Abstract:

Background: The treatment course of drug-resistant tuberculosis is long, the cure rate is low, and the incidence of adverse reactions is high. Most of the full oral short-range drug resistance programs promoted by the World Health Organization cannot be fully promoted in China due to the problem of drug varieties and drug tolerance. It is urgent to explore safer and more effective treatment programs and drugs suitable for China. Methods: The prospective multi-center randomized controlled clinical trial was used in the trial. The patients with rifampicin-resistant pulmonary tuberculosis confirmed by molecular drug sensitivity test or phenotypic drug sensitivity test were randomly divided into the 18-month long-term treatment scheme recommended by the World Health Organization as the control group, and the 6-month oral short-term drug resistance scheme containing bedaquiline, contezolid, delamanid, moxifloxacin or levofloxacin (the patients resistant to fluoroquinolones were changed to clofazimine) to evaluate the efficacy and safety of the new 6-month oral drug resistance scheme containing contezolid in the treatment of rifampicin-resistant pulmonary tuberculosis. Discussion: This study aims to shorten the treatment time of rifampicin-resistant pulmonary tuberculosis, improve the cure rate, optimize the safety of the plan, provide the basis for the development of new drugs and new short-term treatment plans for rifampicin-resistant pulmonary tuberculosis, and provide Chinese data for the World Health Organization to develop treatment guidelines for drug-resistant tuberculosis. Meanwhile, this study includes Class 1 innovative drugs in China, representing the latest achievements in the field of pharmaceutical innovation in China. However, this study is not a head to head clinical trial, but rather a comparison of two different treatment regimens to obtain the overall treatment outcome. In the future, it is necessary to verify factors such as the appropriate dosage of new drugs in the regimen to obtain more specific research conclusions.

Key words: Tuberculosis, Drug resistance, Multicenter study, Clinical trials as topic