Wang Wen, Gao Yun, Chen Dawei, Wang Chun, Feng Xiaobing, Ran Xingwu
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, People's Republic of China.
Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, People's Republic of China.
Diabetes Res Clin Pract. 2017 Jul;129:213-223. doi: 10.1016/j.diabres.2017.05.007. Epub 2017 May 12.
In patients with type 2 diabetes, incretin-based therapies can improve glucose control without increased weight gain or hypoglycemia. Incretin-based drugs added to insulin therapy in type 1 diabetes (T1DM) have also been tried in many studies. However, the results were controversial. We thus performed a meta-analysis to assess the efficacy and safety of incretin-based therapies in patients with T1DM.
We systematically searched Medline, EMBASE, and Cochrane Central Register of Controlled Trials for relevant studies published before August 25, 2016. Data was extracted by two independent reviewers. The main outcomes included glycosylated hemoglobin (HbA1c), insulin dose, weight, hypoglycemia, ketosis and ketoacidosis. All pooled data were assessed using random-effects model.
Twelve randomized controlled trials with a total of 2903 individuals were finally included into the meta-analysis. Incretin-based drugs could significantly reduce HbA1c (MD -0.20, 95% CI -0.30 to -0.10), weight (MD -2.83, 95% CI -4.00 to -1.65) and insulin dose (MD -4.55, 95% CI -6.15 to -2.94). Furthermore, incretin-based drugs did not increase relative risk of severe hypoglycemia (RR 0.79, 95% CI 0.58 to 1.06), ketosis (RR 1.37, 95% CI 0.95 to 1.97) and ketoacidosis (RR 2.62, 95% CI 0.31 to 21.99).
Incretin-based treatment in patients with T1DM may improve glycemic control and reduce insulin dose and weight without increasing the risk of serious adverse event, such as severe hypoglycemia, ketosis or ketoacidosis. The current evidence for the aforementioned adverse effects, however, is weak. A rigorous monitoring of these adverse events should be implemented in well-designed observational studies.
在2型糖尿病患者中,基于肠促胰岛素的疗法可改善血糖控制,且不会增加体重或导致低血糖。在1型糖尿病(T1DM)患者中,将基于肠促胰岛素的药物添加到胰岛素治疗中也已在许多研究中进行了尝试。然而,结果存在争议。因此,我们进行了一项荟萃分析,以评估基于肠促胰岛素的疗法在T1DM患者中的疗效和安全性。
我们系统检索了Medline、EMBASE和Cochrane对照试验中心注册库,以获取2016年8月25日前发表的相关研究。由两名独立的评审员提取数据。主要结局包括糖化血红蛋白(HbA1c)、胰岛素剂量、体重、低血糖、酮症和酮症酸中毒。所有汇总数据均使用随机效应模型进行评估。
最终有12项随机对照试验(共2903名个体)纳入荟萃分析。基于肠促胰岛素的药物可显著降低HbA1c(MD -0.20,95%CI -0.30至-0.10)、体重(MD -2.83,95%CI -4.00至-1.65)和胰岛素剂量(MD -4.55,95%CI -6.15至-2.94)。此外,基于肠促胰岛素的药物不会增加严重低血糖(RR 0.79,95%CI 0.58至1.06)、酮症(RR 1.37,95%CI 0.95至1.97)和酮症酸中毒(RR 2.62,95%CI 0.31至21.99)的相对风险。
T1DM患者采用基于肠促胰岛素的治疗可能改善血糖控制,降低胰岛素剂量和体重,且不会增加严重不良事件(如严重低血糖、酮症或酮症酸中毒)的风险。然而,目前关于上述不良反应的证据不足。应在精心设计的观察性研究中对这些不良事件进行严格监测。