黄厚止泻滴丸治疗急性腹泻(湿热证)Ⅱ期临床研究  

Huanghou Zhixie dripping pills in the treatment of acute diarrhea (damp-heat syndrome):Phase Ⅱ clinical trails

作　　者：龚枚 杨小平[2] 李振华[3] GONG Mei;YANG Xiao-ping;LI Zhen-hua(Department of Gastroenterology,Sichuan Hospital of Traditional Chinese Medicine,Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,610075 Chengdu,Sichuan,China;Department of Hepatobiliary spleen and stomach,Henan Academy of Traditional Chinese Medicine,450003 Zhengzhou,Henan,China;Department of Gastroenterology,Xiyuan Hospital,China Academy of Chinese Medical Sciences,100019 Beijing,China)

机构地区：[1]成都中医药大学附属医院四川省中医医院消化内科,四川成都610075 [2]河南省中医药研究院肝胆脾胃科,河南郑州450003 [3]中国中医科学院西苑医院消化科,北京100091

出　　处：《临床消化病杂志》2023年第4期311-315,共5页Chinese Journal of Clinical Gastroenterology

摘　　要：[目的]评价黄厚止泻滴丸治疗急性腹泻(湿热证)的疗效和安全性。[方法]采用实验中心分层、区段随机、双盲双模拟、阳性药平行对照设计方案,共纳入研究病例240例分为以下3组,每组80例。低剂量试验组每次口服黄厚止泻滴丸12丸,高剂量试验组每次口服黄厚止泻滴丸16丸,对照组每次口服香连丸6 g,2次/d。治疗3 d后,比较试验组与对照组的安全性及有效性评价指标。[结果]治疗3 d后,低剂量试验组对急性腹泻疗效的临床痊愈率为72.15%,愈显率为97.47%,总有效率为100.00%;高剂量试验组分别为78.75%、98.75%、100.00%;对照组分别为53.75%、90.00%、97.50%;试验组疗效均优于对照组,差异有统计学意义(P<0.05),但各组间中医证候疗效比较差异无统计学意义(P>0.05)。试验过程中均未发现与试验药物有关的明显不良反应。[结论]黄厚止泻滴丸能降低急性腹泻(湿热证)患者的腹泻积分,改善中医证候,对急性腹泻(湿热证)具有良好疗效。[Objective]To evaluate the efficacy and safety of Huanghou Zhixie dropping pill in the treatment of acute diarrhea(damp-heat syndrome).[Methods]The experimental center stratified,section randomized,double-blind,double simulation and positive drug parallel control design scheme was adopted.A total of 240 cases were included in the study.The low-dose group took 12 pills of Huanghou Zhixie dropping pill every time and the high-dose group took 16 pills of Huanghou Zhixie dropping pill every time.The control group took 6 g of Xianglian pill every time.All patients took medicine twice a day for 3 days.The safety and effectiveness evaluation indexes of the three groups before and after the treatment were compared.[Results]After 3 days of treatment,the clinical cure rate of low-dose test group for acute diarrhea was 72.15%,the effective rate was 97.47%,and the total effective rate was 100.00%.The high-dose test group was 78.75%,98.75% and 100.00%,respectively,and the control group was 53.75%,90.00% and 97.50%,respectively.Effectiveness of both test groups were significantly better than the control group(P<0.05),while there was no significant difference in the efficacy of TCM syndromes among the three groups(P>0.05).No obvious adverse reactions related to the test medicine were found during the trail.[Conclusion]Huanghou Zhixie dropping pill can reduce the diarrhea score of patients with acute diarrhea(damp-heat syndrome),improve the TCM syndrome of the patients,and have a good therapeutic effect on diarrhea(damp-heat syndrome).

关 键 词：急性腹泻 黄厚止泻滴丸 湿热证 疗效 

分 类 号：R442.2[医药卫生—诊断学]