Adverse Events Associated with Treatment of Multidrug-Resistant Tuberculosis in China: An Ambispective Cohort Study.
Adverse Events Associated with Treatment of Multidrug-Resistant Tuberculosis in China: An Ambispective Cohort Study.
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DOI：
10.12659/msm.904682
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发表时间：
2017-05-18
期刊：
影响因子：
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通讯作者：
Zhan S
中科院分区：
文献类型：
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作者：
Zhang Y;Wu S;Xia Y;Wang N;Zhou L;Wang J;Fang R;Sun F;Chen M;Zhan S
不良事件是未被充分认识的负面后果，对于接受抗耐多药结核病治疗的患者来说，由于治疗持续时间较长且需要同时使用多种二线药物，因此不良事件是严重的临床问题。本研究的目的是确定不良事件的发生率及其对耐多药结核病治疗和治疗结果的影响，并确定中国可能的药物事件对。根据医院病历开展了一项双向队列研究，其中包括一项回顾性研究，纳入了 2009 年 5 月至 2013 年 7 月期间接受标准化治疗的 751 名耐多药结核病患者，以及 2016 年 12 月在中国进行的治疗结果随访调查。根据实验室结果或临床标准确定不良事件。考克斯比例风险回归模型用于评估关联性。有681名（90.7%）患者经历了至少一种不良事件，其中55.2%需要改变耐多药结核病治疗； 51 名（6.8%）患者因不良事件而需要永久停用违规药物。不良事件的发生与不良治疗结果相关（调整后风险比，1.54；95% CI 1.21，1.87）。总共鉴定出 10 个不同的药物事件对。中国耐多药结核病治疗过程中不良事件频繁发生，并常常导致耐多药结核病治疗方案的改变。不良事件的发生影响耐多药结核病治疗后的不良结局。
Adverse events are under-appreciated negative consequences that are significant clinical problems for patients undergoing anti-MDR-TB treatment due to longer duration of treatment and more need for concurrent use of multiple second-line drugs. The aim of this study was to determine the incidence of adverse events and their impact on MDR-TB therapy and treatment outcome, and to identify possible drug-event pairs in China. An ambispective cohort study was conducted based on hospital medical records, which included a retrospective study that enrolled 751 MDR-TB patients receiving standardized regimen between May 2009 and July 2013, and a follow-up investigation of treatment outcome conducted in December 2016 in China. Adverse events were determined according to laboratory results or clinical criteria. Cox’s proportional hazards regression models were used for evaluating associations. There were 681(90.7%) patients experienced at least 1 type of adverse event and 55.2% of them required a changed MDR-TB treatment; 51(6.8%) patients required permanent discontinuation of the offending drug due to adverse events. The occurrence of adverse events was associated with poor treatment outcome (adjusted hazard ratio, 1.54; 95% CI 1.21, 1.87). A total of 10 different drug-event pairs were identified. Adverse events occurred commonly during MDR-TB treatment in China, and often resulted in MDR-TB treatment change. The occurrence of adverse events affected MDR-TB poor outcome after treatment.