Evaluation of safety and efficacy of anti-tuberculosis fixed-dose combination in patients with drug-susceptible pulmonary tuberculosis

doi:10.19982/j.issn.1000-6621.20260253

Abstract

Abstract:

Objective: To evaluate the safety and efficacy of anti-tuberculosis fixed-dose combination (FDC) in the treatment of drug-susceptible pulmonary tuberculosis via a real-world study. Methods: A single-arm prospective cohort design was adopted. A total of 305 patients with drug-susceptible pulmonary tuberculosis were enrolled from September 2024 to September 2025 at 10 provincial and municipal designated tuberculosis hospitals nationwide including Beijing Chest Hospital, Capital Medical University. All patients received anti-tuberculosis FDC therapy: ethambutol hydrochloride, pyrazinamide, rifampicin and isoniazid tablets for a 2-month intensive phase, followed by rifampinand isoniazid tablets/capsules for a 4-month continuation phase. A 6-month follow-up was conducted to assess efficacy and safety. Efficacy indicators included sputum culture conversion rate, drug susceptibility, lung lesion absorption and cavity changes. Safety indicators covered liver and renal function, blood routine, urine routine and the incidence of adverse events. Results: The sputum conversion rate reached 98.7% (150/152) after 6 months of FDC treatment. Pulmonary imaging results revealed marked lesion absorption in 180 patients (59.0%) and partial lesion absorption in 79 patients (25.9%); cavities were closed in 156 patients (51.1%) and shrunk in 88 patients (28.9%). The overall treatment success rate was 91.1% (278/305). A total of 219 adverse events were recorded, among which 203 were Grade Ⅰ, 10 Grade Ⅱ and 5 Grade Ⅲ. One death occurred due to brain tumor, which was unrelated to anti-tuberculosis drugs. The predominant adverse events included 27 (8.9%, 27/305) gastrointestinal adverse reactions, 33 (10.8%, 33/305) cases of elevated transaminases and total bilirubin, and 111 (36.4%, 111/305) cases of hyperuricemia. Conclusion: Anti-tuberculosis FDC demonstrates favorable efficacy, safety and treatment completion rate for drug-susceptible pulmonary tuberculosis.

Key words: Tuberculosis, pulmonary, Antitubercular agents, Fixed-dose combination, Treatment outcome, Evaluation studies

CLC Number:

Li Xinda, Hou Zhili, Ouyang Bing, Du Yadong, Guan Liying, Yu Hongmei, Zhang Haiqin, Xie Yongjie, Tang Peijun, Xiao Yu, Zhang Ying, Lu Yu. Evaluation of safety and efficacy of anti-tuberculosis fixed-dose combination in patients with drug-susceptible pulmonary tuberculosis[J]. Chinese Journal of Antituberculosis, 2026, 48(8): 1158-1162. doi: 10.19982/j.issn.1000-6621.20260253

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