| 吴建才,王萌萌,刘巧玲,等.放射性药品临床试验注册现状分析[J].中华放射医学与防护杂志,2025,45(8):790-794.Wu Jiancai,Wang Mengmeng,Liu Qiaoling,et al.Current status of registration of radiopharmaceutical clinical trials[J].Chin J Radiol Med Prot,2025,45(8):790-794 |
| 放射性药品临床试验注册现状分析 |
| Current status of registration of radiopharmaceutical clinical trials |
| 投稿时间：2025-03-06 |
| DOI：10.3760/cma.j.cn112271-20250306-00079 |
| 中文关键词: 放射性药品 医用同位素 临床研究 药物临床试验 |
| 英文关键词:Radiopharmaceutical Medical isotopes Clinical research Drug clinical trial |
| 基金项目:湖北省卫生健康科研项目(WJ2023M039) |
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| 中文摘要: |
| 目的 分析中国放射性药品临床试验的注册现状,为放射性药品的研发和临床应用提供参考。方法 通过国家药品监督管理局药品审评中心药物临床试验登记与信息公示平台,检索并收集了2014—2024年间注册的放射性药品临床试验数据,对临床试验设计、给药剂量、常见适应证及地域分布等进行分析。结果 共纳入77项临床试验,2014—2024年项目量复合年增长率为40%。诊断用药以18F、 99Tcm为主,治疗用药以177Lu、 90Y为主,适应证均集中于肿瘤领域。试验设计方面,非随机化(71.4%)、开放标签(89.6%)和单臂试验(66.2%)占比较高。地域分布显示,北京市(29项)、上海市(18项)和江苏省(14项)为临床试验集中地区。结论 我国放射性药品临床试验呈现快速增长趋势,但研究主要集中于肿瘤领域,且早期试验占比较高,为挖掘放射性药品潜力及提高临床试验质量,建议研究人员发散研究放射性药品适用范围,谨慎制定临床试验给药剂量,统一临床试验各中心辐射防护的标准化操作规程。 |
| 英文摘要: |
| Objective To analyze the status of registration of clinical trials of radiopharmaceuticals in China, and to provide reference for the development and clinical application of radiopharmaceuticals. Methods By searching the clinical trial registration and information disclosure platform of the Center for Drug Evaluation of the National Medical Products Administration (NMPA), the data on clinical trials of radiopharmaceuticals registered from 2014 to 2024 were collected and analyzed for trial design, administered dose, common indications, and geographical distribution. Results A total of 77 clinical trials were included. The Compound Annual Growth Rate for the number of projects from 2014 to 2024 was 40%. Diagnostic radiopharmaceuticals were predominantly based on 18F and 99Tcm, while therapeutic radiopharmaceuticals primarily utilized 177Lu and 90Y. All indications were concentrated in the field of oncology. Regarding trial design, non-randomized (71.4%), open-label (89.6%), and single-arm (66.2%) trials accounted for the highest proportions. Geographical distribution showed Beijing (29 trials), Shanghai (18 trials), and Jiangsu province (14 trials) as the regions with the highest concentration of clinical trials. Conclusions Radiopharmaceutical clinical trials in China have shown rapid growth. However, research remains predominantly focused on oncology, with a relatively high proportion of early-stage trials. In order to fully utilize the potentials of radiopharmaceuticals and improve the quality of clinical trials, nuclear medicine researches should broaden therapeutic applications, implement prudently administerd dose in clinical trials, and implement optimized radiation protection procedures across all clinical trial centers. |
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