目的 評(píng)價(jià)止瀉保童顆粒治療小兒慢性遷延性腹瀉病(脾胃虛弱、寒熱凝結(jié)證)的有效性及安全性。方法 采用隨機(jī)、雙盲雙模擬、陽(yáng)性藥平行對(duì)照、多中心臨床研究的方法, 計(jì)劃入選140例, 其中試驗(yàn)組、對(duì)照組各70例。試驗(yàn)組應(yīng)用止瀉保童顆粒與小兒腹瀉寧合劑模擬劑, 對(duì)照組應(yīng)用小兒腹瀉寧合劑與止瀉保童顆粒模擬劑。療程5 d。結(jié)果 疾病療效, 兩組顯效率分別為72.86%、37.88%, 試驗(yàn)組明顯高于對(duì)照組(P=0.000 1);中位止瀉時(shí)間, 試驗(yàn)組為5 d, 明顯短于對(duì)照組(P=0.003 9);中醫(yī)證候總有效率, 兩組分別為85.71%、71.21%, 試驗(yàn)組明顯高于對(duì)照組(P=0.041 0);兩組大便稀溏、便次增多、肚腹疼痛、口干舌燥、小便短黃的消失率比較, 試驗(yàn)組均明顯高于對(duì)照組(P<0.05、0.001)。上述結(jié)果的PPS分析與FAS分析結(jié)論一致。結(jié)論 止瀉保童顆粒治療5 d, 對(duì)小兒慢性遷延性腹瀉病(脾胃虛弱、寒熱凝結(jié)證)有效, 能夠明顯減輕腹瀉癥狀, 縮短止瀉時(shí)間, 改善中醫(yī)證候及單項(xiàng)癥狀, 療效優(yōu)于小兒腹瀉寧合劑, 且未發(fā)現(xiàn)不良反應(yīng)。

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.