沙格列汀改善2型糖尿病患者β细胞功能的Meta分析

Effect of Saxagliptin on the β-cell Function of Patients with Type 2 Diabetes: A Systematic Review

目的系统评价沙格列汀改善2型糖尿病患者β细胞功能的效果。方法计算机检索Cochrane图书馆、PubMed、EMbase、CNKI、VIP和CBM,查找沙格列汀改善2型糖尿病患者β细胞功能的随机对照试验(RCT),检索时限均为从建库至2011年11月,文种限中、英文。按纳入与排除标准筛选文献、提取资料和评价纳入研究的方法学质量后,采用RevMan 5.0软件进行Meta分析。结果共纳入5个RCT,2 815例患者。Meta分析结果显示:在改善2型糖尿病患者Homa-β方面,沙格列汀(或沙格列汀+常规治疗)2.5 mg、5 mg、10 mg组均优于对照组[MD=8.03,95%CI(4.57,11.48),P<0.000 01;MD=7.50,95%CI(4.27,10.73),P<0.000 01;MD=17.45,95%CI(13.93,20.97),P<0.000 01];而在改善Homa-IR方面,沙格列汀5 mg组优于对照组[MD=–0.16,95%CI(–0.27,–0.05),P=0.005],而沙格列汀2.5 mg、10 mg组与对照组相当[MD=–0.05,95%CI(–0.18,0.08),P=0.47;MD=–0.18,95%CI(–0.60,0.24),P=0.4]。结论现有证据表明,沙格列汀在改善β细胞功能及胰岛素耐受方面有一定疗效。由于纳入研究随访时间较短、样本量较小,上述结论尚需高质量、大样本、长期随访的RCT进一步验证。

Objective To evaluate the effects of saxagliptin on β cell function of type 2 diabetic patients. Meth- ods The Cochrane Library, PubMed, EMbase, CBM, VIP, and CNKI were searched from their establishment to No- vember, 2011, for relevant randomized controlled trials on the effects of saxagliptin on 13 cell function in type 2 diabetic patients. Language was limited to Chinese and English only. Two reviewers independently screened the literature ac- cording to the inclusion and exclusion criteria, extracted the data, and evaluated and cross-checked the methodological quality. Then meta-analysis was conducted using RevMan 5.0 software. Results Five RCTs were included. The results of meta-analysis showed that： HOMA-B was significantly increased in the saxagliptin （or saxagliptin plus routine treatment） 2.5 mg, 5 mg, and 10 mg groups （MD=8.03, 95%CI 4.57 to 11.48, P〈0.000 01; MD=7.50, 95%CI 4.27 to 10.73, P〈0.000 01; MD=17.45, 95%CI 13.93 to 20.97, P〈0.000 01）; HOMA-IR was similar between saxagliptin 2.5 or 10 mg group, and control group （MD= -0.05, 95%CI -0.18 to 0.08, P=0.47; MD= -0.18, 95%CI -0.60 to 0.24, P=0.4）. Conclusion Current evidence shows that saxagliptin is effective in improving 13 cell function and insulin resistance. Due to short follow-up and small sample size, this conclusion has to be further proved by more high-quality RCTs.