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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, clinical trial of new drug for children has gradually taken place in the world. Children’s Chinese medicine new drugs started earlier in China. In the 1980s, pediatric medicine was included in the tasks undertaken by the Ministry of Health’s Chinese medicine clinical pharmacology base. However, due to the lack of advanced experience both at home and abroad, research methods have been slow to progress. In view of this, under the guidance and guidance of many years of pediatric clinical trials conducted by Professor Hu Siyuan, a clinical study on the treatment of acute upper respiratory tract infections in children with Chinese traditional medicine was put forward and the author’s opinion was raised through literature search. Including the purpose of the experiment and the overall design, diagnostic criteria, diagnosis and dialectical Chinese medicine, the choice of subjects, subjects exit criteria, the choice of controlled drugs, treatment design, effectiveness evaluation, safety indicators, the combined medication and quality of the test Control and so on.