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在2型糖尿病患者中,胰岛素治疗联合二肽基肽酶-4抑制剂的疗效与安全性:一项系统评价与荟萃分析。

Efficacy and safety of the addition of a dipeptidyl peptidase-4 inhibitor to insulin therapy in patients with type 2 diabetes: A systematic review and meta-analysis.

作者信息

Kim Yeong Gi, Min Se Hee, Hahn Seokyung, Oh Tae Jung, Park Kyong Soo, Cho Young Min

机构信息

Division of Endocrinology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea; Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, South Korea.

Division of Endocrinology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.

出版信息

Diabetes Res Clin Pract. 2016 Jun;116:86-95. doi: 10.1016/j.diabres.2016.03.011. Epub 2016 Apr 23.

Abstract

AIMS

To compare the efficacy and safety of the addition of a dipeptidyl peptidase-4 (DPP-4) inhibitor or a placebo in patients with type 2 diabetes inadequately controlled with insulin.

METHODS

We searched randomised controlled trials (RCTs) from MEDLINE, EMBASE, LILACS, the Cochrane Central Register of Controlled Trials and the ClinicalTrials.gov online registry. Studies of at least 12week treatment duration were eligible if they were RCTs in patients with type 2 diabetes comparing addition of a DPP-4 inhibitor to insulin therapy (INS/DPP4i) with addition of a placebo to insulin therapy (INS/PCB) and contained information on the change in glycated haemoglobin (HbA1c) from baseline.

RESULTS

Of 3105 potentially relevant published articles and 206 registered trials, 9 studies were included for meta-analysis. Compared to INS/PCB, INS/DPP4i exhibited a greater reduction in HbA1c (weighted mean difference [WMD] -0.58%; 95% CI -0.70, -0.46) and fasting plasma glucose (WMD -0.59mmol/L; 95% CI -0.79, -0.40) with less daily insulin doses (WMD -1.86IU; 95% CI -3.27, -0.45) and with no difference in weight gain (WMD -0.04kg; 95% CI -0.25, 0.16). The risk of hypoglycaemia was similar between INS/DPP-4i and INS/PCB (the RR in favour of INS/PCB was 0.94; 95% CI 0.84, 1.05).

CONCLUSIONS

Compared to placebo, DPP-4 inhibitors exhibit a better glycaemic control without further increasing the risk of weight gain and hypoglycaemia in patients with type 2 diabetes inadequately controlled with insulin.

摘要

目的

比较在胰岛素治疗血糖控制不佳的2型糖尿病患者中加用二肽基肽酶-4(DPP-4)抑制剂或安慰剂的疗效和安全性。

方法

我们检索了MEDLINE、EMBASE、LILACS、Cochrane对照试验中央注册库和ClinicalTrials.gov在线注册库中的随机对照试验(RCT)。治疗持续时间至少为12周的研究符合条件,这些研究需为2型糖尿病患者的RCT,比较胰岛素治疗加用DPP-4抑制剂(INS/DPP4i)与胰岛素治疗加用安慰剂(INS/PCB),并包含糖化血红蛋白(HbA1c)自基线变化的信息。

结果

在3105篇潜在相关的已发表文章和206项注册试验中,9项研究被纳入荟萃分析。与INS/PCB相比,INS/DPP4i组HbA1c降低幅度更大(加权平均差[WMD] -0.58%;95%置信区间 -0.70,-0.46),空腹血糖降低幅度更大(WMD -0.59mmol/L;95%置信区间 -0.79,-0.40),每日胰岛素剂量更少(WMD -1.86IU;95%置信区间 -3.27,-0.45),体重增加无差异(WMD -0.04kg;95%置信区间 -0.25,0.16)。INS/DPP-4i与INS/PCB之间低血糖风险相似(支持INS/PCB的相对危险度为0.94;95%置信区间0.84,1.05)。

结论

与安慰剂相比,DPP-4抑制剂在胰岛素治疗血糖控制不佳的2型糖尿病患者中能更好地控制血糖,且不会进一步增加体重增加和低血糖风险。

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