耐多药肺结核患者治疗6个月末痰培养阴转的影响因素分析

Analysis of sputum culture conversion at the end of 6 months and related risk factors among multidrug-resistant tuberculosis patients

目的了解耐多药肺结核(MDR-PTB)患者治疗6个月末痰培养阴转情况及其影响因素。方法采用回顾性队列研究的方法,收集2011—2015年杭州市结核病定点医院确诊并开始抗结核药物治疗的365例MDR-PTB患者的人口学信息和实验室检测结果资料,分析研究对象治疗6个月末痰培养阴转情况,并采用Cox比例风险回归模型分析影响研究对象治疗6个月末痰培养阴转的因素。结果 365例研究对象中,332例在治疗6个月末痰培养阴性,阴转率为90.96%;287例(78.63%)治疗成功,78例(21.37%)治疗未成功。332例痰培养阴转的研究对象,阴转时间中位数(四分位数)为85.0(42.0,106.5)d,其中,治疗成功者占84.94%(282例)。33例痰培养未阴转者中,治疗成功者占15.15%(5例),两组比较差异有统计学意义(χ^2=87.00,P=0.000)。Cox回归分析结果显示,杭州户籍的MDR-PTB患者治疗6个月末痰培养易阴转[阴转率为4.09/100人年(149/36.41);调整风险比(aHR)(95%CI):1.37(1.10~1.71)];而对抗结核药物耐药的药品数量(简称“耐药数”)≥4种[阴转率为3.36/100人年(119/35.43);aHR(95%CI):0.76(0.61~0.96)]和年龄≥25岁[25~44岁组阴转率为3.69/100人年(143/38.80);aHR(95%CI):0.56(0.41~0.78)。45~64岁组阴转率为3.36/100人年(108/32.15);aHR(95%CI):0.52(0.37~0.73)。≥65岁组阴转率为3.33/100人年(27/8.10);aHR(95%CI):0.45(0.38~0.72)]的MDR-PTB患者治疗6个月末痰培养不易阴转。结论杭州地区MDR-PTB患者治疗成功率及治疗6个月末痰培养阴转率较高,但治疗6个月末痰培养阴转所需时间较长,应针对非杭州户籍者、耐药数多和年龄大的患者早期加强治疗和督导管理,以提高患者的治疗效果。

Objective To investigate the sputum culture conversion (SCC) at the end of 6 months and related risk factors among patients with multidrug-resistant pulmonary tuberculosis (MDR-PTB).Methods Retrospective cohort study was conducted among 365 MDR-PTB patients who were diagnosed and started anti-TB drug treatment during 2011 and 2015 in designated TB hospitals in Hangzhou. Demographic information and laboratory results were collected to analyze the SCC at the end of 6 months, and identify the related risk factors using the Hazard Cox regression Model.Results Of 365 enrolled participants, 332 were negative at the end of 6 months with the SCC rate of 90.96%;287 (78.63%) were successfully treated, and 78 (21.37%) were unsuccessful. The median (Q1, Q3) time of SCC in the 332 SCC subjects was 85.0 (42.0, 106.5) d, of which 84.94%(282 cases) were successfully treated. Among the 33 cases without SCC, the treatment success rate was 15.15%(5 cases). Significant higher treatment success rate was observed among the participants who initialed SCC at 6 months than the participants who did not (χ^2=87.00,P=0.000). Cox regression analysis revealed that compared with patients without household registration in Hangzhou, patients with household registration in Hangzhou were more likely to initial SCC (SCC rate: 4.09/100 person years (149/36.41), adjusted hazard ratio (aHR)(95%CI): 1.37 (1.10-1.71));compared with patients who were resistant to less than 4 drugs and aged <25 years old, patients who were resistant to no less than 4 drugs (SCC rate: 3.36/100 person years (119/35.43), aHR (95%CI): 0.76 (0.61-0.96)) and aged ≥25 years old (25-44 years group, SCC rate: 3.69/100 person years (143/38.80), aHR (95%CI): 0.56 (0.41-0.78);45-64 years group, SCC rate: 3.36/100 person years (108/32.15), aHR (95%CI): 0.52 (0.37-0.73);≥65 years group, SCC rate: 3.33/100 person years (27/8.10), aHR (95%CI): 0.45 (0.38-0.72)) were less likely to initial SCC. Conclusion The treatment success rate and SCC rate at the end of 6 months were relatively high in MDR-PTB patients in Hangzhou, while it costs longer time to initial SCC at the end of 6 months. Patients without Household registration in Hangzhou, patients with more resistant drugs and elder patients should be especially supervised and managed at early stage during their treatment to improve the treatment outcomes.