中国药物应用与监测
中國藥物應用與鑑測
중국약물응용여감측
CHINESE JOURNAL OF DRUG APPLICATION AND MONITORING
2014年
6期
340-344,345
,共6页
卫晋菲%周亮%张可%张鑫%刘皈阳%王心慧
衛晉菲%週亮%張可%張鑫%劉皈暘%王心慧
위진비%주량%장가%장흠%류귀양%왕심혜
瑞格列奈%那格列奈%2型糖尿病%Meta分析%安全性%随机对照研究
瑞格列奈%那格列奈%2型糖尿病%Meta分析%安全性%隨機對照研究
서격렬내%나격렬내%2형당뇨병%Meta분석%안전성%수궤대조연구
Repaglinide%Nateglinide%Type 2 diabetes%Meta-analysis%Safety%Randomized controlled trial
目的:评价瑞格列奈和那格列奈治疗2型糖尿病的安全性。方法:检索PubMed,Medline,Cochrane,EMbase, CNKI,VIP,万方等文献数据库,根据纳入标准对文献进行筛选和评估,采用RevMan 5.2软件对数据进行Meta分析。结果:经筛选最终纳入10项研究,共计2300例患者,其中瑞格列奈组1150例,那格列奈组1150例。Meta分析结果显示:在降低患者糖化血红蛋白[MD =–0.23,95%CI(–0.34,–0.12),P <0.0001]和空腹血糖水平[MD =–0.16,95%CI(–0.24,–0.07), P =0.0003]方面,瑞格列奈组优于那格列奈组;在降低餐后2小时血糖[MD =0.10,95%CI(–0.29,0.48),P =0.63]水平方面,两组没有统计学差异;瑞格列奈组在低血糖反应[OR =1.92,95%CI(1.16,3.20),P =0.01]和胃肠道反应[OR =2.64,95%CI(1.09,6.39),P =0.03]方面的发生风险高于那格列奈组,而两组在肝功能异常[OR =3.02,95%CI(0.61,15.01), P =0.18]、过敏反应[OR =0.28,95%CI(0.06,1.36),P =0.12]和心血管系统[OR =0.60,95%CI(0.22,1.65),P =0.32]方面的不良反应发生风险相似。结论:瑞格列奈的降糖作用优于那格列奈,同时其低血糖和胃肠道反应的发生风险也相对较高。由于本研究存在一定的局限性,因此结论的可靠性仍需多中心、大样本、高质量的RCT加以验证。
目的:評價瑞格列奈和那格列奈治療2型糖尿病的安全性。方法:檢索PubMed,Medline,Cochrane,EMbase, CNKI,VIP,萬方等文獻數據庫,根據納入標準對文獻進行篩選和評估,採用RevMan 5.2軟件對數據進行Meta分析。結果:經篩選最終納入10項研究,共計2300例患者,其中瑞格列奈組1150例,那格列奈組1150例。Meta分析結果顯示:在降低患者糖化血紅蛋白[MD =–0.23,95%CI(–0.34,–0.12),P <0.0001]和空腹血糖水平[MD =–0.16,95%CI(–0.24,–0.07), P =0.0003]方麵,瑞格列奈組優于那格列奈組;在降低餐後2小時血糖[MD =0.10,95%CI(–0.29,0.48),P =0.63]水平方麵,兩組沒有統計學差異;瑞格列奈組在低血糖反應[OR =1.92,95%CI(1.16,3.20),P =0.01]和胃腸道反應[OR =2.64,95%CI(1.09,6.39),P =0.03]方麵的髮生風險高于那格列奈組,而兩組在肝功能異常[OR =3.02,95%CI(0.61,15.01), P =0.18]、過敏反應[OR =0.28,95%CI(0.06,1.36),P =0.12]和心血管繫統[OR =0.60,95%CI(0.22,1.65),P =0.32]方麵的不良反應髮生風險相似。結論:瑞格列奈的降糖作用優于那格列奈,同時其低血糖和胃腸道反應的髮生風險也相對較高。由于本研究存在一定的跼限性,因此結論的可靠性仍需多中心、大樣本、高質量的RCT加以驗證。
목적:평개서격렬내화나격렬내치료2형당뇨병적안전성。방법:검색PubMed,Medline,Cochrane,EMbase, CNKI,VIP,만방등문헌수거고,근거납입표준대문헌진행사선화평고,채용RevMan 5.2연건대수거진행Meta분석。결과:경사선최종납입10항연구,공계2300례환자,기중서격렬내조1150례,나격렬내조1150례。Meta분석결과현시:재강저환자당화혈홍단백[MD =–0.23,95%CI(–0.34,–0.12),P <0.0001]화공복혈당수평[MD =–0.16,95%CI(–0.24,–0.07), P =0.0003]방면,서격렬내조우우나격렬내조;재강저찬후2소시혈당[MD =0.10,95%CI(–0.29,0.48),P =0.63]수평방면,량조몰유통계학차이;서격렬내조재저혈당반응[OR =1.92,95%CI(1.16,3.20),P =0.01]화위장도반응[OR =2.64,95%CI(1.09,6.39),P =0.03]방면적발생풍험고우나격렬내조,이량조재간공능이상[OR =3.02,95%CI(0.61,15.01), P =0.18]、과민반응[OR =0.28,95%CI(0.06,1.36),P =0.12]화심혈관계통[OR =0.60,95%CI(0.22,1.65),P =0.32]방면적불량반응발생풍험상사。결론:서격렬내적강당작용우우나격렬내,동시기저혈당화위장도반응적발생풍험야상대교고。유우본연구존재일정적국한성,인차결론적가고성잉수다중심、대양본、고질량적RCT가이험증。
[ABSTRACT]Objective:To systematically evaluate the safety of repaglinide versus nateglinide in the treatment of type 2 diabetes.Methods:PubMed, Medline, Cochrane, EMbase, CNKI, VIP and Wanfang databases were retrieved. Literature were selected and assessed according to the inclusion criteria. The meta-analysis was performed by RevMan 5.2 software.Results:Ten studies were included ultimately, with total of 2300 patients (1150 patients receiving repaglinide and 1150 patients receiving nateglinide). The meta-analysis revealed the following results: repaglinide group was better than nateglinide group in reducing the levels of HbA1c [MD =–0.23, 95%CI (–0.34,–0.12),P < 0.000 1] and FPG [MD =–0.16, 95%CI (–0.24,–0.07),P = 0.000 3]. There was no signiifcant difference between two groups in reducing the level of PPG [MD = 0.10, 95%CI (–0.29, 0.48),P = 0.63]. The occurrence risks of hypoglycemia [OR = 1.92, 95%CI (1.16, 3.20),P = 0.01] and gastrointestinal reactions [OR = 2.64, 95%CI (1.09, 6.39),P= 0.03] were higher in repaglinide group than nateglinide group. While the occurrence risks of hepatic dysfunction [OR = 3.02, 95%CI (0.61, 15.01),P = 0.18], anaphylaxis [OR = 0.28, 95%CI (0.06, 1.36),P = 0.12] and cardiovascular system [OR = 0.60, 95%CI (0.22, 1.65),P = 0.32] were similar between two groups.Conclusion:Repaglinide was more effective in reducing blood sugar than that of nateglinide in the treatment of type 2 diabetes, while the occurrence risks of hypoglycemia and gastrointestinal reactions were relatively higher. Further multicenter, large samples, high quality RCTs are warranted to verify the results of this article because of the drawbacks of experimental design.