论述中药新药治疗小儿急性上呼吸道感染临床研究的技术要点  

Clinical research skill point on acute upper respiratory tract infection in children treated by traditional Chinese medicine and new drugs

作　　者：王健[1] 胡思源[2] 晋黎[2] 王卉[2] 

机构地区：[1]天津中医药大学,天津300193 [2]天津中医药大学第一附属医院,天津300193

出　　处：《中华中医药杂志》2014年第4期1109-1111,共3页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家科技重大专项十二五"重大新药创制"课题(No.2011ZX09302-006-03)~~

摘　　要：近年来,儿童新药临床试验在全球逐渐开展。儿童中药新药在国内的起步较早,20世纪80年代,卫生部中药临床药理基地所承担的任务中即包括儿科用药。然而,由于缺乏国内外先进经验,在研究方法上进展较慢。鉴于此,在导师胡思源教授多年儿科临床试验实践基础上及指导下,就中药新药在治疗小儿急性上呼吸道感染的临床研究,通过文献检索提出了作者见解。包括试验目的与总体设计、诊断标准、中医诊断与辨证、受试者的选择、受试者的退出标准、对照药品的选择、疗程设计、有效性评价、安全性指标、合并用药及试验的质量控制等方面。In recent years, children＇s clinical trials of new drugs have carried out in the word gradually. Clinical trials of traditional Chinese medicine and new drugs for children in China startes early. In the 1980s, the tests that Clinical Pharmacology Base of Traditional Chinese Medicine undertaken included pediatric medication. However, due to the lack of advanced experience, there is slow progress in research methods. In view of this, on the basis of many years of practice in pediatric clinical trials and under the guidance of instructor, and through literature search, the authors put forward views on traditional Chinese medicine, new drugs in the treatment of acute upper respiratory tract infection of children in clinical research. The authors＇ views included the purpose of testing, overall design test, diagnosis standard, diagnosis and differentiation of TCM, inclusion criteria, exclusion criteria, exit criteria, choice of control drugs, course design, effectiveness evaluation, safety indicators, combination therapy and quality control of test,etc.

关 键 词：中药 新药 小儿急性上呼吸道感染 临床研究 

分 类 号：R272[医药卫生—中医儿科学]