金叶败毒颗粒治疗风温肺热病（热在肺卫证）的随机双盲阳性药平行对照研究.docVIP

金叶败毒颗粒治疗风温肺热病（热在肺卫证）的随机双盲阳性药平行对照研究 　　[摘要] 了解金?~败毒颗粒治疗风温肺热病（热在肺卫证）的疗效，采用随机双盲阳性药平行对照的设计方法，研究对象是急性上呼吸道感染、风温肺热病（热在肺卫证）的患者，根据受试者发热和咽喉肿痛症状的发生情况，对纳入的所有受试者分为3层：发热、咽喉肿痛、发热合并咽喉肿痛；采用分层区组随机的方法，将各层内的受试者分为治疗组和对照组，治疗组干预措施是金叶败毒颗粒，对照组是复方双花颗粒；结果共纳入623例患者。治疗组与对照组比较，咽痛患者的咽痛症状、咽部症状总计分方面，与对照组比较有显著性差异。因此，在治疗咽痛方面，金叶败毒颗粒有显著优势；安全性良好，偶见恶心、呕吐、胃痛、腹泻的消化道症状，用于脾胃虚寒患者时，应注意观察患者变化，避免不良反应发生。 　　[关键词] 金叶败毒颗粒；风温肺热病；热在肺卫证；随机对照试验 　　Study of Jinye Baidu granule in treatment of wind-warmth 　　lung heat disease （heat in lung-wei pattern）： a randomized， 　　double-blind，parallel-controlled trial 　　JIANG Jun-jie1，XIE Yan-ming1*，WANG Yong-yan1，LI Yuan1，ZHANG Yi-li1，SUN Shuai-ling1， 　　WANG Shuo2，ZHU Yong3，QI Wen-sheng2，CHEN Xun4，CHEN Qin4 　　（1. Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，Beijing 100700，China； 　　2. Guanganmen Hospital Affiliated to China Academy of Chinese Medical Sciences，Beijing 100053，China； 　　3. Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University，Beijing 100010，China； 　　4. Sinopharm Zhonglian Pharmaceutical Co.，Ltd.，Wuhan 430000，China） 　　[Abstract] A randomized， double-blind， active parallel controlled trial will be conducted to include patients with acute upper respiratory infection and wind-warmth lung heat disease （heat in lung-wei pattern）. Patients with serious bacterial infection （white blood cell count1.2×1010， neutrophil80%） will be excluded.so as to further identify Jinye Baidu Granule indications of Wind-warmth lung heat disease （heat in lung-wei pattern）.According to the subjects of symptoms of fever and sore throats，Patients will be divided into three blocks： fever， swelling and sore throat， combined fever and swelling and sore throat. Subjects in three blocks will be divided into treatment group and control group with stratified blocked randomization. The treatment group will be treated with Jinye Baidu Granule， and the control group will be treated with Fufang Shuanghua granule. Primary