摘要
目的 评估六味安消胶囊（邦消安）治疗功能性消化不良（FD）的疗效、安全性以及耐受性,并与莫沙比利比较.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99例符合罗马Ⅱ标准的FD患者,分为2组,试验组50例,对照组49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/d,3粒/次,餐后服用）或对照组莫沙比利（3次/d,5 mg/次,餐前15～30 min服用）治疗期及治疗结束1周随访期.评估标准：对患者全部FD症状进行总体评估,对患者每个FD参数的改善程度以及安全性进行评估.结果 治疗前试验组与对照组间人口统计学特征、体格检查和疾病特征差异均无统计学意义（P＞0.05）.治疗期2周和随访期1周,试验组与对照组间症状总积分及5 h胃排空率比较,差异均无统计学意义（P＞0.05）;试验组及对照组治疗后14 d与随访后28 d症状总积分自身前后比较,差异均有统计学意义（P＜0.05）;生活质量评价在日常活动方面两组间差异有统计学意义（P＜0.05）,其他各项指标试验组亦较对照组下降,但差异均无统计学意义.安全性分析结果示,两组间不良事件、不良反应等指标的差异均无统计学意义（P＞0.05）.结论 六味安消能有效治疗FD各症状,疗效稳定,并具有良好的安全性和耐受性.
Objective To assess the efficacy, safety, and tolerability of liuwei＇anxiao （bangxiao＇an） in treatment of functional dyspepsia （FD） and to compare with those of mosapride. Methods A 4- week, randomized, opened, parallel-controlled multicenters study was conducted in 99 patients who met the Rome 11 criteria for FD. The study consisted of a 1-week baseline period, a 2-week treatment period with either liuwei＇ anxiao （test group） or mosapride （control group）, followed by a 1-week withdraw period. The symptoms, overal quality of life （QOL） as well as side-effects were evaluated. Efficacy was assessed by patient＇s perception of overal symptoms of FD, improvement degree of individual FD para- meter. Results There was good comparability between two groups. After 2-week treatment and 1-week follow-up, there were no significant differences between test group and control group in the total symptom scores and 5-hour gastric emptying rate. There were significant differences in the total symptom scores between pre- and post-treatment（1 week after follow-up） in each group. No significant difference was observed between these two groups for each parameter except for the daily activities （P〈0.05）. Safety analysis indicated that there were no significant differences between these two groups in adverse events and other examing indexes. Conclusions Liuwei＇anxiao is an effective medicine for individual symptom indexes of FD and this drug is well tolerated with a good safety profile.
出处
《中华消化杂志》
CAS
CSCD
北大核心
2006年第1期42-45,共4页
Chinese Journal of Digestion
作者简介
通信作者：罗金燕，西安交通大学第二医院消化科，710004;协作组单位：西安交通大学第二医院（罗金燕、牛春燕）；北京协和医院（柯美云）；第二军医大学长海医院（许国铭、邹多武）；北京大学第一医院（刘新光）；华中科技大学协和医院（侯晓华）；中山大学附属第一医院消化科（胡品津、陈旻湖）
