摘要
目的评估聚卡波非钙片治疗便秘型肠易激综合征(C-IBS)患者的疗效和安全性。方法本试验设计为多中心、随机、双盲、安慰剂对照。经过1周筛选期后,双盲治疗期共入选受试者449例,试验组225例,对照组224例。试验组给予聚卡波非钙片2片,每日3次,三餐后用200 ml水送服,连续服用4周。对照组给予安慰剂,服法同试验组。受试者记录每天腹部不适或疼痛及腹部胀气的严重程度、大便次数、大便Bristol分型、排便不尽感、排便费力症状及每周IBS总体症状(便秘和腹部不适/疼痛等)和便秘的严重程度。同时记录试验期间的不良事件。结果在治疗第2周,聚卡波非钙片改善C-IBS患者总体症状及便秘等级较安慰剂更显著。两组患者腹部不适/疼痛、腹部胀气、大便Bristol分型,减少周无排便不尽感天数及周排便不费力天数均有改善,但两组间差异无统计学意义(P>0.05)。在治疗第3周,试验组患者的排便次数显著多于对照组,但治疗后其余各周次两组间周排便次数比较差异无统计学意义(P>0.05)。试验组发生不良反应率为2.28%,对照组为4.63%,两组间差异无统计学意义(P=0.1996)。结论聚卡波非钙片治疗C-IBS是有效而安全的。
Objective To evaluate the efficacy and safety of calcium polycarbophil in treatment of constipation-predominant irritable bowel syndrome （C-IBS）. Methods A multi-center, randomized, double blind, placebo-controlled clinical study was performed with 449 C-IBS patients. After one-week run-in period, eligible subjects were randomized and allocated to either treatment group （n = 225） or control group （n = 224）. The patients were received either 2 tablets of calcium polycarbophil or placebo together with 200 ml water 3 times a day for consecutive 4 weeks. The symptoms of all subjects including daily abdominal pain or discomfort, bloating, defecation frequencies with consistency per bowel movement, which was judged by Bristol Stool Form Scale, feeling of incomplete bowel movement and straining during a bowel movement were recorded daily. The general feeling of IBS and the severity of constipation were also recorded weekly, and the adverse event were investigated. Results The general feeling and the severity of constipation were significantly relieved in the treatment group at the second week in comparison with the control group（P 〉 0.05）. There was no significant differences between the two groups in improvement of the symptoms of abdominal pain or discomfort, bloating, the consistency per bowel movement, feeling of incomplete bowel movement and straining during a bowel movement after 2 weeks of treatment. At the third week, the frequency of bowel movement was significantly increased in the treatment group than those in the control group. The prevalence of adverse events was 2.28% in the treatment group and 4.63% in the control group （P = 0. 1996）. Conclusion The results indicate that calcium polycarbophil is effective and safe to treat C-IBS.
出处
《中华消化杂志》
CAS
CSCD
北大核心
2007年第10期685-688,共4页
Chinese Journal of Digestion
关键词
肠易激综合征
便秘
聚卡波非钙
多中心研究
Irritable bowel syndrome
Constipation
Calcium polycarbophil
Multicenter studies
