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目的:快速评价抗结核化疗临床反应。方法:应用指数衰减模型对以前发表的关于标准方案与含异烟肼、利福平和环丙沙星方案临床试验的痰活菌计数进行重新评价。将研究结果拟合单相或双相指数衰减模型。采用单相指数衰减模型描述活菌计数衰减曲线。根据这些数据计算出活菌数减少50%所用的时间(vt_(50)),以评价化疗方案的杀菌效果。 结果和结论:研究结果表明本方法可用于早期鉴定由于耐药或免疫应答低下对治疗反应不积极的病人,并可比较临床试验中抗结核方案的效果。双相指数衰减曲线的拟合失败提示,或者痰标本中不含有只有灭菌活性药物才能起作用的细菌,或者是这种细菌数量少对活菌总数难以形成重要影响。需要进一步研究以了解痰标本中的细菌生理状态。
Objective: To evaluate the clinical response of anti-TB chemotherapy. METHODS: Exponentially decaying models were used to re-evaluate previously published counts of sputum viable bacteria in clinical trials of standard regimens and isoniazid, rifampin, and ciprofloxacin regimens. The results fit the single-phase or biphasic exponential decay model. The single-phase exponential decay model is used to describe the viable count decay curve. Based on these data, the time taken to reduce the number of viable cells by 50% (vt_ (50)) was calculated to evaluate the bactericidal efficacy of the chemotherapy regimen. RESULTS AND CONCLUSIONS: The results of the study indicate that this method can be used to identify patients who are not actively responding to treatment due to low resistance or immune response and to compare the efficacy of anti-TB regimens in clinical trials. The failure of the fitting of the biphasic exponential decay curve suggests that the sputum sample does not contain bacteria that only have a sterilizing active drug or that the small number of bacteria does not have a significant effect on the total number of viable cells. Further research is needed to understand the bacterial physiology in sputum samples.