【摘要】 目的观察泻痢康胶囊治疗艾滋病相关慢性腹泻的临床疗效及安全性。方法采用随机、双盲双模拟、对照的临床研究方法 ,分别将158例艾滋病相关慢性腹泻患者按照2:1比例随机分为2组。治疗组106例,口服泻痢康胶囊(2.5克/次,3次/天)及盐酸洛哌丁胺胶囊模拟胶囊(2粒,3次/天)治疗;治疗组52例,口服盐酸洛哌丁胺胶囊(2mg/次,3次/天)及泻痢康胶囊模拟胶囊(5粒,3次/日)治疗。疗程14天。分别在试验进行的当天、第3天、第7天、第14天观测评估。疗效的主要指标为腹泻量表评分及每日大便总量、大便次数。药物的安全性检测指标包括药物不良反应事件、肝功能、肾功能,心电图、血细胞分析、尿液分析、大便潜血、病毒学指标(HIV-RNA)等。结果治疗第14天,试验组和对照组间的患者腹泻量表积分的差异有统计学意义(P<0.05),治疗第7天两组的大便总量变化的差异有统计学意义(P<0.05),治疗第7天与第14天,试验组和对照组间的患者大便次数均明显减少,差异有统计学意义(P<0.05),试验组疗效优于对照组。试验组和对照组间不良反应事件发生率无显著性差异。结论泻痢康胶囊治疗艾滋病相关慢性腹泻安全有效,疗效优于盐酸洛哌丁胺胶囊。更多还原

【Abstract】 Objective To investigate the clinical therapeutic effect of Xielikang Capsule for AIDS-related chronic diarrhea.Methods A randomized,double-blind,double dummy and controlled clinical method was applied to the study.158 AIDS-related chronic diarrhea patients were randomly divided into Xielikang Capsule group(n=106)and loperamide capsule group(n=52).Patients in Xielikang Capsule group were administrated with Xielikang Capsule 2.5 gram/time,3 times/day and loperamide placebo 2 capsules/time,3 times/day,while patients in loperamide group were administrated with loperamide 2mg/time,3 times/day and Xielikang placebo 5 capsules/time,3 times/day for 14 consecutive days.The effects were assessed on day 1,day 3,day 7 and day 14.The main indicators used to evaluate the effects included score of Diarrhea Questionnaire,total daily stool volume and stool frequency.The safety of the drugs was evaluated according to the adverse reactions,liver and renal function,ECG,routine blood,urine,stool test,Fecal occult blood,HIV-RNA and other laboratory indicators.Results After 14 days’ treatment,the difference of Diarrhea Questionnaire score between the two groups was significant(P<0.05).The same result was observed on the change of the total stool volume on day 7.There were significant differences in the frequency of diarrhea between the two groups after 7 days and 14 days’ treatment(P<0.05).There were no significant differences in the incidence of adverse reactions between the two groups.Condusion The Xielikang Capsule was safe and effective on the treatment of AIDS related chronic diarrhea of,and it had better efficacy than Loperamide hydrochloride capsule.更多还原