艾塞那肽与胰岛素治疗2型糖尿病疗效与安全性的Meta分析

A meta-analysis of exenatide versus insulin for type 2 diabetes

目的对艾塞那肽与胰岛素治疗2型糖尿病疗效与安全性进行Meta分析。方法计算机检索Cochrane图书馆、Pubmed、Embase、Elsevier、万方数据库、CNKI数据库,并检索了入选文献的参考文献以及ClinicalTrials.gov等。收集艾塞那肽与各种胰岛素治疗2型糖尿病的临床效果与安全性的随机对照试验(RCT),对纳入的RCT进行质量评价,并用RevMan5.2软件进行Meta分析,糖化血红蛋白(HbA1C)变化值等连续变量结果采用均数差值(MD)进行分析,HbA1C<7%的患者比例等计数资料结果采用相对危险度(RR)进行分析。结果共纳入13个RCT,Meta分析结果显示:与长效胰岛素相比,使用艾塞那肽后空腹血糖下降的效果不如长效胰岛素(MD=0.83,95%CI:0.19～1.48,P<0.05);降低体重的效果优(MD=-3.68,95%CI:-4.68～-2.70,P<0.000 01);降低总胆固醇(MD=-0.16,95%CI:-0.24～-0.08,P<0.000 1)和收缩压(MD=-3.65,95%CI:-5.59～-1.71,P=0.000 2)的效果好;发生低血糖的概率低(RR=0.58,95%CI:0.39～0.86,P=0.007)。与预混胰岛素相比,艾塞那肽降低体重的效果优(MD=-5.52,95%CI:-5.86～-5.18,P<0.000 01),发生低血糖的概率少(RR=0.34,95%CI:0.25～0.47,P<0.000 01)。结论现有资料表明,艾塞那肽降低血糖的效果与各种胰岛素无显著差异,但能显著降低2型糖尿病患者的体重、心血管事件和低血糖发生率。但其长期疗效和安全性尚需进一步研究。

AIM To review the efficacy and safety profiles of exenatide versus insulin in type 2 diabetes. METHODS A systematic search of literature was performed in the Cochrane library, Pubmed, Embase, Elsevier, CNKI and Wanfang databases. Additional data were obtained from reference lists of included trials and relevant Web sites. Randomized controlled trials （RCTs） were included if they compared the efficacy of exenatide with insulin in patients with type 2 diabetes, and reported one or more than one outcomes, including blood glucose, weight, lipids, blood pressure and adverse reactions. The quality of the eligible studies were assessed and the dates were analyzed by using RevMan 5.2 software. Changes in HbAlc levels and other measurement data were reported as mean difference （MD） while proportion of subjects achieving HbA1c 〈 7% and count data were reported as relative risk （RR） for statistical analysis. RESULTS Thirteen RCTs that met the inclusion criteria were identified. The results of the meta- analysis suggested that long- acting insulin was inferior to reduce the fasting blood glucose （MD = 0.83, 95%CI： 0.19 - 1.48, P 〈 0.05） and exhibited greater incidence of hypoglycemia （RR = 0.58, 95%CI： 0.39 ～ 0.86, P = 0.007）. Exenatide was more effective to reduce weight （MD = -3.68, 95%CI： -4.68 ～ -2.70, P 〈 0.000 01）, total cholesterol levels （MD = -0.16, 95%CI： -0.24 ～ -0.08, P 〈 0.000 1） and systolic blood pressure （MD = -3.65, 95%CI： -5.59 ～ -1.71, P = 0.000 2）. Premixed insulin aspart 70/30 exhibited greater incidence of hypoglycemia （RR = 0.34, 95% CI： 0.25 ～0.47, P 〈 0.000 01） while exenatide was more reliable for reducing weight （MD = -5.52, 95%CI： -5.86 ～ -5.18, P 〈 0.000 01）. CONCLUSION Compared with insulin, exenatide exhibits comparable effects on reducing HbAlc levels and FBG levels, however, exenatide shows greater effects on decreasing weight and incidence of hypoglycemia and cardiovascular events. More trials are needed to determine the exact long-term efficacy and safety profiles of exenatide.