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目的:观察专利中药腹泻灵胶囊治疗小儿腹泻病的临床疗效与安全性。方法:随机选择152例患儿分为两组进行临床观察,每组76例;对照组口服西药思密达,治疗组口服腹泻灵胶囊,两组疗程急性腹泻为5 d,迁延性腹泻为14 d,慢性腹泻为21 d;观察两组疗效,检验粪常规、粪培养、粪轮状病毒抗原及尿D-木糖含量。结果:临床研究结果显示,治疗组迁延性腹泻、慢性腹泻有效率均优于对照组(P<0.01),粪常规转阴率、好转率均优于治疗组(P<0.05);粪培养转阴率、粪轮状病毒抗原转阴率、尿D-木糖含量测定前后比较,急性腹泻差异无显著性(P>0.05),迁延性腹泻、慢性腹泻差异具有显著性(P<0.05)。结论:腹泻灵胶囊可有效治疗小儿腹泻病,尤其对迁延性腹泻、慢性腹泻疗效满意;腹泻灵胶囊无明显的不良反应。
Objective: To observe the clinical efficacy and safety of patented traditional Chinese medicine Diarrhea capsule in the treatment of children with diarrhea. Methods: A total of 152 cases were randomly divided into two groups, 76 cases in each group. The control group was given oral Smectite, and the treatment group was given oral Diarrhea Capsule. The acute diarrhea course was 5 days and the persistent diarrhea was 14 d, chronic diarrhea for 21 days. The curative effect of the two groups were observed and the fecal routine, fecal culture, fecal rotavirus antigen and urine D-xylose content were tested. Results: The results of clinical studies showed that the effective rate of persistent diarrhea and chronic diarrhea in the treatment group were significantly higher than those in the control group (P <0.01), and the negative rate and improvement rate in the feces were better than those in the treatment group (P <0.05) (P> 0.05). There was a significant difference between persistent diarrhea and chronic diarrhea (P <0.05). Conclusion: Diarrhea capsule can effectively treat children with diarrheal disease, especially for persistent diarrhea, chronic diarrhea, satisfactory efficacy; no adverse effects of diarrhea capsule.