复黄片治疗痔出血144例的随机双中心单盲临床试验  

A single blind double-center randomized trial of Fuhuang tablets in treating hemorrhoid hemorrhage (144 patients)

作　　者：潘一滨[1] 曹永清[1] 陆金根[1] 

机构地区：[1]上海中医药大学附属龙华医院肛肠科,上海200032

出　　处：《中国新药与临床杂志》2005年第8期643-646,共4页Chinese Journal of New Drugs and Clinical Remedies

基　　金：上海市科委课题资助项目(014319405);上海市中医外科重点学科资助项目(T0304)

摘　　要：目的:评价复黄片治疗痔出血的临床疗效和安全性。方法:144例痔出血病例按双中心随机盲法阳性药物对照试验设计分成2组。试验组口服复黄片4片,tid;对照组口服痔宁片4片,tid。在d3和d7时观察病人的便血、齿线上黏膜等症状体征的变化。结果:试验组完成70例,对照组72例。治疗后,2组各症状体征积分均下降(P<0.01)。治疗d3,试验组便血积分下降1.6±s1.2,对照组下降1.2±1.0(P<0.05);治疗d7,2组便血积分下降幅度有非常显著差异(P<0.01)。治疗d3,试验组总有效率59%,对照组28%,2组疗效差异有非常显著意义(P<0.01);治疗d7,2组疗效无显著差异(P>0.05)。2组均无明显的不良反应发生。结论:复黄片治疗痔出血安全、有效。AIM： To assess the efficacy of Fuhuang tablets in treating hemorrhoid hemorrhage.METHODS： One hundred and forty-four patients with hemorrhoids were divided according to positive drug control trail design by double-center randomized, blind method into testing group and control group. The patients in the testing group were treated with Fuhuang tablets 4 tablets, po, tid and with Zhining tablets 4 tablets, po, tid for those in the control group. After periods of 3 and 7 d, all patients were under examination with their symptoms and signs （hemorrhage and mucous membrane above the dentate line etc. ） recorded. RESULTS： Altogether 142 among 144 patients passed the examination. There were 72 patients （ M 31,F 41;age（48 ± 10） a） in the control group and 70 patients （M 33,F 37;age（47 ± 10） a） in the testing group at the end of the trial. The scores for each symptom and sign were decreased in both groups （P 〈0. O1 ）. The scores of hemorrhage decreased 1.6± 1.2 in the testing group and 1.2 ± 1.0 in the control group at d 3 after treatment, P 〈 0. 05. There was significant difference between the two groups in hemorrhage score decreasing at d 7 after treatment, P 〈 0. 01. The total effective rates of the testing group and the control group were 59 % and 28 % respectively at d 3 after treatment showing significant difference （ P 〈 0. O1 ）. No difference existed between the two groups at d 7 after treatment （ P 〉0. 05）. No serious adverse reactions occuredCONCLUSION： Fuhuang tablets are effective and safe in treating hemorrhoid hemorrhage

关 键 词：痔 出血 药物疗法 随机对照试验 单盲法 复黄片 

分 类 号：R657.18[医药卫生—外科学] R982[医药卫生—临床医学]