《脊柱关节炎靶向药物治疗专家共识》要点解读

杨晓曦, 田新平, 李梦涛, 冷晓梅, 赵岩, 曾小峰

杨晓曦, 田新平, 李梦涛, 冷晓梅, 赵岩, 曾小峰. 《脊柱关节炎靶向药物治疗专家共识》要点解读[J]. 协和医学杂志, 2024, 15(1): 58-67. DOI: 10.12290/xhyxzz.2023-0391
引用本文: 杨晓曦, 田新平, 李梦涛, 冷晓梅, 赵岩, 曾小峰. 《脊柱关节炎靶向药物治疗专家共识》要点解读[J]. 协和医学杂志, 2024, 15(1): 58-67. DOI: 10.12290/xhyxzz.2023-0391
YANG Xiaoxi, TIAN Xinping, LI Mengtao, LENG Xiaomei, ZHAO Yan, ZENG Xiaofeng. Interpretation on the Consensus on Targeted Drug Therapy for Spondyloarthritis[J]. Medical Journal of Peking Union Medical College Hospital, 2024, 15(1): 58-67. DOI: 10.12290/xhyxzz.2023-0391
Citation: YANG Xiaoxi, TIAN Xinping, LI Mengtao, LENG Xiaomei, ZHAO Yan, ZENG Xiaofeng. Interpretation on the Consensus on Targeted Drug Therapy for Spondyloarthritis[J]. Medical Journal of Peking Union Medical College Hospital, 2024, 15(1): 58-67. DOI: 10.12290/xhyxzz.2023-0391

《脊柱关节炎靶向药物治疗专家共识》要点解读

基金项目: 

中国医学科学院医学与健康科技创新工程 2021-I2M-1-005

中央高水平医院临床科研专项 2022-PUMCH-B-013

详细信息
    通讯作者:

    曾小峰, E-mail: zengxfpumc@163.com

  • 中图分类号: R593.22;R593.22;R971+.1

Interpretation on the Consensus on Targeted Drug Therapy for Spondyloarthritis

Funds: 

CAMS Innovation Fund for Medical Sciences 2021-I2M-1-005

National High Level Hospital Clinical Research Funding 2022-PUMCH-B-013

More Information
  • 摘要: 脊柱关节炎(spondyloarthritis, SpA)是一组以中轴骨和/或外周关节受累为主的慢性炎症性、致残性风湿免疫病, 严重影响患者的身体功能和生活质量。随着靶向药物的临床应用越来越多, 其精准且规范应用成为目前关注的重点。遵循共识制订的国际规范, 国家皮肤与免疫疾病临床医学研究中心制定了我国首部《脊柱关节炎靶向药物治疗专家共识》, 该共识对13个靶向药物应用过程中的重点问题作出推荐, 涵盖了靶向药物治疗SpA的原则、适用人群、用药前筛查、用药时机、药物选择和转换、合并用药、不良反应监测等, 并对特殊人群的用药注意事项提出建议, 对临床实践具有重要指导意义。
    Abstract: Spondyloarthritis (SpA) is a group of chronic inflammatory diseases which predominantly involve spine and/or peripheral joints. SpA can be disabling and seriously affect the quality of life and function of patients. With the increasing clinical use of targeted drug therapy, precise and standardized use becomes the focus. China's first Consensus on Targeted Drug Therapy for Spondyloarthritis was developed by National Clinical Research Center for Dermatologic and Immunologic Diseases using international norms for consensus development. The consensus addresses 13 important clinical questions, ranging from principles, patient eligibility, pre-treatment screening, treatment initiation, drug selection and switch, co-medication, to adverse event monitoring of targeted drug therapy in SpA, and recommends treatment for specific patients, playing a key role in guiding clinical practices.
  • 人们对缓和医疗的概念可能并不生疏,但对其认识尚且不够,对其理解抑或存在较大偏颇。无论是医生还是公众,都需要加深对缓和医疗重要性的认识,同时更深入地践行这一理念。

    所谓缓和医疗,是指对慢性疾病、不可自愈/难以治愈之症、疾病晚期患者或年迈体弱者,医疗不力或救治无方,为尊重病患及其家人的意愿,为减轻其痛苦和症状,改善生命或生活质量的一种医疗对策[1]

    事实上,疾病晚期患者临近死亡(或称濒死),是正常的生命过程。缓和医疗也是医疗过程,包含心理调适、营养支持、症状缓解、康复保健、改善预后、慰藉家人等,与延长生命并不矛盾。这些对策和措施,正是人文理念和人文关怀的体现,亦是医学及缓和医疗的本源[2]。正如特鲁多的墓志铭所阐述的,“有时是治愈,常常是帮助,而总是慰籍”。

    “和缓是悉”,由来久矣。早在我国南朝,谢灵运的《山居赋》中即写道: “雷桐是别,和缓是悉”。雷、桐是古代的两位药学先祖,和、缓是古代两位名医,药神辨识草药之别,医圣明确病患之悉。尽管如此,面对诸多疾病,往往神药亦无力,圣医亦无方。此时,或者“古方治今病,和缓技亦穷”,或者人们还在留恋是否“如彼久病者,不敢忘和缓”还是“疏淪(音同药)费虽多,尺寸皆有功”呢?

    于是,我们必须承认,此时最好的医疗是人文关怀,即“和缓是悉”。这就是医圣和、缓留给我们的无价财富与医疗真谛!

    缓和医疗涉及两个重要概念: 临终关怀(terminal care or hospice care)和终极关怀(ultimate concern)[3]。二者是不同的,临终关怀更侧重于具体的医疗措施,“临终”二字又显得狭隘、刺耳和难耐。而终极关怀则是对于生命的终极认识,比如生老病死、苦难痛殇。终极关怀其实是个哲学问题,亦是我们现今惯常的所谓“三观”(世界观、人生观、价值观),这里侧重于对生命、身体、生活、健康、疾病与死亡的认识、理解和态度。这是每个人都必须面对,且必然要经历和选择的。

    诞生或者死亡,发育或者缺陷,健康或者罹病,是科学的、生物学的、哲学的,也是自然的、宗教的、神秘的。医学当然要遵循自然规律和生命规律,但也有可能打破生死的自然轨迹,从而误导人类抗拒必然的生命过程。问题是作为医者,我们需要真正理解什么是生命的意义,以及什么是死亡的意义。现实中,我们确实在寻找消除病痛、延长生命的药物和方法,但也应该避免无意义的,甚至善意的扰乱。我们应该清楚地认识到,长生不老、无疾而终、健康长寿、万寿无疆,只不过是敬语和神话。

    有了对于终极关怀的认识和理解,有了对于临终关怀的具体办法,我们对于缓和医疗就有了更深层次的认识和领会,也有助于更好地开展缓和医疗工作。可以认为,终极关怀是临终关怀或缓和医疗的目标和升华,临终关怀或缓和医疗是终极关怀的体现和实施。

    医学是一个复杂的认知系统,是自然科学与社会科学或人文科学的结合。其关乎国家、民族、社会、家庭、个人健康及幸福。所谓“天地神圣,生命至上”。为此,我们要实施全生命周期的健康管理。所谓全生命周期,就是从生到死的人生各个阶段。现阶段,缓和医疗可能更多实施于年长者,但在生命的各个阶段我们都会遇到不同的健康问题,缓和医疗理念在这些阶段具有同样重要的意义。

    医学的认识和实践有两个明显的特征:一是局限性,二是风险性。所谓局限性,就是认知的局限,由于人体的复杂性以及人与环境(自然与社会)的交叉性,形成了诸多影响和变数。因此,我们对于疾病的认识和处理可能是局限的、片面的,甚至是错误的。二是风险性,因为医疗的对象是活的人体,诊断、治疗、药物、手术等都会有风险,是“危险的丛林”。先哲们告诫我们,临床工作“如临深渊,如履薄冰”,要“戒慎恐惧”。

    近二三十年,医学在其他各个学科,特别是在遗传学、分子生物学、机械工艺学等技术的推动下,于颠簸中快速发展。诚然,技术的进步给医疗领域带来了巨大推动力,但也带来了诸多问题。过度诊断、过度治疗,过分相信和依赖机器检查及化验报告,脱离临床、脱离实际等的倾向日趋严重。数字化冲淡了医学的人文观念, 隔离了医生与患者,这给临床医学带来了巨大影响,却也进一步凸显了缓和医疗的重要性。

    缓和医疗方兴未艾,可以说其是个幸运者,同时又是个逆行者。未来,缓和医疗必须紧密联系临床,既要走到患者床边去做面对面的具体工作,更要进行多学科协作,共同管理患者全生命周期各个阶段的各种问题。无论是大医院还是小诊所,缓和医疗都同样重要,都要践行和发展这一理念。北京协和医院是全国疑难重症诊疗中心,是医疗、教学和科研的结合与转化基地,应该在推动缓和医疗发展中发挥引领和示范作用,因此任重而道远。

    缓和医疗不是一枝奇葩的花朵,而是一片关爱的森林。

    作者贡献:杨晓曦、田新平、李梦涛、冷晓梅、赵岩负责文献查阅、资料收集及论文撰写;曾小峰负责选题组织及论文审校。
    利益冲突:所有作者均声明不存在利益冲突
  • 表  1   脊柱关节炎患者围术期靶向药物应用建议

    Table  1   Recommendations for perioperative targeted drug application in patients with spondyloarthritis

    药物名称 用药间隔
    推荐手术时间(自最后一次用药后)
    英夫利昔单抗 每4周或每6周或每8周 第5周或第7周或第9周
    阿巴西普 每月(静脉注射)或每周(皮下注射) 第5周(静脉注射)或第2周(皮下注射)
    培塞利珠单抗 每2周或每4周 第3周或第5周
    利妥昔单抗 每隔4~6个月用下一剂,两剂间隔2周 第5个月或第7个月
    托珠单抗 每周(皮下注射)或每4周(静脉注射) 第2周(皮下注射)或第5周(静脉注射)
    司库奇尤单抗 每4周 第5周
    乌司奴单抗 每12周 第13周
    依奇珠单抗 每4周 第5周
    古塞奇尤单抗 每8周 第9周
    托法替布 每日或每日2次 第4天
    乌帕替尼 每日 第4天
    下载: 导出CSV

    表  2   脊柱关节炎患者不同妊娠阶段和哺乳期靶向药物应用建议

    Table  2   Recommendations for targeted drug application in patients with spondyloarthritis during different stages of pregnancy and lactation

    药物名称 围孕期 妊娠早期 妊娠中晚期
    哺乳期
    英夫利昔单抗 可用 可用 妊娠20周停药 可用,但证据不足
    依那西普 可用 可用 孕早期、中期可用;孕晚期停药 可用,但证据不足
    阿达木单抗 可用 可用 孕早期、中期可用;孕晚期停药 可用,但证据不足
    培塞利珠单抗 可用 可用 可用,但证据不足 可用,但证据不足
    戈利木单抗 无数据 无数据 无数据 无数据
    乌司奴单抗 可用,但证据不足 无数据 无数据 无数据
    司库奇尤单抗 可用,但证据不足 可用,但证据不足 无数据 无数据
    注:参考英国风湿病学会和英国风湿病卫生专业人员协会关于肿瘤坏死因子抑制剂的处方处理意见[66]
    下载: 导出CSV
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出版历程
  • 收稿日期:  2023-08-22
  • 录用日期:  2023-09-10
  • 网络出版日期:  2023-10-24
  • 刊出日期:  2024-01-29

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