| 2005—2021年批准上市中药复方新药的回顾分析 |
| 投稿时间：2022-08-08 点此下载全文
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| 引用本文：刘乐环,周跃华,周刚,李天泉.2005—2021年批准上市中药复方新药的回顾分析[J].中国现代中药,2023,25(1):1-8 |
| DOI：10.13313/j.issn.1673-4890.20220808006 |
| 摘要点击次数: 367 |
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| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 刘乐环 |
LIU Le-huan |
国家药品监督管理局 药品审评中心，北京 100022 |
Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| 周跃华* |
ZHOU Yue-hua |
国家药品监督管理局 药品审评中心，北京 100022 |
Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| 周刚 |
ZHOU Gang |
国家药品监督管理局 药品审评中心，北京 100022 |
Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| 李天泉 |
LI Tian-quan |
重庆康洲大数据有限公司，重庆 401336 |
Chongqing Kangzhou Big Data Co., Ltd., Chongqing 401336, China |
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| 中文摘要:中药复方新药是中药新药的重要组成部分，是中药研发创新研究成果的重要体现。对2005—2021年批准的中药复方新药进行了回顾分析，结果显示：新药的处方来源以临床经验方占比最多；处方药味平均为8味，最少2味，最多21味；适应证主要集中于消化、妇科、呼吸、心脑血管等，总占比达51%，同时在一些新适应证的研究方面取得了进展；新药的剂型以胶囊剂、颗粒剂、片剂较多，三者之和>80%；2008年后开始进行临床试验的新药普遍采用了随机对照临床试验；中药新药Ⅱ期临床试验组病例数平均为119例，Ⅲ期临床试验组病例数平均为332例；约87%的中药新药临床试验用时在6年以内。此外，对中药新药研发相关问题进行了讨论。对已获批中药复方新药的回顾分析可为今后相关新药研发提供有益参考。 |
| 中文关键词:中药复方新药 适应证 临床试验 回顾分析 |
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| Retrospective Analysis of New Compound Drugs of TCM Approved from 2005 to 2021 |
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| Abstract:The new compound drug of traditional Chinese medicine (TCM) is the main part of the new Chinese medicine and embodies the achievements of Chinese medicine innovation research. This paper reviewed and analyzed the new compound drugs of TCM approved from 2005 to 2021. The results showed that the most prescription source of new drugs was clinical experience. The average number of drugs in prescriptions was 8, with a minimum of 2 and a maximum of 21. Indications mainly focused on digestion, gynecology, respiration, cardio-cerebrovascular, and so on, accounting for 51%. Meanwhile, progress was made in the research of some new indications. The dosage forms of new drugs were mainly capsules, granules, and tablets, and the total percentage of the three was more than 80%. Randomized clinical trial (RCT) design had been widely used in the clinical tests of new Chinese medicines since 2008. The mean of treatment group cases were 119 in phase Ⅱ clinical trials and 332 in phase Ⅲ clinical trials . About 87% of the clinical trials of new compound drugs of TCM took less than 6 years. In addition, some problems related to the research and development (R&D) of new Chinese medicine were discussed. In this paper, the review and analysis of the approved new compound drugs of TCM can provide useful references for the R&D of relevant new drugs in the future. |
| keywords:new compound drugs of TCM indications clinical trials retrospective analysis |
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