McAnulty Jeremy M, Jauncey Marianne E, Monger Claire K, Hailstone Susan T, Alam Noore K M, Mannes Trish F, Capon Adam G, Irvine Katie, Armstrong Paul K, Kaldor John M
NSW Health Department, Communicable Diseases Branch, North Sydney, Australia.
Drug Alcohol Rev. 2007 May;26(3):321-31. doi: 10.1080/09595230701247798.
In late 2004, NSW Health received several reports of a serious desquamating rash among clients of the methadone program. We sought to identify the extent and likely cause of this outbreak. We initiated active surveillance for cases throughout Australia, a survey of dosing points in NSW, and a case control study of clients receiving methadone syrup (MS) at two clinics. Between October 2004 and March 2005, 388 cases were identified, largely in NSW. The dosing point survey found almost all cases were clients prescribed MS (attack rate 4.5%). In multivariate analysis of data from dosing points that dispensed MS, use of take away doses or location of the dosing point in greater western Sydney were associated with illness. In the case control study, MS injection, use of street MS, high doses of MS, frequent takeaway doses, or use of benzodiazepines were associated with illness. Testing found no abnormality in associated batches of MS. Batches of MS temporally associated with the outbreak were quarantined from use and the outbreak subsided. While a direct causal link could not be established, available evidence suggests that a contaminant may have caused the outbreak. Epidemiological analyses are important for assessing concerns about product safety following marketing approval.
2004年末，新南威尔士州卫生部收到多起关于美沙酮项目患者中出现严重脱屑性皮疹的报告。我们试图确定此次疫情的范围及可能病因。我们在全澳大利亚启动了病例主动监测，对新南威尔士州的配药点进行了调查，并在两家诊所对接受美沙酮糖浆（MS）治疗的患者开展了病例对照研究。2004年10月至2005年3月期间，共确认了388例病例，主要集中在新南威尔士州。配药点调查发现，几乎所有病例都是开具了美沙酮糖浆的患者（发病率为4.5%）。在对配发美沙酮糖浆的配药点数据进行多变量分析时，发现外带剂量的使用或大悉尼西部地区配药点的位置与发病有关。在病例对照研究中，美沙酮糖浆注射、使用街头美沙酮、高剂量美沙酮、频繁外带剂量或使用苯二氮䓬类药物与发病有关。检测发现相关批次的美沙酮糖浆没有异常。与此次疫情在时间上相关的美沙酮糖浆批次被停用，疫情得到缓解。虽然无法建立直接的因果联系，但现有证据表明可能是一种污染物导致了此次疫情。流行病学分析对于评估上市批准后对产品安全性的担忧非常重要。
