Abstract:

Objective To analysis the effect of standard anti-tuberculosis regimen and long course multidrug-resistant pulmonary tuberculosis (MDR-PTB) regimen in the treatment of initial MDR-PTB after classification and evaluation, and to provide evidence for classified treatment of initial MDR-PTB. Methods A prospective cohort study was conducted with 140 patients efficiently treated with standard anti-tuberculosis regimen (3H-R-Z-E/6H-R; H: isoniazid; R: rifampicin; Z: pyrazinamide; E: ethambutol) for 1-2 months from the Drug-resistant Tuberculosis Department, Xi’an Chest Hospital between January 2017 and December 2018. The patients were divided into two groups using random number table method (n=70 each). After evaluation by the expert group based on imaging findings and drug sensitivity test results, the patients in one group were divided into group A (low-risk group, n=28, continued the standard anti-tuberculosis regimen) and group B (high-risk group, n=42, adjusted to long course MDR regimen). The patients in the other group were divided into group C (n=25, continued the standard anti-tuberculosis regimen) and group D (adjusted to long course MDR regimen, not included in this study) according to the chemotherapy guidelines for drug-resistant tuberculosis (2015 and 2019) and patients’wishes. The patients in group A and group C continued standard anti-tuberculosis regimen. The treatment outcomes, adverse reactions and recurrence of patients in groups A, B and C were compared and analyzed. Results At the end of treatment, the success rates in groups A, B and C were 82.1% (23/28), 71.4% (30/42) and 56.0% (14/25), respectively; the absorption rates of the three groups were 85.7% (24/28), 54.8% (23/42) and 56.0% (14/25), respectively. The success rate and absorption rate between group A and group B was not statistically significant (χ²=1.049, P=0.232; χ ²=0.567, P=0.452), but they all significantly higher than those in group C (χ ²=4.238, P=0.038; χ ²=5.747, P=0.018). The incidences of adverse reactions in groups A, B and C were 21.4% (6/28), 45.2% (19/42) and 20.0% (5/25), respectively. The incidence of adverse reactions in group A was significantly lower than that in group B (χ ²=4.148,P=0.042), but the difference was not significant between group A and group C (χ²=0.016, P=0.898). The recurrence rate of group A was lower than that of group C, but the difference was not statistically significant ((8.7% (2/23) vs. 14.3% (2/14), Fisher exact test, P=0.625). Conclusion The efficacy of the standard anti-tuberculosis regimen was consistent with that of the long course MDR regimen for the initial MDR-PTB patients, but the incidence of adverse reactions in patients treated with standard anti-tuberculosis regimen was lower than those treated with long course MDR regimen. Treatment outcome of MDR-PTB patients initially assessed as “low risk” was significantly better than those of the patients not assessed; however, the adverse reactions and recurrence rates were consistent. It is suggested that the standard anti-tuberculosis regimen should be applied based on scientific evaluation of initial MDR-TB patients.

Key words: Tuberculosis,lung, Multi-drug resistant, Treatment evaluation, Treatment effect