Objective: To analyze the therapeutic effects of the standard regimen and the optimized regimen in retreatment pulmonary tuberculosis complicated with diabetes mellitus (DM).
Methods: In a multi-center cohort study, patients with smear positive retreatment pulmonary tuberculosis (TB) with DM and those without DM [excluding multi-drug resistance (MDR), extensively drug-resistant (XDR) and non-tuberculosis Mycobacterium pulmonary disease(NTM)] were enrolled. There were a total of 178 cases, including 60 smear positive retreatment TB patients with DM and 118 without DM, who were randomly divided into 4 groups: Optimized group 1 [individualized treatment in 30 DM cases, 29 males, age (48 ± 11)], retreatment group 1 [standard retreatment regimen in 30 DM cases, 28 males, age(48 ± 10)], Optimized group 2[individual regimen in 57 non-DM cases, 37 males, age (41 ± 14)], and retreatment group 2 [standard retreatment regimen in 61 non-DM cases, 49 males, age (43 ± 13)]. Patients in the optimized group were treated with optimized individualized regimen based on DST result, with 3-4 sensitive drugs in the regimen, while those in the retreatment group were treated with national standard retreatment regimen. The therapeutic effect of different groups were recorded and the related factors of treatment outcome were analyzed with Chi-square test and multi-factor analysis.
Results: The treatment success rates of the optimized group 1 and the retreatment group 1 were 83.3%(25/30) and 60.0%(18/30), respectively, and the difference was statistically significant (χ(2)=4.02, P=0.045<0.05). The treatment failure rate of the optimized group 1 (6.7%, 2/30) and the retreatment group 1(30.0%, 9/30) was statistically different (χ(2)=5.46, P=0.02<0.05). The outcome difference between the optimized group 2 and the retreatment group 2 showed no statistical significance. Multi-factor analysis showed that treatment regimen, DM, gender and drug resistance were the significant factors related with treatment outcome. The probability of treatment success using the individualized treatment regimen was 2.7 times higher than that using the standard regimen (P=0.025). The risk of treatment failure of the drug resistance cases was 2.8 times higher than that of the drug sensitive cases (P=0.038). The probability of treatment success in DM cases was 0.4 times that in non-DM cases (P<0.05).
Conclusion: The outcome of the optimized regimen group was better than that of the standard regimen group, and retreatment TB patients complicated with DM faced a higher risk of treatment failure, which should receive more attention.