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中国防痨杂志 ›› 2018, Vol. 40 ›› Issue (2): 161-167.doi: 10.3969/j.issn.1000-6621.2018.02.010

• 论著 • 上一篇    下一篇

2013—2015年温州市耐多药肺结核患者队列标准化疗方案的治疗转归

何贵清,孙峰,苏菲菲,施伎蝉,朱海燕,戴建义,杨守峰,宁洪叶,崔小亚,李君桦,蒋贤高(),张文宏   

  1. 325000 温州市中心医院感染科(何贵清、苏菲菲、施伎蝉、朱海燕、戴建义、杨守峰、宁洪叶、崔小亚、李君桦、蒋贤高);复旦大学附属华山医院感染科(孙峰、张文宏)
  • 收稿日期:2018-01-16 出版日期:2018-02-10 发布日期:2018-03-14
  • 通信作者: 何贵清 E-mail:xiangao368@163.com

Treatment outcomes of the standardized regimens for patients with multildrug-resistant pulmonary tuberculosis in Wenzhou during 2013 to 2015

Gui-qing HE,Feng SUN,Fei-fei SU,Ji-chan SHI,Hai-yan ZHU,Jian-yi DAI,Shou-feng YANG,Hong-ye NING,Xiao-ya CUI,Qun-hua LI,Xian-gao JIANG(),Wen-hong. ZHANG   

  1. Department of Infectious Diseases,Wenzhou Central Hospital, Wenzhou 325000, China
  • Received:2018-01-16 Online:2018-02-10 Published:2018-03-14
  • Contact: Gui-qing HE E-mail:xiangao368@163.com

摘要: 目的

研究温州市耐多药肺结核患者队列标准化疗方案的治疗转归,并分析其影响因素。

方法

搜集2013年8月至2015年12月筛查确诊的耐多药肺结核患者198例,其中,10例患者拒绝接受治疗,3例患者治疗前已死亡,2例患者治疗前已失访,43例患者化疗方案及转归不详,1例患者基线临床分离菌株经药物敏感性试验(简称“药敏试验”)复核对一线抗结核药物均敏感,7例基线菌株经16S rRNAhsp65基因测序鉴定为非结核分枝杆菌(NTM),16例为非标准化耐多药肺结核化疗方案,最终纳入耐多药肺结核标准化疗方案治疗的患者有116例。记录上述患者的基线临床特征、药敏试验结果和随访时痰培养阴转情况、症状改善情况及影像学变化,判定最终治疗的转归情况。

结果

耐多药肺结核纳入标准化疗方案治疗的116例患者中,初治39例(33.6%)、复治77例(66.4%);男83例(71.6%)、女33例(28.4%);年龄范围15~77岁,平均年龄(48.7±12.6)岁。治疗成功59例(50.9%)、治疗失败19例(16.4%)、死亡5例(4.3%)、失访33例(28.4%)。 初治患者治疗成功率(69.2%,27/39)高于复治患者(41.6%,32/77),差异有统计学意义(χ 2=7.932,P=0.005)。单纯MDR-TB患者治疗成功率(67.7%,21/31)高于早期广泛耐药结核病(pre-XDR-TB)患者(42.6%,20/47)和XDR-TB患者(15.4%,2/13),差异均有统计学意义(分别为χ 2=4.753,P=0.029和χ 2=10.064,P=0.002)。单纯MDR-TB患者失访率(25.8%,8/31)分别与pre-XDR-TB患者(27.7%,13/47)和XDR-TB患者(23.1%,3/13)比较,差异均无统计学意义(分别为χ 2=0.033,P=0.857和χ 2=0.036,P=0.849)。对91例MDR-TB患者基线菌株进行二线抗结核药物的药敏试验结果显示,单纯MDR-TB、pre-XDR-TB和XDR-TB分别占34.1%(31/91)、51.6%(47/91)和14.3%(13/91),其中对Ofx耐药的患者占63.7%(58/91)。单纯MDR-TB患者痰菌阴转率(87.1%, 27/31)高于pre-XDR-TB患者(66.0%, 31/47)和XDR-TB患者(38.5%, 5/13),差异有统计学意义(log-rank趋势检验,χ 2=14.500, P<0.001)。

结论

温州市耐多药肺结核治疗成功率较低,可能与基线pre-MDR-TB和XDR-TB所占比率及失访率较高有关。

关键词: 结核, 抗多种药物性, 泛耐药结核病, 回顾性研究, 队列研究, 治疗结果

Abstract: Objective

To study the treatment outcomes of multidrug-resistant pulmonary tuberculosis and analyze the factors associated with treatment outcome in Wenzhou.

Methods

Data of 198 MDR-TB patients diagnosed from August 2013 to December 2015 were retrospectively collected. Among them, 10 patients refused to accept treatment, 3 patients died and 2 patients were lost to follow-up before treatment, the chemotherapy regimens and treatment outcomes of 43 patients were unknown, the baseline strain of 1 patient was confirmed as sensitive by the drug sensitivity test three times, the baseline strains of 7 patients were identified as non-tuberculous mycobacteria by 16S rRNA and hsp65 gene, and 16 patients received non-standardized multidrug-resistant tuberculosis regimens. Finally 116 patients received standardized regimens for MDR-TB. We recorded their baseline clinical characteristics, baseline drug susceptibility results, sputum culture conversion, clinical symptom and imaging changes. The primary endpoint was cure, treatment completed, treatment failure, death, or default (lost to follow-up) at the end of the treatment period.

Results

Of 116 patients enrolled into the standardized regimens for MDR-TB, the number of new patients and previously treated patients were 39 (33.6%) and 77 (66.4%), respectively. There were 83 male patients accounting for 71.6% and 33 female patients accounting for 28.4%. The average age was (48.7±12.6) years old and the age ranged from 15 to 77 years old. Of the 116 MDR-TB patients, 59 (50.9%) were cured or completed treatment, 19 (16.4%) experienced treatment failure, 5 (4.3%) died, and 33 (28.4%) were lost to follow-up. The success rate of new patients was higher than that of previously treated patients (69.2% vs 41.6%), and the difference was statistically significant (χ 2=7.932, P=0.005). The success rate of MDR-TB (67.7%, 21/31) was higher than that of pre-XDR-TB (42.6%, 20/47) and XDR-TB (15.4%, 2/13), the differences were statistically significant (χ 2=4.753,P=0.029 and χ 2=10.064,P=0.002). The loss rate of MDR-TB (25.8%, 8/31) was respectively compared with that of pre-XDR-TB (27.7%, 13/47) and XDR-TB (23.1%, 3/13), while there was no statistically significant difference among them (χ 2=0.033, P=0.857; χ 2=0.036, P=0.849). Of the 91 patients with baseline second-line drug susceptibility, 34.1% (31/91), 51.6% (47/91) and 14.3% (13/91), respectively, was simple MDR-TB, pre-XDR-TB, and XDR-TB. And the resistant proportion of ofloxacin accounted for 63.7% (58/91). Simple MDR-TB (87.1%, 27/31) was higher than the pre- XDR-TB (66.0%, 31/47) and XDR-TB (38.5%, 5/13) in terms of sputum culture conversion rates, the difference were statistically significant (log-rank trend test, χ 2=14.500, P<0.001).

Conclusion

The low success rates of MDR-TB treatment in Wenzhou may be related to the high proportion of Pre-XDR-TB and XDR-TB and the high default rates.

Key words: Tuberculosis, multidrug-resistant, Extensively drug-resistant tuberculosis, Retrospective studies, Cohort studies, Treatment outcome