津力达颗粒联合二甲双胍治疗2型糖尿病有效性及安全性的Meta分析

Meta-analysis of the efficacy and safety of Jinlida Granules combined with metformin in the treatment of type 2 diabetes mellitus

目的系统评价津力达颗粒联合二甲双胍治疗2型糖尿病(T2DM)的有效性及安全性,为临床使用提供相应的依据。方法系统检索国家知识基础设施数据库、万方数据知识服务平台、维普网、PubMed数据库,检索时间为建库起至2023年4月15日,检索津力达颗粒联合二甲双胍治疗T2DM的研究文献。由2名研究者共同完成文献筛选、质量评价以及资料的提取,使用RevMan5.4软件对纳入的文献进行Meta分析。对比津力达颗粒联合二甲双胍组(试验组)与二甲双胍组(对照组)空腹血糖(FPG)、餐后2小时血糖(2 hPG)、糖化血红蛋白(HbA_(1c))及不良反应等指标。结果最终纳入6项随机对照试验,总样本量618例,其中试验组310例,对照组308例。Meta分析结果显示,试验组降低HbA_(1c)的效果高于对照组[MD(95%CI)=-0.69(-1.01~-0.37),P<0.001],试验组降低FPG的效果高于对照组[MD(95%CI)=-1.28(-2.25~-0.31),P=0.001],试验组降低2 hPG的效果高于对照组[MD(95%CI)=-0.77(-1.23~-0.30),P=0.002],试验组与对照组不良反应的发生率差异无统计学意义[OR(95%CI)=0.52(0.26~1.03),P=0.063]。结论津力达颗粒联合二甲双胍治疗T2DM疗效显著,优于单用二甲双胍,且增加不良反应的风险小。

Objective To systematically evaluate the efficacy and safety of Jinlida Granules combined with metformin in the treatment of type 2 diabetes mellitus(T2DM),so as to provide a corresponding basis for clinical use.Methods The National Knowledge Infrastructure Database,Wanfang Data Knowledge Service Platform,VIP.com,and PubMed databases were systematically searched from the establishment of the database to April 15,2023,and the research literature of Jinlida Granules combined with metformin in the treatment of T2DM was searched.Two researchers jointly completed the literature screening,quality evaluation and data extraction,and the included literature were meta-analyzed using RevMan5.4 software.The fasting blood glucose(FPG),2-hour postprandial blood glucose(2hPG),glycosylated hemoglobin(HbA_(1c))and adverse reactions of Jinlida Granules combined with metformin group(experimental group)and metformin group(control group)were compared.Results Six randomized controlled trials with a total sample size of 618 cases were included,including 310 in the experimental group and 308 in the control group.The results of meta-analysis showed that the effect of reducing HbA_(1c) in the experimental group was higher than that in the control group[MD(95%CI)=-0.69(-1.01 to-0.37),P<0.001],the effect of reducing FPG in the experimental group was higher than that in the control group[MD(95%CI)=-1.28(-2.25 to-0.31),P=0.001],the effect of reducing 2hPG in the experimental group was higher than that in the control group[MD(95%CI)=-0.77(-1.23 to-0.30),P=0.002],and there was no significant difference in the incidence of adverse reactions between the experimental group and the control group[OR(95%CI)=0.52(0.26-1.03),P=0.063].Conclusion The efficacy of Jinlida Granules combined with metformin in the treatment of T2DM is significant,which is better than metformin alone,and the risk of adverse reactions is small.