CAJ | 학술논문

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。
목적：평개음생환치료급성인염（풍열증）적림상료효화안전성。방법채용분층구조수궤、맹법、양성약평행대조、비렬효적、다중심림상시험방법，공관찰병례336례。치료조252례，복용음생환화후질령모의제。대조조84례，복용후질령편화음생환모의제。음생환위1차6환，1일3차；후질령편위1차3편，1일3차。5천위1개료정。결과치료조총유효솔위97.21％（244／251）、대조조위97.59％（81／83），조간료효차이무통계학의의（ P＞0.05）。치료기간미견유여시험약물상관적실험실지표이상적변화，미견유엄중불량사건급불량반응발생。결론음생환능명현개선풍열증인기적인통、탄인통이급인부홍종등증상체정，치료풍열인기적급성인염안전유효。
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.