ABSTRACT
Objective
The study aimed to observe the efficacy and safety of an all-oral bedaquiline (BDQ)-containing regimen for pediatric multidrug/rifampicin-resistant tuberculosis (MDR/RR-TB) through a multicenter, retrospective study in China.
Methods
In the study, pediatric patients receiving all-oral BDQ-containing regimen (BDQ group) with clinical matched control group were included, the control group received an injection-containing regimen. The treatment outcomes and the incidence of adverse events (AEs) were compared and analyzed.
Results
79 pediatric patients were enrolled, including 37 cases in BDQ group and 42 cases in the control group, the median age was 12 {8–16} and 11 {9–15} in both groups respectively. Favorable treatment outcome and cure rate in BDQ group were significantly higher than those in control group (100%vs 83.3%, p 0.03; 94.6%vs 63.3%, p 0.00). Median time of sputum culture conversion in BDQ group was significantly shorter than that in the control group (4 weeks vs 8 weeks, p 0.00). The incidence of AEs in the BDQ group was significantly less than that in the control group (48.6% vs 71.4%, p 0.03). No AEs leading to treatment discontinuation of BDQ occurred.
Conclusions
The all-oral BDQ-containing regimens may be effective and safe in the Chinese pediatric population.
Declaration of interest
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgments
The authors wish to thank all participants for their efforts.
Ethics statement
This retrospective study was performed in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the Shanghai Pulmonary Hospital (Approval No K20–430). The present study was a retrospective study, the informed consent was waived signed, however, the privacy of each participant was fully protected.
Author contribution statement
WS, MY: Data statistics, writing the manuscript; JZ, HC, HW and CF: Data collation and statistics; LF and CY: Research design and revised the manuscript. All authors read and approved the final submitted version.