PMID- 36038829 OWN - NLM STAT- MEDLINE DCOM- 20220831 LR - 20220902 IS - 1471-2334 (Electronic) IS - 1471-2334 (Linking) VI - 22 IP - 1 DP - 2022 Aug 29 TI - Effectiveness and safety of bedaquiline-containing regimens for treatment on patients with refractory RR/MDR/XDR-tuberculosis: a retrospective cohort study in East China. PG - 715 LID - 10.1186/s12879-022-07693-9 [doi] LID - 715 AB - OBJECTIVE: Refractory rifampicin-resistant/multidrug resistant/extensively-drug resistant tuberculosis (RR/MDR/XDR-TB) were defined as patients infected with Mycobacterium tuberculosis (MTB) resistant to rifampicin(RR-TB), or at least resistant to rifampicin and isoniazid (MDR-TB) or added resistant to fluoroquinolones (FQs) and one of second line injectable agents (XDR-TB), a patient for whom an effective regimen (fewer than 4 effective agents due to adverse events (AEs) or multiple drug resistances) cannot be developed. To compare the effectiveness and safety of bedaquiline (BDQ)-containing and BDQ-free regimens for treatment of patients with refractory RR/MDR/XDR-TB. METHODS: Patients with refractory RR/MDR/XDR-TB receiving BDQ-containing regimens (BDQ group, n = 102) and BDQ-free regimens (non-BDQ group, n = 100) satisfied with included criteria were strictly included in this retrospective historical control study across East China. Culture conversion, treatment outcome, cavity closing rate, and AEs were compared between two groups. RESULTS: The baseline characteristics involved all possible aspects of patients were well balanced between two groups (p > 0.05). Culture conversion rates in the BDQ group at month 3 (89.2% vs. 66.0%), month 6 (90.2% vs 72.0%), month 9 (91.2% vs. 66.0%), and month 12 (94.1% vs 65.0%) were all significantly higher than those in non-BDQ group (p < 0.001). Similar results were observed in the cavity closing rate at month 9 (19.6% vs 8.0%, p = 0.0) and month 12 (39.2% vs 15.0%, p < 0.001). Patients receiving BDQ-containing regimens had more treatment success than those receiving BDQ-free regimens (p < 0.001; cure rate, 69.6% vs. 45.0%; complete the treatment, 22.5% vs. 18.0%; treatment success, 92.2% vs. 63.0%); the use of BDQ and combined with Linezolid or Clofazimine or Cycloserine were identified as independent predictors of treatment success and no culture reversion (P < 0.05). AEs were similarly reported in 26.5% of patients in the BDQ group and 19.0% in the non-BDQ group (p = 0.2). CONCLUSIONS: BDQ-containing regimens resulted in better treatment outcomes and similar safety relative to BDQ-free regimens for patients with refractory pulmonary RR/MDR/XDR-TB. CI - (c) 2022. The Author(s). FAU - Zhang, Shao-Jun AU - Zhang SJ AD - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai, 200433, China. FAU - Yang, Yan AU - Yang Y AD - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai, 200433, China. FAU - Sun, Wen-Wen AU - Sun WW AD - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai, 200433, China. FAU - Zhang, Zhong-Shun AU - Zhang ZS AD - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai, 200433, China. FAU - Xiao, He-Ping AU - Xiao HP AD - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai, 200433, China. FAU - Li, Yu-Ping AU - Li YP AD - Department of Pharmacy, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, China. gracelyp@163.com. FAU - Zhang, Zhe-Min AU - Zhang ZM AD - Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, 200433, China. zhemindoc@163.com. FAU - Fan, Lin AU - Fan L AD - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai, 200433, China. fanlinsj@163.com. LA - eng GR - 2018ZX10725-509/National Science and Technology Major Project for Infectious Diseases/ GR - FK1945/Shanghai Pulmonary Hospital fund/ GR - FKLY20017/Clinical Research foundation of Shanghai Pulmonary Hospital/ PT - Journal Article DEP - 20220829 PL - England TA - BMC Infect Dis JT - BMC infectious diseases JID - 100968551 RN - 0 (Antitubercular Agents) RN - 0 (Diarylquinolines) RN - 78846I289Y (bedaquiline) RN - VJT6J7R4TR (Rifampin) SB - IM MH - Antitubercular Agents/adverse effects MH - Diarylquinolines MH - *Extensively Drug-Resistant Tuberculosis/drug therapy/microbiology MH - Humans MH - Retrospective Studies MH - Rifampin/adverse effects MH - *Tuberculosis, Multidrug-Resistant/drug therapy MH - *Tuberculosis, Pulmonary/drug therapy PMC - PMC9422092 OTO - NOTNLM OT - BDQ OT - Multidrug-resistant OT - Refractory tuberculosis OT - Rifampicin-resistant COIS- The authors declare that they have no competing interest. EDAT- 2022/08/30 06:00 MHDA- 2022/09/01 06:00 PMCR- 2022/08/29 CRDT- 2022/08/29 23:33 PHST- 2021/08/21 00:00 [received] PHST- 2022/08/16 00:00 [accepted] PHST- 2022/08/29 23:33 [entrez] PHST- 2022/08/30 06:00 [pubmed] PHST- 2022/09/01 06:00 [medline] PHST- 2022/08/29 00:00 [pmc-release] AID - 10.1186/s12879-022-07693-9 [pii] AID - 7693 [pii] AID - 10.1186/s12879-022-07693-9 [doi] PST - epublish SO - BMC Infect Dis. 2022 Aug 29;22(1):715. doi: 10.1186/s12879-022-07693-9.