| 引用本文:周贝1，吕祥2，何晓红3，唐健元1.关于急性痛风性关节炎复方中药新药临床试验设计的考虑[J].世界中医药,2017,(09):. |
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| 关于急性痛风性关节炎复方中药新药临床试验设计的考虑 |
| Thoughts on Clinical Trial Design of New Compound Chinese Medicine for Acute Gouty Arthritis |
| 投稿时间：2017-08-24 |
| DOI：10.3969/j.issn.1673-7202.2017.09.055 |
| 中文关键词: 中药新药 急性痛风性关节炎 临床试验设计 考虑 |
| English Keywords:New drugs of Chinese medicine Acute gouty arthritis Clinical trial design Insight |
| 基金项目:国家中医药管理局中医药行业科研专项(201207009) |
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| 中文摘要: |
| 结合近年来对申请用于急性痛风性关节炎的中药新药6类复方品种的审评工作思考,对本适应证中药新药研发的临床试验设计的关键点进行初步探讨。本文从临床定位、受试者选择、对照的设计、疗程和随访的考虑等方面较为细致的进行了说明,尤其对有效性指标选择问题、结合申报品种常含有毒性药材的安全性指标设计问题和临床试验质量控制问题进行了重点说明和探讨。 |
| English Summary: |
| Based on the thoughts on the evaluation of 6 types of new drug of compound traditional Chinese medicine for the acute gouty arthritis applied in recent years, this article made the preliminary study on the key points of the clinical trial design of TCM new drug, and also elaborated on clinical orientation, the choice of subjects, control design, treatment course and follow-up visit.The validity index selection was especially explained and discussed combined with safety index design of applied drugs containing toxic herbs and quality control of the clinical trials. |
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