Thomson J A, Fairley C K, Ugoni A M, Forbes A B, Purcell P M, Desmond P V, Smallwood R A, McNeil J J
Department of Social and Preventive Medicine, Monash University, Alfred Hospital, Melbourne, VIC.
Med J Aust. 1995 Jun 19;162(12):638-40. doi: 10.5694/j.1326-5377.1995.tb126049.x.
To identify risk factors for the development of amoxycillin-clavulanic acid associated jaundice.
Retrospective case-control study. Cases were selected from those reported to the Adverse Drug Reactions Advisory Committee from the time of introduction of amoxycillin-clavulanic acid to Australia in 1986 until December 1993.
Thirty-four cases, defined as individuals who developed jaundice within eight weeks of starting amoxycillin-clavulanic acid, with a biochemical picture of cholestasis, normal calibre bile ducts and no other recognised causes of jaundice or recent use of other hepatotoxic drugs, were selected. For each case, four controls who had been prescribed amoxycillin-clavulanic acid without developing jaundice were randomly selected from the patient register of the prescribing doctor.
Increasing age was a risk factor for amoxycillin-clavulanic acid associated jaundice; patients over 55 years had an odds ratio of 16.1 (95% confidence interval [CI], 2.9-88.9) compared with patients less than 30 years. Men had an odds ratio of 2.5 (95% CI, 1.1-5.4) compared with women, although the proportion of men in the study group was larger than in the reported cases overall. History of serious medical illness, drug dose, route and duration of therapy, other medications, smoking and previous drug allergies or use of amoxycillin-clavulanic acid were not significantly associated with jaundice.
Because of the higher risk of jaundice with increasing age, the risk-benefit ratio of amoxycillin-clavulanic acid should be carefully considered in older patients. Further assessment is necessary to clarify the association between jaundice and male sex.
确定阿莫西林-克拉维酸相关性黄疸发生的危险因素。
回顾性病例对照研究。病例选自1986年阿莫西林-克拉维酸引入澳大利亚至1993年12月期间向药物不良反应咨询委员会报告的病例。
选取34例病例，定义为在开始使用阿莫西林-克拉维酸后8周内出现黄疸，伴有胆汁淤积的生化表现、胆管管径正常且无其他公认的黄疸病因或近期未使用其他肝毒性药物的个体。对于每例病例，从开处方医生的患者登记册中随机选取4例接受过阿莫西林-克拉维酸治疗但未发生黄疸的对照。
年龄增长是阿莫西林-克拉维酸相关性黄疸的一个危险因素；55岁以上患者与30岁以下患者相比，比值比为16.1（95%置信区间[CI]，2.9 - 88.9）。男性与女性相比，比值比为2.5（95%CI，1.1 - 5.4），尽管研究组中男性比例高于总体报告病例中的男性比例。严重疾病史、药物剂量、治疗途径和持续时间、其他药物、吸烟以及既往药物过敏或使用阿莫西林-克拉维酸与黄疸均无显著相关性。
由于年龄增长导致黄疸风险增加，在老年患者中应仔细考虑阿莫西林-克拉维酸的风险效益比。有必要进一步评估以明确黄疸与男性性别之间的关联。
