六味安消胶囊(邦消安)治疗慢性功能性便秘的多中心临床....docVIP

六味安消胶囊（邦消安）治疗慢性功能性便秘的多中心临床研究 六味安消（邦消安）临床研究协作组* [摘要] 目的 通过对患者慢性功能性便秘（FC）症状和生活质量的总体评估、对每个FC症状的个别评估、以及不良反应的观察，并与福松比较，评估六味安消胶囊（邦消安）治疗功能性便秘的疗效、安全性以及耐受性。方法 采用多中心、随机、开放、平行、阳性药物对照方法进行研究。入选108例符合罗马II标准的FC患者，分为2组，试验组46例，对照组62例，试验为期4周，包括1周基线期，2周试验组六味安消（3次/日，4粒/次，餐后服用）或对照组福松（2次/日，10g/次，早晚餐后服用）治疗期及1周停药随访期。评估标准：对患者全部FC症状进行总体评估，对患者每个FC参数的改善程度以及安全性进行评估。结果 试验组与对照组在治疗前无论是一般情况、主要疗效指标或次要疗效指标上均具有较好的可比性。试验组随访1周排便困难程度和48小时GITT结果均较对照组的好，并且在0.1的显著性水平上两组间有统计学差异。治疗期2周和随访期1周，试验组与对照组其它主要疗效指标和次要疗效指标的差异均无显著性。另外基线期和治疗期2周生活质量问卷差值的比较，试验组分数均比对照组下降的多，并且在感觉方面和日常活动方面，2组间差异有显著性（p均0.05）。安全性分析结果，两组间不良事件、不良反应和其他检查指标的差异均无显著性。结论 六味安消能有效改善FC患者的大便次数、大便性状、排便困难以及腹痛、腹胀、食欲不振等伴随症状，提高生活质量，并且具有良好的安全性和耐受性。 [关键词] 六味安消（邦消安） 功能性便秘 福松 A randomized, opened, parallel group, positive-drug-controlled, multicenters study to evaluate the efficacy, safety, and tolerability of liuwei’anxiao (bangxiao’an) on functional constipation. Liuwei’anxiao (bangxiao’an) Clinical Research Group. Corresponding author: Luo Jin-yan, Department of Gastroenterolgy, The Second Hospital of Xi’an Jiaotong univerdity, Xi’an 710004, China [Abatract] Objective To assess the efficacy, safety, and tolerability of liuwei’anxiao (bangxiao’an) versus mosapride in treatment of functional constipation (FC) in relational to the symptoms, overal quality of life (QOL) as well as side-effects, and compared with those of forlax. Methods A 4-week, randomized, opened, parallel group, positive-drug-controlled multicenter- clinical study in 108 patients who met the Rome II criteria for FC. The study consisted of a 1-week baseline period, 2-week opened, treatment period with either bangxiao’an (trial group)or mosapride (controll group), followed by a 1-week withdraw period. Efficacy was assessed by patient’s perception of overal symptoms of FC, improvement degree of individual FC variable and safety of bangxiao’an. Results Testing group was of good comparability with control group at base line in regard to primary effect indexes and subordinate effect indexes. Du