摘要
目的系统评价利拉鲁肽对2型糖尿病患者的疗效和安全性。方法计算机检索MEDLINE、Cochrane图书馆临床对照试验资料库、中国生物医学文献数据库（CBM）、中国知识基础设施工程（CNKI）、万方等数据库，同时筛查纳入文献的参考文献，按纳入与排除标准纳入利拉鲁肽治疗2型糖尿病的随机对照试验。由两名评价员独立评价文献质量、提取资料并交叉核对，而后采用RevMan5．0软件进行荟萃分析。结果共纳入16项临床试验，包括4745例2型糖尿病患者。荟萃分析结果显示：（1）利拉鲁肽组糖化血红蛋白（HbAlC）达标率显著高于磺脲类药物组[RR=2．50，95％CI（1．39，4．47），P〈0．01]，西格列汀组[RR=2．38，95％CI（1．97，2．88），P〈0．01]和安慰剂组[RR=8．83，95％C1（4．02，19．36），P〈0．01]，差异有统计学意义（P〈0．01），但利拉鲁肽联用VI服降糖药组与对照组比较差异无统计学意义（P〉0．05）。（2）利拉鲁肽组胰岛13细胞功能指数（HOMA-13）显著高于对照组，差异有统计学意义[加权均数差（WMD）=25．34，95％CI（18．51，32．18），P〈0．01]。（3）利拉鲁肽组胃肠道不良反应发生率显著高于磺脲类药物组[RR=1．83，95％C1（1．49，2．24），P〈0．01]及口服降糖药联用组[RR=2．76，95％CI（2．25，3．40），P〈0．01]，差异有统计学意义（P〈0．01）。（4）利拉鲁肽组严重不良反应发生率与其他组比较差异均无统计学意义（P〉0．05）。结论现有证据表明利拉鲁肽降糖疗效优于口服降糖药，胃肠道不良反应是其主要副作用，应密切关注严重不良事件。
Objective To evaluate the effect and safety of liraglutide on the patients with type 2 diabetes. Methods We searched for randomized controlled trials in the following electronic databases： MEDLINE, the Cochrane Library, CBM, CNKI and collect all clinical controlled trials. Quality assessment and data extraction were conducted by two reviewers independently. Disagreement were resolved through discussion. All data were analyzed using Review Manager 5.0. Results Sixteen studies involving 4745 participants were included. The results of meta-analysis showed that： （1） percentage reaching an glyeosylated hemoglobin（HbAlc） 〈 7. 0% of liraglutide was sigfinicantly higher than sulfonylurea（ RR = 2. 50, 95%C1（1.39,4.47）,P 〈0.01）, sitagliptin（RR =2.38,95%CI（1.97,2.88）,P 〈0.01） and placebo （ RR = 8.83,95% CI （ 4. 02,19. 36 ） , P 〈 O. 01 ） , but no significant difference was found between liraglutide and oral antidiabetic drug（ P 〉 0. 05 ） ; （ 2 ） [3-cell function （ % ） （ HOMA-[3 ） of liraglutide was significantly higher than controls（ 1VMD = 25.34,95% （31（ 18.51,32. 18 ） , P 〈 0. 01 ） ; （ 3 ） incidence of gastrointestinal disorder of liraglutide was significantly higher than sulfonylurea （RR = 1.83,95% CI（ 1.49, 2. 24）, P 〈 0.01 ） and mixed oral antidiabetie drugs （ RR = 2.76,95 % CI （ 2. 25,3.40 ）, P 〈 0. 01 ） ; （ 4 ） there was no significant difference in the severe adverse reaction between liraglutide and controls （ P 〉 0. 05 ）. Conclusions Based on the current studies, liraglutide is superior to oral antidiabetic drugs. Gastrointestinal disorder is its main adverse reaction and the severe adverse reaction should be closely monitored.
出处
《中华糖尿病杂志》
CAS
2011年第6期449-456,共8页
CHINESE JOURNAL OF DIABETES MELLITUS
