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[摘要]
目的 评价止泻保童颗粒治疗小儿慢性迁延性腹泻病(脾胃虚弱、寒热凝结证)的有效性及安全性。方法 采用随机、双盲双模拟、阳性药平行对照、多中心临床研究的方法, 计划入选140例, 其中试验组、对照组各70例。试验组应用止泻保童颗粒与小儿腹泻宁合剂模拟剂, 对照组应用小儿腹泻宁合剂与止泻保童颗粒模拟剂。疗程5 d。结果 疾病疗效, 两组显效率分别为72.86%、37.88%, 试验组明显高于对照组(P=0.000 1);中位止泻时间, 试验组为5 d, 明显短于对照组(P=0.003 9);中医证候总有效率, 两组分别为85.71%、71.21%, 试验组明显高于对照组(P=0.041 0);两组大便稀溏、便次增多、肚腹疼痛、口干舌燥、小便短黄的消失率比较, 试验组均明显高于对照组(P<0.05、0.001)。上述结果的PPS分析与FAS分析结论一致。结论 止泻保童颗粒治疗5 d, 对小儿慢性迁延性腹泻病(脾胃虚弱、寒热凝结证)有效, 能够明显减轻腹泻症状, 缩短止泻时间, 改善中医证候及单项症状, 疗效优于小儿腹泻宁合剂, 且未发现不良反应。
[Key word]
[Abstract]
Objective To assess the efficacy and safety of Zhixie Baotong Granules for the treatment of Children chronic persisting diarrhea due to the syndrome of spleen and stomach weakness and cold-heat congealing. Methods By the methods of random, double blind, and double dummy, parallel control of positive drug, and multi-center clinical trial, 140 cases were used in the study, which were divided into experimental and control groups; There were 70 in each group. Zhixie Baotong Granules with the simulated agent of Xiaoer-Fuxiening Mixture was used in the experimental group, Xiaoer-Fuxiening Mixture with the simulated agent of Zhixie Baotong Granules was used in the control group.The course of treatment was 5 d. Results After the treatment, the remarkable effect rates in the two groups were 72.86% and 37.88%, which was higher than in the experimental group than in the control group obviously (P=0.000 1).The median time to check diarrhea, the experimental group was 5 d, shorter than the control group (P =0.003 9). The total efficacy rate of TCM syndrome in the two groups was 85.71% and 71.21%, which was higher in the experimental group than in the control group obviously (P=0.041 0). Comparing with the syndrome of loose stool, stool frequency, abdominal pain, mouth parched and tongue scorched, short yellow urine, the experimental group, the rate of disappearance was higher in the experiment group than in the control groups (P<0.05, 0.001). The conclusion of the PPS analysis and the FAS analysis was identical. Conclusion After the 5 d, Zhixie Baotong Granules is effective in the treatment of children chronic persisting diarrhea due to the syndrome of the spleen and stomach weakness and the coagulation of cold and heat by reducing the diarrhea symptoms, shortening the diarrhea time, changeing the TCM syndrome, and the efficacy is better than Xiaoer-Fuxiening Mixture .There is no side reaction found in the clinical treatment.
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