Fundació Institut Català de Farmacologia, Universitat Autònoma de Barcelona, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
BMC Gastroenterol. 2011 Jul 15;11:80. doi: 10.1186/1471-230X-11-80.
Acute liver injury (ALI) induced by paracetamol overdose is a well known cause of emergency hospital admission and death. However, there is debate regarding the risk of ALI after therapeutic dosages of the drug.The aim is to describe the characteristics of patients admitted to hospital with jaundice who had previous exposure to therapeutic doses of paracetamol. An assessment of the causality role of paracetamol was performed in each case.
Based on the evaluation of prospectively gathered cases of ALI with detailed clinical information, thirty-two cases of ALI in non-alcoholic patients exposed to therapeutic doses of paracetamol were identified. Two authors assessed all drug exposures by using the CIOMS/RUCAM scale. Each case was classified into one of five categories based on the causality score for paracetamol.
In four cases the role of paracetamol was judged to be unrelated, in two unlikely, and these were excluded from evaluation. In seven of the remaining 26 cases, the RUCAM score associated with paracetamol was higher than that associated with other concomitant medications. The estimated incidence of ALI related to the use of paracetamol in therapeutic dosages was 0.4 per million inhabitants older than 15 years of age and per year (99%CI, 0.2-0.8) and of 10 per million paracetamol users-year (95% CI 4.3-19.4).
Our results indicate that paracetamol in therapeutic dosages may be considered in the causality assessment in non-alcoholic patients with liver injury, even if the estimated incidence of ALI related to paracetamol appears to be low.
扑热息痛过量导致的急性肝损伤（ALI）是急诊住院和死亡的常见原因。然而，关于药物治疗剂量后发生 ALI 的风险仍存在争议。本研究旨在描述先前接触过治疗剂量扑热息痛的黄疸患者住院的特点，并评估扑热息痛在每个病例中的因果关系作用。
基于对具有详细临床信息的前瞻性 ALI 病例评估，确定了 32 例非酒精性患者接触治疗剂量扑热息痛后发生的 ALI。两名作者使用 CIOMS/RUCAM 量表评估所有药物暴露情况。根据扑热息痛的因果关系评分，将每个病例分为五个类别之一。
在 4 例中，扑热息痛的作用被判断为无关，2 例不太可能，这两例被排除在评估之外。在剩余的 26 例中，有 7 例与扑热息痛相关的 RUCAM 评分高于与其他同时使用药物相关的评分。与使用治疗剂量扑热息痛相关的 ALI 发生率估计为每 15 岁以上居民 0.4 例/百万人年（99%CI，0.2-0.8）和每 100 万扑热息痛使用者年 10 例（95%CI，4.3-19.4）。
我们的结果表明，在非酒精性肝损伤患者的因果关系评估中，即使与扑热息痛相关的 ALI 发生率似乎较低，也可以考虑治疗剂量的扑热息痛。
