金芪降糖片治疗2型糖尿病改善胰岛功能的系统评价

Jinqi Jiangtang tablets improve islet function in the treatment of type 2 diabetes mellitus: a systematic review

关键词:  金芪降糖片  2型糖尿病  胰岛素抵抗  系统评价  随机对照试验

Key words:  Jinqi Jiangtang tablets  type 2 diabetes mellitus  insulin resistance  systematic review  RCT

摘要:

[目的] 系统评价金芪降糖片治疗2型糖尿病改善胰岛功能的有效性和安全性。[方法] 计算机检索中文全文期刊数据库（CNKI）、万方数据库（Wanfang Data）、中国生物医学文献数据库（SinoMed），英文数据库检索PubMed、Embase、the Cochrane library，检索金芪降糖片治疗2型糖尿病，报告胰岛素敏感性或胰岛素抵抗指数等反应胰岛功能相关指标的随机对照试验（RCTs）。检索时间为建库至2023年6月。由两位研究者独立进行文献筛选、资料提取并，采用Cochrane手册推荐的偏倚风险评估工具对纳入研究进行偏倚风险评价，采用RevMan 5.3.0软件进行统计分析。[结果] 研究纳入16个RCTs，包含患者1 306例。主要结局指标结果如下：在降低胰岛素抵抗（HOMA-IR）方面，金芪降糖片联合胰岛素促泌剂优于胰岛素促泌剂单用，组间差异有统计学意义[MD=-0.69，95%CI（-1.04，-0.35）]；金芪降糖片联合噻唑烷二酮类（TZDs）优于TZDs单用，组间差异有统计学意义[MD=-0.86，95%CI（-1.06，-0.66）]。在改善胰岛β功能（HOMA-IS）方面，金芪降糖片联合TZDs优于TZDs单用，组间比较差异有统计学意义[MD=-0.61，95%CI（-1.99，-0.02）]。在增加胰岛素敏感性指数（Sen、IAI、ISI）方面，金芪降糖片联合二甲双胍优于二甲双胍单用，组间差异有统计学意义[MD=0.45，95%CI（0.19，0.71）]；金芪降糖片联合格列齐特优于单用格列齐特，组间差异有统计学意义[MD=2.00，95%CI（1.28，2.72）]；金芪降糖片联合胰岛素促泌剂优于单用胰岛素促泌剂，差异有统计学意义[MD=0.97，95%CI（0.75，1.20）]。[结论] 当前证据表明，金芪降糖片与胰岛素促泌剂联用在协同降低血糖的同时可改善胰岛素抵抗、增加胰岛素敏感性，降低糖化血红蛋白水平；金芪降糖片与TZDs联用时在改善胰岛素抵抗、增加胰岛素敏感、降血糖、改善空腹胰岛素及餐后2 h胰岛素方面均具有协同作用；金芪降糖片与降糖西药联用不增加不良反应的发生。由于纳入研究质量低，结论尚需要高质量随机对照试验予以验证。

Abstract:

[Objective] To evaluate the efficacy and safety of Jinqi Jiangtang tablets for improving islet function in the treatment of type 2 diabetes mellitus. [Methods] The Chinese full-text Journal Database(CNKI),WanFang Data,and Chinese Biomedical Literature Database(SinoMed) were searched by computer,and the English database was searched by PubMed,Embase,and Cochrane library to search for Jinqi Jiangtang tablets in the treatment of type 2 diabetes from inception to June 2023. Randomized controlled trials(RCTS) reporting insulin sensitivity or insulin resistance index. Literature screening and data extraction were carried out independently by two researchers,and the quality of included studies was evaluated using bias risk assessment tools recommended in the Cochrane manual. RevMan 5.3.0 software was used for statistical analysis. [Results] Sixteen RCTS were included,with a total of 1306 patients. The main outcome indicators were as follows:In terms of reducing insulin resistance(HOMA-IR),Jinqi Jiangtang tablets combined with insulin secretagogues was superior to insulin secretagogues alone,and the difference between groups was statistically significant[MD=-0.69,95%CI(-1.04,-0.35)]. Jinqi Jiangtang tablets combined with thiazolidinediones(TZDs) were superior to TZDs alone,and the difference between groups was statistically significant[MD=-0.86,95%CI(-1.06,-0.66)]. In terms of improving islet β function(HOMA-IS),Jinqi Jiangtang tablets combined with TZDs was superior to TZDs alone,and the difference between groups was statistically significant[MD=-0.61,95%CI(-1.99,-0.02)]. In terms of increasing insulin sensitivity index(Sen,IAI,ISI),Jinqi Jietong tablets combined with metformin was superior to metformin alone,and the difference between groups was statistically significant[MD=0.45,95%CI(0.19,0.71)]. Jinqi Jiangtang tablets combined with gliclazide was superior to Gliclazide alone,and the difference between groups was statistically significant[MD=2.00,95%CI(1.28,2.72)]. Jinqi Jiangtang tablets combined with insulin secretagogues were superior to insulin secretagogues alone,and the difference was statistically significant[MD=0.97,95%CI(0.75,1.20)]. [Conclusion] Current evidence shows that Jinqi Jiangtang tablets combined with insulin secretagogues can improve HOMA-IR,increase insulin sensitivity and reduce the level of glycosylated hemoglobin while synergically reducing blood glucose. Jinqi Jiangtang tablets and TZDs,which increase insulin sensitivity,have synergistic effects on improving insulin resistance,increasing islet function,lowering blood glucose,improving fasting insulin and 2 h postprandial insulin. The combination of Jinqi Jiangtang tablets and Western medicine did not increase the occurrence of adverse reactions. Due to the low quality of the included studies,the conclusions need to be validated by high-quality randomized controlled trials.