利司鲁肽治疗2型糖尿病的系统评价

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HbA_1c水平、HbA_1c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。

Systematic review of lixisenatide against type 2 diabetes mellitus

OBJECTIVE To evaluate the efficacy and safety of novel GLP-1 receptor agonist lixisenatide against type 2 diabetes mellitus.METHODS RCT up to May 2016 for on lixisenatide against type 2 diabetes mellitus was retrieved by Chinese and English databases. Two researchers independently reviewed the literatures, performed screening and quality evaluation. RevMan 5.0 software was used to analyze the effects.RESULTS Seven RCTs were included, and literature quality evaluation showed low risk. Totally 2089 patients with type 2 diabetes mellitus were included, including 1 128 in test group (lixisenatide) and 961 in control group (placebo). Meta-analysis results showed that, at the end of the treatment period, HbA1c levels and HbA1c standardized rate (≤6.5%) showed statistical significance (P<0.05), the level of FPG showed no significant difference (P>0.05). Incidences of nausea, vomiting, gastrointestinal disorders, symptomatic hypoglycemia and any AE resulting in discontinuation showed statistical significance (P<0.05), and incidences of diarrhea, headache, dizziness, nasopharyngitis and SAE showed no statistical significance (P>0.05).CONCLUSION In patients receiving lixisenatide, blood glucose level is well controlled, but the incidence of adverse reactions is still quite different. A larger sample size and multi-center, random clinical trial are needed to confirm these findings.