临床评价中药新药临床试验的前期工作基础简析.PDFVIP

- 448 - Drug Evaluation Research 第 37 卷 第 5 期 2014 年 10 月 • 临床评价 • 中药新药临床试验的前期工作基础简析 1 2 1 1* 倪天庆 ，李海红 ，钟成梁 ，胡思源 1. 天津中医药大学第一附属医院，天津 300193 2. 天津中新药业集团股份有限公司，天津 300193 摘 要：根据中国《药品注册管理办法》，中药新药进入临床试验阶段前需要进行系列的非临床研究，并以此作为背景资料。 临床试验作为药物研究中具有决定性意义的一个重要环节，其研究结果最终决定一个药品能否被批准运用于临床，及其在临 床上如何使用。临床试验方案设计的优劣，直接关系到试验的成败。简述中药临床试验方案的前期基础工作以及需要注意的 首要问题，包括文献基础、药学基础、药效学基础、安全性研究基础和既往临床研究基础等。 关键词：中药新药；临床试验；背景资料；试验方案 中图分类号：R286 文献标志码：A 文章编号：1674 - 6376 (2014) 05 - 0448 - 03 DOI: 10.7501/j.issn.1674-6376.2014.05.017 Brief analysis on preliminary work foundation for clinical trials of new Chinese materia medica 1 2 1 1 NI Tian-qing , LI Hai-hong , ZHONG Cheng-liang , HU Si-yuan 1.The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China 2.Tianjin Zhongxin Pharmaceutical Group Corporation Ltd., Tianjin 300193, China Abstract: According to the Management Method of Drug Registration, before the new drugs are used in clinical trials, non clinical studies are set as background information. Clinical trial as an important part of drug research has the decisive significance, and its research results could ultimately determine whether a drug would be approved in the clinical application, and its clinical use. The quality of clinical trial design was directly related to the success or failure of the test. This article briefly analyzed the work based on clinical trials of traditional Chinese medicine scheme and problems, including literature and pharmaceutical basis, pharmacodynamics, safety research foundation, and previous clinical research foundation. Key words: new drug of traditional Chinese medicine; clinical trials; background information; test program 临床试验是指任何在人体（病人或健康志愿者） 应列入该