| Objective: Glycemic control and statins are associated with anti-tuberculosis treatment outcomes in patients suffering from diabetes mellitus combined with pulmonary tuberculosis(PTB-DM).However,there are insufficient population-based studies on the role of statins in antituberculosis treatment.In addition,there is insufficient evidence on whether there is an interaction between statins and glycemic control.Therefore,the aim of this study was to explore the effect of glycemic control and statins on the outcome of antituberculosis treatment in PTBDM patients and to provide some effective recommendations for the treatment of these patients.Methods: This study conducted a nested case-control study based on a cohort of tuberculosis patients constructed by the Innovation Alliance on Tuberculosis Diagnosis and Treatment(Beijing).The study population consisted of PTB-DM patients who visited the four member hospitals in the alliance from September 1,2009,to September 1,2019.Patients who experienced an unfavorable outcome on antituberculosis treatment were included in the case group and those with a favorable outcome on antituberculosis treatment were included in the control group.Glycemic control outcomes were assessed based on glycosylated hemoglobin test results performed at baseline,and statin use was obtained from patients’ clinic records during hospitalization.Other variables were obtained from the baseline survey,clinical consultation information,and follow-up data.Patients’ glycemic control and statin use were analyzed by chi-square test,and variables were screened.Multifactorial logistic regression was used to analyze the effects of glycemic control and statins on antituberculosis treatment outcomes.Quantitative analyses of interactions were performed using an Excel calculation table created by Andersson et al.Indicators for quantitative analysis included: excess relative risk of interaction effect(RERI),percentage of attributable interaction effect(AP),effect index(SI)and their 95% confidence intervals.A sensitivity analysis was additionally performed for patients entering the cohort after 2016 due to continuous advances in tuberculosis diagnosis and treatment.Results: A total of 5145 PTB-DM patients were included in this study,of whom 1239(25.83%)had an unfavorable outcome on anti-tuberculosis treatment.The differences in glycemic control outcomes were statistically significant among patients of different sexes,age groups,tuberculosis types,Age-adjusted Charlson Comorbidity Index(ACCI),and serum C-reactive protein and globulin levels(P<0.05).There were statistically significant differences in glycemic control outcomes among patients with different age groups,tuberculosis types,and ACCI(P<0.05).There was no statistically significant difference in glycemic control effect among patients with different statin use(P>0.05).There were statistically significant differences in the incidence of unfavorable outcomes of anti-tuberculosis treatment by gender,age group,type of tuberculosis,ACCI,drug-related liver injury,anti-tuberculosis treatment regimen,statin use,glycemic control effect,and serum C-reactive protein and globulin levels(P<0.05)The results of multivariate logistic regression showed that both good glycemic control(OR=0.494,95% CI: 0.396-0.615)and statin use(OR=0.608,95% CI: 0.465-0.794)were protective factors against unfavorable outcomes of antituberculosis treatment.The results of the interaction analysis showed an interaction between glycemic control outcome and statins(RERI=0.325,95% CI: 0.048-0.602;AP=0.541,95% CI: 0.190-0.893;SI=0.552,95% CI: 0.309-0.986).Among them,patients with good glycemic control and statin use had the lowest risk of treatment adverse outcomes(OR=0.600,95% CI: 0.415-0.867);patients with poor glycemic control and statin use had a reduced risk of treatment adverse outcomes compared with patients with poor glycemic control and no statin use(OR=0.643,95% CI: 0.528-0.783);the risk of treatment failure was slightly lower in patients with good glycemic control and no statin use(OR=0.633,95% CI: 0.512-0.783)than in patients with poor glycemic control and statin use.After correction for serum C-reactive protein and globulin levels,the interaction between glycemic control and statins in anti-TB treatment outcome was statistically significant(RERI=0.397,95% CI: 0.133-0.661;AP=1.016,95% CI: 0.459-1.574;SI=0.605,95% CI: 0.429-(0.854).In sensitivity analysis,the interaction between glycemic control and statins in anti-tuberculosis treatment outcomes remained in patients entering the cohort after 2016(RERI=0.397,95% CI: 0.133-0.661;AP=1.016,95% CI: 0.459-1.574;SI=0.605,95% CI: 0.429-0.854);the interaction also remained after correction for serum C-reactive protein and globulin(RERI=0.381,95% CI: 0.080-0.682;AP=1.154,95% CI: 0.344-1.964;SI=0.637,95% CI: 0.450-0.903).Conclusion: There was an interaction between blood glucose control effect and statins in the outcome of anti-tuberculosis treatment in PTB-DM patients.Glycemic control has a stronger effect on the outcome of antituberculosis treatment in PTB-DM patients than statin use and should be given adequate attention in the treatment of these patients.Statins can reduce the risk of unfavorable outcomes of antituberculosis treatment in PTB-DM patients,and this protective effect remains even when patients have poor glycemic control,and statins can be considered as adjunctive therapy in the antituberculosis treatment of PTB-DM patients.PTB-DM patients with good glycemic control and taking statins have the lowest risk of unfavorable outcomes of antituberculosis treatment,so glycemic control and adjuvant therapy with statins should be given simultaneously in the treatment of PTB-DM patients.The dose and type of statin may have an impact on the outcome of antituberculosis treatment,so appropriate prospective studies or experimental studies should be conducted to explore these factors. |
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