| 标题： | 索凡替尼超说明书用药专家共识 |
| title： | Expert consensus on off-label use of solvatinib |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 专家共识 |
| classification： | Experts consensus |
| 领域： | 管理 |
| field： | Administration |
| 国家和地区： | 中国 |
| Country and region： | China |
| 指南使用者： | 肿瘤相关临床医生、药师 |
| Guide users： | Oncology-related clinicians, pharmacists |
| 证据分级方法： | 参考CSCO指南证据评价标准： （1）1A：水平：高，来源：严谨的 meta 分析、大型随机对照临床研究，专家共识度：一致共识(支持意见≥80%)； （2）1B：水平：高，来源：严谨的 meta 分析、大型随机对照临床研究，专家共识度：基本一致共识，但争议小(支持意见 60%~80%)； （3）2A：水平：稍低，来源：一般质量的 meta 分析、小型随机对照研究、设计良好的大型回顾性研究、病例-对照研究，专家共识度：一致共识(支持意见≥80%)； （4）2B：水平：稍低，来源：型随机对照研究、设计良好的大型回顾性研究、病例-对照研究，专家共识度：基本一致共识，但争议小(支持意见 60%~80%)； （5）3：水平：低，来源：非对照的单臂临床研究、病例报告、专家观点，专家共识度：无共识，且争议大 (支持意见<60%)。 |
| Evidence grading method： | Refer to the CSCO guidelines for evidence evaluation criteria: (1) 1A: Level: high, source: rigorous meta-analysis, large randomized controlled clinical studies, expert consensus: consensus (support opinion ≥80%); (2) 1B: Level: high, source: rigorous meta-analysis, large randomized controlled clinical studies, expert consensus: basically unanimous consensus, but little controversy (support opinions 60%~80%); (3) 2A: Level: slightly low, sources: meta-analyses of general quality, small randomized controlled studies, large well-designed retrospective studies, case-control studies, expert consensus: consensus (support ≥80%); (4) 2B: Level: slightly lower, sources: type II randomized controlled studies, well-designed large retrospective studies, case-control studies, expert consensus: basically unanimous consensus, but little controversy (support opinions 60%~80%); (5) 3: Level: low, sources: non-controlled single-arm clinical studies, case reports, expert opinions, expert consensus: no consensus, and highly controversial (Support opinion <60%). |
| 制定单位： | 浙江省抗癌协会肿瘤临床药学专业委员会，浙江省药学会抗肿瘤药物专业委员会 |
| Formulating unit： | Zhejiang Anti-Cancer Association Oncology Clinical Pharmacy Professional Committee, Zhejiang Pharmaceutical Association Anti-Tumor Drug Professional Committee |
| 注册时间： | 2024-03-26 |
| Registration time： | |
| 注册编号： | PREPARE-2024CN466 |
| Registration number： | |
| 指南制订的目的： | 索凡替尼是中国自主研发的一种新型口服酪氨酸激酶抑制剂，国家药品监督管理局批准的适应证为神经内分泌瘤，但临床超说明书用药普遍存在。为更合理使用索凡替尼，本共识基于药品说明书、已发表的文献证据、指南与专家共识，对索凡替尼的循证证据进行总结评价，为索凡替尼的超说明书用药提供参考。 |
| Purpose of the guideline： | Sopantinib is a new oral tyrosine kinase inhibitor independently developed in China. The indication approved by the State Drug Administration is neuroendocrine tumor, but off-label drug use is common in clinical practice. In order to make more rational use of solantinib, this consensus summarizes and evaluates the evidence-based evidence of solantinib based on drug labels, published literature evidence, guidelines and expert consensus, and provides reference for off-label use of solantinib. |
