清咽喷雾剂治疗急性咽炎肺胃实热证的Ⅲ期临床研究  

Phase Ⅲ Clinical Trial of Qingyan Spray in Treatment of Acute Pharyngitis with Lung-stomach Excess-heat Syndrome

作　　者：袁捷[1] 李锦清[1] 吴凤玲[1] 张洁[1] 吴玲[1] 李婧[1] 羊彪[1] 

机构地区：[1]广州中医药大学,广州510006

出　　处：《世界科学技术-中医药现代化》2010年第4期575-579,共5页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：广州市科技局科技攻关重点项目(2005z2-e5041):清咽喷雾剂的产业化研究;负责人:羊彪

摘　　要：目的:观察清咽喷雾剂治疗急性咽炎肺胃实热证的的安全性和有效性。方法:采用分层区组随机、双盲、多中心、阳性药平行对照的方法,观察清咽喷雾剂治疗急性咽炎肺胃实热证患者440例。结果:全分析集试验组总有效率71.21%,对照组总有效率67.27%,总有效率相差的95%CI(-8.22,16.10),且两组疗效差别无统计学意义。临床试验未见有不良反应。结论:清咽喷雾剂治疗急性咽炎肺胃实热证是安全的、有效的。This work observed safety and effectiveness of Qingyan Spray for acute pharyngitis with lung-stomach excess-heat syndrome. A stratified, block-randomized, double-blind, muhicenter, active controlled and parallel-group trail was conducted. 440 patients with acute pharyngitis combined with lung-stomach excess-heat syndrome were observed. FAS analysis showed that the response rates were 71.21% and 67.27% respectively for the treatment group and the control group, with the 95% CI of the total effectiveness ranging from -8.22 to 16.10. No significant differences were found between the two groups, and no severe adverse events were observed. The results show that Qingyan Spray is effective and safe in treatment of acute pharyngitis with lung-stomach excess-heat syndrome.

关 键 词：清咽喷雾剂 急性咽炎 肺胃实热证 Ⅲ期临床 

分 类 号：R272.5[医药卫生—中医儿科学]