Ernawati Desak Ketut, Stafford Leanne, Hughes Jeffery David
Laboratorium of Pharmacy, School of Medicine, Udayana University, Jl PB Sudirman Denpasar, Bali, Indonesia.
Br J Clin Pharmacol. 2008 Jul;66(1):82-7. doi: 10.1111/j.1365-2125.2008.03177.x. Epub 2008 May 6.
A number of factors have been hypothesized to increase the risk of amiodarone-induced pulmonary toxicity (AIPT). This study aimed to confirm these risk factors and determine whether a cohort of tertiary hospital patients diagnosed with AIPT demonstrated comparable characteristics.
Phase I of this study involved compilation of a database of adverse reactions to amiodarone reported to the Australian and US drug agencies, and identification of risk factors for AIPT using logistic regression analysis. In Phase II, AIPT cases were identified via a retrospective review of medical records of patients discharged from Fremantle Hospital and Health Service, Western Australia (FHHS) between 2000 and 2005 with diagnosed interstitial lung disease. Data were collected regarding these patients' risk factors for AIPT and compared with those previously identified in Phase I.
A total of 237 cases of AIPT were identified from agency data. Patients aged > 60 years and those on amiodarone for 6-12 months (odds ratio 18.28, 95% confidence interval 6.42, 52.04) were determined to be at the highest risk of AIPT. Australian data also suggested increased risk in patients who had received cumulative doses of 101-150 g. The seven AIPT cases identified among the FHHS patients were all at high risk of AIPT based on their age and duration of amiodarone therapy.
Contrary to previous findings, only patient age and the duration of amiodarone therapy were confirmed as significant risk factors for AIPT. Targeted monitoring of these patients may facilitate early identification and management of AIPT.
已有多种因素被假定会增加胺碘酮所致肺毒性(AIPT)的风险。本研究旨在证实这些风险因素,并确定一组被诊断为AIPT的三级医院患者是否具有可比的特征。
本研究的第一阶段涉及汇编向澳大利亚和美国药品机构报告的胺碘酮不良反应数据库,并使用逻辑回归分析确定AIPT的风险因素。在第二阶段,通过回顾性审查2000年至2005年期间从西澳大利亚弗里曼特尔医院及卫生服务机构(FHHS)出院且被诊断为间质性肺病的患者的病历,来识别AIPT病例。收集这些患者的AIPT风险因素数据,并与第一阶段先前确定的因素进行比较。
从机构数据中总共识别出237例AIPT病例。年龄大于60岁且服用胺碘酮6 - 12个月的患者(优势比18.28,95%置信区间6.42,52.04)被确定为发生AIPT的风险最高。澳大利亚的数据还表明,累积剂量为101 - 150 g的患者风险增加。在FHHS患者中识别出的7例AIPT病例,根据其年龄和胺碘酮治疗时长,均处于发生AIPT的高风险。
与先前的研究结果相反,只有患者年龄和胺碘酮治疗时长被确认为AIPT的重要风险因素。对这些患者进行针对性监测可能有助于早期识别和管理AIPT。