摘要
目的系统评价阿格列汀与其他口服降糖药治疗2型糖尿病(T2DM)的有效性和安全性。方法计算机检索PubMed、EMbase、Cochrane Library、中国知网、万方、维普等数据库,并手工检索相关期刊杂志,查找以阿格列汀为干预措施治疗T2DM的随机对照试验(RCT)。对符合纳入标准的RCT,按Cochrane系统评价的方法进行资料提取及质量评价,并采用RevMan5.2软件进行Meta分析。结果共纳入9项RCT,共4 381例患者。合并分析结果显示:阿格列汀在降低糖化血红蛋白(HbA_(1c))方面[WMD=-0.47,95%CI(-0.64,-0.29),P<0.000 01]及改善胰岛β细胞功能方面[WMD=8.32,95%CI(4.98,11.67),P<0.000 01]均优于阳性对照药。亚组分析显示,阿格列汀降低HbA_(1c)的效应优于二甲双胍[WMD=-0.70,95%CI(-0.85,-0.56),P<0.000 01]、格列吡嗪[WMD=-0.11,95%CI(-0.20,-0.02),P=0.02]及吡格列酮[WMD=-0.66,95%CI(-0.78,-0.54),P<0.000 01]。安全性方面,阿格列汀与阳性对照药相比,引起总不良事件、严重不良事件、心血管不良事件风险均无显著差异(均P>0.05),引起低血糖事件的风险亦较低。结论与其他口服降糖药相比,阿格列汀可有效降低T2DM患者的HbA_(1c)水平,并在一定程度上改善胰岛β细胞功能,引发不良事件风险相当。上述结论还需更多的大规模、多中心随机对照试验进一步研究证实。
AIM To assess efficacy and safety compared with other oral hyperglycemic agents. METHODS of alogliptin for type 2 diabetes mellitus （T2DM） The PubMed, EMbase, Cochrane Library, CNKI, Wanfang, VIP database were searched and literature from some relative paper based magazines were also retrieved. Randomized controlled trials （RCT） of alogliptin compared with active comparator in T2DM were selected. The RCT according to the inclusion criterion were evaluated critically by Cochrane handbook. Metaanalysis was performed by using RevManS.2 software. RESULTS Total 9 RCT involving 4 381 patients with T2DM were analyzed. The metaanalysis indicated that： compared with active comparator, alogliptin led to higher reduction in HbA1c （WMD = -0.47, 95%CI （-0.64, -0.29）, P 〈 0.000 01 ） and greater improvement in β-cell function （WMD = 8.32, 95%CI （4.98, 11.67） , P 〈 0.000 01）. Subgroup analysis showed that alogliptin also led to higher reduction in HbA1c levels compared with metformin （WMD = -0.70, 95%CI （-0.85, -0.56）, P〈 0.000 01）, glipizide （WMD = -0.11, 95%CI （-0.20, -0.02）, P = 0.02） and pioglitazone （WMD = -0.66, 95%CI （-0.78, -0.54）, P 〈 0.000 01）. In aspect of safety, alogliptin led to no higher risk of overall adverse event, serious adverse event and cardiovascular event compared with active comparator （P 〉 0.05） , with low risk of hypoglycaemia. CONCLUSION Compared with other antihyperglycaemic agents, alogliptin provides better efficacy in improving HbA1c levels and β- cell function with similar risk of adverse event. The above conclusion should be proved by more large-scale multicenter high quality studies in future.
出处
《中国新药与临床杂志》
CSCD
北大核心
2017年第4期226-233,共8页
Chinese Journal of New Drugs and Clinical Remedies
关键词
阿格列汀
降血糖药
糖尿病
2型
系统评价
alogliptin
antihyperglycemic agents
diabetes mellitus, type 2
systematic review
