采用随机、开放、阳性药物平行对照研究评价玄柏爽声颗粒治疗喉瘖的临床疗效  

A randomized,open and positive drug parallel controlled study of the effects of Xuanbo Shuangsheng granule on hoarseness

作　　者：黄滔敏 吴海涛 闫晶超 沈剑文 胡霜 魏春生 张毅 谢明 曹文俊 臧朝平 沈雁 倪荣玲 陈琦 顾以瑾 陈念祖 HUANG Tao-min;WU Hai-tao;YAN Jing-chao;SHEN Jian-wen;HU Shuang;WEI Chun-sheng;ZHANG Yi;XIE Ming;CAO Wen-jun;ZANG Chao-ping;SHEN Yan;NI Rong-ling;CHEN Qi;GU Yi-jin;CHEN Nian-zu(Department of Pharmacy,Eye,Ear,Nose&Throat Hospital,Fudan University,Shanghai 200031,China;Department of Otorhinolaryngology,Eye,Ear,Nose&Throat Hospital,Fudan University,Shanghai 200031,China;Department of Clinical Laboratory,Eye,Ear,Nose&Throat Hospital,Fudan University,Shanghai 200031,China)

机构地区：[1]复旦大学附属眼耳鼻喉科医院药剂科,上海200031 [2]复旦大学附属眼耳鼻喉科医院耳鼻喉科,上海200031 [3]复旦大学附属眼耳鼻喉科医院检验科,上海200031

出　　处：《复旦学报（医学版）》2020年第6期837-842,874,共7页Fudan University Journal of Medical Sciences

基　　金：上海市科委生物医药领域项目(11DZ1972100,19401900600)。

摘　　要：目的评价中成药玄柏爽声颗粒治疗喉瘖的安全性和有效性。方法采用随机、开放、阳性药物平行对照的临床研究方法,所有喉瘖患者被随机分配服用黄氏响声丸(对照药)或玄柏爽声颗粒(试验药)。安全性研究终点为随访第4周受试者实验室检查、心电图检查及不良反应情况。有效性研究主要终点为随访第4周受试者嗓音嘶哑评估(grade,roughness,breathiness,asthenia and strain scale,GRBAS)评分变化,次要终点为受试者主观感受(patient-reported outcome,PRO)评分变化。结果 2014年8月至2015年6月总计143位喉瘖患者参与研究。玄柏爽声颗粒的总有效率为81.9%,PRO评分疗效指数为70%±28%;对照药黄氏响声丸的总有效率为55.1%,PRO评分疗效指数为30%±35%。玄柏爽声颗粒组的总有效率和PRO评分疗效指数均高于黄氏响声丸组,差异有统计学意义(P<0.05)。两组服药前后实验室检查、心电图检查、生命体征检查等均未出现有临床意义的改变,无不良事件发生。结论与黄氏响声丸相比,玄柏爽声颗粒治疗喉瘖的效果更佳。Objective To evaluate the safety and efficacy of Xuanbo Shuangsheng granule,a traditional Chinese medicine(TCM),in the treatment of hoarseness.Methods All patients were randomly assigned to take Huangshi Xiangsheng pill as control or Xuanbo Shuangsheng granule by randomized,open and positive drug parallel controlled method.The safety endpoint included the laboratory examination,electrocardiogram results and adverse reactions of the subjects at the fourth week of follow-up.The primary endpoint of validity was the change in GRBAS score at the fourth week of follow-up,and the secondary endpoint was the change in patient-reported outcome(PRO)score.Results A total of 143 patients in our hospital participated this study from Aug 2014 to Jun 2015.The total effective rate of Xuanbo Shuangsheng granule was 81.9%and the PRO score index was 70%±28%;the total effective rate of Huangshi Xiangsheng pill was 55.1%,and the PRO score index was 30%±35%.The total effective rate and the PRO score index of Xuanbo Shuangsheng granule group were higher than those of Huangshi Xiangsheng pill group with statistical difference(P<0.05).There were no significant changes in laboratory examination,electrocardiogram results and vital signs before and after medicine administration in both groups,and no adverse events occurred.Conclusion Compared with Huangshi Xiangsheng pill,Xuanbo Shuangsheng granule has better curative effect.

关 键 词：喉瘖 玄柏爽声颗粒 黄氏响声丸 平行对照试验 中药 

分 类 号：R767.11[医药卫生—耳鼻咽喉科]