吉林大学学报(医学版) ›› 2018, Vol. 44 ›› Issue (06): 1235-1242.doi: 10.13481/j.1671-587x.20180622

• 临床研究 • 上一篇    下一篇

沙格列汀联合胰岛素治疗2型糖尿病疗效随机对照试验的Meta分析

漆璐1,2, 白微2, 于玮莹2, 李媛媛2, 华婉晴2, 寇长贵2   

  1. 1. 首都医科大学附属北京世纪坛医院药物Ⅰ期临床试验研究室, 北京 100038;
    2. 吉林大学公共卫生学院流行病与卫生统计学教研室, 吉林 长春 130021
  • 收稿日期:2018-03-05 出版日期:2018-11-28 发布日期:2018-11-28
  • 通讯作者: 寇长贵,教授,硕士研究生导师(Tel:0431-85619173,E-mail:koucg@jlu.edu.cn) E-mail:koucg@jlu.edu.cn
  • 作者简介:漆璐(1982-),女,江西省宜春市人,主管护师,医学硕士,主要从事药物Ⅰ期临床试验研究和质量控制方面的工作。
  • 基金资助:
    吉林省卫计委科研项目资助课题(2013Z060)

Randomized controlled trials for curative effect of saxagliptin combined with insulin in treatment of patients with type 2 diabetes mellitus: Meta-analysis

QI Lu1,2, BAI Wei2, YU Weiying2, LI Yuanyuan2, HUA Wanqing2, KOU Changgui2   

  1. 1. Phase I Clinical Trial Research Center, Affiliated Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China;
    2. Department of Epidemiology and Health Statistics, School of Public Health, Jilin University, Changchun 130021, China
  • Received:2018-03-05 Online:2018-11-28 Published:2018-11-28

摘要: 目的:系统评价沙格列汀联合胰岛素与单独应用胰岛素治疗2型糖尿病的有效性和安全性。方法:计算机检索中国知网(CNKI)、维普数据库、万方数据库、中国生物医学文献数据库(CBM)、PubMed和CochraneLibrary,时间为各个数据库建库至2017年12月31日,按照纳入和排除标准选择纳入的随机对照试验(RCT)。在对纳入研究进行质量评价的基础上,对提取的数据采用Review Manager 5.3和Stata 12.0软件进行Meta分析。结果:初检得到647篇文献,经过筛选最终纳入22篇,包括2 243例患者。Meta分析,有效性指标中,沙格列汀联合胰岛素(病例)组患者糖化血红蛋白(HbA1c)(MD=-0.86,95% CI:-1.03~-0.68,P<0.01)、空腹血糖(FBG)(MD=-0.95,95% CI:-1.22~-0.67,P<0.01)、餐后2 h血糖(PBG)(MD=-1.28,95% CI:-1.61~-0.94,P<0.01)和每日胰岛素用量(MD=-18.47,95% CI:-22.00~-14.95,P<0.01)较单独应用胰岛素(对照)组均明显降低;在安全性方面,病例组患者总不良反应发生率(OR=0.39,95% CI:0.28~0.52,P<0.01)和低血糖发生率(OR=0.31,95% CI:0.22~0.45,P<0.01)均低于对照组。漏斗图左右基本对称,尚不能认为存在发表偏倚,敏感性分析提示结果稳定。结论:与单用胰岛素治疗比较,沙格列汀联合胰岛素治疗方案能有效降低2型糖尿病患者的HbA1c、FPG和PBG水平,减低每日胰岛素用量,安全性良好,不增加发生低血糖等不良反应的风险。

关键词: 沙格列汀, 胰岛素, 2型糖尿病, Meta分析

Abstract: Objective: To evaluate the efficacy and safety of saxagliptin combined with insulin and insulin used in the treatment of the patients with type 2 diabetes systematically.Methods: CNKI database, VIP database,Wanfang database,CBM database,PubMed and Cochrane Library were searched.The time was from the begining of the databases to Dec 31,2017. The randomized controlled trials (RCT) were selected according to the inclusion and exclusion criteria. Then the qualities of included studies were evaluated and the data was extracted. The Meta-analysis was performed by Review Manager 5.3 and Stata 12.0 softwares.Results: A total of 647 articles were selected initially and 22 articles involving 2 243 patients were included in this Meta-analysis. The results of Meta-analysis of effectiveness indicators showed that compared with insulin used alone(control) group, the HbA1c level(MD=-0.86, 95%CI:-1.03——0.68,P<0.01), FBG level (MD=-0.95, 95%CI:-1.22——0.67,P<0.01), PBG level (MD=-1.28, 95%CI:-1.61——0.94,P<0.01) and level of daily insulin dosage(MD=-16.17, 95%CI:-17.40——14.95,P<0.01) of the patients in saxagliptin combined with insulin(case) group were decreased. The safety analysis results showed that the total incidences of adverse reactions (OR=0.39, 95%CI:0.28-0.52,P<0.01) and the incidence of hypoglycemia (OR=0.31, 95%CI:0.22-0.45,P<0.01) of the patients in case group were lower than those in control group.The funnel-plot of these indicators displayed a symmetrical figure, and there was no publication bias; the sensitivity analysis results showed that there was no difference between all the indicators, and the results were stable.Conclusion: Compared with insulin used alone, saxagliptin combined with insulin therapy has certain advantages to reduce the levels of HbA1c, FPG, PBG of the type 2 diabetes patients and the daily insulin dosage, has high safety and dosen't increase the risk of hypoglycemia and other adverse reactions.

Key words: saxagliptin, insulin, type 2 diabetes mellitus, Meta-analysis

中图分类号: 

  • R587.1