基于GRADE系统的胰高血糖素样肽1受体激动剂治疗2型糖尿病的系统评价的再评价

Reappraisal of Systematic Reviews of Glucagon-like Peptide-1 Receptor Agonist in the Treatment of Type 2 Diabetes Mellitus Based on GRADE System

目的:对胰高血糖素样肽1(GLP-1)受体激动剂治疗2型糖尿病(T2DM)的有效性和安全性的系统评价/Meta分析进行再评价,以期为临床应用该类药物治疗T2DM提供循证参考。方法:计算机检索Cochrane图书馆、PubMed、Embase、中国生物医学文献数据库、万方数据库和中国知网,搜集GLP-1受体激动剂治疗T2DM的系统评价/Meta分析,检索时限均为各数据库建库起至2019年12月。对符合纳入与排除标准的文献进行资料提取后,采用证据质量分级和推荐强度(GRADE)系统对纳入研究的证据质量等级进行评价,并对疗效和安全性的结局指标证据进行总结。结果:最终纳入31篇文献,结局指标共计91个,总体GRADE证据质量为中高质量,其中极低质量的结局指标有4个(4.4%),低质量的结局指标有33个(36.3%),中等质量的结局指标有45个(49.5%),高质量的结局指标有9个(9.9%)。证据总结表明,GLP-1受体激动剂降低糖化血红蛋白(HbA1c)水平的程度优于或类似于安慰剂和其他口服降糖药,优于二肽基肽酶(DPP-4)抑制剂;降低空腹血糖水平的程度优于或类似于安慰剂,优于其他口服降糖药和DPP-4抑制剂;引起低血糖的发生率与DDP-4类似,高于或类似于安慰剂,低于其他口服降糖药;引起腹泻、恶心的发生率高于其他口服降糖药、安慰剂和DPP-4抑制剂;引起呕吐的发生率高于其他口服降糖药和安慰剂。结论:GLP-1受体激动剂治疗T2DM的系统评价/Meta分析的证据质量为中高质量;该类药物治疗T2DM具有较好的临床疗效,但安全性不及安慰剂或其他口服降糖药。

OBJECTIVE:To reappraise systematic review/Meta-analysis(SRs/MAs)of the efficacy and safety of glucagon-like peptide 1(GLP-1)receptor agonist in the treatment of type 2 diabetes mellitus(T2 DM),and to provide evidence-based reference for clinical use of these drugs in the treatment of T2 DM.METHODS:Retireved from Cochrane library,PubMed,Embase,CBM,Wanfang database and CNKI,systematic review/Meta-analysis about GLP-1 receptor agonist in the treatment of T2 DM were collected during the inception to Dec.2019.After data extraction of literatures met inclusion and exclusion criteria,GRADE system was used to evaluate the quality of evidence included in the study,and the evidence of efficacy and safety outcome indexes were summarized.RESULTS:Finally 31 literatures were included,involving 91 outcome indexes,and GRADE evidence quality was medium,among which 4(4.4%)were very-low-quality,33(36.3%)were low-quality,45(49.5%)were medium-quality,and 9(9.9%)were high-quality outcome indicators.The results of evidence summary showed that GLP-1 receptor agonists were better than or similar to placebo and other oral hypoglycemic drugs,better than dipeptidyl peptidase 4(DPP-4)inhibitors in reducing the level of HbA1 c;better than or similar to placebo,better than other oral hypoglycemic agents and DPP-4 inhibitors in reducing the level of fasting glucose;similar to DDP-4 inhibitors,higher than or similar to placebo,lower than other oral hypoglycemic drugs in the incidence of hypoglycemia;higher than other oral hypoglycemic drugs,placebo and DPP-4 inhibitors in the incidence of diarrhea and nausea;higher than other oral hypoglycemic drugs and placebo in the incidence of vomiting.CONCLUSIONS:The evidence quality of systematic review/Meta-analysis about GLP-1 receptor agonist in the treatment of T2 DM are moderate.These drugs have good clinical efficacy in the treatment of T2 DM,but their safety are not as good as placebo or other oral hypoglycemic drugs.