关键词: 结核, 抗多种药物性, 药物疗法, 联合, 方案评价, 疗效比较研究

Abstract:

Objective We observed and analyzed the effect of 18 months regimen containing 6 drugs in the treatment of multidrug-resistant pulmonary tuberculosis (MDR-PTB) with the purpose to provide evidence for shortening the treatment course of MDR-TB.Methods Six hundred and eighty-one confirmed MDR-TB patients were enrolled from 20 TB specialized hospitals in China from July, 2009 to December, 2015 among which 515 were treated with the 18 months regimen containing 6 drugs (observation group) and 166 were treated with 24 months regimen containing 5 drugs (control group). Results of TB bacilli culture, complete blood count, hepatic and renal function, electrocardiograph,etc were collected throughout the treatment. The treatment outcome (success, death, failure and lost to follow-up) and adverse effect were assessed at the end of treatment.Data were analyzed using SPSS 22.0 software. Measurement data were analyzed by t test or z test.Enumeration data were analyzed by Chi-square test.The clinical indicator with significant difference before treatment were further analyzed by logistic regression to identify the risk factors associated with treatment success rate.P<0.05 was considered significant difference statistically.Results The treatment success rate (64.66%, 333/515) in the observation group was higher than that of the control group (54.22%, 90/166) (χ ²=5.818, P=0.002) and the death rate in the observation group (2.33%, 12/515) was lower than that of the control group (5.42%, 9/166) (χ ²=4.015, P=0.045). The rate of failure (17.86% (92/515) vs 23.49% (39/166))(χ ²=2.561, P=0.109) and lost to follow-up ((11.46%, 59/515) vs 11.45% (19/166)(χ ²=0.000, P=0.997)) were similar between the two groups. The total incidence of adverse reactions in the observation group (24.85%, 128/515)was close to that of the control group (25.90%, 43/166)(χ ²=0.095, P=0.757). Analysis using logistic regression showed that ≥50 age (β=0.549,s $\bar{x}$=0.204,Wald χ ²=7.262,P=0.007,OR(95%CI)=1.731(1.161-2.579)) and selection of ethambutol (β=0.485,s$\bar{x}$=0.190,Wald χ ²=6.516,P=0.011,OR(95%CI)=1.625(1.119-2.359)) in the regimen were the risk factors for treatment success. Conclusion The efficacy of the 18 months regimen containing 6 drugs was equivalent to the regimen of standard 24 months regimen and didn’t increase the adverse reaction occurrence. Therefore, it is worth for clinical application.

Key words: Tuberculosis, multidrug-resistant, Drug combined therapy, Regimen evaluation, Efficacy Comparative study