抗结核药物超说明书用法专家共识(2023年更新版)  

Expert consensus on off-label use of antituberculosis drugs(2023 Update)

作　　者：中华医学会结核病学分会 刘一典[2] 林明贵 唐神结[4] Chinese Society for Tuberculosis,Chinese Medical Association;Liu Yidian;Lin Minggui;Tang Shenjie(不详;Shanghai Pulmonary Hospital Affiliated to Tongji University,Shanghai 200433,China;Beijing Tsinghua Changgung Hospital,Beijing 102218,China;Beijing Chest Hospital Affiliated to Capital Medical University,Beijing Institute of Tuberculosis and Chest Cancer,Beijing 101149,China)

机构地区：[1]不详 [2]同济大学附属上海市肺科医院,上海200433 [3]北京清华长庚医院,北京102218 [4]首都医科大学附属北京胸科医院北京市结核病胸部肿瘤研究所,北京101149

出　　处：《中华结核和呼吸杂志》2023年第11期1085-1102,共18页Chinese Journal of Tuberculosis and Respiratory Diseases

基　　金：国家重点研发计划(2022YFC2304802);上海市感染性疾病(结核病学)临床医学研究中心项目(19MC1910800);上海市2020年度“科技创新行动计划”医学创新研究专项项目(20Z11900500);上海市临床重点专科建设项目(结核病科)(shslezdzk03001);北京市临床重点专科项目(20201214)。

摘　　要：2018年中华医学会结核病学分会组织撰写了《抗结核药物超说明书用法专家共识》,较为全面地涵盖了抗结核药物超说明书使用的相关内容,是临床工作者在无可替代情况下超出药物说明书抗结核治疗用药的依据,也是对超说明书用药情况的良好规范,对临床工作具有良好的指导作用。4年来,随着国内外研究成果的不断报道,抗结核治疗药物有所调整,多种药物的使用方法也已有所改进。为此,中华医学会结核病学分会对《抗结核药物超说明书用法专家共识》进行了更新。本共识对异烟肼、利福霉素类药物(利福平、利福喷丁)、氟喹诺酮类药物(左氧氟沙星、莫西沙星)、利奈唑胺、氯法齐明、贝达喹啉、德拉马尼、氨基糖苷类药物(链霉素、阿米卡星)、β-内酰胺类药物(亚胺培南/西司他丁、美罗培南)共9类13种药物的超适应证、超剂量用法、超用药途径、超适用人群等的内容进行了整理与修订,并按照GRADE证据分级方法进行了证据质量分级和推荐强度的系统评价,供我国结核病防治工作者借鉴与参考,以规范用药、合理治疗、提升疗效,更好地实现患者获益。In 2018,Chinese Society of Tuberculosis,Chinese Medical Association organized and wrote the Expert consensus on off-label use of antituberculosis drugs,which covered more comprehensively the contents related to off-label use of antituberculosis drugs,and was the basis for clinical workers to exceed the drug instructions for the use of antituberculosis treatment in irreplaceable cases,and was also a good regulation for off-label use,which had a great guiding effect on clinical work.In the last four years,with the reported national and international research results,the anti-tuberculosis treatment drugs have been adjusted and there are more new advances in the use of some drugs.For this reason,Chinese Society for Tuberculosis,Chinese Medical Association has updated the expert consensus on off-label use of antituberculosis drugs.This consensus included isoniazid,rifamycins(rifampicin,rifapentine),fluoroquinolones(levofloxacin,moxifloxacin),linezolid,clofazimine,bedaquiline,delamanid,aminoglycosides(streptomycin,amikacin),andβ-lactam antibacterial(imipenem/cilastatin,meropenem),and a total of 13 drugs in 9 categories were reviewed for off-label use,overdose,route of administration and patient populations.The GRADE evidence classification method was used to conduct a systematic evaluation of evidence quality and recommended strength.The revised consensus provides a reference for tuberculosis prevention and control workers in China for standardized drug use and rationalized treatment,and therefore for improved effectiveness and better patient benefits.

关 键 词：中华医学会 超说明书用药 结核病学 药物说明书 利福喷丁 抗结核药物 左氧氟沙星 质量分级 

分 类 号：R978.3[医药卫生—药品]