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

Abstract

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), and β-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.