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Abstract
Purpose
Cycloserine has been used in multidrug-resistant tuberculosis (MDR-TB) treatment since the 1950s. We evaluated the efficacy and safety of cycloserine and sought to clarify the role of cycloserine for treatment of simple MDR-TB, pre-extensively drug-resistant tuberculosis (pre-XDR-TB), and extensively drug-resistant tuberculosis (XDR-TB).
Materials and methods
A retrospective observational study was performed in Zhejiang Province, China. We enrolled 144 cycloserine-treated and 181 cycloserine-nontreated patients consecutively and determined the treatment outcome as the primary outcome. The proportion of patients with sputum culture conversion and the frequency of adverse drug reactions were also assessed.
Results
One-hundred (69.4%) out of 144 patients in the cycloserine group successfully completed treatment. The HR of any unfavorable treatment outcome after the introduction of cycloserine was 0.58 (95% CI: 0.38–0.86, P=0.008). Subgroup analysis showed that cycloser-ine could benefit simple MDR-TB cases reducing the risk of unfavorable treatment outcomes (HR: 0.43, 95% CI: 0.24–0.76, P=0.004), but not pre-XDR-TB (HR: 0.65, 95% CI: 0.30–1.38, P=0.263) or XDR-TB (HR: 0.73, 95% CI: 0.22–2.37, P=0.589). The culture conversion rate at the intensive phase was similar whether cycloserine was administered or not (P=0.703). Of the 144 patients treated with cycloserine, a total of 16 (11.1%) patients experienced side effects attributed to cycloserine.
Conclusion
Cycloserine is an attractive agent for the treatment of MDR-TB, and its safety profile warrants its use in most MDR-TB cases. Cycloserine significantly improved the chance of a favorable outcome for patients with simple MDR-TB but not pre-XDR-TB and XDR-TB. Thus, more aggressive regimens might be required for pre-XDR-TB or XDR-TB patients.
Data availability
Individual participant data after deidentification that underlie the results reported in the article could be shared from 12 months following article publication for 2 years. Study documents could be available immediately after publication. The data set could only be shared with investigators who provide a methodologically sound proposal for individual participant data meta-analysis. Proposals should be directed to [email protected]. Data requestors will need to sign a data access and proposals do not necessarily mean it will be assented.
Supplementary material
Table S1 Univariate Cox regression analysis of potential independent variables associated with unfavorable treatment outcome in multidrug-resistant tuberculosis cases
Acknowledgments
We thank all patients for affording their treatment profiles and all health care workers who participated in this effort. This study is funded by Zhejiang-National Committee of Health and Family Planning Co-Sponsored Project (WKJ-ZJ-07).
Author contributions
All authors contributed to data analysis, drafting or revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
The authors report no conflicts of interest in this work.