德谷胰岛素治疗糖尿病有效性与安全性的荟萃分析被引量：9

Efficacy and safety of insulin degludec for diabetes mellitus： a meta-analysis

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摘要目的系统评价德谷胰岛素治疗糖尿病的有效性与安全性。方法对Corchane Library、PubMed、Embase、万方数据库、中国生物医学文献数据库、维普网和中国知网进行计算机检索，查找关于德谷胰岛素治疗糖尿病的随机对照试验（RCT），试验组采用德谷胰岛素治疗，对照组采用甘精胰岛素或地特胰岛素治疗，随访时间〉12周。检索年限为建库至2016年2月。筛选符合纳入标准的RCT并进行质量评价，运用RevMan5．0统计软件对提取的相关数据进行荟萃分析。结果研究最终纳入12个RCT，共计6527例糖尿病患者，其中试验组4358例，对照组2169例。德谷胰岛素注射频率为1次／d时，降低空腹血糖的能力优于对照组（MD=-0．40，95％CI：-0．65--0．16，P=0．001）。但在改善糖化血红蛋白水平方面德谷胰岛素略逊于其他基础胰岛素（MD=0．13，95％CI：0．08～0．17，P〈0．001）。在不良事件发生率方面，德谷胰岛素与对照组相比，差异无统计学意义（OR=0．98，95％CI：0．87～1．10，P=0．700），但德谷胰岛素夜间低血糖事件发生率更低（OR=0．82，95％CI：0．72—0．94，P=0．004）。结论德谷胰岛素的降糖效果并不劣于其他长效胰岛素，但是夜间低血糖事件发生率更低，安全性更好。其远期有效性和安全性有待于进一步探讨。 Objective To systematically evaluate the efficacy and safety of insulin degludec for diabetes mellitus （DM）. Methods Databases including Coehrane Library, PubMed, Embase, Wanfang Data, China Biology Medicine disc （CBM） and China National Knowledge Infrastructure （CNKI） were searched electronically for randomized controlled trials （RCTs） meeting including criteria and the methodological quality of studies was assessed. Then meta-analysis was performed using RevMan 5.0 software. Results Twelve RCTs with 6 527 patients were included into our study： 4 358 patients in degludec group and 2 169 patients in control group. Compared with insulin glargine, insulin degludec was more effective in reducing fasting blood glucose （MD = - 0. 40, 95% CI： -0. 65 - - 0. 16, P = 0. 001 ） , but less effective in improving levels of glyeated hemoglobin （ MD = 0. 13, 95% CI： 0. 08 - 0. 17, P 〈 0. 001 ）. There was no significant difference in the incidence rate of adverse events in two groups （ OR = 0. 98, 95% CI：0. 87 - 1.10, P = 0. 700）, but incidence rate of nocturnal hypoglycaemia was significantly lower in insulin degludec group （OR=0.82, 95%CI：0.72-0.94, P=0.004）. Conclusions Insulin degludee is non-inferior to other basal insulin in reducing levels of blood glucose, but insulin degludec can obviously reduce the incidence rate of nocturnal hypoglycaemia, so it is safer than other basal insulin. The long-term efficacy and safety should be further studied .

作者孙世萌丁乐刘宏霞邓欣如景春贝郑瑞芝汪艳芳

机构地区新乡医学院锦州医科大学河南省人民医院内分泌科

出处《中华医学杂志》 CAS CSCD 北大核心 2016年第32期2563-2568,共6页 National Medical Journal of China

基金河南省科技厅科技攻关项目（132102310466）志谢位立辉教授在统计学分析方面给予指导,肖伟老师在文献检索及文章修改细节方面给予帮助,冯国华老师在数据提取及质量评价方面给予指点,图书馆工作人员提供文献支持

关键词糖尿病低血糖胰岛素荟萃分析随机对照试验 Diabetes mellitus Hypoglycemia Insulin Meta-analysis Randomized controlled trial

分类号 R587.1 [医药卫生—内分泌]

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