| 标题： | 托珠单抗治疗风湿性疾病超说明书用药中国专家共识 |
| title： | Chinese expert consensus on off-label administration of tocilizumab in rheumatic diseases |
| 版本： | 原创版 |
| version： | Original |
| 分类： | 专家共识 |
| classification： | Experts consensus |
| 领域： | 治疗 |
| field： | Treatment |
| 国家和地区： | 中国 |
| Country and region： | China |
| 指南使用者： | 各级临床医生和药师（风湿病、药学、儿科风湿病和其他相关领域） |
| Guide users： | Clinicians at all levels (rheumatology, pharmacy, pediatric rheumatology and other related fields) |
| 证据分级方法： | 采用2009版牛津大学循证医学中心分级系统进行分级，其中证据水平等级分为1级（1a，1b，1c）、2级（2a，2b，2c）、3级（3a，3b）、4级和5级，推荐等级分为A、B、C、D和E共5个等级 |
| Evidence grading method： | The rating system of the Centre for Evidence-Based Medicine of the University of Oxford 2009 was adopted, in which the level of evidence was divided into level 1 (1a, 1b, 1c), level 2 (2a, 2b, 2c), level 3 (3a, 3b), level 4 and level 5, and the recommended level was divided into A, B, C, D and E |
| 制定单位： | 中山大学孙逸仙纪念医院 |
| Formulating unit： | Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University |
| 注册时间： | 2024-01-30 |
| Registration time： | |
| 注册编号： | PREPARE-2023CN510 |
| Registration number： | |
| 指南制订的目的： | 目前全球已上市的IL-6靶向药包括靶向IL-6的司妥昔单抗(Siltuximab)，靶向IL-6受体的托珠单抗（Tocilizumab)、Sarilumab和Satralizumab，以及Janus激酶（JAK）抑制剂，其中司妥昔单抗、托珠单抗和JAK抑制剂已在国内上市。司妥昔单抗鲜有治疗风湿免疫病的报道。JAK抑制剂治疗风湿免疫病的超说明书用药专家共识已经发表。托珠单抗在风湿免疫科临床实践中超药品说明书用药十分常见。因此，有必要对托珠单抗超说明书用药治疗风湿免疫病形成专家共识，旨在为临床医生提供合理用药依据的同时也为药学部门管理提供参考。 |
| Purpose of the guideline： | IL-6 targeted drugs in the world currently include Siltuximab targeting IL-6, Tocilizumab, Sarilumab and Satralizumab targeting IL-6 receptor, and Janus kinase (JAK) inhibitors. In China, siltuximab, tocilizumab and JAK inhibitors have been marketed. There are few reports on the application of siltuximab in patients with rheumatic diseases. The expert consensus on the off-label administration of JAK inhibitors in the treatment of rheumatic diseases has been published. The off-label administration of tocilizumab in clinical practice of rheumatic diseases is very common and increasing. Therefore, it is necessary to form an expert consensus aiming to provide the reference for rational use of tocilizumab among clinicians and the pharmacovigilance monitoring. |
