中国甲状腺疾病药物临床试验的变化,2009-2022年
Chen Li1, Jun Hao2, Chuangshi Wang2
1Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital; Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing, People's Republic of China.
Drug design, development and therapy
|August 10, 2023
概括
中国的甲状腺疾病药物试验从2009年至2022年增加,重点是甲状腺癌治疗. 开发非瘤甲状腺疾病药物试验的进展仍然缓慢.
科学领域:
- 临床药理学 临床药理学
- 内分泌学 在内分泌学.
- 在瘤学瘤学.
背景情况:
- 全球甲状腺疾病发病率的上升需要改进治疗策略.
- 临床试验对于开发用于甲状腺疾病的新疗法至关重要.
研究的目的:
- 分析2009年至2022年中国甲状腺疾病药物临床试验的趋势和特征.
- 确定甲状腺疾病治疗的研究缺口和未来发展领域.
主要方法:
- 在NMPA平台上注册的65项甲状腺疾病药物临床试验的回顾性分析.
- 收集关于试验特征,时间趋势,指示和地理分布的数据.
主要成果:
- 甲状腺癌试验 (44) 超过非瘤疾病试验 (21).
- 多位氨酸激酶抑制剂主导了甲状腺癌研究 (35项试验).
- 生物等效研究是最常见的 (49.2%),而I/II期试验是有限的 (18.5%).
结论:
- 在甲状腺癌药物开发方面取得了重大进展,特别是针对性疗法.
- 在治疗非瘤甲状腺疾病的药物试验中观察到的缓慢发展.
- 研究集中在上海和北京等主要城市.
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