目的:系统评价西格列汀改善2型糖尿病患者胰岛B细胞功能的效果,为临床提供循证参考。方法:计算机检索 PubMed、Cochrane图书馆、EMBase、中国期刊全文数据库、万方数据库、中文科技期刊数据库和中国生物医学文献数据库,收集西格列汀单药或联合常规方案(试验组)对比安慰剂单用或联合常规方案(对照组)治疗2型糖尿病的随机对照试验(RCT),由两位研究者根据纳入与排除标准独立筛选文献、提取资料,按照Cochrane系统评价员手册5.1.0评价纳入研究的方法学质量后,采用 Rev Man 5.3统计软件进行Meta分析。结果:纳入了5项RCT,合计1 253例患者。Meta分析结果显示,试验组患者胰岛B 细胞功能指数(Homa-B)变化值[西格列汀单药治疗组:MD=9.21,95%CI(4.16,14.25),P<0.001;联合用药组:MD=7.24,95%CI(0.80,13.68),P=0.03]和胰岛素抵抗指数(Homa-IR)变化值[西格列汀单药治疗组:MD=-0.40,95%CI(-0.44,-0.36),P<0.001;联合用药组:MD=-0.35,95%CI(-0.63,-0.07),P=0.02]均显著优于对照组,差异均有统计学意义。结论:西格列汀在改善胰岛B细胞功能及胰岛素抵抗方面有一定效果。
Abstract
OBJECTIVE: To evaluate the improvement effects of sitagliptin on islet B-cell function in type 2 diabetic patients systematically, and to provide evidenced-based reference. METHODS: Retrieved from PubMed, Cochrane library, EMBase, CJFD, Wanfang database, VIP and CBM, RCTs about sitagliptin alone or combined with routine plan (trial group) vs. placbo alone or combined with routine plan (control group) in the treatment of type 2 diabetes were collected. Two reviewers independently screened studies according to exclusion and inclusion criteria, extracted data, and assessed the methodological quality according to Cochrane Manual 5.1.0. Meta-analysis was performed by using RevMan 5.3 software. RESULTS: A total of 5 RCTs were included, involving 1 253 patients. The result of Meta-analysis showed that changes of islet B cell function index (Homa-B) [sitagliptin alone group: MD=9.21,95%CI(4.16, 14.25),P<0.001; drug combination group: MD=7.24,95%CI(0.80, 13.68),P=0.03] and changes of insulin resistance index (Homa-IR) [sitagliptin alone group: MD=-0.40,95%CI(-0.44,-0.36),P<0.001; drug combination group: MD=-0.35,95%CI(-0.63,-0.07),P=0.02] of trial group were significantly better than those of control group, with statistical significance. CONCLUSIONS: Sitagliptin shows certain therapeutic efficacy in improving islet B cell function and insulin resistance.