elobixibat治疗慢性便秘有效性和安全性的Meta分析

Efficacy and safety of elobixibat in treatment of chronic constipation: a metaanalysis

目的评价elobixibat治疗慢性便秘的有效性和安全性。方法计算机检索PubMed、Embase、Clinical Trials Website、Cochrane Library、中国知网、维普和万方数据库中关于elobixibat治疗慢性便秘的临床随机对照试验(RCT)。采用修改后的Jadad量表对纳入文献进行质量评价,采用RevMan 5.3统计软件进行Meta分析。结果共纳入8项RCT,1260例患者。Meta分析结果显示,与安慰剂组相比,elobixibat 5、10、15 mg组每周自发排便频次显著增多(分别为WMD=0.87,95%CI:0.63~1.11,P<0.00001;WMD=1.93,95%CI:0.95~2.92,P=0.0001;WMD=3.68,95%CI:3.40~3.97,P<0.00001),elobixibat 5、10 mg组每周完全自发排便频次显著增多(分别为RR=1.82,95%CI:1.30~2.55,P=0.0005;RR=1.82,95%CI:1.37~2.43,P<0.0001)。安全性方面,elobixibat组总不良反应、腹泻、腹痛发生率高于安慰剂组(P<0.05),均为轻中度,患者可耐受。结论现有证据表明elobixibat能显著改善慢性便秘,不良反应可耐受。

AIM To evaluate the efficacy and safety of elobixibat in treatment of chronic constipation.METHODS All randomized controlled trials(RCTs)about the efficacy and safety of elobixibat in treatment of chronic constipation were searched and retrieved from the databases including PubMed,Embase,Clinical Trials Website,Cochrane Liabrary,CNKI,VIP and Wanfang database.The quality of the included literatures were evaluated using the modified Jadad scale.Meta-analysis of the data was performed by RevMan 5.3 software.RESULTS Eight RCTs were included,with a total of 1260 patients.Compared with placebo group,the frequency of spontaneous bowel movements per week was significantly increased in the elobixibat 5,10,and 15 mg groups(WMD=0.87,95%CI:0.63-1.11,P<0.00001;WMD=1.93,95%CI:0.95-2.92,P=0.0001;WMD=3.68,95%CI:3.40-3.97,P<0.00001).And the frequency of complete spontaneous bowel movements per week was significantly increased in the elobixibat of 5,10 mg groups(RR=1.82,95%CI:1.30-2.55,P=0.0005;RR=1.82,95%CI:1.37-2.43,P<0.0001).In terms of safety,the incidences of total adverse reactions,diarrhea,and abdominal pain in the elobixibat groups were higher than those in the placebo group(P<0.05).The adverse reactions were mild to moderate and elobixibat was well tolerated.CONCLUSION Available evidences suggest that elobixibat is effective in treatment of chronic constipation and its adverse reactions can be tolerated.