Spengler R F, Arrowsmith J B, Kilarski D J, Buchanan C, Von Behren L, Graham D R
Epidemiology Program Office, Centers for Disease Control, Atlanta.
Arch Intern Med. 1988 Jun;148(6):1329-33.
From April 8, 1982, through June 1984, 11 patients in a single hospital experienced 17 episodes of limb edema and discoloration after the intravenous (IV) administration of phenytoin sodium (Dilantin). One patient required a below-the-elbow amputation; all other patients recovered. No single drug lot was implicated. A case-control study was performed using three controls for each case; controls received IV infusions of phenytoin and were hospitalized close in time to the case patients. Compared with controls, patients with reactions were more often female and elderly and had underlying cardiovascular disease. Affected patients also received phenytoin through an IV catheter smaller than 20 gauge (50% vs 6%), at a rate greater than 25 mg/min (63% vs 19%), and in two or more IV infusions of phenytoin given "IV push" at the same site (81% vs 24%). High-risk patients require careful monitoring and stricter guidelines for the IV administration of phenytoin.
从1982年4月8日至1984年6月，一家医院的11名患者在静脉注射苯妥英钠（地伦丁）后出现了17次肢体水肿和变色情况。1例患者需要进行肘部以下截肢；其他所有患者均康复。未发现与单一药品批次有关。进行了一项病例对照研究，每个病例设置3名对照；对照者接受苯妥英钠静脉输注，并在时间上与病例患者相近时住院。与对照者相比，发生反应的患者女性和老年人更多，且患有潜在心血管疾病。受影响患者还通过小于20号（50%对6%）的静脉导管接受苯妥英钠治疗，给药速度大于25 mg/min（63%对19%），并且在同一部位通过两次或更多次“静脉推注”进行苯妥英钠静脉输注（81%对24%）。高危患者在苯妥英钠静脉给药时需要仔细监测并遵循更严格的指导原则。
