Chinese Journal of Antituberculosis ›› 2021, Vol. 43 ›› Issue (11): 1146-1152.doi: 10.3969/j.issn.1000-6621.2021.11.008
• Original Articles • Previous Articles Next Articles
TIAN Dan, HU Xiao-meng, JIN Wu, CHENG Chang-hao, XIONG Lei-qun, HU Rong-hua, JIN Qian, LIU Yun, DU Juan()
Received:
2021-07-14
Online:
2021-11-10
Published:
2021-11-02
Contact:
DU Juan
E-mail:dudu1109@126.com
TIAN Dan, HU Xiao-meng, JIN Wu, CHENG Chang-hao, XIONG Lei-qun, HU Rong-hua, JIN Qian, LIU Yun, DU Juan. Sixty-seven MDR-,and XDR-PTB cases with sputum culture conversion then treated with bedaquiline-containing regimens: A singal arm, single center observational study[J]. Chinese Journal of Antituberculosis, 2021, 43(11): 1146-1152. doi: 10.3969/j.issn.1000-6621.2021.11.008
Add to citation manager EndNote|Ris|BibTeX
URL: https://www.zgflzz.cn/EN/10.3969/j.issn.1000-6621.2021.11.008
治疗时间 | 例数 | 病灶 | 例数 | 空洞 | |||||||
---|---|---|---|---|---|---|---|---|---|---|---|
明显吸收 | 吸收 | 不变 | 恶化 | 闭合 | 缩小 | 不变 | 增大 | ||||
12周 | 67 | 8(11.9) | 42(62.7) | 15(22.4) | 2(3.0) | 20 | 10(50.0) | 5(25.0) | 5(25.0) | 0(0.0) | |
24周 | 63 | 12(19.0) | 44(69.8) | 7(11.1) | 0(0.0) | 19 | 14(73.7) | 2(10.5) | 3(15.8) | 0(0.0) | |
36周 | 60 | 22(36.7) | 34(56.7) | 3(5.0) | 1(1.7) | 17 | 15(88.2) | 1(5.9) | 1(5.9) | 0(0.0) | |
48周 | 57 | 26(45.6) | 27(47.4) | 4(7.0) | 0(0.0) | 17 | 16(94.1) | 0(0.0) | 1(5.9) | 0(0.0) | |
80~88周 | 57 | 26(45.6) | 29(50.9) | 2(3.5) | 0(0.0) | 17 | 16(94.1) | 0(0.0) | 1(5.9) | 0(0.0) |
AE分类 | 例次 (率,%) | Ⅰ级 (例次) | Ⅱ级 (例次) | Ⅲ级 (例次) | Ⅳ级 (例次) | Ⅴ级 (例次) | 时间 [周,M(Q1,Q3)] |
---|---|---|---|---|---|---|---|
心电图异常 | |||||||
QTc延长 | 21(11.5) | 1 | 5 | 15 | 0 | 0 | 12.0(3.5,22.0) |
房扑 | 1(0.5) | 0 | 1 | 0 | 0 | 0 | NA |
肝功能异常 | 66(36.3) | ||||||
ALT升高 | 16(8.8) | 10 | 5 | 1 | 0 | 0 | 13.5(2.5,38.0) |
AST升高 | 38(20.9) | 34 | 4 | 0 | 0 | 0 | 24.0(4.8,40.5) |
Tbil升高 | 5(2.7) | 5 | 0 | 0 | 0 | 0 | 28.0(3.0,43.5) |
GGT升高 | 4(2.2) | 1 | 3 | 0 | 0 | 0 | 5.0(1.5,19.8) |
ALP升高 | 3(1.6) | 3 | 0 | 0 | 0 | 0 | 3.0(1.0,7.0) |
肾功能异常 | 10(5.5) | ||||||
肌酐升高 | 3(1.6) | 3 | 0 | 0 | 0 | 0 | NA |
高尿酸血症 | 7(3.8) | 0 | 5 | 2 | 0 | 0 | 4.0(2.0,8.0) |
骨髓抑制 | 57(31.3) | ||||||
白细胞减少 | 14(7.7) | 2 | 12 | 0 | 0 | 0 | 4.0(2.0,10.0) |
中性粒细胞减少 | 12(6.6) | 1 | 9 | 2 | 0 | 0 | 3.0(2.0,8.0) |
贫血 | 26(14.3) | 8 | 12 | 5 | 1 | 0 | 4.0(1.0,8.0) |
血小板减少 | 5(2.7) | 2 | 0 | 3 | 0 | 0 | 28.0(10.0,28.5) |
低钾血症 | 6(3.3) | 5 | 1 | 0 | 0 | 0 | 10.0(1.0,21.0) |
症状或体征 | |||||||
视力减退/视物模糊 | 6(3.3) | 0 | 0 | 6 | 0 | 0 | 28.0(18.0,56.0) |
耳鸣 | 1(0.5) | 0 | 1 | 0 | 0 | 0 | NA |
神经系统症状 | 4(2.2) | 0 | 1 | 3 | 0 | 0 | NA |
精神系统症状 | 3(1.6) | 0 | 1 | 2 | 0 | 0 | NA |
胃肠道症状 | 3(1.6) | 1 | 1 | 1 | 0 | 0 | NA |
死亡 | 4(2.2) | 0 | 0 | 0 | 0 | 4 | 28.0(14.0,45.0) |
[1] |
任坦坦, 陆普选, 邓国防, 等. 2020 WHO全球结核报告:全球与中国关键数据分析. 新发传染病电子杂志, 2020, 5(4):280-284. doi: 10.19871/j.cnki.xfcrbzz.2020.04.015.
doi: 10.19871/j.cnki.xfcrbzz.2020.04.015 |
[2] |
Koul A, Vranckx L, Dendouga N, et al. Diarylquinolines are bactericidal for dormant mycobacteria as a result of disturbed ATP homeostasis. J Biol Chem, 2008, 283(37):25273-25280. doi: 10.1074/jbc.M 803899200.
doi: 10.1074/jbc.M 803899200 |
[3] |
Maher D, Dye C, Floyd K, et al. Planning to improve global health: the next decade of tuberculosis control. Bull World Health Organ, 2007, 85(5):341-347. doi: 10.2471/blt.06.037820.
doi: 10.2471/blt.06.037820 |
[4] |
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, 47(10):1025-1073. doi: 10.3969/j:issn.1000-6621.2019.10.001.
doi: 10.3969/j:issn.1000-6621.2019.10.001 |
[5] | World Health Organization. WHO treatment guidelines for multidrug and rifampicin resistant tuberculosis 2018 update Pre-final text. Geneva: World Health Organization, 2018. |
[6] |
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.
doi: 10.3760/cma.j.issn.1001-0939.2019.10.006 |
[7] |
Matteelli A, Carvalho AC, Dooley KE, et al. TMC207: the first compound of a new class of potent anti-tuberculosis drugs. Future Microbiol, 2010, 5(6):849-858. doi: 10.2217/fmb.10.50.
doi: 10.2217/fmb.10.50 |
[8] |
Andries K, Verhasselt P, Guillemont J, et al. A diarylquinoline drug active on the ATP synthase of Mycobacterium tuberculosis. Science, 2005, 307(5707):223-227. doi: 10.1126/science.1106753.
doi: 10.1126/science.1106753 |
[9] |
Huitric E, Verhasselt P, Andries K, et al. In vitro antimycobacterial spectrum of a diarylquinoline ATP synthase inhibitor. Antimicrob Agents Chemother, 2007, 51(11):4202-4204. doi: 10.1128/AAC.00181-07.
doi: 10.1128/AAC.00181-07 |
[10] |
Lounis N, Veziris N, Chauffour A, et al. Combinations of R207910 with drugs used to treat multidrug-resistant tuberculosis have the potential to shorten treatment duration. Antimicrob Agents Chemother, 2006, 50(11):3543-3547. doi: 10.1128/AAC.00766-06.
doi: 10.1128/AAC.00766-06 |
[11] |
Borisov SE, Dheda K, Enwerem M, et al. Effectiveness and safety of bedaquiline-containing regimens in the treatment of MDR- and XDR-TB: a multicentre study. Eur Respir J, 2017, 49(5):1700387. doi: 10.1183/13993003.00387-2017.
doi: 10.1183/13993003.00387-2017 |
[12] |
Conradie F, Diacon AH, Ngubane N, et al. Treatment of Highly Drug-Resistant Pulmonary Tuberculosis. N Engl J Med, 2020, 382(10):893-902. doi: 10.1056/NEJMoa1901814.
doi: 10.1056/NEJMoa1901814 |
[13] |
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 |
[14] |
Cohen K, Maartens G. A safety evaluation of bedaquiline for the treatment of multi-drug resistant tuberculosis. Expert Opin Drug Saf, 2019, 18(10):875-882. doi: 10.1080/14740338.2019.1648429.
doi: 10.1080/14740338.2019.1648429 |
[15] |
Gao M, Gao J, Xie L, 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, 2021, 27(4):597-602. doi: 10.1016/j.cmi.2020.06.004.
doi: 10.1016/j.cmi.2020.06.004 |
[16] |
时正雨, 吴桂辉, 黄涛, 等. 含贝达喹啉方案治疗耐多药/广泛耐药结核病的24周单组观察性研究. 中国防痨杂志, 2021, 43(5):487-494. doi: 10.3969/j.issn.1000-6621.2021.05.014.
doi: 10.3969/j.issn.1000-6621.2021.05.014 |
[17] |
Chakaya J, Khan M, Ntoumi F, et al. Global Tuberculosis Report 2020-Reflections on the Global TB burden, treatment and prevention efforts. Int J Infect Dis, 2021. doi: 10.1016/j.ijid.2021.02.107.
doi: 10.1016/j.ijid.2021.02.107 |
[18] |
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 |
[19] |
Vasilyeva I, Mariandyshev A, Kazennyy B, et al. Early access to bedaquiline for extensively drug-resistant (XDR) and pre-XDR tuberculosis. Eur Respir J, 2019, 54(1):1802208. doi: 10.1183/13993003.02208-2018.
doi: 10.1183/13993003.02208-2018 |
[1] | Li Yang, Sun Feng, Zhang Wenhong. Short-course treatment for tuberculosis: past achievements and future directions [J]. Chinese Journal of Antituberculosis, 2024, 46(9): 991-997. |
[2] | Shi Chunjing, Liu Xing, Li Longfen, Li Wenming, Zhang Huajie, Wang Ge, Zeng Haiyan, Liu Li, Shen Lingjun. Research progress on the effects of bedaquiline,delamanid and pretomanid on liver function in the treatment of multidrug-resistant tuberculosis [J]. Chinese Journal of Antituberculosis, 2024, 46(12): 1560-1565. |
[3] | Wang Xueyu, Shi Wenhui, Li Qi, Jing Wei, Chu Naihui, Nie Wenjuan. Efficacy and safety of Baidiziyin Pill and Shenqiyifei Pill in adjuvant treatment of susceptible pulmonary tuberculosis patients: a national randomized controlled multicenter clinical study [J]. Chinese Journal of Antituberculosis, 2024, 46(11): 1306-1312. |
[4] | Fu Liang, Deng Guofang. MDR-Chin study analysis: prospects of using all-oral short-course treatment regimens for multidrug-resistant pulmonary tuberculosis in China [J]. Chinese Journal of Antituberculosis, 2024, 46(1): 18-22. |
[5] | Zhou Feng, Li Tongxin, Yang Song, Tang Shenjie. Progress on short-course regimens for the treatment of tuberculosis [J]. Chinese Journal of Antituberculosis, 2023, 45(3): 311-317. |
[6] | Ge Qiping, Zhang Lijie, Huang Xuerui, Jiang Guanglu, Han Xiqin, Wang Jingping, Du Jian, Ma Yan, Gao Weiwei. Effect of a new treatment regimen on patients with initially retreated drug-sensitive pulmonary tuberculosis [J]. Chinese Journal of Antituberculosis, 2023, 45(11): 1078-1083. |
[7] | Gao Dan, Wang Linghua, Huang Jinpeng, Zhang Yue, Mao Xiaoxiao. Construction of pulmonary rehabilitation nursing program of integrated traditional Chinese and Western medicine for patients with tuberculous empyema under thoracoscopic clearance [J]. Chinese Journal of Antituberculosis, 2023, 45(10): 932-939. |
[8] | Gao Dan, Wang Linghua, Huang Jinpeng, Zhang Yue, Mao Xiaoxiao. Analysis of the application effect of integrated traditional Chinese and Western medicine pulmonary rehabilitation nursing program for patients with tuberculous empyema undergoing thoracoscopic clearance [J]. Chinese Journal of Antituberculosis, 2023, 45(10): 940-948. |
[9] | Wang Yuxiang, Chen Qiuqi, Yu Xinxin, Zhan Senlin, Zhang Peize, Deng Guofang. 3HP regimen in the treatment of rheumatic diseases complicated with Mycobacterium tuberculosis latent infection:a prospective study [J]. Chinese Journal of Antituberculosis, 2022, 44(9): 906-910. |
[10] | Yao Rong, Lu Yu. Research progress on the drug resistance and mechanism of the anti-tuberculosis drug bedaquiline [J]. Chinese Journal of Antituberculosis, 2022, 44(9): 973-977. |
[11] | LIU Hai-ting, LI Dong-shuo, ZHANG Lei, WANG Ning, WANG Bin, DING Yang-ming, YAO Rong, LU Yu. A preliminary study on the synergy and mechanism of pyrifazimine and bedaquiline [J]. Chinese Journal of Antituberculosis, 2022, 44(7): 646-653. |
[12] | YU Chun-hong, LIU Xing, SHEN Ling-jun, LI Hai-wen, LI Xie, WU Rong-shuang, LI Xian-rui, FAN Hao. Meta analysis of efficacy and safety of the treatment containing bedaquiline for multidrug-resistant pulmonary tuberculosis [J]. Chinese Journal of Antituberculosis, 2022, 44(7): 660-668. |
[13] | XIE Li, ZHU Hui, GAO Jing-tao, LIU Zhong-quan, MA Li-ping, ZHANG Li-qun, GE Qi-ping, NIE Li-hui, KONG Zhong-shun, WU Xiao-guang, LIU Rong-mei, CHEN Hong-mei, SONG Yan-hua, LI Qiang, LYU Zi-zheng, LIU Yu-hong, LU Yu, PANG Yu, GAO Meng-qiu. Changes of plasma concentration of bedaquiline during the treatment of drug-resistant pulmonary tuberculosis and its assocation with QTc interval prolongation [J]. Chinese Journal of Antituberculosis, 2022, 44(3): 219-226. |
[14] | LI Dong-shuo, WANG Bin, LU Yu, XU Jian. Study of expression and function of Mycobacterium tuberculosis membrane protein MmpL5-MmpS5 [J]. Chinese Journal of Antituberculosis, 2022, 44(3): 227-233. |
[15] | ZHANG Yu-xia, XIONG Yu, CHANG Ting-ting, LIU Feng-xia. Analysis of adverse reactions of bedaquiline containing regimen in the treatment of drug-resistant pulmonary tuberculosis [J]. Chinese Journal of Antituberculosis, 2022, 44(3): 239-245. |
Viewed | ||||||
Full text |
|
|||||
Abstract |
|
|||||