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中国肾移植受者巨细胞病毒感染临床诊疗指南(2023版)

中华医学会器官移植学分会, 中国医师协会器官移植医师分会, 中国医疗保健国际交流促进会肾脏移植学分会, 等. 中国肾移植受者巨细胞病毒感染临床诊疗指南(2023版)[J]. 器官移植. doi: 10.3969/j.issn.1674-7445.2024096
引用本文: 中华医学会器官移植学分会, 中国医师协会器官移植医师分会, 中国医疗保健国际交流促进会肾脏移植学分会, 等. 中国肾移植受者巨细胞病毒感染临床诊疗指南(2023版)[J]. 器官移植. doi: 10.3969/j.issn.1674-7445.2024096
Branch of Organ Transplantation of Chinese Medical Association, Branch of Organ Transplantation Physician of Chinese Medical Doctor Association, Branch of Kidney Transplantation of China International Exchange and Promotive Association for Medical and Health Care, et al. Clinical diagnosis and treatment guidelines for cytomegalovirus infection in kidney transplant recipients in China (2023 edition)[J]. ORGAN TRANSPLANTATION. doi: 10.3969/j.issn.1674-7445.2024096
Citation: Branch of Organ Transplantation of Chinese Medical Association, Branch of Organ Transplantation Physician of Chinese Medical Doctor Association, Branch of Kidney Transplantation of China International Exchange and Promotive Association for Medical and Health Care, et al. Clinical diagnosis and treatment guidelines for cytomegalovirus infection in kidney transplant recipients in China (2023 edition)[J]. ORGAN TRANSPLANTATION. doi: 10.3969/j.issn.1674-7445.2024096

中国肾移植受者巨细胞病毒感染临床诊疗指南(2023版)

doi: 10.3969/j.issn.1674-7445.2024096
基金项目: 国家自然科学基金(82370802、82170766、82270789、81970646);陕西省卫生健康肾脏移植科研创新平台(2023PT-06)
详细信息
    作者简介:
    通讯作者:

    丁小明(西安交通大学第一附属医院),Email:xmding@xjtu.edu.cn

    薛武军(西安交通大学第一附属医院),Email:xwujun126@xjtu.edu.cn

  • 中图分类号: R617, R373

Clinical diagnosis and treatment guidelines for cytomegalovirus infection in kidney transplant recipients in China (2023 edition)

More Information
  • 摘要: 近几年在实体器官移植(SOT)受者巨细胞病毒(CMV)感染诊疗领域,无论是诊断方法还是新型抗CMV药物都有了一些新的进展,对CMV感染的诊治产生了积极的影响。为了进一步规范中国肾移植术后CMV感染的管理,中华医学会器官移植学分会组织了国内多个学科相关领域专家,参考《中国实体器官移植受者巨细胞病毒感染诊疗指南(2016版)》和国内外已发表的最新文献和指南,制定了《中国肾移植受者巨细胞病毒感染诊疗指南(2023版)》,新版指南更新了CMV流行病学,CMV感染的危险因素和普遍性预防的研究进展,新增CMV感染定义,细化CMV血症和CMV病的诊断标准,并对新型抗CMV药物进行了介绍。

     

  • 图  1  抢先治疗的推荐流程

    Figure  1.  Recommended procedure for pre-emptive treatment

    图  2  临床对于SOT受者耐药CMV的诊治流程

    注:GCV为更昔洛韦;VGCV为缬更昔洛韦;FOS为膦甲酸钠;CDV为西多福韦;EC50为半最大效应浓度。a为6周内少见;b为症状无改善或病毒载量不降;c为根据肾功能选择足量更昔洛韦(5 mg/kg,静脉注射,每日2次)或高剂量更昔洛韦(10 mg/kg,静脉注射,每日2次);d为包括导致<2倍EC50变化的序列变异;e为根据高剂量更昔洛韦成功治疗病例报告,更昔洛韦浓度为5~10倍EC50;f为西多福韦有效性临床研究数据有限,高剂量更昔洛韦是部分突变类型的治疗选择。

    Figure  2.  Clinical diagnosis and treatment process for drug-resistant CMV in SOT recipients

    表  1  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

    推荐强度 证据级别 描述
    A 1a 随机对照试验的系统评价
    1b 结果可信区间小的随机对照试验
    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(包括低质量的随机对照试验,如失访率>20%)
    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)
    下载: 导出CSV

    表  2  CMV感染和CMV病的定义

    Table  2.   Definition of CMV infection and CMV disease

    类别 确诊 临床诊断
    CMV综合征 未定义 经病毒分离、快速培养、抗原血症或NAT检测到血液中的CMV。且至少有以下症状中的2项:(1)发热≥38 ℃至少2 d;(2)新或加重的不适或疲劳;(3)2次独立检测的白细胞减少或中性粒细胞减少;(4)5%非典型淋巴细胞;(5)血小板减少症;(5)肝移植受者肝转氨酶增加至正常值上限2倍
    胃肠道CMV病 存在上消化道和(或)下消化道症状,同时胃肠镜下可见的黏膜病变,以及组织病理学、病毒分离、快速培养、免疫组织化学或DNA杂交技术检测到胃肠道组织有CMV 存在上消化道和(或)下消化道症状和组织中检测到CMV,但胃肠镜下无可见的黏膜病变;仅通过核酸或pp65抗原检测在血液中检测到CMV不足以诊断CMV胃肠道疾病
    CMV肺炎 存在肺炎的临床症状和(或)体征,如影像学上的新浸润、缺氧、呼吸急促和(或)呼吸困难,同时病毒分离、快速培养、组织病理学、免疫组织化学或DNA杂交技术检测到肺组织中有CMV 肺炎的临床症状和(或)体征,如影像学上的新浸润、缺氧、呼吸急促和(或)呼吸困难,及通过肺泡灌洗液的病毒分离和快速培养检测到CMV,或肺泡灌洗液中的CMV DNA定量阳性
    CMV肝炎 肝功能检查异常[胆红素和(或)肝酶升高],同时组织病理学、免疫组织化学、病毒分离、快速培养或DNA杂交技术在肝组织中检测到CMV,排除其他原因导致的肝炎 未定义
    CMV视网
    膜炎
    经眼科医师诊断有典型的CMV视网膜炎体征;如果表现不典型或没有经验丰富的眼科医师参与,则应通过QNAT在玻璃体液中检测到CMV来支持诊断 未定义
    CMV脑炎 神经系统症状,同时病毒分离、快速培养、免疫组织化学、原位杂交或QNAT神经系统组织中有CMV 神经系统症状及脑脊液中CMV检测阳性,没有可见的血液污染(“血液抽吸”),同时合并异常的影像学结果
    难治性CMV感染 经适当剂量的抗病毒治疗至少2周后,全血或血浆中病毒载量持续增加(即第2周之后检测的病毒载量峰值相比于第1周增加>1 log10) 经适当剂量的抗病毒治疗至少2周后,病毒载量持续存在(即随后第2周之后检测的病毒载量峰值和第1周相同或更高,但增加<1 log10)
    难治性CMV病 经适当剂量的抗病毒治疗至少2周后,临床体征和症状恶化或进展 经适当剂量的抗病毒治疗至少2周后,临床体征和症状没有改善
    耐药CMV
    感染
    由于CMV基因突变导致其对1种及以上抗病毒药物失去敏感性 未定义
    下载: 导出CSV

    表  3  不同肾功能状态下缬更昔洛韦剂量调整

    Table  3.   Dose adjustment of valganciclovir under different renal function states

    CrCl(mL/min) 诱导剂量 维持剂量/预防剂量
    ≥60 900 mg每日2次 900 mg每日1次
    40~59 450 mg每日2次 450 mg每日1次
    25~39 450 mg每日 1次 450 mg每2日1次
    10~24 450 mg每2日1次 450 mg每周2次
    <10 不推荐 不推荐
    下载: 导出CSV
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