国内曲美布汀联用氟哌噻吨美利曲辛治疗肠易激综合征疗效和安全性的Meta分析

A Meta-analysis on efficacy and safety of combination of Trimebutine with Flupentixol and Melitracen for the treatment of irritable bowel syndrome in china

目的评价曲美布汀联用氟哌噻吨美利曲辛(黛力新)治疗肠易激综合征的疗效和安全性。方法计算机检索中国医院知识总库(CHKD)期刊全文数据库(建库至2013年2月)、万方医药中文数据库(1998—2013年2月)、中文科技期刊全文数据库(VIP)(1989—2013年2月)、Pubmed数据库、Sciencedirect数据库及Google scholor中关于曲美布汀联用黛力新治疗肠易激综合征的随机对照试验。对文献进行质量评价,应用Revman 5.0软件进行Meta分析。结果共纳入11项试验,共1 218例患者,Meta分析结果提示曲美布汀联用黛力新组对肠易激综合征的总有效率[OR=6.26,95%CI=(4.49,8.72),P<0.001]和显效率[OR=3.42,95%CI=(2.66,4.40),P<0.001]均高于不联用黛力新组,且能显著改善腹痛、腹泻,但腹胀、便秘未得到显著改善;增加了不良反应发生率[OR=9.68,95%CI=(3.79,24.71),P<0.001],尤其是口干、头晕或头昏、嗜睡或失眠,但均能耐受。结论曲美布汀联用黛力新治疗肠易激综合征可有效缓解总体症状,尤其是腹痛、腹泻;不良反应发生率显著增加,尤其是口干、头晕或头昏、失眠或嗜睡,但无严重不良反应,安全性尚可。受纳入研究质量的限制,以上结论尚需更多大规模、高质量的临床对照试验予以证实。

Objective To compare the efficacy and safety of combination of Trimebutine with Flupentixol and Melitracen （Deanxit） for the treatment of irritable bowel syndrome （IBS） in China. Methods CHKD （form its inception to February 2013）, Wanfang （from 1998 to February 2013）, VIP databases （ from 1989 to February 2013 ）, Pubmed, Sciencedirect, Google scholor were searched for randomized controlled trials（RCTs） on Trimebutine and Deanxit for the treatment of IBS. The methodological quality of the included studies was as- sessed and the Meta-analysis was＇ performed with RevmanS. 0. Results A total of 11 RCTs involving 1218 patients were included. The total effective rate [ OR = 6.26,95% CI = （4.49,8.72）, P 〈 0. 001 ] and significant rate [ OR = 3.42,95% CI = （ 2.66,4.40）, P 〈 0. 001 ] of Trimebutine with Deanxit treatment group were superior to that of the treatment without Deanxit group, which could effectively relieve abdominal pain and diarrhea. But there was no significant difference between the two groups in alleviating abdominal distention and constipation. The incidence of adverse drug reactions （ADRs） was increased [ OR = 9.68,95 % CI = （ 3.79,24.71 ）, P 〈 0.001 ], such as dry mouth,dizziness,insomnia or lethargy. But all of these ADRs were tolerant. Conclusions Combination of Trimebutine and Deanxit is effective for the treatment of IBS especially in abdominal pain and diarrhea. Though there is increased incidence of ADRs espe- cially in dry mouth, dizziness and insomnia or lethargy, no serious ADR was found. However, due to the quality of included studies, more large-scale and high quality RCTs are expected to verify the conclusion in future.