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抗结核病和/或抗逆转录病毒治疗HIV感染者的肝损伤-使用更新的罗塞尔UCLAF因果关系评估方法评估因果关系

H M Gunter¹, G Tatz¹, G Maartens¹

¹Division of Clinical Pharmacology, Department of Medicine, Faculty of Health Sciences, University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa.

Pharmacoepidemiology and drug safety

|October 10, 2024

概括

罗塞尔·乌克拉夫因果关系评估方法 (RUCAM) 在识别因结核病和艾滋病毒治疗引起的药物诱导性肝损伤 (DILI) 时显示出低灵敏度. 专家小组审查对于在多种药物治疗的患者中准确评估因果关系至关重要.

科学领域:

药物监督药物监督药物监督
肝病学肝病学是一种肝病学.
传染性疾病传染性疾病

背景情况:

药物诱导性肝损伤 (DILI) 是接受抗结核治疗 (ATT) 和/或抗逆转录病毒治疗 (ART) 的患者的一个重大问题.
在多种药物治疗的患者中,特别是艾滋病毒感染者 (PWH) 中,评估DILI的因果关系是复杂的.
准确的因果关系评估对于管理DILI和优化治疗方案至关重要.

研究的目的:

将罗塞尔·乌克拉夫因果关系评估方法 (RUCAM) 的性能与多学科专家小组审查进行比较.
评估RUCAM在医院住院患者中鉴定ATT和/或ART引起的DILI的准确性.

主要方法:

在南非开普敦,利用了一份因ATT和/或ART而疑似DILI的住院成年人的潜在登记册.
在世界卫生组织乌普萨拉监测中心标准的指导下,专家小组的审查作为因果关系评估的参考标准.
对每种可能涉及的药物进行了RUCAM,并根据专家小组的调查结果计算了其敏感性和特异性.

主要成果:

该研究包括48名参与者,他们都是艾滋病毒感染者 (PWH).
27名参与者同时服用ART和ATT,每例中位数为6种潜在的肝毒药物.
与专家小组审查相比,RUCAM在识别可能或某些药物导致肝损伤的原因方面表现出7%的灵敏度和100%的特异性.

结论:

接受ATT和/或ART的DILI患者,尤其是PWH患者,经常服用多种潜在的肝毒药物,复杂化因果关系评估.
与专家小组审查相比,RUCAM在检测可能或确定的药物诱导肝损伤方面表现出较低的灵敏度.
多学科专家小组审查仍然是精确的DILI因果关系评估在涉及ATT和ART的复杂案件的关键工具.

关键词:

鲁卡姆 (Rucam) 是一个古老的语言.抗逆转录病毒药物治疗对抗结核病的治疗方法.对因果关系的评估.药物诱导的肝损伤是由药物引起的.专家小组审查专家小组的审查.

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