Department of Pharmacy, West China Hospital of Sichuan University, Chengdu, Sichuan, PR China.
J Evid Based Med. 2012 Aug;5(3):154-65. doi: 10.1111/j.1756-5391.2012.01189.x.
To evaluate the benefits and harms of sitagliptin in people with type 2 diabetes mellitus.
Randomized controlled trials (RCTs) were retrieved from PubMed, Embase, and the Cochrane central register of controlled trials (Cochrane Library). We used the method recommend by the Cochrane Collaboration to perform a meta-analysis of RCTs of sitagliptin therapy for type 2 diabetes.
Of 817 studies retrieved in the literature search, 18 were eligible for inclusion. When sitagliptin was compared with placebo there was a statistically significant reduction in haemoglobin A1C (HbA1c) (MD = 0.74, 95% CI 0.63 to 0.85) and fasting plasma glucose (FPG) (MD = 1.20, 95% CI 1.03 to 1.38). Sitagliptin significantly improved the homeostasis model assessment of β-cell (HOMA-β index) (MD =-10.84, 95% CI -14.07 to -7.80) versus placebo. In participants treated with placebo, hypoglycemia adverse experiences (RR = 2.11, 95% CI 1.50 to 2.36) and serious adverse experiences (RR = 1.20, 95% CI 0.89 to 1.63) were less common. Meta-analysis did not show a significant difference in change in FPG (MD =-0.32, 95% CI -0.76 to 0.13) or HOMA-β index (MD = 4.42, 95% CI -1.22 to 10.07) between the sitagliptin and active control groups, but active treatments provided modestly greater reduction in HbA1c (MD =-0.20, 95% CI -0.37 to -0.03) compared with sitagliptin. No significant difference was observed between the sitagliptin and active treatments in incidence of hypoglycemia adverse experiences (RR = 0.38, 95% CI 0.14 to 1.08) or serious adverse experiences (RR = 1.15, 95% CI 0.83 to 1.65).
Sitagliptin treatment for type 2 diabetes was effective and well tolerated. Sitagliptin offers a novel therapeutic approach for the treatment of type 2 diabetes. Continued assessment in longer term studies is required to determine the role of sitagliptin in type 2 diabetes.
评估西他列汀在 2 型糖尿病患者中的疗效和安全性。
检索 PubMed、Embase 和 Cochrane 图书馆中的随机对照试验（RCT）。我们使用 Cochrane 协作网推荐的方法对西他列汀治疗 2 型糖尿病的 RCT 进行荟萃分析。
在文献检索中，共检索到 817 项研究，其中 18 项符合纳入标准。与安慰剂相比，西他列汀可显著降低糖化血红蛋白（HbA1c）（MD=0.74，95%CI：0.63 至 0.85）和空腹血糖（FPG）（MD=1.20，95%CI：1.03 至 1.38）。西他列汀可显著改善胰岛β细胞功能的稳态模型评估（HOMA-β 指数）（MD=-10.84，95%CI：-14.07 至-7.80）。与安慰剂组相比，接受安慰剂治疗的患者低血糖不良事件（RR=2.11，95%CI：1.50 至 2.36）和严重不良事件（RR=1.20，95%CI：0.89 至 1.63）的发生率较低。Meta 分析显示，西他列汀与活性对照组之间在 FPG（MD=-0.32，95%CI：-0.76 至 0.13）或 HOMA-β 指数（MD=4.42，95%CI：-1.22 至 10.07）的变化方面无显著差异，但活性治疗可适度降低 HbA1c（MD=-0.20，95%CI：-0.37 至-0.03），与西他列汀相比。西他列汀与活性治疗在低血糖不良事件（RR=0.38，95%CI：0.14 至 1.08）或严重不良事件（RR=1.15，95%CI：0.83 至 1.65）的发生率方面无显著差异。
西他列汀治疗 2 型糖尿病有效且耐受良好。西他列汀为 2 型糖尿病的治疗提供了一种新的治疗方法。需要在更长时间的研究中进一步评估西他列汀在 2 型糖尿病中的作用。
