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
Fudan University Journal of Medical Sciences（2020）
Abstract
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瘠的效果更佳.
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