众生丸治疗急性咽炎(风热证)临床研究  

Clinical Studies on Zhongsheng Pills in treating acute pharyngitis(windheat syndrome)

作　　者：朱厚曦 柴峰[3] 曹波[4] 

机构地区：[1]广东众生药业股份有限公司,东莞523325 [2]广州中医药大学,广州510006 [3]河南省中医院,郑州450002 [4]北京大学医学部生物统计教研室,北京100871

出　　处：《海峡药学》2014年第5期67-70,共4页Strait Pharmaceutical Journal

摘　　要：目的评价众生丸治疗急性咽炎(风热证)的临床疗效和安全性。方法采用分层区组随机、盲法、阳性药平行对照、非劣效的、多中心临床试验方法,共观察病例336例。治疗组252例,服用众生丸和喉疾灵模拟剂。对照组84例,服用喉疾灵片和众生丸模拟剂。众生丸为1次6丸,1日3次;喉疾灵片为1次3片,1日3次。5天为1个疗程。结果治疗组总有效率为97.21%(244/251)、对照组为97.59%(81/83),组间疗效差异无统计学意义(P>0.05)。治疗期间未见有与试验药物相关的实验室指标异常的变化,未见有严重不良事件及不良反应发生。结论众生丸能明显改善风热证引起的咽痛、吞咽痛以及咽部红肿等症状体征,治疗风热引起的急性咽炎安全有效。OBJECTIVE To evaluate the efficacy and safety of Zhongsheng Pills in the treatment of acute phar-yngitis（wind-heat syndrome）.METHODS A randomized,blind,positive parallel controlled,multi-center clinical trial was carried out in 336 patients.The trial group （252 cases） was given Zhongsheng Pills plus Placebo Houjiling Tablets and the contral group （84 cases） was given Houjiling Tablets plus placebo Zhongsheng Pills orally ,3 times per day （6 pills/times,3 tablets/times）,with the course of 5 days.RESULTS The total effective rate was 97.21%（244/251） in the trial group and 97.59%（81/83） in the control group.the difference was not statistically signifi-cant between the two groups （ P〉0.05 ）.There were no significant changes of laboratory indexes and side effects re-lated to trial drugs.CONCLUSION Zhongsheng Pills can improve exogenous wind-heat-induced sore throat ,pain-ful swallowing ,throat irritation ,etc.It is safe and effective in the treatment of acute pharyngitis.

关 键 词：众生丸 风热证 急性咽炎 临床试验 

分 类 号：R969.4[医药卫生—药理学]