结核病患者使用面对面与电子直接观察治疗的不良事件
M M Salerno1, J Burzynski2, J M Mangan3
1Bureau of Tuberculosis Control, New York City Department of Health and Mental Hygiene, Queens, NY, Division of Pulmonary, Allergy & Critical Care, Columbia University, New York, NY.
概括
电子直接观察治疗 (eDOT) 显示出与结核病治疗的亲临DOT (ipDOT) 相似的患者安全结果. 这两种方法之间的不良事件率并没有显著差异,因此需要进一步调查.
科学领域:
- 公共卫生 公共卫生
- 传染性疾病 传染性疾病
- 临床试验 临床试验
背景情况:
- 患者安全是结核病 (TB) 治疗坚持的一个关键问题.
- 直接观察治疗 (DOT) 是结核病管理的基石.
- 电子直接观察疗法 (eDOT) 的出现为传统的面对面的DOT (ipDOT) 提供了潜在的替代方案.
研究的目的:
- 在结核病患者中评估和比较eDOT和ipDOT之间的患者安全性.
- 评估与每个DOT方法相关的不良事件报告率和特征.
主要方法:
- 采用了一种随机交叉试验设计.
- 参与者的症状,严重程度和临床管理被系统地记录下来.
- 考克斯的比例危险混合效应模型被用于分析不良事件报告.
主要成果:
- 在211名参与者中,27.0%的人报告了不良事件 (AE).
- 在eDOT (54.4%) 和ipDOT (45.6%) 之间,AE报告率相似,调整后的危险比率为0.98 (95% CI 0.49-1.93).
- 胃肠道症状是最常见的AE;DOT方法之间没有观察到AER类型,严重程度或医疗照顾时间的显著差异.
结论:
- 目前的研究结果表明eDOT和ipDOT在结核病治疗中的患者安全概况相似.
- 虽然在统计学上并不显著,但需要进一步的研究来确定不良事件概况的差异.
- 由于DOT方法的安全问题,没有参与者停止治疗.
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