，95%CI -7.90 to -4.04，P<0.000 01) and in reducing high-density lipoprotein cholesterol(MD=0.24，95%CI 0.12 to 0.35，P<0.000 1).Subgroup analysis showed that the group with the application of Liuwei Dihuang Pills was superior to the control group in lowering FBG，2h PBG，HbA1c,TC，LDL-C，HOMA-IR，and FINS.Conclusion:Liuwei Dihuang Pills and its analogous prescriptions combined with metformin demonstrated significant therapeutic effect in the treatment of T2DM with few adverse reactions.Since the available RCTs generally had low quality，the conclusions remain to be validated by the studies with more rigorous design and larger sample sizes. |
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