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二肽基肽酶-4 抑制剂在伴有中重度慢性肾脏疾病的 2 型糖尿病患者中的作用:使用未调整数据的随机对照试验的荟萃分析。

Effects of dipeptidyl peptidase-4 inhibitors in type 2 diabetes patients with moderate to severe chronic kidney disease: Meta-analysis of randomized controlled trials using unadjusted data.

机构信息

Department of Nephrology, Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China.

出版信息

J Diabetes. 2017 Dec;9(12):1107-1117. doi: 10.1111/1753-0407.12546. Epub 2017 May 29.

DOI:10.1111/1753-0407.12546
PMID:28266136
Abstract

BACKGROUND

Three meta-analyses recently evaluated the effects of dipeptidyl peptidase (DPP)-4 inhibitors in type 2 diabetes (T2D) patients with chronic kidney disease (CKD). However, the combination of adjusted and unadjusted data in these meta-analyses may be questionable. The present study performed a meta-analysis of the effects of DPP-4 inhibitors in T2D patients with moderate to severe CKD using unadjusted data from randomized controlled trials (RCTs).

METHODS

The PubMed, Embase (via Ovid), and Cochrane Central databases were searched for papers regarding the effects of DPP-4 inhibitors in CKD patients published before 1 August 2016. Data were independently extracted by two authors. A pooled analysis of unadjusted data was performed using random-effects models.

RESULTS

Twelve studies representing 10 RCTs were included in the present analysis. Comparing mean HbA1c change between placebo and treatment, DPP-4 inhibitors significantly improved HbA1c levels at 12 weeks (mean difference [MD] -0.42; 95% confidence interval [CI] -0.54, -0.29), but improvements in HbA1c were seen only in dialysis patients at 24 weeks (MD -0.52; 95% CI -0.72, -0.32)*. Improvements in HbA1c were equivalent between DPP-4 inhibitors and sulfonylureas at 52 or 54 weeks. There were no significant differences in the incidence of severe or any hypoglycemic events between DPP-4 inhibitors and control (placebo or sulfonylureas) at 12, 24, and 52 or 54 weeks. However, DPP-4 inhibitors induced fewer symptomatic hypoglycemic events compared with sulfonylureas at 52 or 54 weeks. *[Correction added on 30 October 2017, after first online publication: The value '0.32' has been corrected to '-0.32'.] CONCLUSIONS: The present analysis shows that DPP-4 inhibitors are effective and comparable with sulfonylureas in T2D patients with moderate to severe CKD.

摘要

背景

最近有三项荟萃分析评估了二肽基肽酶-4(DPP-4)抑制剂在合并慢性肾脏病(CKD)的 2 型糖尿病(T2D)患者中的作用。然而,这些荟萃分析中调整后和未调整数据的结合可能存在疑问。本研究使用来自随机对照试验(RCT)的未调整数据对 DPP-4 抑制剂在合并中重度 CKD 的 T2D 患者中的作用进行了荟萃分析。

方法

检索了截至 2016 年 8 月 1 日发表的有关 DPP-4 抑制剂在 CKD 患者中作用的文献,检索PubMed、Embase(通过 Ovid)和 Cochrane 中心数据库。两位作者独立提取数据。采用随机效应模型对未调整数据进行汇总分析。

结果

本分析纳入了 10 项 RCT 的 12 项研究。与安慰剂相比,DPP-4 抑制剂在 12 周时显著降低平均糖化血红蛋白(HbA1c)水平(平均差值[MD] -0.42;95%置信区间[CI] -0.54,-0.29),但仅在透析患者中观察到 24 周时 HbA1c 的改善(MD -0.52;95% CI -0.72,-0.32)。DPP-4 抑制剂与磺酰脲类药物在 52 或 54 周时的 HbA1c 改善程度相当。在 12、24 和 52 或 54 周时,DPP-4 抑制剂与对照组(安慰剂或磺酰脲类药物)之间严重或任何低血糖事件的发生率均无显著差异。然而,与磺酰脲类药物相比,DPP-4 抑制剂在 52 或 54 周时引起的症状性低血糖事件更少。[2017 年 10 月 30 日更正:首次在线发表后,对第 12、24、52 和 54 周时“0.32”的值进行了更正,改为“-0.32”。]

结论

本分析表明,在合并中重度 CKD 的 T2D 患者中,DPP-4 抑制剂是有效的,与磺酰脲类药物相当。

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