那格列奈治疗2型糖尿病有效性与安全性的Meta分析

Effectiveness and Safety of Nateglinide for Type 2 Diabetes Mellitus: A Meta-Analysis

目的系统评价那格列奈(NATE)与米格列奈(MITI)比较治疗2型糖尿病(T2DM)的有效性和安全性。方法计算机检索PubMed、EMbase、MEDLINE、The Cochrane Library(2013年第3期)、CNKI、VIP和WanFang Data,收集NATE与MITI比较治疗T2DM的随机对照试验(RCT),检索时限为从建库至2013年10月。由2位评价员按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用RevMan 5.2软件进行Meta分析。结果最终纳入8个RCT,共计966例患者。Meta分析结果显示:1 NATE组在降低FPG[WMD=0.07,95%CI(–0.19,0.34),P=0.58]、2hPG[WMD=0.33,95%CI(–0.22,0.87),P=0.24]、HbA1c[WMD=0.11,95%CI(–0.03,0.25),P=0.12]方面与MITI组疗效相似,其差异均无统计学意义。2两组均能显著降低胰岛素抵抗水平、改善B细胞功能及抑制氧化应激。3两组在低血糖[OR=1.49,95%CI(0.85,2.60),P=0.17]和胃肠道不良反应发生率[OR=–0.80,95%CI(0.37,1.75),P=0.58]方面差异均无统计学意义。结论 NATE和MITI在治疗T2DM的有效性和安全性方面差异无统计学意义。受纳入研究数量和质量所限,上述结论尚待开展更多大样本、多中心的高质量研究进行验证。

Objective To systematically review the effectiveness and safety of nateglinide versus mitiglinide in patients with type 2 diabetes mellitus （T2DM）. Methods Such databases as PubMed, EMbase, MEDLINE, The Cochrane Library （Issue 3, 2013）, CNKI, VIP and WanFang Data were searched through computer to investigate references and collect randomized controlled trials （RCTs） about nateglinide （trial group） compared with mitiglinide （control group） in treating T2DM from the date of their establishment to October 2013. Literature screening according to the inclusion and exclusion criteria, data extraction and methodological quality assessment of the included studies were completed by two reviewers independently. Meta-analysis was then conducted using RevMan 5.2 software. Results A total of eight RCTs involving 966 patients were included. The results of meta-analysis indicated that： a） the effects of nateglinide were similar to those of mitiglinide in lowering FPG （WMD=0.07, 95%CI -0.19 to 0.34, P=0.58）, 2hPG （WMD=0.33, 95%CI -0.22 to 0.87, P=0.24）, and HbAlc （WMD=0.11, 95%CI -0.03 to 0.25, P=0.12）. b） In both groups, insulin resistance levels were lowered down, B-cell function was improved, and oxidative stress was significantly suppressed, c） No significant difference was found between the two groups in the incidences of hypoglycemia （OR=1.49, 95%CI 0.85 to 2.60, P=0.17） and gastro- intestinal adverse reaction （OR= -0.80, 95%CI 0.37 to 1.75, P=0.58）. Conclusion Nateglinide and mitiglinide have the similar effectiveness and safety in the treatment of T2DM. Due to the limited quantity and quality of the included studies, the above conclusion should be probed by more large-scale multicenter high quality studies in future.