Department of Anesthesiology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA 19107, USA.
J Clin Anesth. 2010 Sep;22(6):477-83. doi: 10.1016/j.jclinane.2009.12.006.
The prevalence of latex allergy is increasing in surgical patient populations. Avoidance of exposure to the allergen is essential to minimizing perioperative complications in patients suspected to be at risk. Natural rubber latex has historically been ubiquitous in medical devices containing rubber. In 1998, the Food and Drug Administration (FDA) began to require the labeling of medical devices made from natural rubber latex; since that time substantial progress has been made in identifying latex-free alternatives. However, the rubber stoppers commonly found in pharmaceutical vial closures are exempt from FDA labeling requirements. Examination of the clinical and basic science literature regarding pharmaceutical vial closures supports limiting the rubber stopper to a single needle puncture as a safer practice, with the caveat that no strategy exists for the complete elimination of risk as long as stoppers made from natural rubber latex are used in pharmaceutical vials intended for human use.
乳胶过敏的患病率在手术患者人群中不断增加。避免接触过敏原对于减少疑似有风险的患者围手术期并发症至关重要。天然橡胶乳胶在含有橡胶的医疗器械中历来无处不在。1998 年,美国食品和药物管理局(FDA)开始要求对天然橡胶乳胶制成的医疗器械进行标签标注;自那时以来,在确定无乳胶替代品方面取得了重大进展。然而,制药小瓶密封用的橡胶瓶塞不受 FDA 标签要求的约束。对关于制药小瓶密封的临床和基础科学文献的研究表明,限制橡胶瓶塞只被单一的针穿刺是一种更安全的做法,但前提是只要在用于人类的制药小瓶中使用天然橡胶乳胶制成的瓶塞,就不存在完全消除风险的策略。