Abstract:

Objective: To verify the feasibility, safety and efficacy of a 9-11-month all-oral, short-course standardized treatment regimen (abbreviated “short-term plan”) for multidrug/rifampicin-resistant tuberculosis (MDR/RR-TB) patients under the framework of tuberculosis control programs. Methods: A prospective study was conducted from March 2022 to March 2024, patients with MDR/RR-PTB who were diagnosed with rifampicin resistance and fluoroquinolone susceptibility at Kashgar Prefectural Pulmonary Hospital, Xinjiang Uygur Autonomous Region. Patients were enrolled in the short-course treatment group (short-course group) based on the inclusion criteria. The remaining MDR/RR-PTB patients were assigned to the 18-20-month long-course treatment group (long-course group). The treatment outcomes and costs of the two groups of completed patients were observed and evaluated, and to analyze the characteristics of adverse reactions and treatment outcomes in the short-term group. Results: A total of 242 MDR/RR-PTB patients who met the inclusion criteria and completed treatment were enrolled. The overall treatment success rate was 54.13% (131/242). Among them, the treatment success rates were 76.25% (61/80) for the 80 patients treated with the short-course regimen and 43.21% (70/162) for the 162 patients treated with the long-course regimen, respectively. In the short-course group, the treatment success rate of retreated patients (44.26% (27/61)) was significantly lower than that of new patients (55.74% (34/61)), with a statistically significant difference (χ²=6.989, P=0.008); the incidences of liver function abnormalities, gastrointestinal reactions and high uric acid were 21.25% (17/80), 16.25% (13/80) and 3.75% (3/80), respectively. Only one patient discontinued the drug for 2 weeks due to severe liver dysfunction, none of the remaining patients discontinued treatment due to adverse drug reactions. The average treatment cost per patient in the short-course group was 61000 yuan less than that in the long-course group, with drug costs being the main component (59000 yuan). Conclusion: The 9-11-month all-oral standardized short-course treatment achieves a relatively high treatment success rate and exhibits favorable safety profiles in eligible MDR/RR-TB patients, which is generally consistent with existing literatures. It can also reduce medical costs and is suitable for application in regions equipped with rapid diagnostic capabilities for rifampicin and fluoroquinolone resistance.

Key words: Tuberculosis, multidrug-resistant, Combination drug therapy, Clinical protocols, Therapeutic uses, Evaluation studies, Factor analysis, statistical