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目的:系统评价新型GLP-1受体激动剂利司鲁肽治疗2型糖尿病的疗效与安全性。方法:电子检索中英文数据库中有关利司鲁肽治疗2型糖尿病的随机临床试验(RCT),时限至2016年5月;2位研究者独立评阅文献,并筛选及予以质量评价;采用RevMan 5.0软件对各效应指标进行Meta分析。结果:纳入7篇RCT,文献质量评价均属低偏倚风险,2型糖尿病患者共计2 089例,其中试验组(利司鲁肽治疗)1 128例,对照组(安慰剂)961例,Meta分析结果显示,于治疗周期末,2组HbA1c水平、HbA1c达标率(≤6.5%)有统计学差异(P<0.05),FPG水平变化无统计学差异(P>0.05),恶心、呕吐、胃肠功能紊乱、低血糖反应及因不良事件(AE)退出治疗的发生率有统计学差异(P<0.05),腹泻、头痛、头晕、鼻咽炎及SAE发生率无统计学差异(P>0.05)。结论:利司鲁肽对2型糖尿病患者血糖水平有较好控制作用,但其不良反应发生率仍有较大差异,尚需更多大样本、多中心随机临床试验予以证实。
Objective: To systematically evaluate the efficacy and safety of a new GLP-1 receptor agonist, lipase, in the treatment of type 2 diabetes mellitus. METHODS: Electronic randomized clinical trials (RCTs) were conducted in both Chinese and English databases on the treatment of type 2 diabetes with liserudin, with a time limit of up to May 2016; two independent reviewers reviewed and screened and evaluated their quality; RevMan 5.0 Software Meta-analysis of the various indicators of the effect. Results: Seven RCTs were included in the literature. The quality of the literatures were all at low risk of bias. A total of 2,089 patients with type 2 diabetes were included. Among them, 1 128 in the study group (treatment with liluzlutamate), 961 in the control group (placebo) and Meta-analysis The results showed that at the end of the treatment period, there were significant differences in HbA1c and HbA1c (≤ 6.5%) between the two groups (P <0.05) and no significant difference in FPG levels (P> 0.05) The incidence of dysfunction, hypoglycemia and withdrawal due to adverse events (AE) were statistically significant (P <0.05). There was no significant difference in the incidence of diarrhea, headache, dizziness, nasopharyngitis and SAE between the two groups (P> 0.05). Conclusion: Lizcermitin has a better control effect on blood glucose level in patients with type 2 diabetes, but the incidence of adverse reactions is still quite different. More large samples are needed, and multi-center randomized clinical trials confirm.