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出 处:《儿科药学杂志》2009年第6期20-22,共3页Journal of Pediatric Pharmacy
摘 要:目的:探讨小麦纤维素颗粒(商品名:非比麸Fiberform)用于小儿功能性便秘的疗效和安全性。方法:本试验采用随机、平行对照试验。75例功能性便秘患者随机分为试验组和对照组。两组均给予基础治疗,试验组另给予口服小麦纤维素治疗,疗程2周,此后2周两组仅坚持基础治疗,观察排便次数和大便性状的变化。结果:两组患儿平均每周排便次数、大便形状复常率及伴随症状缓解率在治疗后2周、4周比较,试验组均优于对照组,差异有统计学意义(P<0.05)。两组患儿Bristol大便分型评分在治疗后2周、4周比较差异无统计学意义(P>0.05)。治疗2周试验组和对照组的总有效率分别为100%和78.9%,组间比较差异有统计学意义(P<0.01);治疗4周总有效率分别为100%和97.4%,组间比较差异无统计学意义(P>0.05)。两组均未见明显不良反应。结论:小儿功能性便秘病程较短,程度多较轻,小麦纤维素颗粒治疗安全、有效。在药物治疗的同时,应强化基础治疗,可获得满意而持久的疗效。Objective: To study the efficacy and safety of Fiberform in treatment of functional constipation in children under 4 years old. Methods :A total of 75 children with functional constipation were enrolled in this randomized and comparative trial. There were 38 patients received general therapy, which consisted of defecation habit practice, increasing in number of dietary fiber, enough water drinking, suitable exercise and psychotherapy. And the other 37 patients in the treatment group received oral Fiberform on the base of general therapy for 2 weeks. Results: The normalization of the stool form, frequency of defecation and main digestive symptoms in the patients treated with Fibefform was significantly higher in comparison with the control group ( P 〈 0.05 ). The mean Bristol score of stool was similar in the two groups, there was no difference ( P 〉 0.05 ). After 2 weeks, the total efficacy rates were 100% and 78.9% in the treatment group and the control group respectively. There was significant difference between the two groups (P 〈 0.01 ). After 4 weeks, they were 100% and 97. 4% respectively. There was no significant difference (P 〉 0.05). There was no side-effect in both groups. Conclusions: Fiberform is safe and effective in treatment of functional constipation in children.
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