Volume 44 Issue 12
Dec.  2023
Turn off MathJax
Article Contents
Xing LIU, Chunhong YU, Weixian LI, Bing OUYANG, Lingjun SHEN. A Randomized Controlled Study on the Treatment of Multidrugresistant Tuberculosis with a Regimen Containing Bedaquiline Fumarate Tablets[J]. Journal of Kunming Medical University, 2023, 44(12): 150-158. doi: 10.12259/j.issn.2095-610X.S20231224
Citation: Xing LIU, Chunhong YU, Weixian LI, Bing OUYANG, Lingjun SHEN. A Randomized Controlled Study on the Treatment of Multidrugresistant Tuberculosis with a Regimen Containing Bedaquiline Fumarate Tablets[J]. Journal of Kunming Medical University, 2023, 44(12): 150-158. doi: 10.12259/j.issn.2095-610X.S20231224

A Randomized Controlled Study on the Treatment of Multidrugresistant Tuberculosis with a Regimen Containing Bedaquiline Fumarate Tablets

doi: 10.12259/j.issn.2095-610X.S20231224
  • Received Date: 2023-09-15
    Available Online: 2023-12-19
  • Publish Date: 2023-12-25
  •   Objective  To explore the clinical efficacy and safety of betaquiline fumarate tablets in the treatment of multi drug resistant pulmonary tuberculosis.   Methods  Patients with multidrug-resistant tuberculosis(MDR-TB) admitted to the Third People's Hospital of Kunming from March 2019 to September 2022 were selected as the research objects. They were divided into two groups by random number table method. The observation group (n = 93) received anti tuberculosis treatment with a regimen containing bedaquiline fumarate tablets, while the control group (n = 90) received anti tuberculosis treatment with a regimen without bedaquiline fumarate tablets. The lesion absorption rate, sputum negative conversion rate, cavity reduction rate, treatment efficiency, and adverse drug reactions during treatment were collected at the end of 24 weeks.  Results  At the end of the 24th week of treatment, the differences between the observation group and the control group in the rates of lesion absorption rate(85.7%, 63.3%), negative conversion of sputum smears(89.7%, 71.4%), negative conversion of sputum cultures(82.1%, 68.6%), cavity shrinkage rate(88. 2%, 69. 4%), and total treatment efficacy(81.9%, 60.2%) were statistically significant(P<0.05). The difference in the incidence of adverse drug reactions between the observation group and the control group(69.9% and 83.4%) was statistically significant(P<0.05), but the difference in the severity of adverse reactions was not statistically significant(P> 0.05).   Conclusion  The regimen containing betaquiline fumarate tablets has good efficacy and is safe in the treatment of multidrug-resistant pulmonary tuberculosis.
  • loading
  • [1]
    World Health Organization. Global tuberculosis report 2022[R/OL]. Geneva: World Health Organization, 2022. https://www.who.int/teams/global-tuberculosis-programme/TB-reports/g-lobal-tuberculosis-report-2022.
    [2]
    余春红,刘幸,沈凌筠,等. 含贝达喹啉方案治疗耐多药肺结核疗效与安全性的Meta分析[J]. 中国防痨杂志,2022,44(7):660-668.
    [3]
    WHO consolidated guidelines on tuberculosis: Module 4: Treatment-drug-resistant tuberculosistreatment[M]. Geneva: World Health Organization, 2020: 12-20.
    [4]
    US department of health and human services, National institutes of health (NIH) and national cancer institute (NCI). Common terminology criteria for adverse events (CTCAE) version4.0[EB/OL]. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. [2021-01-21].
    [5]
    Dheda K,Gumbo T,Gandhi N R,et al. Global control of tuberculosis: From extensively drug-resistant to untreatable tuberculosis[J]. Lancet Respir Med,2014,2(4):321-338. doi: 10.1016/S2213-2600(14)70031-1
    [6]
    中国防痨协会. 耐药结核病化学治疗指南(2019年简版)[J]. 中国防痨杂志,2019,41(10):1025-1073.
    [7]
    Haagsma A C,Podasca I,Koul A,et al. Probing the interaction of the diarylquinoline TMC207 with its target mycobacterial ATP synthase[J]. PLoS One,2011,6(8):e23575. doi: 10.1371/journal.pone.0023575
    [8]
    唐神结, 许绍发, 李亮. 耐药结核病学[M]. 北京: 人民卫生出版社, 2014: 126-287.
    [9]
    Chahine E B,Karaoui L R,Mansour H. Bedaquiline: A novel diarylquinoline for multidrug-resistant tuberculosis[J]. Ann Pharmacother,2014,48(1):107-115. doi: 10.1177/1060028013504087
    [10]
    Olayanju O,Limberis J,Esmail A,et al. Long-term bedaquiline-related treatment outcomes in patients with extensively drug-resistant tuberculosis from South Africa[J]. Eur Respir J,2018,51(5):540-544.
    [11]
    Ke H,Gui X,Sun W,et al. 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[J]. Infect Drug Resist,2023,7(16):5055-5064.
    [12]
    Ahmad N,Ahuja S D,Akkerman O W,et al. 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[J]. Lancet,2018,392(10150):821-834. doi: 10.1016/S0140-6736(18)31644-1
    [13]
    耿鑫,杨莹,文小桐,等. 贝达喹啉治疗耐多药结核的临床综合评价[J]. 中华结核和呼吸杂志,2023,46(6):572-579.
    [14]
    邹莉萍,时正雨,梁丽,等. 含贝达喹啉及利奈唑胺方案治疗耐多药结核病24周疗效及安全性观察[J]. 临床肺科杂志,2022,27(3):415-421.
    [15]
    Brust J C M. Weighting the evidence: How much bedaquiline is enough[J]. Am J Respir Crit Care Med,2023,207(11):1423-1424. doi: 10.1164/rccm.202303-0373ED
    [16]
    Ghajavand H,Kargarpour Kamakoli M,Khanipour S,et al. High prevalence of bedaquiline resistance in treatment-naive tuberculosis patients and verapamil effectiveness[J]. Antimicrob Agents Chemother,2019,63(3):e02530-18.
    [17]
    Nguyen T V A,Anthony R M,Bañuls A L,et al. Bedaquiline resistance: Its emergence,mechanism,and prevention[J]. Clin Infect Dis,2018,66(10):1625-1630. doi: 10.1093/cid/cix992
    [18]
    Tong E,Zhou Y,Liu Z,et al. Bedaquiline resistance and molecular characterization of rifampicin-resistant mycobacterium tuberculosis isolates in Zhejiang,China[J]. Infect Drug Resist,2023,31(16):6951-6963.
    [19]
    Mbuagbaw L,Guglielmetti L,Hewison C,et al. Outcomes of bedaquiline treatment in patients with multidrug-resistant tuberculosis[J]. Emerg Infect Dis,2019,25(5):936-943. doi: 10.3201/eid2505.181823
    [20]
    Gao M,Gao J,Xie L,et al. Early outcome and safety of bedaquiline-containing regimens for treatment of MDR-TB and XDR-TB in China: A multicentrestudy[J]. Clin Microbiol Infect,2021,27(4):597-602. doi: 10.1016/j.cmi.2020.06.004
    [21]
    Salhotra V S,Sachdeva K S,Kshirsagar N,et al. Effectiveness and safety of bedaquiline under conditional access program for treatment of drug-resistant tuberculosis in India: An interim analysis[J]. Indian J Tuberc,2020,67(1):29-37. doi: 10.1016/j.ijtb.2019.10.002
    [22]
    Brust J C M,Gandhi N R,Wasserman S,et al. Effectiveness and cardiac safety of bedaquiline-based therapy for drug-resistant tuberculosis: A prospective cohort study[J]. Clin Infect Dis,2021,73(11):2083-2092. doi: 10.1093/cid/ciab335
    [23]
    Gao J T,Du J,Wu G H,et al. Bedaquiline-containing regimens in patients with pulmonary multidrug-resistant tuberculosis in China: Focus on the safety[J]. Infect Dis Poverty,2021,10(1):1-10. doi: 10.1186/s40249-020-00791-3
    [24]
    陈艳,陈竹,黄涛,等. 含贝达喹啉的联合方案治疗耐多药结核病的疗效及安全性研究[J]. 华西医学,2021,36(10):1392-1398.
    [25]
    张玉霞,熊瑜,常婷婷,等. 含贝达喹啉方案治疗耐药肺结核的不良反应分析[J]. 中国防痨杂志,2022,44(3):239-245.
    [26]
    Diacon A H,Pym A,Grobusch M,et al. The diarylquinoline TMC207 for multidrug-resistant tuberculosis[J]. N Engl J Med,2009,360(23):397-405.
    [27]
    Singh B. Bedaquiline in drug-resistant tuberculosis: A mini-review[J]. Curr Mol Pharmacol,2023,16(3):243-253. doi: 10.2174/1874467215666220421130707
    [28]
    Kotwal P,Khajuria P,Dhiman S,et al. Molecular mechanism for the involvement of CYP2E1/NF-κB axis in bedaquiline-induced hepatotoxicity[J]. Life Sci,2023,15(5):315-375.
    [29]
    Tang S,Yao L,Hao X,et al. Efficacy,safety and tolerability of linezolid for the treatment of XDR-TB: A study in China[J]. Eur Respir J,2015,45(1):161-170. doi: 10.1183/09031936.00035114
    [30]
    梁晨,于佳佳,唐神结. 世界卫生组织《全球结核病报告2022》解读[J]. 诊断学理论与实践,2023,22(1):21-30.
    [31]
    Holt E. Questioning bedaquiline availability[J]. Lancet Infect Dis,2023,9(23):496-497.
    [32]
    Rawal T,Patel S,Butani S. Chitosan nanoparticles as a promising approach for pulmonary delivery of bedaquiline[J]. Eur J Pharm Sci,2018,1(124):273-287.
    [33]
    Momin M A M,Rangnekar B,Sinha S,et al. Inhalable dry powder of bedaquiline for pulmonary tuberculosis: In vitro physicochemical characterization,antimicrobial activity and safety studies[J]. Pharmaceutics,2019,11(10):502-511. doi: 10.3390/pharmaceutics11100502
    [34]
    Ionescu A M,Mpobela Agnarson A,Kambili C,et al. Bedaquiline versus injectable-containing drug-resistant tuberculosis regimens: A cost-effectiveness analysis[J]. Expert Rev Pharmacoecon Outcomes Res,2018,18(6):677-689. doi: 10.1080/14737167.2018.1507821
  • Relative Articles

    [1] Liyuan YUN, Junfeng WANG, Ning GUO, Ruimei DING, Haipeng LI, Xueping ZHANG. Analysis of the Efficacy and Safety of GM1 Injection Combined with Batroxobin in the Treatment of Sudden Deafness Patients. Journal of Kunming Medical University, 2024, 45(6): 140-144.  doi: 10.12259/j.issn.2095-610X.S20240619
    [2] Fen TENG, Bo TIAN, Chongxi LI, Yongmei JIN, Haiyun CHEN, Jun LIU. Real-World Clinical Efficacy and Safety of Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Single-Tablet Regimen. Journal of Kunming Medical University, 2024, 45(4): 74-80.  doi: 10.12259/j.issn.2095-610X.S20240411
    [3] Jianmei LI, Yanling JIN. Efficacy and Safety of Bortezomib,Lenalidomide Combined with Dexamethasone in the Treatment of Multiple Myeloma. Journal of Kunming Medical University, 2023, 44(6): 120-125.  doi: 10.12259/j.issn.2095-610X.S20230610
    [4] Xiaohua LU, Hongxin YUAN. The Analysis of the Correlation between BTLA,CTLA-4 Gene Polymorphisms and the Efficacy and Prognosis of TACE Combined Targeted Therapy for Liver Cancer. Journal of Kunming Medical University, 2023, 44(9): 126-135.  doi: 10.12259/j.issn.2095-610X.S20230927
    [5] Rui CUN, Meiling CHEN. Efficacy and Clinical Application of Flunarizine Combined with Ginkgo damo in Treatment of Senile Vertigo. Journal of Kunming Medical University, 2022, 43(7): 116-120.  doi: 10.12259/j.issn.2095-610X.S20220703
    [6] Chunhong YU, Yanhong ZHAO, Xing LIU, Lingjun SHEN, Weixian LI, Haiwen LI, Hao FAN. Early Effectiveness of Bedaquiline Containing Regimen in Treatment of Multidrug-resistant and Extensively Drug-resistant Pulmonary Tuberculosis: An One-arm Observational Study of 24 Weeks. Journal of Kunming Medical University, 2022, 43(11): 99-106.  doi: 10.12259/j.issn.2095-610X.S20221113
    [7] Zhi-rong ZHAO, Hai-wen LI, Xiao-fei LI, Ni-hong LU, Yong-rui YANG. Efficacy and Safety of Sofosbuvir/Vipatavir Combined with Ribavirin in Treatment of Genotype 3 Patients with Chronic Hepatitis C. Journal of Kunming Medical University, 2021, 42(3): 98-103.  doi: 10.12259/j.issn.2095-610X.S20210325
    [8] Zhi-rong ZHAO, Hai-wen LI, Ni-hong LU, Ling SHEN, Xiao-fei LI, Yong-rui YANG. A Clinical Study on the Use of Propofol Tenofovir in the Treatment of Chronic Hepatitis B. Journal of Kunming Medical University, 2021, 42(1): 89-93.  doi: 10.12259/j.issn.2095-610X.S20210141
    [9] Xing LIU, Bing OUYANG, Na LI, Ji LUO, Xu-qin SHI, Jie CHEN, Hui SUN, Hai-wen LI. Effect and Economic Evaluation of the Combination of Traditional Chinese and Western Medicine in Treatment of MDR-TB. Journal of Kunming Medical University, 2020, 41(11): 49-55.  doi: 10.12259/j.issn.2095-610X.S20201106
    [10] Jin-jiang YANG, Liu-jiang LI, Shi-jun SHEN, Zhao-xiang LI, Yong YANG, Guo-jian LI. Clinical Trial of Rivaroxaban after Implantation of Stent for Femoral Popliteal Atherosclerosis Occlusion. Journal of Kunming Medical University, 2020, 41(11): 83-87.  doi: 10.12259/j.issn.2095-610X.S20201122
    [11] Luo Wei , Wang Shun Jun , Fang Ke Wei , Chen Tao , Chen Rong Qiong , Wang Hui Tao , Yang Bo Wei , Guo Hai Xiang , Zhang Hai Yan , Li Pei , Ke Chang Xing , Liu Jian He . . Journal of Kunming Medical University, 2019, 40(12): 124-129.
    [12] Chang Song Jie . The Clinical Efficacy and Safety of Decreasing Blood Uric Acid by Benzene Bromine Malone in Treatment of Hyperuricemia with Elderly Hypertension and Diabetes Mellitus. Journal of Kunming Medical University,
    [13] Pan Zi Peng . Analysis and Safety Evaluation of the Clinical Efficacy of Laparoscopic Appendectomy for Acute Appendicitis. Journal of Kunming Medical University,
    [14] Zeng Hai Ping . . Journal of Kunming Medical University,
    [15] Yang Yong Rui . . Journal of Kunming Medical University,
    [16] Wang Ji Cai . . Journal of Kunming Medical University,
    [17] Hu Hai Yan . . Journal of Kunming Medical University,
    [18] . . Journal of Kunming Medical University,
    [19] Yang Xi Yun . . Journal of Kunming Medical University,
    [20] Wang Ji Cai . . Journal of Kunming Medical University,
  • 加载中

Catalog

    通讯作者: 陈斌, bchen63@163.com
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Tables(9)

    Article Metrics

    Article views (1081) PDF downloads(17) Cited by()
    Proportional views
    Related

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return