한국에서 다제내성결핵에 대한 경구 단기 치료 요법
Shorter Oral Regimen for Multidrug Resistant Tuberculosis in South Korea
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
The treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) poses significant challenges, including frequent adverse drug reactions associated with complex treatment regimens involving multiple drugs administered over prolonged periods. However, recent clinical trials, such as Nix-TB, ZeNix, NExT, MDR-END, TB-PRACTECAL, and BEAT-India, have demonstrated that shorter oral regimens yield superior outcomes compared with conventional approaches. Furthermore, the World Health Organization guidelines for MDR/RR-TB treatment recommend a 6-month all-oral regimen that includes bedaquiline, pretomanid, linezolid, and moxifloxacin. However, the implementation of these shorter oral regimens in South Korea requires careful consideration. Health insurance coverage policies must be reviewed to include new TB drugs, such as pretomanid. The optimal dosage and treatment duration of linezolid should be determined to minimize side effects and prevent drug resistance; moreover, alternative regimens should be identified for patients who discontinue linezolid because of adverse drug reactions.
Abstract
The treatment of multidrug- and rifampin-resistant tuberculosis (MDR/RR-TB) poses significant challenges, including frequent adverse drug reactions associated with complex treatment regimens involving multiple drugs administered over prolonged periods. However, recent clinical trials, such as Nix-TB, ZeNix, NExT, MDR-END, TB-PRACTECAL, and BEAT-India, have demonstrated that shorter oral regimens yield superior outcomes compared with conventional approaches. Furthermore, the World Health Organization guidelines for MDR/RR-TB treatment recommend a 6-month all-oral regimen that includes bedaquiline, pretomanid, linezolid, and moxifloxacin. However, the implementation of these shorter oral regimens in South Korea requires careful consideration. Health insurance coverage policies must be reviewed to include new TB drugs, such as pretomanid. The optimal dosage and treatment duration of linezolid should be determined to minimize side effects and prevent drug resistance; moreover, alternative regimens should be identified for patients who discontinue linezolid because of adverse drug reactions.
참고문헌 (28)
- "Global tuberculosis report 2022" (2022)[URL]
- "Annual report on the notified tuberculosis in Korea 2022" (2022)[URL]
- "WHO consolidated guidelines on tuberculosis: module 4: treatment: drug-susceptible tuberculosis treatment" (2022)[URL]
- 최홍조, "Nationwide Treatment Outcomes of Patients With Multidrug", Rifampin-Resistant Tuberculosis in Korea, 2011–2017: A Retrospective Cohort Study (Korean TB-POST), 2023, pp.38(5), 1~11[DOI]
- Kim DH, "Treatment outcomes and long-term survival in patients with extensively drug-resistant tuberculosis", Am J Respir Crit Care Med, 178, pp.1075~1082 (2008)
- Kwak N, "Changes in treatment outcomes of multidrug-resistant tuberculosis", Int J Tuberc Lung Dis, 19, pp.525~530 (2015)
- Kwon YS, "Tuberculosis : clinical trials and new drug regimens", Curr Opin Pulm Med, 20, pp.280~286 (2014)
- Kwon YS, "Delamanid when other anti-tuberculosis-treatment regimens failed due to resistance or tolerability", Expert Opin Pharmacother, 16, pp.253~261 (2015)
- Kwon YS, "Synthetic investigational new drugs for the treatment of tuberculosis", Expert Opin Investig Drugs, 25, pp.183~193 (2016)
- "WHO consolidated guidelines on drug-resistant tuberculosis treatment" (2019)[URL]
- von Groote-Bidlingmaier F, "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, pp.249~259 (2019)
- "Korean guidelines for tuberculosis" (2020)[URL]
- "WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment" (2022)[URL]
- "WHO treatment guidelines for drug-resistant tuberculosis" (2016)[URL]
- Collaborative Group for the Meta-Analysis of Individual Patient Data in MDR-TB treatment-2017, "Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis : an individual patient data meta-analysis", Lancet, 392, pp.821~834 (2018)
- Conradie F, "Treatment of highly drug-resistant pulmonary tuberculosis", N Engl J Med, 382, pp.893~902 (2020)
- Conradie F, "Bedaquilinepretomanid-linezolid regimens for drug-resistant tuberculosis", N Engl J Med, 387, pp.810~823 (2022)
- Esmail A, "An all-oral 6-month regimen for multidrug-resistant tuberculosis : a multicenter, randomized controlled clinical trial(the NExT study)", Am J Respir Crit Care Med, 205, pp.1214~1227 (2022)
- Goodall RL, "Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis(STREAM stage 2) : an open-label, multicentre, randomised, non-inferiority trial", Lancet, 400, pp.1858~1868 (2022)
- Mok J, "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, 2022, pp.400, 1522~1530
- Ndjeka N, "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, pp.1042~1051 (2022)
- Nyang'wa BT, "A 24-week, all-oral regimen for rifampin-resistant tuberculosis", N Engl J Med, 387, pp.2331~2343 (2022)
- Padmapriyadarsini C, "Bedaquiline, delamanid, linezolid and clofazimine for treatment of pre-extensively drug-resistant tuberculosis", Clin Infect Dis, 76, pp.e938~e946 (2022)
- "Detailed information on the application standards and methods of medical care benefits, notice No. 2022-312" (2022)[URL]
- Lan Z, "Drug-associated adverse events in the treatment of multidrug-resistant tuberculosis : an individual patient data meta-analysis", Lancet Respir Med, 8, pp.383~394 (2020)
- Alghamdi WA, "Population pharmacokinetics of linezolid in tuberculosis patients : dosing regimen simulation and target attainment analysis", Antimicrob Agents Chemother, 64, pp.e01174~20 (2020)
- 양정성, "Delamanid, Bedaquiline, and Linezolid Minimum Inhibitory Concentration Distributions and Resistance-related Gene Mutations in Multidrug-resistant and Extensively Drug-resistant Tuberculosis in Korea", Annals of Laboratory Medicine, 38(6), pp.563~568 (2018), 대한진단검사의학회
- Lee M, "Linezolid for treatment of chronic extensively drug-resistant tuberculosis", N Engl J Med, 367, pp.1508~1518 (2012)