痰菌阴转时间与耐多药结核病治疗结局的关联及其影响因素分析

发布时间：2018-03-22 12:13

本文选题：耐多药结核病　切入点：危险因素　出处：《南京医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：背景:痰阴转在耐多药结核病患者的监测中发挥重要作用,患者治疗随访过程中的痰菌改变是预测治疗转归的重要指标。定期的痰培养的监测对于早期发现治疗失败的耐多药结核病患者至关重要。目前有关痰阴转与普通结核治疗结局的研究有很多,但很少有队列研究调查耐多药结核病患者治疗结局和痰培养阴转之间的关系以及不同治疗时间后痰培养的阴转对耐多药结核病患者治疗结局的预测效率。在中国或印度等结核病高负担地区也没有进行过类似的研究。此外耐多药结核痰培养阴转的影响因素相关研究也很少,迄今为止在国内还没类似的研究。方法:2011年12月-2014年3月在江苏省的四个地级市(徐州、连云港、镇江和南通市)连续纳入确诊的耐多药结核病患者作为研究对象。耐多药结核病患者在当地的市级定点医院结核病参比实验室通过传统药敏实验确诊。纳入到研究中的耐多药患者都将签署患者知情同意书,随后当地调查员将会对患者进行问卷调查并收集患者的人口学和治疗相关信息。耐多药患者根据药敏结果及用药史采用标准治疗方案或个体治疗方案,并定期对病人进行痰培养检查,注射期每月1次,非注射期每两个月1次。计算2月、3月、6月和24月末的痰培养的阴转率,采用Cox比例风险模型探讨痰菌阴转时间对耐多药结核病患者治疗结局的影响。结果:研究共纳入139名有治疗结局的耐多药结核病患者。其中106(76.3%)人的痰培养发生阴转,中位阴转时间是91.5天(四分位数间距:34.0天-111.8天)。84(60.4%)名患者治疗成功,55(39,6%)名患者治疗失败或死亡。治疗成功病人的痰培养中位阴转时间是92.0天(95%CI:85.5-98.5天),低于(χ2 =26.05,P0.001)治疗失败或死亡病人的痰培养阴转时间174天(95%CI:0-513天)。2月末痰培养阴转与治疗结局之间关联无统计学意义(HR=2.0;95%CI=0.9-4.5;P=0.087)。然而3月末(HR=2.7;95%CI=1.3-5.5;P=0.007)、6月末(HR=12.3;95%CI=5.0-30.3;P0.001)以及24月末(HR=22.3;95%CI=7.2-69.4;P0.001)痰培养阴转的患者的治愈率大大增加。2月、3月、6月和24月末的灵敏度分别为33.3%、52.4%、90.5%和95.2%,特异度分别为80.0%,70.9%,56.4%和52.7%。经多因素分析结果显示,吸烟(HR=0.44;95%CI:0.23-0.83;P=0.011)、饮酒(HR=0.41;95%CI:0.21-0.81;P=0.011)、氧氟沙星耐药(HR=0.43;95%CI:0.24-0.76;P=0.003)以及初始涂片等级1(HR=0.51;95%CI:0.31-0.83;P=0.008)为耐多药结核病患者痰培养阴转的影响因素。结论:与2月末及3月末痰培养阴转相比,6月末的痰培养阴转更适合预测MDR-TB患者的治疗结局。吸烟、饮酒、有氧氟沙星耐药及高涂片等级影响耐多药结核患者的痰培养阴转,应提高重视。
[Abstract]:Background: phlegm-negative conversion plays an important role in the monitoring of MDR-TB patients. The change of sputum bacteria during follow-up is an important index to predict the outcome of treatment. Regular monitoring of sputum culture is very important for early detection of MDR-TB patients who fail in treatment. There are a lot of studies on the outcome of TB treatment. However, few cohort studies have investigated the relationship between treatment outcome and sputum culture negativity in MDR-TB patients and the predictive effectiveness of sputum culture negative-conversion in MDR-TB patients after different treatment periods. No similar studies have been carried out in high-burden areas such as India. In addition, few studies have been conducted on the factors affecting the negative sputum culture of MDR-TB. Methods: from December 2011 to March 2014, there are four prefecture-level cities in Jiangsu Province (Xuzhou, Lianyungang). Zhenjiang and Nantong)) continuous inclusion of confirmed MDR-TB patients as research objects. MDR-TB patients were confirmed by traditional drug-sensitivity tests in the tuberculosis reference laboratory of the local designated hospitals at the municipal level. All patients who are investigated for multi-drug resistance will sign the informed consent form of the patient. Local investigators will then conduct questionnaires on patients and collect demographic and treatment-related information. Multidrug resistant patients will adopt standard or individual treatment programs based on drug sensitivity results and drug history. Sputum culture was examined regularly, once a month for injection period and once every two months for non-injection period. The negative rate of sputum culture was calculated at the end of 2 months, 3 months, 6 months and 24 months. Cox proportional risk model was used to investigate the effect of sputum negative transition time on the outcome of treatment in patients with MDR-TB. Results: one hundred and nine patients with MDR-TB with therapeutic outcome were enrolled in the study. The sputum culture turned negative in 106 patients with MDR-TB. The median negative conversion time was 91.5 days (quartile interval: 34.0 days -111.8 days and 84,60.4 days). The median negative conversion time of sputum culture in successful patients was 92.0 days, 95.5-98.5 days, which was lower than that of successful patients (蠂 2 / 26.05 / P 0.001). The sputum culture negative conversion time of dead patients was 174 days and 95CI: 0-513 days. There was no significant correlation between sputum culture negativity and the outcome of treatment at the end of February. 2. There was no statistical significance. However, at the end of March, HR2.795 CII 1.3-5.5P0.007CII 1.3-5.5P0.007CII and HR12.395CII 5.0-30.3CII at the end of 24 months had a great cure rate. At the end of 24 months, the patients with negative sputum culture were 22.395 CI 7.2-69.4P0.001). The sensitivities at the end of February, March, June and the end of 24 were 90.5% and 95.2%, respectively, and the specificity were 80.0% and 70.9%, 56.4% and 52.7%, respectively. Smoking and initial smear grade 1HR0.551% 0.31-0.83P0.008) are the influencing factors of sputum conversion in patients with MDR-TB. Conclusion: sputum culture negative turn in late February and the end of March compared with sputum negative conversion in late February and end of March, ofloxacin resistance HR0.4395 CIW 0.24-0.76 P0.003) and initial smear grade 1HR0.551 / 95CI0.31-0.83P0.008) are the influencing factors of sputum conversion in patients with multidrug-resistant tuberculosis (MDR-TB). Conclusion: compared with the sputum culture in late February and the end of March, the sputum culture turns negative to negative in patients with multidrug resistance. Suitable for predicting the outcome of treatment in patients with MDR-TB. Drinking, ofloxacin resistance and high smear grade influence the sputum culture negativity of MDR-TB patients, and should be paid more attention to.
【学位授予单位】：南京医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R52

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