Clinical outcomes of multidrug-resistant tracheobronchial tuberculosis receiving anti-tuberculosis regimens containing bedaquiline or delamanid.
Bedaquiline
China
Delamanid
Drug-resistant tuberculosis
Tracheobronchial tuberculosis
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
29 Jul 2024
29 Jul 2024
Historique:
received:
31
10
2023
accepted:
24
07
2024
medline:
29
7
2024
pubmed:
29
7
2024
entrez:
28
7
2024
Statut:
epublish
Résumé
The treatment of multidrug-resistant tracheobronchial tuberculosis poses challenges, and research investigating the efficacy of bedaquiline or delamanid as treatment for this condition is limited. This retrospective cohort study was conducted from 2017 to 2021. The study extracted data of patients with multidrug-resistant tracheobronchial tuberculosis from medical records and followed up on prognoses. Participants were divided into three groups: the bedaquiline, delamanid, and control group. Clinical outcomes and the risk factors associated with early culture conversion were analyzed. This study included 101 patients, with 32, 25, and 44 patients in the bedaquiline, delamanid, and control groups respectively. The differences in the treatment success rates among the three groups did not show statistical significance. Both the bedaquiline and delamanid groups had significantly higher culture conversion rates compared to the control after 2 or 6 months of treatment, with significantly shorter median times to culture conversion (bedaquiline group: 2 weeks, delamanid group: 2 weeks, control group: 12 weeks, P < 0.001). Treatment with bedaquiline or delamanid were identified as independent predictors of culture conversion at 2 months (bedaquiline group: aOR = 13.417, 95% CI 4.067-44.260, delamanid group: aOR = 9.333, 95% CI 2.498-34.878) or 6 months (bedaquiline group: aOR = 13.333, 95% CI 3.379-52.610, delamanid group: aOR = 5.000, 95% CI 1.357-18.426) of treatment through multivariable logistic regression analyses. The delamanid group showed better improvement in lumen stenosis compared to bedaquiline. Regimens containing bedaquiline or delamanid may accelerate the culture conversion during the early treatment phase in multidrug-resistant tracheobronchial tuberculosis, and delamanid appears to have the potential to effectively improve airway stenosis.
Identifiants
pubmed: 39069547
doi: 10.1038/s41598-024-68550-0
pii: 10.1038/s41598-024-68550-0
doi:
Substances chimiques
bedaquiline
78846I289Y
Nitroimidazoles
0
Antitubercular Agents
0
Oxazoles
0
OPC-67683
0
Diarylquinolines
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
17347Subventions
Organisme : the Medical Research Project of Chengdu Health Commission
ID : 2023038
Organisme : the Medical Research Project of Chengdu Health Commission
ID : 2022262
Organisme : Sichuan Medical Association (Hengrui) Research Fund Special Research Project
ID : 2021HR75
Organisme : the Technology Innovation Research and Development project of Chengdu Science and Technology Bureau
ID : 2022-YF05-02139-SN
Organisme : the Technology Innovation Research and Development project of Chengdu Science and Technology Bureau
ID : 2022-YF05-02148-SN
Informations de copyright
© 2024. The Author(s).
Références
World Health Organization. Global Tuberculosis Report, 2022 (World Health Organization, 2022).
Chung, H. S. & Lee, J. H. Bronchoscopic assessment of the evolution of endobronchialtuberculosis. Chest 117, 385–392. https://doi.org/10.1378/chest.117.2.385 (2000).
doi: 10.1378/chest.117.2.385
pubmed: 10669679
Um, S. W. et al. Predictors of persistent airway stenosis in patients with endobronchial tuberculosis. Int. J. Tuberc. Lung Dis. 12, 57–62 (2008).
pubmed: 18173878
Han, J. K. et al. Bronchial stenosis due to endobronchial tuberculosis: Successful treatment with self-expanding metallic stent. Am. J. Roentgenol. 159, 971–972 (1992).
doi: 10.2214/ajr.159.5.1414809
Kashyap, S., Mohapatra, P. R. & Saini, V. Endobronchial tuberculosis. Indian J. Chest Dis. Allied Sci. 45, 247–256 (2003).
pubmed: 12962459
Ozkaya, S. et al. Endobronchial tuberculosis: Histopathological subsets and microbiological results. Multidiscip. Respir. Med. 7, 34 (2012).
pubmed: 23088170
pmcid: 3488328
doi: 10.1186/2049-6958-7-34
World Health Organization. Rapid communication: Key changes to treatment of multidrug- and rifampicin-resistant tuberculosis (MDR/RR-TB) [M] (World Health Organization, 2018).
Chinese Society of Tuberculosis of Chinese Medical Association. [Chinese expert consensus on multidrug-resistant tuberculosis and Rifampicin-resistant tuberculosis treatment]. Zhonghua Jie He He Hu Xi Za Zhi 2019; 42(10):733-49.
Association Chinese Medical. Diagnosis and treatment guideline for tracheobronchial tuberculosis. Chin. J. Tuberc. Respir. Dis. 35, 581–587 (2012).
Chung, H. S. & Lee, J. H. Bronchoscopic assessment of the evolution of endobronchial tuberculosis. Chest 117(2), 385–392 (2000).
pubmed: 10669679
doi: 10.1378/chest.117.2.385
Hu, T. et al. Early and regular bronchoscopy examination on effect of diagnosis and prognosis for patients with tracheobronchial tuberculosis. Front. Med. (Lausanne) 9, 825736 (2022).
pubmed: 35242788
doi: 10.3389/fmed.2022.825736
World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: Treatment-drug-resistant tuberculosis treatment, 2022 update [M]. Geneva: World Health Organization 2022.
De Kantor, I. N. et al. Laboratory Services in Tuberculosis Control (World Health Organization, 1998).
Goussard, P. & Gie, R. The role of bronchoscopy in the diagnosis and management of pediatric pulmonary tuberculosis. Expert Rev. Respir. Med. 8(1), 101–109 (2014).
pubmed: 24378192
doi: 10.1586/17476348.2013.863712
Chen, Q. et al. Differences in epidemiological and clinical features between adult and pediatric tracheobronchial tuberculosis patients in Southwest China. Front. Public Health 11, 1225267 (2023).
pubmed: 37538277
pmcid: 10395115
doi: 10.3389/fpubh.2023.1225267
World Health Organization. WHO treatment guidelines for multidrug- and rifampicin-resistant tuberculosis, 2016 update (World Health Organization, 2016).
World Health Organization. WHO treatment guidelines for multidrug- and rifampicin-resistant tuberculosis, 2018 update (World Health Organization, 2018).
World Health Organization. WHO consolidated guidelines on drug-resistant tuberculosis treatment (World Health Organization, 2019).
World Health Organization. WHO consolidated guidelines on tuberculosis. Module 4: Treatment - drug-resistant tuberculosis treatment. Geneva: World Health Organization 2020.
World Health Organization. Definitions and reporting framework for tuberculosis -2013 revision: updated December 2014 and January 2020 (World Health Organization, 2013).
Lee, J. Y. et al. CT scan features as predictors of patient outcome after bronchial intervention in endobronchial TB. Chest 138(2), 380–385 (2010).
pubmed: 20299630
doi: 10.1378/chest.09-1846
Jung, S. S., Park, H. S., Kim, J. O. & Kim, S. Y. Incidence and clinical predictors of endobronchial tuberculosis in patients with pulmonary tuberculosis. Respirology 20(3), 488–495 (2015).
pubmed: 25620110
pmcid: 4409824
doi: 10.1111/resp.12474
Su, Z. et al. Incidence and predictors of tracheobronchial tuberculosis in pulmonary tuberculosis: A multicentre, large-scale and prospective study in Southern China. Respiration 97(2), 153–159 (2019).
pubmed: 30205411
doi: 10.1159/000492335
Wang, M. G., Wu, S. Q. & He, J. Q. Efficacy of bedaquiline in the treatment of drug-resistant tuberculosis: A systematic review and meta-analysis. BMC Infect. Dis. 21(1), 970 (2021).
pubmed: 34535090
pmcid: 8447831
doi: 10.1186/s12879-021-06666-8
Zhang, Q., Liu, Y., Tang, S., Sha, W. & Xiao, H. Clinical benefit of delamanid (OPC-67683) in the treatment of multidrug-resistant tuberculosis patients in China. Cell Biochem. Biophys. 67(3), 957–963 (2013).
pubmed: 23546935
doi: 10.1007/s12013-013-9589-5
von Groote-Bidlingmaier, F. et al. Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: A multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial. Lancet Respir. Med. 7(3), 249–259 (2019).
doi: 10.1016/S2213-2600(18)30426-0
Maretbayeva, S. M. et al. Culture conversion at six months in patients receiving bedaquiline- and delamanid-containing regimens for the treatment of multidrug-resistant tuberculosis. Int. J. Infect. Dis. 113(Suppl 1), S91–S95 (2021).
pubmed: 33823277
doi: 10.1016/j.ijid.2021.03.075
Lachâtre, M. et al. Bedaquiline plus delamanid for XDR tuberculosis. Lancet Infect. Dis. 16(3), 294 (2016).
pubmed: 26973310
doi: 10.1016/S1473-3099(16)00047-5
Ndjeka, N. et al. Treatment outcomes 24 months after initiating short, all-oral bedaquiline-containing or injectable-containing rifampicin-resistant tuberculosis treatment regimens in South Africa: A retrospective cohort study. Lancet Infect. Dis. 22(7), 1042–1051 (2022).
pubmed: 35512718
pmcid: 9217754
doi: 10.1016/S1473-3099(21)00811-2
Ahmad, N. et al. Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis: An individual patient data meta-analysis. Lancet 392(10150), 821–34 (2018).
pubmed: 30215381
pmcid: 6463280
doi: 10.1016/S0140-6736(18)31644-1
Mok, J. et al. 9 months of delamanid, linezolid, levofloxacin, and pyrazinamide versus conventional therapy for treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis (MDR-END): A multicentre, randomised, open-label phase 2/3 non-inferiority trial in South Korea. Lancet 400(10362), 1522–1530 (2022).
pubmed: 36522208
doi: 10.1016/S0140-6736(22)01883-9
Nasiri, M. J. et al. Delamanid-containing regimens and multidrug-resistant tuberculosis: A systematic review and meta-analysis. Int. J. Infect. Dis. 124(Supp 1), S90-103 (2022).
pubmed: 35245659
pmcid: 9731904
doi: 10.1016/j.ijid.2022.02.043
Kwon, Y. S. et al. Treatment outcomes of multidrug-resistant TB with selective use of new drugs. Int. J. Tuberc. Lung Dis. 27(1), 55–60 (2023).
pubmed: 36853130
doi: 10.5588/ijtld.22.0343
Diacon, A. H. et al. Multidrug-resistant tuberculosis and culture conversion with bedaquiline. N. Engl. J. Med. 371(8), 723–732 (2014).
pubmed: 25140958
doi: 10.1056/NEJMoa1313865
Gao, M. et al. Early outcome and safety of bedaquiline-containing regimens for treatment of MDR- and XDR-TB in China: A multicentre study. Clin. Microbiol. Infect. 27(4), 597–602 (2021).
pubmed: 32553880
doi: 10.1016/j.cmi.2020.06.004
Ghosh, S. et al. Compassionate use of delamanid in adults and children for drug-resistant tuberculosis: 5-year update. Eur. Respir. J. 57(5), 2002483 (2021).
pubmed: 33243846
doi: 10.1183/13993003.02483-2020
A trial to evaluate safety, tolerability, and efficacy of orally administered OPC-67683. 2015. https://clinicaltrials.gov/ct2/show/results/NCT02573350 . Accessed 8 October 2023.
Gler, M. T. et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N. Engl. J. Med. 366(23), 2151–2160 (2012).
pubmed: 22670901
doi: 10.1056/NEJMoa1112433
Seung, K. J. et al. Culture conversion at 6 months in patients receiving delamanid-containing regimens for the treatment of multidrug-resistant tuberculosis. Clin. Infect. Dis. 71(2), 415–418 (2020).
pubmed: 31676905
doi: 10.1093/cid/ciz1084
Shibata, M. et al. Absorption, distribution and excretion of the anti-tuberculosis drug delamanid in rats: Extensive tissue distribution suggests potential therapeutic value for extrapulmonary tuberculosis. Biopharm. Drug Dispos. 38(4), 301–312 (2017).
pubmed: 28092695
doi: 10.1002/bdd.2064
Shibata, M. et al. Prediction of human pharmacokinetic profiles of the antituberculosis drug delamanid from nonclinical data: Potential therapeutic value against extrapulmonary tuberculosis. Antimicrob. Agents Chemother 65(8), e0257120 (2021).
pubmed: 34097484
doi: 10.1128/AAC.02571-20
Qiao, M. et al. Delamanid suppresses CXCL10 expression via regulation of JAK/STAT1 signaling and correlates with reduced inflammation in tuberculosis patients. Front. Immunol. 13, 923492 (2022).
pubmed: 36426362
pmcid: 9679411
doi: 10.3389/fimmu.2022.923492
Zhang, Q. et al. Clinical benefit of delamanid (OPC-67683) in the treatment of multidrug-resistant tuberculosis patients in China. Cell Biochem. Biophys. 67(3), 957–963 (2013).
pubmed: 23546935
doi: 10.1007/s12013-013-9589-5
Ferlazzo, G. et al. Early safety and efficacy of the combination of bedaquiline and delamanid for the treatment of patients with drug-resistant tuberculosis in Armenia, India, and South Africa: A retrospective cohort study. Lancet Infect. Dis. 18(5), 536–544 (2018).
pubmed: 29452942
doi: 10.1016/S1473-3099(18)30100-2
Olayanju, O., Esmail, A., Limberis, J. & Dheda, K. A regimen containing bedaquiline and delamanid compared to bedaquiline in patients with drug-resistant tuberculosis. Eur. Respir. J. 55(1), 1901181 (2020).
pubmed: 31619478
doi: 10.1183/13993003.01181-2019
Guglielmetti, L. et al. Safety and efficacy of exposure to bedaquiline-delamanid in multidrug-resistant tuberculosis: A case series from France and Latvia. Eur. Respir. J. 51(3), 1702550 (2018).
pubmed: 29419439
doi: 10.1183/13993003.02550-2017
Kang, H., Jo, K. W., Jeon, D., Yim, J. J. & Shim, T. S. Interim treatment outcomes in multidrug-resistant tuberculosis using bedaquiline and/or delamanid in South Korea. Respir. Med. 167, 105956 (2020).
pubmed: 32421540
doi: 10.1016/j.rmed.2020.105956
Hafkin, J., Hittel, N., Martin, A. & Gupta, R. Compassionate use of delamanid in combination with bedaquiline for the treatment of multidrug-resistant tuberculosis. Eur. Respir. J. 53(1), 1801154 (2019).
pubmed: 30361253
doi: 10.1183/13993003.01154-2018
Sarin, R. et al. Early efficacy and safety of Bedaquiline and Delamanid given together in a “Salvage Regimen” for treatment of drug-resistant tuberculosis. Indian J. Tuberc. 66(1), 184–188 (2019).
pubmed: 30878066
doi: 10.1016/j.ijtb.2019.02.006
Xu, C. H. et al. Cost-effectiveness analysis of combined chemotherapy regimen containing Bedaquiline in the treatment of multidrug-resistant tuberculosis in China. Biomed. Environ. Sci. 36(6), 501–509 (2023).
pubmed: 37424243