二甲双胍缓释片与普通片对2型糖尿病患者胃肠道副作用的风险比较:Meta分析  

Risks of metformin sustained release versus metformin immediate release on gastrointestinal side effects in patients with type 2 diabetes:a Meta-analysis

作　　者：周月 孔姿莉 王翔[1] 黄雅静 王颜刚[1] Zhou Yue;Kong Zili;Wang Xiang;Huang Yajing;Wang Yangang(Department of Endocrinology,Affiliated Hospital of Qingdao University,Qingdao 266003,China)

机构地区：[1]青岛大学附属医院内分泌科,266003

出　　处：《中华糖尿病杂志》2019年第1期32-39,共8页CHINESE JOURNAL OF DIABETES MELLITUS

基　　金：山东省自然科学基金资助项目(ZR2014HM021).

摘　　要：摘要目的通过Meta分析比较二甲双胍缓释片(MXR)与普通片(MIR)治疗2型糖尿病(T2DM)患者胃肠道副作用的发生风险。方法检索美国国立医学图书馆数据库(PubMed)、循证医学数据库(The Cochrane Library)、科学引文索引数据库(Web of Science)、中国生物医学文献数据库、万方和中国知网(CNKI)等数据库,选择从建库至2018年3月发表的有关MXR与MIR治疗T2DM的随机对照试验(RCT)。采用Stata 12.0及RevMan 5.3软件对入选人群发生胃肠道不良反应的风险性进行Meta分析。结果入选13项RCT,共计3 039例T2DM患者。与MIR相比,MXR可降低恶心/呕吐、消化不良及胀气的发生风险(分别为RR=0.61,95%CI:0.43~ 0.85,Z=2.87,P=0.004;RR=0.47,95%CI:0.30~ 0.74,Z=3.32,P=0.0009;RR=0.35,95%CI:0.17~ 0.69,Z=3.02,P=0.002)。亚组分析显示,MXR可有效降低50岁以下患者腹泻的发生风险(RR=0.21,95%CI:0.08~ 0.54,Z=3.25,P=0.001),在50岁以上的患者中两种剂型的差异无统计学意义(RR=0.99,95%CI:0.76~ 1.29,Z=0.08,P=0.940);Meta回归显示,年龄为此效应主要的异质性来源,性别、体质指数、糖尿病病程及用药剂量未显著影响胃肠道副作用的发生。结论与MIR相比,MXR可降低T2DM患者恶心/呕吐、消化不良及胀气的发生风险。对于50岁以下因胃肠道副作用不能耐受MIR的T2DM患者,MXR可作为MIR的替代治疗。ObjectiveTo compare the risks of gastrointestinal side effects in patients with type 2 diabetes mellitus (T2DM) by Meta-analysis between metformin extended-release (MXR) and metformin immediate-release (MIR) treatment.MethodsDatabases of PubMed, the Cochrane Library, Web of Science, SinoMed, Wanfang and CNKI were searched for randomized controlled trials (RCTs) with therapy of MXR and MIR in T2DM patients from establishment of the database to March 2018. Stata 12.0 and RevMan 5.3 were used to analyze the risk of gastrointestinal adverse reactions.ResultsThirteen RCTs with a total of 3 039 patients were recruited. Compared with MIR treatment, MXR treatment significantly reduced the risks of nausea/vomiting, dyspepsia and flatulence (RR=0.61, 95%CI: 0.43-0.85, Z=2.87, P=0.004;RR=0.47, 95%CI: 0.30-0.74, Z=3.32, P=0.0009;RR=0.35, 95%CI: 0.17-0.69, Z=3.02, P=0.002) . The risks of diarrhea events were associated with the age of the patients: subgroup analysis showed that MXR treatment significantly reduced the risk of diarrhea in patients under 50 years of age (RR=0.21, 95%CI: 0.08-0.54, Z=3.25, P=0.001) instead of those patients over 50 years old (RR=0.99, 95%CI: 0.76-1.29, Z=0.08, P=0.940);Meta-regression showed that age was the main source of heterogeneity in diarrhea-studying group, while gender, body mass index, duration of diabetes, and drug dosage didn′t significantly affect the incidence of diarrhea events.ConclusionsCompared with MIR treatment, MXR treatment could effectively lower the risks of nausea/vomiting, dyspepsia and flatulence in T2DM patients. MXR can be used as an alternative therapy for T2DM patients under 50 yrs who are unable to tolerate MIR treatment due to gastrointestinal side effects.

关 键 词：糖尿病 2型 二甲双胍 胃肠道副作用 二甲双胍缓释片 

分 类 号：R587[医药卫生—内分泌]