清喉咽含片治疗急性咽炎临床研究.docVIP

清喉咽含片治疗急性咽炎临床研究 　　[摘要]研究评价了清喉咽含片相较于清喉咽合剂治疗急性咽炎（肺热阴虚证）的临床有效性和安全性。本试验共纳入144例受试者，随机分为试验组和对照组（各72例），试验组服用清喉咽含片，对照组服用清喉咽合剂，疗程5d，以咽痛或吞咽痛消失率、中医证候的综合疗效、中医证候积分、单项症状及体征的消失率等为有效性评价指标，试验过程中密切观察生命体征、实验室检查指标、不良事件安全性评价指标。FAS结果显示，咳嗽消失率、中医证候愈显率、咽黏膜、悬雍垂轻度充血水肿体征消失率均为试验组优于对照组（Plt;0.05），中医证候积分的变化值2组间差异有统计学意义（Plt;0.05）;试验组有3例不良事件，对照组有6例不良事件，2组之间不良事件发生率差异无统计学意义，无严重实验室检查异常，无生命体征异常。综合以上研究，清喉咽含片治疗急性咽炎（肺热阴虚证）疗效优于清喉咽合剂，安全性良好。 　　[关键词]清喉咽含片;急性咽炎;咽痛;吞咽痛 　　Clinical stury on Qinghouyan lozenge in treatment of acute pharyngitis 　　YU Jiao-jiao1， XUAN Zhen-yu1*， RUAN Yan2， ZHANG Hui-yong3， SHI Ke-hua4， GUO Yu4 　　（1. Suzhou Youseen New Drug Ramp;D Co.Ltd.， Suzhou 215123， China; 　　2. The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine， Guangzhou 510405， China; 　　3. Longhua Hospital Shanghai University of Traditional Chinese Medicine， Shanghai 200032， China; 　　4. Shanghai Municipal Hospital of Traditional Chinese Medicine， Shanghai 200071， China） 　　[Abstruct]To evaluate the clinical efficacy and safety of Qinghouyan lozenge in the treatment of acute pharyngitis due to Lung-heat and Yin-deficiency， and compare with Qinghouyan oral Liquid. Totally 144 subjects were enrolled and randomly divided into two groups （72 in the test group and 72 in the control group）. The participants in the test group were given Qinghouyan lozenge for 5 days， and those in the control group were given Qinghouyan oral Liquid for 5 days. The effectiveness evaluation indexes were pharyngalgia/odynophagia disappearance rate， overall efficacy of TCM syndromes， TCM syndrome scores， and single syndrome and sign disappearance rate. During the test， the safety was evaluated by vital sign， lab examination indexes and adverse events. The results for the full analysis set showed that the couth disappearance rate， the incidence rate of TCM syndromes， and the throat/uvula congestion disappearance rate of the test group were higher than that of the control group （Plt;0.05）， with significant difference