复方碳酸氢钠栓治疗功能性便秘的多中心、随机、双盲、安慰剂对照临床试验

Treatment of Functional Constipation with Compound Sodium Bicarbonate Suppository: A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Study

背景:功能性便秘是一种常见慢性肠道功能性疾病,目前其治疗药物虽较多,但疗效不尽如人意。目的:观察复方碳酸氢钠栓治疗功能性便秘的临床疗效和安全性。方法:2006年5月～2007年5月由6家医院进行多中心、随机、双盲、安慰剂对照临床试验。1周筛选期后,218例功能性便秘患者随机分为试验组和对照组,每组109例,分别给予复方碳酸氢钠栓和安慰剂纳肛,1粒/d,连续7d。治疗第1d,用药1次后若无排便,可重复用药1次。治疗第2d起每日用药1次。受试者每日记录排便次数、大便性状以及排便费力、排便不尽感、服用缓泻剂天数和药物用量。结果:治疗1周后,与治疗前和对照组相比,试验组周排便次数、周大便性状、周排便不尽感天数均显著改善(P<0.05),但两组周排便费力天数、周服用缓泻剂天数和周药物用量相比差异均无统计学意义。两组均未出现严重不良事件。结论:复方碳酸氢钠栓治疗功能性便秘有效而安全。

Background： Functional constipation is a common chronic functional bowel disease. There are many medications, but the efficacy is unsatisfactory. Aims： To evaluate the efficacy and safety of compound sodium bicarbonate suppository in the treatment of functional constipation. Methods： A multi-center, randomized, double-blind, placebo-controlled clinical study was carried out from May 2006 to May 2007 in 6 hospitals. After one-week screening period, 218 functional constipation patients were randomly allocated into treatment group （n=109） and control group （n=109）. Compound sodium bicarbonate suppository and placebo were put into the anus of functional constipation patients once a day consecutively for 1 week, respectively. On the first day, if there was absence of defecation after the first dose, the dose could be repeated. From the second day, it was given only once a day. The defecation frequency, stool form, days of defecation strain, days of defecation incompletion, days of taking laxative, and doses of the drug used were recorded daily. Results： After 1 week treatment, the defecation frequency, stool form, and days of defecation incompletion in the treatment group were significantly improved than those before treatment and those in control group （P〈0.05）. No statistically significant differences were found in days of defecation strain, days of taking laxative, and doses of the drug used between the two groups. No serious adverse events were observed during the course of treatment. Conclusions： The results indicate that compound sodium bicarbonate suppository is effective and safe for treatment of functional constipation.