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促动力药治疗以便秘为主的肠易激综合征:西沙必利的一项安慰剂对照研究

"Prokinetic" treatment of constipation-predominant irritable bowel syndrome: a placebo-controlled study of cisapride.

作者信息

Van Outryve M, Milo R, Toussaint J, Van Eeghem P

机构信息

University Hospital of Antwerp, Belgium.

出版信息

J Clin Gastroenterol. 1991 Feb;13(1):49-57. doi: 10.1097/00004836-199102000-00012.

DOI:10.1097/00004836-199102000-00012
PMID:2007745
Abstract

The effects of prokinetic treatment with cisapride in patients with constipation-predominant irritable bowel syndrome (IBS) were evaluated in a randomized, double-blind, placebo-controlled study. Sixty-nine IBS patients were assigned to a 12-week treatment with either 5 mg cisapride or placebo t.i.d.; this dosage could be changed if necessary. The mean weekly number of days on which a stool was passed in the cisapride and placebo group increased to 5.3 and 4.4 (p less than 0.05) during weeks 8-12 of treatment, and the number of days with stools of normal consistency increased to 3.5 and 1.9 (p less than 0.05), respectively. At week 12, the reduction in severity and frequency scores for abdominal pain was significantly greater (p less than or equal to 0.05) in the cisapride group (60 and 61%) than in the placebo group (40 and 32%), as it was for abdominal distension (p less than 0.05). Cisapride tended to be better than placebo in diminishing flatulence. In 71% versus 39% of the patients the overall rating for the response to treatment was good or excellent at week 12. Cisapride was well tolerated. These results suggest that the drug will be useful for the management of constipation-predominant IBS.

摘要

在一项随机、双盲、安慰剂对照研究中,评估了西沙必利促动力治疗对以便秘为主的肠易激综合征(IBS)患者的疗效。69例IBS患者被分配接受为期12周的治疗,分别服用5毫克西沙必利或安慰剂,每日3次;必要时可调整剂量。在治疗的第8 - 12周,西沙必利组和安慰剂组每周排便天数的平均值分别增加到5.3天和4.4天(p<0.05),大便性状正常的天数分别增加到3.5天和1.9天(p<0.05)。在第12周时,西沙必利组腹痛严重程度和频率评分的降低幅度(分别为60%和61%)显著大于安慰剂组(分别为40%和32%)(p≤0.05),腹胀情况也是如此(p<0.05)。在减轻肠胃胀气方面,西沙必利的效果倾向于优于安慰剂。在第12周时,71%的患者对治疗的总体评价为良好或优秀,而安慰剂组这一比例为39%。西沙必利耐受性良好。这些结果表明,该药物对以便秘为主的IBS的治疗将是有用的。

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