黄厚止泻滴丸治疗急性腹泻的多中心、随机对照临床研究  

A multicenter,randomized controlled clinical study of Huanghou Zhixie Dripping Pills in the treatment of acute diarrhea

作　　者：宋秀江[1] 李振华[1] 胡洋叶 SONG Xiujiang;LI Zhenhua;HU Yangye(Department of Spleen and Stomach Diseases,Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Lei Yun Shang Pharmaceutical Group Co.,Ltd.,Suzhou 215009,China)

机构地区：[1]中国中医科学院西苑医院脾胃病科,北京100091 [2]雷允上药业集团有限公司,江苏苏州215009

出　　处：《吉林中医药》2023年第12期1434-1437,共4页Jilin Journal of Chinese Medicine

基　　金：北京市自然科学基金资助项目(Z211100006619063)。

摘　　要：目的评价黄厚止泻滴丸治疗湿热证急性腹泻的有效性及安全性。方法采用多中心、随机、双盲双模拟、平行对照临床研究方法,研究共纳入465例受试者,其中试验组351例,对照组114例。试验组给予黄厚止泻滴丸12丸与对照药物模拟剂6 g,每日2次。对照组给予试验药物模拟剂12丸及香连丸6 g,每日2次。疗程均为3 d。评价治疗3 d后临床有效率、中医证候评分、大便常规复常率以及治疗前后腹泻频率、单项症状改善情况。结果治疗3 d后,试验组的临床痊愈率(68.09%)显著优于对照组(55.26%)(P<0.05);试验组中医证候评分临床痊愈率(65.43%)明显优于对照组(53.98%)(P<0.05);试验组治疗前后次数差值与对照组之间具有统计学意义(P<0.05);治疗后2组的大便常规复常率无统计学意义;在泻下不爽和恶心的症状评分2组间具有统计学意义(P<0.05),试验组明显优于对照组,其余中医证候指标无统计学意义。结论黄厚止泻滴丸对湿热证急性腹泻疗效显著,在减少腹泻次数和改善临床症状方面效果显著。Objective To evaluate the effectiveness and safety of Huanghou Zhixie Dripping Pills in the treatment of acute diarrhea with the syndrome of dampness-heat.Methods A multi-center,randomized,double-blind,doublesimulation,and parallel-controlled clinical research method was adopted in the study,and 465 subjects were involved,including 351 in the experimental group and 114 in the control group.The experimental group was given 12 pills of Huanghou Zhixie Dripping Pills and 6 g of control drug simulants orally,twice a day,while the control group was given 12 pills of experimental drug simulants and 6 g of Xianglian Pills orally,twice a day.The course of treatment lasted 3 days.The clinical effective rate,traditional Chinese medicine syndrome score,reversal rate of normal stool after 3 days of treatment,as well as the frequency of diarrhea and improvement of individual symptoms were evaluated before and after treatment.Results After 3 days of treatment,the clinical recovery rate of the experimental group(68.09%)was significantly higher than that of the control group(55.26%)(P<0.05).The clinical recovery rate of TCM syndrome in the experimental group(65.43%)was significantly higher than that in the control group(53.98%)(P<0.05).The number of diarrhea was significantly decreased in the experimental group than that in the control group after treatment(P<0.05).The routine stool reversal rates had no statistical difference between the two groups.There was a statistically significant difference in the symptom scores of diarrhea discomfort and nausea between the two groups(P<0.05),and the experimental group was significantly higher than the control group.The other TCM syndrome indicators were not statistically significant.Conclusion Huanghou Zhixie Dripping Pills is effective in the treatment of acute diarrhea with the syndrome of dampness-heat,which can reduce the frequency of diarrhea and improve its clinical symptoms.

关 键 词：黄厚止泻滴丸 急性腹泻 湿热证 

分 类 号：R256.34[医药卫生—中医内科学]