Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives
Prucalopride (Resolor) in the treatment of severe chronic constipation in patients dissatisfied with laxatives
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DOI：
10.1136/gut.2008.162404
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发表时间：
2009-03-01
期刊：
影响因子：
24.5
通讯作者：
Vandeplassche, L.
中科院分区：
文献类型：
--
作者：
Tack, J.;van Outryve, M.;Vandeplassche, L.
目的：探讨选择性高亲和力5-HT4受体激动剂普芦卡必利治疗慢性便秘患者的疗效、对生活质量（QOL）的影响及安全性。方法：在这项多中心、随机、安慰剂对照、平行组、III期研究中，慢性便秘（2次或更少的自发性完全排便(SCBM)/周）患者接受2mg或4mg普鲁卡普利或安慰剂治疗，每天1次，持续12周。主要疗效终点是达到3个或更多SCBM/周的患者比例。关键的次要疗效终点是每周增加一个或多个SCBM的患者比例。主要生活质量终点为便秘患者生活质量满意度量表评分。安全性参数包括不良事件、实验室值和心血管事件。结果：对713例患者进行疗效评价。平均超过12周，服用普卡必利2mg的患者比例更高(19.5%
Objective: To determine the efficacy, impact on quality of life (QOL) and safety of prucalopride, a selective, high-affinity 5-HT4 receptor agonist, in patients with chronic constipation.Methods: In this multicentre, randomised, placebo controlled, parallel-group, phase III study, patients with chronic constipation (two or fewer spontaneous complete bowel movements (SCBM)/week) received 2 mg or 4 mg prucalopride or placebo, once daily, for 12 weeks. The primary efficacy endpoint was the proportion of patients reaching three or more SCBM/week. The key secondary efficacy endpoint was the proportion of patients having an increase of one or more SCBM/week. The primary QOL endpoint was the patient assessment of constipation QOL satisfaction subscale score. Safety parameters included adverse events, laboratory values and cardiovascular events.Results: Efficacy was evaluated over 713 patients. Averaged over 12 weeks, higher proportions of patients on prucalopride 2 mg (19.5%; p