聚卡波菲钙治疗便秘型肠易激综合征临床疗效及安全性评价

Efficacy and safety of calcium polycarbophil in the treatment of constipation-predominant irritable bowel syndrome

目的:评估聚卡波菲钙治疗便秘型肠易激综合征(C-IBS)疗效和安全性。方法:采用随机、安慰剂对照的临床研究,把符合罗马Ⅲ标准的36例C-IBS患者随机分为试验组(聚卡波菲钙片2片,tid,18例)和对照组(安慰剂2片,tid,18例)。研究包括1周基线期和4周治疗期。主要疗效指标为每周C-IBS总体症状的评分,次要疗效指标包括每周便秘、腹部不适/疼痛、腹胀、排便次数、排便费力及排便不尽感的严重程度评分。同时观察治疗期的不良事件。结果:聚卡波菲钙治疗后,患者每周C-IBS总体症状较对照组有显著改善,且改善等级组内比较差异均有统计学意义(P<0.05)。治疗第2周排便次数多于对照组,其余各症状组间比较无差异。治疗第3周和第4周治疗组患者便秘严重程度较治疗前有显著改善,其余症状组内比较无显著差异。研究期间未出现严重不良反应。结论:聚卡波菲钙是一种有效、安全的缓解C-IBS症状的药物。

Objective： To evaluate the efficacy and safety of calcium polycarbophil in the treatment of constipation-predominant irritable bowel syndrome （C-IBS）. Methods： In a randomized and placebo-controlled clinical study, 36 C-IBS patients consistent with Rome Ⅲ criteria were enrolled and divided into 2 groups. They were treated with either 2 calcium polyearbophil tablets （ n = 18） or 2 placebo tablets （ control, n = 18 ）, tid. This study consisted of 1-week baseline period and 4-week randomized treatment period. The main efficacy was assessed by perception of overall symptom of C-IBS every week. The secondary efficacy variables included the severity of constipation, abdominal discomfort/pain, bloating, frequencies of defecation and straining during defeeationand feeling of incomplete defecation every week. The adverse events were observed as well. Results： After treatment with calcium polycarbophil, the overall weekly symptoms in polycarbophil group were significantly improved in comparison with the control group （P 〈 0.05）. At the 2nd week, the defecation was more frequent in polycarbophil group than in the control group. At the 3rd and 4th weeks, severity of constipation was significantly relieved in polycarbophil group. No adverse event was found in this study. Conclusion： Calcium polyearbophil is an effective and safe medicine for alleviation of C-IBS symptoms.