Research progress on the effectiveness and adverse reactions of clofazimine in the treatment of multidrug-resistant tuberculosis

doi:10.3969/j.issn.2096-8493.2021.01.017

Abstract

Abstract:

Clofazimine is a representative repurposed drug in the field of multidrug-resistant tuberculosis (MDR-TB). Clofazimine can effectively increase the sputum negative conversion, lung lesion absorption, and cavity reduction of MDR-TB, without increasing the incidence of adverse reactions. It is an important drug recommended by the WHO guidelines. We briefly reviewed the clinical application progress and adverse reaction management of clofazimine in the treatment of MDR-TB, in order to provide references for clinical medication and clinical research.

Key words: Tuberculosis, multidrug-resistant, Clofazimine, Drug toxicity

GUI Min, CHEN Jing-fang, DENG Guo-fang, FU Liang, ZENG Gu-qing. Research progress on the effectiveness and adverse reactions of clofazimine in the treatment of multidrug-resistant tuberculosis[J]. Journal of Tuberculosis and Lung Disease , 2021, 2(1): 78-82. doi: 10.3969/j.issn.2096-8493.2021.01.017

References 54

[1]	马啸楠, 龚军侠, 石海萍. 氯法齐明联合二线药物治疗耐多药结核病18个月转阴率、临床疗效及不良反应观察. 中国煤炭工业医学杂志, 2019,22(4):371-374. doi: 10.11723/mtgyyx 1007-9564 201904008.
[2]	冯宇. 氯法齐明联合方案治疗耐多药结核病的疗效. 航空航天医学杂志, 2019,30(11):1378-1380.
[3]	李学玲, 陈晓红, 翁丽珍, 等. 含氯法齐明的联合化疗方案对耐多药肺结核的临床疗效观察. 中国临床医生杂志, 2019,47(1):46-48. doi: 10.3969/j.issn.2095-8552.2019.01.015.
[4]	Du Y, Qiu C, Chen X, et al. Treatment Outcome of a Shorter Regimen Containing Clofazimine for Multidrug-resistant Tuberculosis: A Randomized Control Trial in China. Clin Infect Dis, 2020,71(4):1047-1054. doi: 10.1093/cid/ciz915. doi: 10.1093/cid/ciz915 URL pmid: 31549147
[5]	李荣珍, 赵智慧, 李涛. 氯法齐明联合方案治疗多重耐药肺结核的疗效及安全性. 中国医院用药评价与分析, 2018,18(3):320-322. doi: 10.14009/j.issn.1672-2124.2018.03.009.
[6]	石海萍, 刘云. 氯法齐明联合方案治疗致耐多药结核病的疗效及安全性. 医学综述, 2017,23(2):394-397. doi: 10.3969/j.issn.1006-2084.2017.02.044.
[7]	Cholo MC, Steel HC, Fourie PB, et al. Clofazimine: current status and future prospects. J Antimicrob Chemother, 2012,67(2):290-298. doi: 10.1093/jac/dkr444. doi: 10.1093/jac/dkr444 URL pmid: 22020137
[8]	Rojo A, Ibáñez MA, Alonso CA, et al. Multidrug-resistant tuberculosis presenting as a solitary splenic mass in an immunocompetent patient. Diagn Microbiol Infect Dis, 2011,70(4):522-524. doi: 10.1016/j.diagmicrobio.2011.03.013. doi: 10.1016/j.diagmicrobio.2011.03.013 URL pmid: 21767708
[9]	中华医学会结核病学分会. 中国耐多药和利福平耐药结核病治疗专家共识(2019年版). 中华结核和呼吸杂志, 2019,42(10):733-749. doi: 10.3760/cma.j.issn.1001-0939.2019.10.006.
[10]	Oliva B, O’Neill AJ, Miller K, et al. Anti-staphylococcal activity and mode of action of clofazimine. J Antimicrob Chemother, 2004,53(3):435-440. doi: 10.1093/jac/dkh114. doi: 10.1093/jac/dkh114 URL pmid: 14762055
[11]	Yano T, Kassovska-Bratinova S, Teh JS, et al. Reduction of clofazimine by mycobacterial type 2 NADH:quinone oxidoreductase: a pathway for the generation of bactericidal levels of reactive oxygen species. J Biol Chem, 2011,286(12):10276-10287. doi: 10.1074/jbc.M110.200501. doi: 10.1074/jbc.M110.200501 URL pmid: 21193400
[12]	Parak RB, Wadee AA. The synergistic effects of gamma interferon and clofazimine on phagocyte function: restoration of inhibition due to a 25 kilodalton fraction from Mycobacterium tuberculosis. Biotherapy, 1991,3(3):265-272. doi: 10.1007/BF02171691. doi: 10.1007/BF02171691 URL pmid: 1906725
[13]	Wadee AA, Anderson R, Rabson AR. Clofazimine reverses the inhibitory effect of Mycobacterium tuberculosis derived factors on phagocyte intracellular killing mechanisms. J Antimicrob Chemother, 1988,21(1):65-74. doi: 10.1093/jac/21.1.65. doi: 10.1093/jac/21.1.65 URL pmid: 3128522
[14]	Shen GH, Wu BD, Hu ST, et al. High efficacy of clofazimine and its synergistic effect with amikacin against rapidly growing mycobacteria. Int J Antimicrob Agents, 2010,35(4):400-404. doi: 10.1016/j.ijantimicag.2009.12.008. doi: 10.1016/j.ijantimicag.2009.12.008 URL pmid: 20138481
[15]	Mothiba MT, Anderson R, Fourie B, et al. Effects of clofazimine on planktonic and biofilm growth of Mycobacterium tuberculosis and Mycobacterium smegmatis. J Glob Antimicrob Resist, 2015,3(1):13-18. doi: 10.1016/j.jgar.2014.12.001. doi: 10.1016/j.jgar.2014.12.001 URL pmid: 27873644
[16]	World Health Organization. World Health Organization treatment guidelines for drug-resistant tuberculosis,2016. Geneva:World Health Organization, 2016.
[17]	World Health Organization. Position statement on the continued use of the shorter MDR-TB regimen following an expedited review of the STREAM Stage 1 preliminary results. Geneva:World Health Organization, 2018.
[18]	Javaid A, Ahmad N, Khan AH, et al. Applicability of the World Health Organization recommended new shorter regimen in a multidrug-resistant tuberculosis high burden country. Eur Respir J, 2017,49(1):1601967. doi: 10.1183/13993003.01967-2016. doi: 10.1183/13993003.01967-2016 URL pmid: 28049176
[19]	van der Werf MJ, Hollo V, Ködmön C, et al. Eligibility for shorter treatment of multidrug-resistant tuberculosis in the European Union. Eur Respir J, 2017,49(3):1601992. doi: 10.1183/13993003.01992-2016. doi: 10.1183/13993003.01992-2016 URL pmid: 28331041
[20]	Dalcolmo M, Gayoso R, Sotgiu G, et al. Resistance profile of drugs composing the “shorter” regimen for multidrug-resistant tuberculosis in Brazil, 2000—2015. Eur Respir J, 2017,49(4):1602309. doi: 10.1183/13993003.02309-2016. doi: 10.1183/13993003.02309-2016 URL pmid: 28404651
[21]	Piubello A, Harouna SH, Souleymane MB, et al. High cure rate with standardised short-course multidrug-resistant tuberculosis treatment in Niger: no relapses. Int J Tuberc Lung Dis, 2014,18(10):1188-1194. doi: 10.5588/ijtld.13.0075. doi: 10.5588/ijtld.13.0075 URL pmid: 25216832
[22]	Aung KJ, Van Deun A, Declercq E, et al. Successful ‘9-month Bangladesh regimen’ for multidrug-resistant tuberculosis among over 500 consecutive patients. Int J Tuberc Lung Dis, 2014,18(10):1180-1187. doi: 10.5588/ijtld.14.0100. doi: 10.5588/ijtld.14.0100 URL pmid: 25216831
[23]	Nahid P, Mase SR, Migliori GB, et al. Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline. Am J Respir Crit Care Med, 2019,200(10):e93-e142. doi: 10.1164/rccm.201909-1874ST. doi: 10.1164/rccm.201909-1874ST URL pmid: 31729908
[24]	Padayatchi N, Gopal M, Naidoo R, et al. Clofazimine in the treatment of extensively drug-resistant tuberculosis with HIV coinfection in South Africa: a retrospective cohort study. J Antimicrob Chemother, 2014,69(11):3103-3107. doi: 10.1093/jac/dku235. doi: 10.1093/jac/dku235 URL pmid: 24986495
[25]	Diacon AH, Dawson R, von Groote-Bidlingmaier F, et al. Bactericidal activity of pyrazinamide and clofazimine alone and in combinations with pretomanid and bedaquiline. Am J Respir Crit Care Med, 2015,191(8):943-953. doi: 10.1164/rccm.201410-1801OC. doi: 10.1164/rccm.201410-1801OC URL pmid: 25622149
[26]	Dalcolmo M, Gayoso R, Sotgiu G, et al. Effectiveness and safety of clofazimine in multidrug-resistant tuberculosis: a nationwide report from Brazil. Eur Respir J, 2017,49(3):1602445. doi: 10.1183/13993003.02445-2016. doi: 10.1183/13993003.02445-2016 URL pmid: 28331044
[27]	Gopal M, Padayatchi N, Metcalfe JZ, et al. Systematic review of clofazimine for the treatment of drug-resistant tuberculosis. Int J Tuberc Lung Dis, 2013,17(8):1001-1007. doi: 10.5588/ijtld.12.0144. doi: 10.5588/ijtld.12.0144 URL pmid: 23541151
[28]	Tang S, Yao L, Hao X, et al. Clofazimine for the treatment of multidrug-resistant tuberculosis: prospective, multicenter, randomized controlled study in China. Clin Infect Dis, 2015,60(9):1361-1367. doi: 10.1093/cid/civ027. doi: 10.1093/cid/civ027 URL pmid: 25605283
[29]	Duan H, Chen X, Li Z, et al. Clofazimine improves clinical outcomes in multidrug-resistant tuberculosis: a randomized controlled trial. Clin Microbiol Infect, 2019,25(2):190-195. doi: 10.1016/j.cmi.2018.07.012. doi: 10.1016/j.cmi.2018.07.012 URL pmid: 30036672
[30]	Pang Y, Lu J, Huo F, et al. Prevalence and treatment outcome of extensively drug-resistant tuberculosis plus additional drug resistance from the National Clinical Center for Tuberculosis in China: A five-year review. J Infect, 2017,75(5):433-440. doi: 10.1016/j.jinf.2017.08.005. doi: 10.1016/j.jinf.2017.08.005 URL pmid: 28804028
[31]	Tang S, Yao L, Hao X, et al. Efficacy, safety and tolerability of linezolid for the treatment of XDR-TB: a study in China. Eur Respir J, 2014,45(1):161-170. doi: 10.1183/09031936.00035114. doi: 10.1183/09031936.00035114 URL pmid: 25234807
[32]	张建武, 王芳, 王燕波, 等. 含氯法齐明联合方案治疗耐多药肺结核患者的临床疗效和安全性. 中国生化药物杂志, 2016,36(12):103-106,110. doi: 10.3969/j.issn.1005-1678.2016.12.029.
[33]	许桂桃, 赵利军. 含氯法齐明联合方案运用于耐多药结核治疗中的效果观察. 世界最新医学信息文摘, 2016,16(89):116. doi: 10.3969/j.issn.1671-3141.2016.89.105.
[34]	石海萍, 韩莉. 含氯法齐明方案治疗耐多药肺结核近期疗效观察. 陕西医学杂志, 2015,44(5):605-607. doi: 10.3969/j.issn.1000-7377.2015.05.038.
[35]	首都医科大学附属北京胸科医院, 中国防痨协会临床试验专业分会, 《中国防痨杂志》编辑委员会. 氯法齐明治疗结核病的临床应用指南. 中国防痨杂志, 2020,42(5):409-417. doi: 10.3969/j.issn.1000-6621.2020.05.001.
[36]	Van Deun A, Maug AK, Salim MA, et al. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med, 2010,182(5):684-692. doi: 10.1164/rccm.201001-0077OC. doi: 10.1164/rccm.201001-0077OC URL pmid: 20442432
[37]	Trébucq A, Schwoebel V, Kashongwe Z, et al. Treatment outcome with a short multidrug-resistant tuberculosis regimen in nine African countries. Int J Tuberc Lung Dis, 2018,22(1):17-25. doi: 10.5588/ijtld.17.0498. doi: 10.5588/ijtld.17.0498 URL pmid: 29149917
[38]	Kuaban C, Noeske J, Rieder HL, et al. High effectiveness of a 12-month regimen for MDR-TB patients in Cameroon. Int J Tuberc Lung Dis, 2015,19(5):517-524. doi: 10.5588/ijtld.14.0535. doi: 10.5588/ijtld.14.0535 URL pmid: 25868018
[39]	Collaborative Group for the Meta-Analysis of Individual Patient Data in MDR-TB treatment-2017, Ahmad N, Ahuja SD, et al. Treatment correlates of successful outcomes in pulmonary multidrug-resistant tuberculosis: an individual patient data meta-analysis. Lancet, 2018,392(10150):821-834. doi: 10.1016/S0140-6736(18)31644-1. doi: 10.1016/S0140-6736(18)31644-1 URL pmid: 30215381
[40]	Sun F, Li Y, Chen Y, et al. Introducing molecular testing of pyrazinamide susceptibility improves multidrug-resistant tuberculosis treatment outcomes: a prospective cohort study. Eur Respir J, 2019,53(3):1801770. doi: 10.1183/13993003.01770-2018. doi: 10.1183/13993003.01770-2018 URL pmid: 30578402
[41]	中国防痨协会. 耐药结核病化学治疗指南(2019年简版). 中国防痨杂志, 2019,41(10):1025-1073. doi: 10.3969/j.issn.1000-6621.2019.10.001.
[42]	周明广, 李艳杰, 徐建国. 氯法齐明治疗耐多药结核病临床观察. 吉林医学, 2012,33(4):779. doi: 10.3969/j.issn.1004-0412.2012.04.065.
[43]	Ramachandran G, Swaminathan S. Safety and tolerability profile of second-line anti-tuberculosis medications. Drug Saf, 2015,38(3):253-269. doi: 10.1007/s40264-015-0267-y. doi: 10.1007/s40264-015-0267-y URL pmid: 25676682
[44]	O’Donnell MR, Padayatchi N, Metcalfe JZ. Elucidating the role of clofazimine for the treatment of tuberculosis. Int J Tuberc Lung Dis, 2016,20(12):52-57. doi: 10.5588/ijtld.16.0073. doi: 10.5588/ijtld.16.0073 URL pmid: 28240574
[45]	Xu HB, Jiang RH, Tang SJ, et al. Notice of retraction. Role of clofazimine in the treatment of multidrug-resistant tuberculosis: a retrospective observational cohort assessment. J Antimicrob Chemother, 2014,69(3):e1. doi: 10.1093/jac/dks077. doi: 10.1093/jac/dks077 URL pmid: 22396431
[46]	Dey T, Brigden G, Cox H, et al. Outcomes of clofazimine for the treatment of drug-resistant tuberculosis: a systematic review and meta-analysis. J Antimicrob Chemother, 2013,68(2):284-293. doi: 10.1093/jac/dks389. doi: 10.1093/jac/dks389 URL pmid: 23054996
[47]	程武, 谭守勇, 李艳. 16例耐多药肺结核患者服用氯法齐明后的不良反应分析. 结核病与肺部健康杂志, 2016,5(3):247-249. doi: 10.3969/j.issn.2095-3755.2016.03.020.
[48]	Tadolini M, Lingtsang RD, Tiberi S, et al. Cardiac safety of extensively drug-resistant tuberculosis regimens including bedaquiline, delamanid and clofazimine. Eur Respir J, 2016,48(5):1527-1529. doi: 10.1183/13993003.01552-2016. doi: 10.1183/13993003.01552-2016 URL pmid: 27799401
[49]	Wallis RS. Cardiac safety of extensively drug-resistant tuberculosis regimens including bedaquiline, delamanid and clofazimine. Eur Respir J, 2016,48(5):1526-1527. doi: 10.1183/13993003.01207-2016. doi: 10.1183/13993003.01207-2016 URL pmid: 27799400
[50]	Silva DR, Dalcolmo M, Tiberi S, et al. New and repurposed drugs to treat multidrug- and extensively drug-resistant tuberculosis. J Bras Pneumol, 2018,44(2):153-160. doi: 10.1590/s1806-37562017000000436. doi: 10.1590/s1806-37562017000000436 URL pmid: 29791557
[51]	Anderson R, Theron AJ, Nel JG, et al. Clofazimine, but Not Isoniazid or Rifampicin, Augments Platelet Activation in vitro. Front Pharmacol, 2018,9:1335. doi: 10.3389/fphar.2018.01335. doi: 10.3389/fphar.2018.01335 URL pmid: 30515097
[52]	Lan Z, Ahmad N, Baghaei P, et al. Drug-associated adverse events in the treatment of multidrug-resistant tuberculosis: an individual patient data meta-analysis. Lancet Respir Med, 2020,8(4):383-394. doi: 10.1016/S2213-2600(20)30047-3. doi: 10.1016/S2213-2600(20)30047-3 URL pmid: 32192585
[53]	World Health Organization. WHO treatment guidelines for multidrug- and rifampicin-resistant tuberculosis,2018 update. Geneva:World Health Organization, 2018.
[54]	Hwang TJ, Dotsenko S, Jafarov A, et al. Safety and availability of clofazimine in the treatment of multidrug and extensively drug-resistant tuberculosis: analysis of published guidance and meta-analysis of cohort studies. BMJ Open, 2014,4(1):e004143. doi: 10.1136/bmjopen-2013-004143. doi: 10.1136/bmjopen-2013-004143 URL pmid: 24384902