PMID- 37576523
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230815
IS  - 1178-6973 (Print)
IS  - 1178-6973 (Electronic)
IS  - 1178-6973 (Linking)
VI  - 16
DP  - 2023
TI  - The Safety and Efficacy of Prolonged Use of Bedaquiline for the Treatment of 
      Patients with Pulmonary Multi-Drug Resistant/Rifampin-Resistant Tuberculosis: A 
      Prospective, Cohort Study in China.
PG  - 5055-5064
LID - 10.2147/IDR.S419996 [doi]
AB  - OBJECTIVE: To evaluate the safety, tolerability, and efficacy of prolonged 
      bedaquiline (Bdq) treatment in patients with multi-drug/rifampin-resistant 
      tuberculosis (MDR/RR-TB). METHODS: This prospective cohort study was performed 
      from August 2018 to August 2021. Patients diagnosed with MDR/RR-TB who met the 
      inclusion criteria were prospectively included. Patients were treated with 
      individual regimens of 18-20 months containing Bdq for six months or a prolonged 
      course of nine or 12 months according to treatment demands, and the efficacy and 
      safety with a different course of Bdq-containing regimens were compared and 
      evaluated. RESULTS: A total of 159 MDR/RR-TB patients were included in the study, 
      including 96 cases with six months of Bdq, 50 cases with nine months of Bdq, and 
      13 patients with 12 months of Bdq. The treatment success rates were 89.6%, 90%, 
      and 84.6% in Bdq at six months, nine months, and 12 months, respectively, which 
      were not statistically different (P = 0.85). The main adverse events (AEs) were 
      anemia, thrombocytopenia, and liver dysfunction in all patients, with no 
      significant difference among the three groups. Patients who had fewer drugs 
      chosen, disseminated lesions or lesions that were slowly absorbed, and severe 
      cavities were the common reasons for prolonged use of Bdq. CONCLUSION: Prolonged 
      course use of Bdq from six months to 12 months clinically proved to be safe and 
      efficient, and patients with severe or disseminated lesions had the chance to 
      prolong the use of Bdq for more than six months to achieve optimal treatment 
      outcomes.
CI  - (c) 2023 Ke et al.
FAU - Ke, Hui
AU  - Ke H
AD  - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School 
      of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key 
      Laboratory of Tuberculosis, Shanghai, People's Republic of China.
FAU - Gui, Xuwei
AU  - Gui X
AD  - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School 
      of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key 
      Laboratory of Tuberculosis, Shanghai, People's Republic of China.
FAU - Sun, Wenwen
AU  - Sun W
AD  - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School 
      of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key 
      Laboratory of Tuberculosis, Shanghai, People's Republic of China.
FAU - Zhang, Shaojun
AU  - Zhang S
AD  - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School 
      of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key 
      Laboratory of Tuberculosis, Shanghai, People's Republic of 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 
      Laboratory of Tuberculosis, Shanghai, People's Republic of China.
FAU - Zhang, Zhemin
AU  - Zhang Z
AD  - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School 
      of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key 
      Laboratory of Tuberculosis, Shanghai, People's Republic of China.
FAU - Fan, Lin
AU  - Fan L
AUID- ORCID: 0000-0002-9411-496X
AD  - Department of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School 
      of Medicine, Shanghai Clinic and Research Center of Tuberculosis, Shanghai Key 
      Laboratory of Tuberculosis, Shanghai, People's Republic of China.
LA  - eng
PT  - Journal Article
DEP - 20230807
PL  - New Zealand
TA  - Infect Drug Resist
JT  - Infection and drug resistance
JID - 101550216
PMC - PMC10417604
OTO - NOTNLM
OT  - MDR-TB
OT  - RR-TB
OT  - bedaquiline
OT  - prolonged course
OT  - safety
COIS- The authors declare that they have no competing interests in this work.
EDAT- 2023/08/14 06:42
MHDA- 2023/08/14 06:43
PMCR- 2023/08/07
CRDT- 2023/08/14 04:44
PHST- 2023/05/04 00:00 [received]
PHST- 2023/07/20 00:00 [accepted]
PHST- 2023/08/14 06:43 [medline]
PHST- 2023/08/14 06:42 [pubmed]
PHST- 2023/08/14 04:44 [entrez]
PHST- 2023/08/07 00:00 [pmc-release]
AID - 419996 [pii]
AID - 10.2147/IDR.S419996 [doi]
PST - epublish
SO  - Infect Drug Resist. 2023 Aug 7;16:5055-5064. doi: 10.2147/IDR.S419996. 
      eCollection 2023.