Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]

Publication Date:
2018-03-28
Publisher:
The American Society for Microbiology (ASM)
Print ISSN:
0066-4804
Electronic ISSN:
1098-6596
Topics:
Biology
Medicine
Published by:
http://www.asm.org/
_version_ 1836398868030291968
autor Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
beschreibung We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of "cure" and 1 (4.5%) "complete treatment," for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; P = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn ] under identifier ChiCTR1800014800.)
citation_standardnr 6218880
datenlieferant ipn_articles
feed_id 515
feed_publisher The American Society for Microbiology (ASM)
feed_publisher_url http://www.asm.org/
insertion_date 2018-03-28
journaleissn 1098-6596
journalissn 0066-4804
publikationsjahr_anzeige 2018
publikationsjahr_facette 2018
publikationsjahr_intervall 7984:2015-2019
publikationsjahr_sort 2018
publisher The American Society for Microbiology (ASM)
quelle Antimicrobial Agents and Chemotherapy
relation http://aac.asm.org/cgi/content/short/62/4/e02149-17?rss=1
search_space articles
shingle_author_1 Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
shingle_author_2 Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
shingle_author_3 Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
shingle_author_4 Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
shingle_catch_all_1 Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of "cure" and 1 (4.5%) "complete treatment," for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; P = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn ] under identifier ChiCTR1800014800.)
Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
The American Society for Microbiology (ASM)
0066-4804
00664804
1098-6596
10986596
shingle_catch_all_2 Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of "cure" and 1 (4.5%) "complete treatment," for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; P = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn ] under identifier ChiCTR1800014800.)
Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
The American Society for Microbiology (ASM)
0066-4804
00664804
1098-6596
10986596
shingle_catch_all_3 Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of "cure" and 1 (4.5%) "complete treatment," for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; P = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn ] under identifier ChiCTR1800014800.)
Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
The American Society for Microbiology (ASM)
0066-4804
00664804
1098-6596
10986596
shingle_catch_all_4 Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
We performed a multicenter, prospective, randomized study to investigate the efficacy and safety of clofazimine (CLO) for treatment of extensively drug-resistant tuberculosis (XDR-TB) in China. Forty-nine patients infected with XDR-TB were randomly assigned to either the control group or the CLO group, both of which received 36 months of individually customized treatment. The primary endpoint was the time to sputum culture conversion on solid medium. Clinical outcomes of patients were evaluated at the time of treatment completion. Of the 22 patients in the experimental group, 7 (31.8%) met the treatment criterion of "cure" and 1 (4.5%) "complete treatment," for a total of 8 (36.4%) exhibiting successful treatment outcomes without relapse. In the control group, 6 patients (22.2%) were cured and 6 (22.2%) completed treatment by the end of the study. Statistical analysis revealed no significant difference in successful outcome rates between the CLO group and the control group. The average sputum culture conversion time for the experimental group was 19.7 months, which was not statistically different from that for the control group (20.3 months; P = 0.57). Of the 22 patients in the CLO group, 12 (54.5%) experienced adverse events after starting CLO treatment. The most frequently observed adverse event was liver damage, with 31.8% of patients (7/22 patients) in the CLO group versus 11.1% (3/27 patients) in the control group exhibiting this adverse event. Our study demonstrates that inclusion of CLO in background treatment regimens for XDR-TB is of limited benefit, especially since hepatic disorders arise as major adverse events with CLO treatment. (This study is registered with the Chinese Clinical Trial Registry [ChiCTR, www.chictr.org.cn ] under identifier ChiCTR1800014800.)
Wang, Q., Pang, Y., Jing, W., Liu, Y., Wang, N., Yin, H., Zhang, Q., Ye, Z., Zhu, M., Li, F., Liu, P., Wu, T., Chen, W., Wu, W., Qin, Z., Qiu, C., Deng, Q., Xu, T., Wang, J., Guo, R., Du, Y., Wang, J., Huang, H., Chen, X., Chu, N.
The American Society for Microbiology (ASM)
0066-4804
00664804
1098-6596
10986596
shingle_title_1 Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
shingle_title_2 Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
shingle_title_3 Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
shingle_title_4 Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
timestamp 2025-06-30T23:33:52.711Z
titel Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
titel_suche Clofazimine for Treatment of Extensively Drug-Resistant Pulmonary Tuberculosis in China [Clinical Therapeutics]
topic W
WW-YZ
uid ipn_articles_6218880