中医药治疗艾滋病相关性慢性腹泻患者311例临床研究

Clinical Research on Chinese Medication for 311 Cases of AIDS-Related Chronic Diarrhea

目的观察中医药治疗艾滋病相关性慢性腹泻的疗效及安全性。方法采用多中心、对照的临床研究方法,所有入组病例均进行大便病原学检查,对其中240例进行电子结肠镜检查,将311例艾滋病慢性腹泻患者辨证分为健脾祛湿治疗组(健脾止泻颗粒)102例、补肾固涩治疗组(泻痢康胶囊)106例及对照组(盐酸洛哌丁胺胶囊)103例。疗程均为2周,观察治疗前后各组患者腹泻量表积分、大便频次变化和慢性腹泻临床有效率。结果艾滋病慢性腹泻病原学阴性者263例占84.57%,而病原学阳性者中隐孢子虫32例。治疗2周后,健脾祛湿治疗组、补肾固涩治疗组与对照组腹泻量表积分差异均有统计学意义(P<0.05);治疗1周后与治疗2周后各组大便频次均较治疗前下降(P<0.05)。结论健脾祛湿与补肾固涩为主两种治疗方案治疗艾滋病相关性慢性腹泻均可改善患者症状,减少每日大便频次,明显提高慢性腹泻临床有效率。

Objective To observe the therapeutic effect and safety of Chinese medication on acquired immune deficiency syndrome （AIDS）-related chronic diarrhea. Methods The multi-center controlled clinical trial was conducted. Patients with AIDS-related chronic diarrhea were randomized to the treatment group A, the treatment group B and the control group. The treatment group A of 102 eases was given Jianpi Zhixie Granules （Spleen-Fortifying Antidiarrheal Granules） and the treatment group B of 106 cases was given Xielikang Capsule （antidiarrheal capsule）. The control group of 103 cases was given Loperam ide Hydrochloride Capsules. The treatment course lasted for 2 weeks. The diarrhea scale scores, stool frequency changes and the clinical control of chronic diarrhea rates were observed in all groups before and after treatment. All enrolled patients were checked for stool specimens of the etiology and 240 patients for electronic eolonoscopy. Results The etiological negativity accounted for 84. 57% （263/311） in the AIDS-related patients. Of the etiologically positive cases, 32 cases were cryptosporidium infection. After 2 weeks of treatment, the diarrhea scale scores were significantly decreased in both treatment groups （P〈 0.05）. The stool frequency and total effective rates in the treatment groups were improved significantly after treatment （P〈 0.05）. Conclusion Jianpi Zhixie Granules and Xielikang Capsule could relieve the symptoms, reduce the daily stool frequency and improve the effective rate for AIDS-related chronic diarrhea.