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Clin Microbiol Infect. 2019 Feb;25(2):190-195. doi: 10.1016/j.cmi.2018.07.012. Epub 2018 Jul 21.

Clofazimine improves clinical outcomes in multidrug-resistant tuberculosis: a randomized controlled trial.

Duan H1, Chen X2, Li Z3, Pang Y4, Jing W1, Liu P5, Wu T6, Cai C7, Shi J8, Qin Z8, Yin H9, Qiu C10, Li C11, Xia Y11, Chen W12, Ye Z13, Li Z14, Chen G15, Wang S16, Liu Y17, Chu L18, Zhu M19, Xu T20, Wang Q1, Wang J1, Du Y1, Wang J1, Chu N21, Xu S22.

Author information

1
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.
2
Department of Tuberculosis, Pulmonary Hospital of Fuzhou of Fujian Province, Fuzhou, China.
3
Department of Tuberculosis, Hebei Chest Hospital, Shijiazhuang, China.
4
National Clinical Laboratory on Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China.
5
Department of Respiratory Medicine, The People's Hospital of Changshou Distirct, Chongqing, China.
6
Department of Respiratory Medicine, The Second Affiliated Hospital of Chengdu, Chongqing Medical University, China.
7
Department of Tuberculosis, Guiyang Pulmonary Hospital, Guiyang, China.
8
Department of Tuberculosis, The Sixth People's Hospital of Nantong City Jiangsu Province, Nantong, China.
9
Department of Tuberculosis, Shanghai Pulmonary Hospital Affiliated to Tongji University, Shanghai, China.
10
Department of Drug-resistant Tuberculosis, Jiamusi Tuberculosis Control Hospital, Jiamusi, China.
11
The Third Ward of Pulmonary Hospital, Changsha Central Hospital, Changsha, China.
12
Department of Tuberculosis, Shenyang Chest Hospital, Liaoning Province Shenyang, China.
13
Department of Pulmonary, The First Affiliated Hospital of Xiamen University, Xiamen, China.
14
Department of Tuberculosis, Liaoyang Tuberculosis Hospital of Liaoning Province, Liaoyang, China.
15
Department of Tuberculosis, Chongqing Pulmonary Hospital, Chongqing, China.
16
Department of Thoracic Surgery, Chest Hospital of Xinjiang Uyghur Autonomous Region of the PRC, Wulumuqi, China.
17
Department of Chest, Qingdao Chest Hospital, Qingdao, China.
18
Department of Tuberculosis, The Seventh People's Hospital of Mudanjiang, Mudanjiang, China.
19
Tuberculosis Treatment Centre, Hangzhou Red Cross Hospital, Hangzhou, China.
20
Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College, Beijing, China.
21
Department of Tuberculosis, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing Tuberculosis & Thoracic Tumour Research Institute, Beijing, China. Electronic address: chunaihui1994@sina.com.
22
Department of Thoracic Surgery, Beijing Chest Hospital Affiliated to Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, China. Electronic address: xushaofa@263.net.

Abstract

OBJECTIVES:

We carried out a randomized multicentre study in China to investigate whether the clofazimine would improve the efficacy of the standardized regimen in patients with multidrug-resistant tuberculosis (MDR-TB).

METHODS:

Patients with MDR-TB managed in 17 TB specialist hospitals in China between September 2009 and September 2011 were randomly assigned to the treatment groups at enrolment. In the intervention group, 100 mg clofazimine per day was added to the standardized regimen. The primary outcome was the proportion of patients with successful outcomes.

RESULTS:

From the 156 patients that were screened, 74 were assigned to the control group and 66 to the clofazimine group. Of the 66 cases analysed for clinical outcome in the clofazimine group, 36 patients were cured, and seven completed treatment, yielding a favourable outcome rate of 65.1%. The proportion of patients with favourable outcomes receiving the control regimen was 47.3% (35/74), which was significantly lower than that in the clofazimine group (p 0.034, relative risk 0.661, 95% CI 0.243-0.949).

CONCLUSIONS:

The addition of clofazimine to the standard regimen improved the treatment of MDR-TB.

KEYWORDS:

Adverse events; China; Clofazimine; Multidrug-resistant tuberculosis; Treatment

PMID:
30036672
DOI:
10.1016/j.cmi.2018.07.012
[Indexed for MEDLINE]

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