Abstract:

Objective: To compare the efficacy and safety of two short-course regimens, B-Pa-L/M and B-D-L-Lfx/C, in patients with rifampicin-resistant pulmonary tuberculosis, and to provide evidence for optimizing clinical treatment strategies. Methods: A randomized, multicenter study was conducted. A total of 90 patients with rifampicin-resistant pulmonary tuberculosis (RR-PTB) treated at two sites in Anhui Chest Hospital and Yunnan Provincial Infectious Disease Hospital between August 2024 and August 2025 were enrolled. Using a random number table, patients were allocated in a 1∶2 ratio into a B-Pa-L/M group (30 cases) and a B-D-L-Lfx/C group (60 cases). The sputum Mycobacterium tuberculosis culture conversion rate was used as the primary efficacy endpoint. The sputum culture conversion rates at each follow-up time point during treatment and the median time to conversion were compared between the two groups. In parallel, all adverse events (AEs) occurring during treatment were observed and recorded, and the incidence of AEs was compared between the two groups to evaluate the safety of the regimens. Results: No statistically significant differences were observed between the two groups in sputum culture conversion rates at weeks 4, 8, 16, or 24 (all Ps>0.05). At week 12, the sputum culture conversion rate in the B-Pa-L/M group (96.67%, 29/30) was significantly higher than that in the B-D-L-Lfx/C group (80.00%, 48/60)(χ²=4.495,P=0.034). At week 24, both groups achieved high sputum culture conversion rates: 96.67% (29/30) in the B-Pa-L/M group and 91.67% (55/60) in the B-D-L-Lfx/C group. The median time to sputum culture conversion was significantly shorter in the B-Pa-L/M group (4 weeks) than in the B-D-L-Lfx/C group (8 weeks)(log-rank χ²=4.063, P=0.044). Safety results showed that the incidence of headache in the B-Pa-L/M group was 0/30 (0%), which was significantly lower than that in the B-D-L-Lfx/C group (13/60, 21.67%), and the difference was statistically significant (Fisher’s exact test, P=0.004). Conclusion: Both the B-Pa-L/M and B-D-L-Lfx/C short-course regimens demonstrate favorable efficacy and safety in the treatment of rifampicin-resistant pulmonary tuberculosis. Compared with the B-D-L-Lfx/C regimen, the B-Pa-L/M regimen exhibits superior mid-term mycobacterial clearance and a lower incidence of headache, suggesting better intermediate efficacy and neurological tolerability.

Key words: Tuberculosis, Drug resistance, Treatment outcome, Drug toxicity, Pretomanid, Delamanid