【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。更多还原

【Abstract】 OBJECTIVE To evaluate the efficacy and safety of Zhongsheng Pills in the treatment of acute pharyngitis( 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 significant between the two groups( P > 0. 05). There were no significant changes of laboratory indexes and side effects related to trial drugs. CONCLUSION Zhongsheng Pills can improve exogenous wind-heat-induced sore throat,painful swallowing,throat irritation,etc. It is safe and effective in the treatment of acute pharyngitis.更多还原