世界中医药

作者	单位
田明¹，倪量¹，万钢¹，杨小平²，高辉³，谭行华⁴，孙丽君⁵，王玉光¹，王融冰¹	1 北京地坛医院感染病诊疗中心首都医科大学附属北京地坛医院； 2 河南省中医药研究院； 3 新疆维吾尔自治区传染病医院； 4 广州市第八人民医院； 5 北京佑安医院

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中文摘要:

目的：观察健脾止泻方治疗艾滋病相关性慢性腹泻的临床疗效及安全性。方法：采用多中心、开放、实用性随机对照的临床研究方法，将143例艾滋病慢性腹泻患者随机分为2组，其中中医药治疗组96例，以健脾止泻中药配方颗粒加减治疗；对照组以易蒙停治疗47例，易蒙停胶囊（2mg/次，3次/日）；疗程均为2周。分别在试验进行的第0天、第3天、第1周、第2周进行相应指标的观测，评估中医药治疗艾滋病慢性腹泻的疗效和安全性。疗效的主要指标为腹泻量表评分及每日大便总量、大便次数相对患者基线的变化，以药物不良事件记录肝功能、肾功能、心电图、血尿便常规、便潜血、病毒学指标（HIV-RNA）等实验室检测指标监测药物的安全性。结果：治疗组和对照组的患者腹泻量表积分差异在疗程结束后有统计学意义（P=0.05），治疗1周后2组的大便总量变化差异有统计学意义（P=0.05），治疗组明显好于对照组。结论：健脾止泻方治疗艾滋病慢性腹泻安全有效，疗效优于易蒙停。

English Summary:

To investigate efficacy and safety of Jianpi Zhixie Granule on chronic diarrhea of AIDS patients. Methods:In the multi-center, open-label, controlled and randomized clinical trial, 143 AIDS patients with the symptom of chronic diarrhea were randomized to take Jianpizhixie granule (n=96) or Loperamide capsule(n=47, 2mg, 3times per day) for 2 consecutive weeks. The primary efficacy endpoints were score of Diarrhea Questionnaire, total stool volume and frequency changes relative to baseline levels. The safety parameters include adverse events, liver function, renal function, ECG, routine blood, urine, stool test, fecal occult blood, HIV-RNA and other laboratory indicators. Results:At week2, the score of Diarrhea Questionnaire between the two treatment arms was significantly different (P=0.0196). At week1, change of total stool volume was significantly different (P=0.0497). Conclusion: The Jianpizhixie granule has better efficacy and safety than Loperamide capsule on chronic diarrhea of AIDS patients.

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