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实体器官移植受者新型冠状病毒感染诊疗专家共识(2023年版)

国家传染病医学中心, 中华医学会器官移植学分会, 中国康复医学会器官移植康复专业委员会, 等. 实体器官移植受者新型冠状病毒感染诊疗专家共识(2023年版)[J]. 器官移植, 2023, 14(2): 163-182. doi: 10.3969/j.issn.1674-7445.2023.02.001
引用本文: 国家传染病医学中心, 中华医学会器官移植学分会, 中国康复医学会器官移植康复专业委员会, 等. 实体器官移植受者新型冠状病毒感染诊疗专家共识(2023年版)[J]. 器官移植, 2023, 14(2): 163-182. doi: 10.3969/j.issn.1674-7445.2023.02.001
National Medical Center for Infectious Diseases, Branch of Organ Transplantation of Chinese Medical Association, Organ Transplant Rehabilitation Committee of China Association Rehabilitation Medicine, et al. Expert consensus on diagnosis and treatment of SARS-CoV-2 infection in solid organ transplant recipients (2023 edition)[J]. ORGAN TRANSPLANTATION, 2023, 14(2): 163-182. doi: 10.3969/j.issn.1674-7445.2023.02.001
Citation: National Medical Center for Infectious Diseases, Branch of Organ Transplantation of Chinese Medical Association, Organ Transplant Rehabilitation Committee of China Association Rehabilitation Medicine, et al. Expert consensus on diagnosis and treatment of SARS-CoV-2 infection in solid organ transplant recipients (2023 edition)[J]. ORGAN TRANSPLANTATION, 2023, 14(2): 163-182. doi: 10.3969/j.issn.1674-7445.2023.02.001

实体器官移植受者新型冠状病毒感染诊疗专家共识(2023年版)

doi: 10.3969/j.issn.1674-7445.2023.02.001
基金项目: 

上海申康医院发展中心临床三年行动计划 SHDC2020CR2021B

国家自然科学基金专项项目 82241225

上海市重大专项 HS2021SHZX001

详细信息
  • 中图分类号: R617, R373.1

Expert consensus on diagnosis and treatment of SARS-CoV-2 infection in solid organ transplant recipients (2023 edition)

  • 摘要: 自2019年底以来,新型冠状病毒(新冠病毒)感染大流行已席卷全球。虽然目前的新冠病毒变异株的致病性和毒力已较原始株有所下降,大多数患者预后良好,但实体器官移植(SOT)受者为新冠病毒感染脆弱人群,即使全程接种新冠病毒疫苗,SOT受者感染新冠病毒的住院或死亡风险依然较高。SOT受者新冠病毒感染后其临床表现、诊断和治疗均与普通人群存在很大的特殊性,需要高度关注。目前尚缺乏针对SOT受者可供参考的新冠病毒感染诊疗领域的指南或共识。因此,参考《新型冠状病毒感染诊疗方案(试行第十版)》及国内外文献,编写团队撰写了《实体器官移植受者新型冠状病毒感染诊疗专家共识(2023年版)》。本共识基于国内外新冠病毒感染的循证医学证据,并经过专家多次研讨达成一致意见后撰写成文,形成21条推荐意见,为SOT受者感染新冠病毒的诊疗提供参考。

     

  • 表  1  2009牛津大学证据分级与推荐意见强度分级标准

    Table  1.   Level of evidence and recommended grades of Oxford University in 2009

    推荐强度 证据级别 治疗或危害
    A 1a RCT的系统评价
    1b 结果可信区间小的RCT
    1c 显示“全或无效应”的任何证据
    B 2a 队列研究的系统评价
    2b 单个的队列研究(包括低质量的RCT,如失访率>20%者)
    2c 基于患者结局的研究
    3a 病例对照研究的系统评价
    3b 单个病例对照研究
    C 4 病例系列报告、低质量队列研究和低质量病例对照研究
    D 5 专家意见(即无临床研究支持的仅依据基础研究或临床经验的推测)
    注:对于因以下任一原因导致无法得出确定性的结论的证据,使用者可以在证据级别后加上“-”,这类证据不具有确定性,只能获得D级推荐,包括单个结果具有较宽的可信区间或一个存在很大异质性的系统评价。
    下载: 导出CSV

    表  2  推荐意见汇总

    Table  2.   Summary of recommendations

    序号 推荐意见 推荐强度 证据等级
    1 SOT受者对新冠病毒普遍易感。目前没有证据证明SOT受者新冠病毒感染的潜伏期与其他新冠病毒感染者有差异。SOT受者感染新冠病毒,在潜伏期即具有传染性,由于SOT受者感染新冠病毒的排毒期更长,其具有传染性的时间更长 B 2a
    2 SOT受者感染新冠病毒的症状与普通人群相似,主要临床表现为发热、乏力和肌痛,还有一些患者表现为咽痛、咳嗽、呼吸短促、腹泻、头晕头痛、失嗅症和厌食等。需警惕SOT受者因使用免疫抑制剂导致早期症状隐匿而后期病情进展较快。尤其需要警惕SOT受者腹泻导致免疫抑制剂药物浓度的变化,需要密切监测血药浓度 B 2a
    3 SOT受者感染新冠病毒后,相较于普通人群,重型或危重型发生率和病死率更高。高龄和基础合并症多的SOT受者新冠病毒感染的预后可能更差 B 2a
    4 SOT受者二次感染新冠病毒的风险较高,仍需要加强防护 B 2b
    5 SOT受者如果有流行病学史,且出现发热等与新冠病毒感染一致的症状,应立即进行新冠病毒核酸或抗原检测。在病程最初5~7天内检测,阳性率较高。在确诊6天后,可定期检测新冠病毒核酸或抗原以评估患者新冠病毒是否转阴(2次采样至少间隔24小时) B 2a
    6 低氧血症进行性加重、外周血淋巴细胞进行性减少、炎症生物标志物和细胞因子水平升高、D-二聚体等凝血功能相关指标持续异常、乳酸脱氢酶、天冬氨酸转氨酶、丙氨酸转氨酶、肌酸激酶、高敏肌钙蛋白等指标明显升高、胸部影像学显示肺部病变明显进展,以及移植物功能不全是SOT受者感染新冠病毒后发生重型或危重型的重要预警指标 B 2a
    7 SOT受者在感染新冠病毒后,合并或继发细菌和(或)真菌感染风险增高,应尽早进行相关实验室检测、留取标本培养及完善胸部影像学检查 B 2b
    8 对于SOT受者,一旦出现新冠病毒感染的症状,应尽早在专科医师指导下明确诊断、评估各项生命体征和高危预警实验室指标,并完善胸部影像学检查,综合患者病情调整免疫抑制剂的剂量,符合抗新冠病毒治疗条件的患者应尽早使用抗新冠病毒药物。对于中型、重型或危重型患者,建议住院治疗,在制订SOT受者感染新冠病毒后的治疗方案时,要注意抗新冠病毒药物与免疫抑制剂的相互作用 B 2b
    9 SOT是轻型和中型新冠病毒感染患者进展为重型或危重型的高风险因素之一,应结合患者病程、病情及基础用药情况,尽早合理地选用抗新冠病毒药物,抑制病毒复制并控制病毒感染进程 A 1a
    对于重型和危重型患者,若新冠病毒核酸阳性(Ct值≤30),亦建议使用抗病毒药物治疗 D 5
    10 SOT受者易出现新冠病毒核酸持续阳性(Ct值≤30),在评估获益风险比后,可适当延长小分子药物抗病毒疗程。在病情治疗需要的情况下,可以尝试换用或者联用其他不同作用机制的抗病毒药物治疗 D 5
    11 SOT受者新冠病毒感染发生炎症反应的免疫治疗总体可参考普通人群诊疗指南 D 5
    12 对于新冠病毒感染轻型的SOT受者,建议维持原有的免疫抑制方案 B 3a
    对于新冠病毒感染中型的SOT受者,建议减少或停用霉酚酸类药物,综合评估病情后个体化调整钙调磷酸酶抑制剂或哺乳动物雷帕霉素靶蛋白抑制剂方案 B 2b
    对于新冠病毒感染重型或危重型的SOT受者,应停用所有非激素类免疫抑制剂 D 5
    13 在使用奈玛特韦/利托那韦或先诺特韦/利托那韦时应注意其与免疫抑制剂的相互作用,注意调整钙调磷酸酶抑制剂、哺乳动物雷帕霉素靶蛋白抑制剂和糖皮质激素的剂量,密切监测药物浓度 B~C 2c~4
    在使用莫诺拉韦、阿兹夫定、氢溴酸氘瑞米德韦、巴瑞替尼或托珠单抗时,初始无需调整免疫抑制剂剂量,但仍应加强药物浓度监测,同时不建议巴瑞替尼或托珠单抗与巴利昔单抗联用,警惕增加免疫抑制风险 D 5
    14 在使用奈玛特韦/利托那韦、先诺特韦/利托那韦和阿兹夫定时,应注意其与抗菌药物的相互作用,注意药物联合使用的禁忌 B~C 2c~4
    在使用莫诺拉韦、氢溴酸氘瑞米德韦、巴瑞替尼或托珠单抗时,初始无需调整抗菌药物剂量,但仍应加强药物浓度监测 D 5
    15 对于重型或危重型高危人群、病情进展较快的中型病例以及重型或危重型病例,无禁忌情况下推荐预防剂量低分子肝素或者普通肝素进行预防性抗凝;治疗性抗凝适用于确诊血栓形成的患者。如使用利伐沙班等其他抗凝方案,应注意抗凝药物与抗新冠病毒药物的相互作用 B 2a
    16 可使用没有出现免疫逃逸的中和抗体药物,联合小分子抗病毒药物对具有较高风险因素的感染新冠病毒的SOT受者进行治疗 A 1a
    17 感染新冠病毒的SOT受者,呼吸支持策略与普通肺部感染患者基本类似。根据患者的病情,可以选择普通氧疗(鼻导管、普通面罩、文丘里面罩或非重复呼吸储氧面罩等)、经鼻高流量氧疗、无创正压通气、有创正压通气和体外膜肺氧合。氧疗目标:(1)无高碳酸血症风险患者,脉搏血氧饱和度92%~96%;(2)高碳酸血症高风险患者,脉搏血氧饱和度88%~92%
    具有重症化危险因素、病情进展较快的中型、重型和危重型病例,应当早期给予规范的俯卧位通气治疗,建议每日不少于12小时
    B
    B
    2b
    2b
    18 推荐SOT等待者在移植前2周完成全程新冠病毒疫苗接种。推荐SOT手术4周后可酌情接受除了减毒活疫苗以外的新冠疫苗接种 D 5
    若SOT受者接受T细胞或B细胞消除治疗(如使用抗胸腺细胞球蛋白或利妥昔单抗),结束治疗12周后可接受新冠病毒疫苗接种 D 5
    SOT受者接种新冠病毒疫苗,可降低其感染新冠病毒后重症化的风险 C 4
    19 可使用没有出现免疫逃逸的中和抗体药物,在区域疫情流行时,对暴露后的SOT受者进行新冠病毒感染的预防 A 1a
    接受B细胞耗竭剂治疗的SOT受者,可适当予以暴露前中和抗体预防 B 3a
    20 对于新冠病毒感染患者,不建议进行非抢救性SOT。对于抢救性SOT,需经过多学科讨论权衡利弊后决定 D 5
    21 出院指导和随访基本同移植术后,需补充新冠病毒防护相关内容。推荐在移植科医师指导下进行规律随访 A 1b
    下载: 导出CSV

    表  3  抗病毒药物与免疫抑制剂的相互作用

    Table  3.   Interaction of antiviral drugs with immunosuppressants

    抗病毒药物 免疫抑制剂 药物相互作用原理及剂量调整方案
    奈玛特韦/利托那韦(paxlovid) 他克莫司 合用可显著增加他克莫司血药浓度
    在paxlovid治疗的第1天,给予他克莫司常规日剂量的1/8,然后停止;第6天给予1/2日剂量;第7天给予3/4日剂量;第8天重启常规日剂量
    注意事项:在治疗期间的第3天监测他克莫司浓度,并评估患者免疫状态
    环孢素 合用可显著增加环孢素血药浓度
    在paxlovid治疗期间,每日给予环孢素常规日剂量的1/5;第6天给予1/2日剂量;第7天给予3/4日剂量;第8天重启常规日剂量
    MPA 无显著药物相互作用,无需调整剂量
    mTOR抑制剂 联合给药可增加mTOR抑制剂血药浓度
    在使用paxlovid前12小时停用mTOR抑制剂。paxlovid治疗结束后第2天mTOR抑制剂以原始剂量的20%重新使用,每日增加20%,并根据检测的mTOR抑制剂血药谷浓度调整剂量
    糖皮质激素 合用可能会增加糖皮质激素的暴露量,但相互作用弱,可以不调整糖皮质激素剂量
    先诺特韦/利托那韦 免疫抑制剂 药物相互作用数据尚缺,但先诺特韦作用机制与奈玛特韦相似,可以参考奈玛特韦/利托那韦调整药物剂量
    阿兹夫定 免疫抑制剂 无显著药物相互作用,无需调整剂量,但需监测药物浓度
    莫诺拉韦 免疫抑制剂 无显著药物相互作用,无需调整剂量
    氢溴酸氘瑞米德韦 免疫抑制剂 无显著药物相互作用,无需调整剂量
    下载: 导出CSV

    表  4  抗病毒药物与SOT继发感染时常用的抗生素药物相互作用

    Table  4.   Antivirals interact with antibiotic drugs commonly used in secondary infections in SOT

    抗病毒药物 与抗生素相互作用 常用抗生素种类
    奈玛特韦/利托那韦 禁忌联合使用 利福平、利福喷丁
    谨慎联合使用 克拉霉素(部分大环内酯类抗生素)、伊曲康唑、伏立康唑、泊沙康唑、艾沙康唑、氟康唑、索磷布韦/维帕他韦、贝达喹啉、利福布汀
    弱相互作用 克林霉素
    无相互作用 青霉素类、头孢菌素、舒巴坦、他唑巴坦、阿维巴坦、碳青霉烯类、氨基糖苷类、喹诺酮类、黏菌素类、利奈唑胺、康替唑胺、万古霉素、达托霉素、磺胺类、甲硝唑、磷霉素、呋喃妥因、多西环素(四环素类)、阿奇霉素、异烟肼、吡嗪酰胺、两性霉素B、棘白菌素类、氟胞嘧啶、替诺福韦
    先诺特韦/利托那韦 联合使用 与抗生素相互作用数据尚缺,但先诺特韦作用机制与奈玛特韦相似,可以参考奈玛特韦/利托那韦选择可以配伍使用的药物
    阿兹夫定 谨慎联合使用 与P-gp抑制剂(如伊曲康唑、伏立康唑、泊沙康唑、克拉霉素等)和P-gp诱导剂(如利福平等)
    莫诺拉韦 无相互作用 无需调整剂量
    氢溴酸氘瑞米德韦 无相互作用 无需调整剂量
    下载: 导出CSV
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  • 收稿日期:  2023-02-11
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