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  

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

作　　者：姜俊杰[1] 谢雁鸣[1] 王永炎[1] 李园[1] 章轶立[1] 孙帅玲 王硕[2] 祝勇[3] 齐文升[2] 陈训 陈琴 

机构地区：[1]中国中医科学院中医临床基础医学研究所,北京100700 [2]中国中医科学院广安门医院,北京100053 [3]首都医科大学附属北京中医医院,北京100010 [4]国药集团中联药业有限公司,湖北武汉430000

出　　处：《中国中药杂志》2017年第8期1467-1473,共7页China Journal of Chinese Materia Medica

基　　金：中国中医科学院基本科研业务费专项(ZZ10-018-02;Z0465);中央级公益性科研院所基本业务费项目(Z0406);世界中医药学会联合会项目(SCEPCM12E001)

摘　　要：了解金叶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。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 count〉1.2＆#215;1010, neutrophil〉80%） 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 outcome measure of patients with fever will be body temperature recovery time. Primary outcome measure of patients with swelling and sore throat will be throat symptom score. Primary outcome measures of patients combined with fever and swelling and sore throat will be body temperature recovery time and throat symptom score. Before and after all of the patients in the group were collected blood and urine routine, liver and renal function, electrocardiogram （ECG） data as the safety index while observing it adverse events. A total of 623 patients were included. Compared with control group,sore throat symptoms of patients with sore throat and pharyngeal symptoms total score have significantly different. so Jinny Baidu granule have a significant advantage in the treatment of sore throat. All of the experiments showed that the safety of the drug was good. Nausea, vomiting, stomach pain, diarrhea, digestive tract symptoms may occur only occasionally. We should pay attention to the changes when using in patients with spleen deficiency cold to avoid adverse reaction.

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 

分 类 号：R256.1[医药卫生—中医内科学]