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Treatment and recurrence on re-treatment tuberculosis patients: a randomized clinical trial and 7-year perspective cohort study in China

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Abstract

Previously treated TB patients still pose a serious threat to global control of TB, yet new re-treatment therapies were little studied. This study aimed to examine the therapeutic effects of new re-treatment regimens, and explore risk factors associated with recurrence after successful treatment. We conducted a cohort study in nine regions of China and enrolled previously treated TB patients from October, 2008 to December, 2010. Patients were randomly divided into four treatment regimen groups including standard, high-dose, long-course, and individualized treatment. After treatment, those with successful treatment outcomes were followed up to 7 years. The effects of different regimens and the information of recurrence were recorded. Risk factors to poor treatment outcomes were calculated using logistic regression model, while risk factors to recurrence or death were calculated using Cox model. Four hundred ninety-two participants were enrolled during the study time and 419 patients were included in our analysis of treatment effects. Overall, the treatment success rate is 75.9%, and the recurrence and death rate is 6.9% and 3.8%, respectively. Reduced risks of poor outcomes were observed in patients who were treated with high-dose and individualized regimen compared with standard regimen, and the adjusted ORs were 0.3 (0.1–0.6), 0.2 (0.1–0.5), respectively. In our analysis of factors associated with recurrence, all documented variables were not significant. Revised re-treatment regimen has better therapeutic effects compared to standard regimen, but it was not associated with lower risk of TB recurrence. Further studies are warranted to evaluate the role of other revised re-treatment regimens in recurrence risk. Trial registration: chictr.org Identifier: ChiCTR1800017441.

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Acknowledgments

We would like to thank all participants from Guangdong Center for Tuberculosis Control and prevention, Tianjin Center for Tuberculosis Control, Affiliated Hospital of Zunyi Medical College, Beijing Research Institute for Tuberculosis Control, The 309th Hospital of Chinese People’s Liberation Army, First Affiliated Hospital, Chongqing Medical University, Shenyang Chest Hospital, First Affiliated Hospital, Xinxiang Medical University, Henan Center for Disease Control and Prevention, Heilongjiang institute for tuberculosis control and prevention, Zhejiang Center for Disease Control and Prevention, Harbin Chest Hospital, Inner Mongolia Fourth Hospital, Jingzhou Infectious Disease Hospital, Jingmen Center for Tuberculosis Prevention and Control, The Third People’s Hospital of Baotou City, The Fourth Hospital of Tangshan, The Third Hospital of Qinhuangdao, Beijing Geriatric Hospital, Xuzhou Infectious Disease Hospital, and Jingmei Group General Hospital in the present study for their hard work.

Financial support

This study was supported by the National Science and Technology Major Project of China (2008ZX10003-009).

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Correspondence to Weiwei Gao or Zhongwei Jia.

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Ethics approval was granted by the Institutional Ethics Review Committee of Beijing Tuberculosis and Thoracic Tumor Research Institute, and the nine regions TB Control and Prevention Centers (TB special hospital) in China. A written informed consent was obtained from eligible patients prior to interview.

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The authors declare that they have no competing interests.

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Du, J., Zhang, L., Ma, Y. et al. Treatment and recurrence on re-treatment tuberculosis patients: a randomized clinical trial and 7-year perspective cohort study in China. Eur J Clin Microbiol Infect Dis 39, 93–101 (2020). https://doi.org/10.1007/s10096-019-03696-8

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