Kostis John B, Kim Harold J, Rusnak James, Casale Thomas, Kaplan Allen, Corren Jonathan, Levy Elliott
Department of Medicine, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick 08903-0019, USA.
Arch Intern Med. 2005 Jul 25;165(14):1637-42. doi: 10.1001/archinte.165.14.1637.
Angioedema is a rare but potentially serious adverse event of angiotensin-converting enzyme inhibitor therapy. However, no prospective, controlled studies have reported on its incidence and clinical characteristics.
We studied the occurrence of angioedema in a randomized, double-blind, controlled trial of 12 557 persons with hypertension treated with enalapril maleate, 5 to 40 mg/d, using a prospective ascertainment and adjudication of angioedema by an expert committee.
Angioedema occurred in 86 (0.68%) of the subjects. Stepwise logistic regression identified black race (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.72-4.82), history of drug rash (OR, 3.78; 95% CI, 1.80-7.92), age greater than 65 years (OR, 1.60; 95% CI, 1.02-2.53), and seasonal allergies (OR, 1.79; 95% CI, 1.06-3.00) as independent risk factors for angioedema. The incidence of angioedema was higher after initiation of therapy (3.6/1000 patients per month) and declined to 0.4/1000 patients per month. Treatment was not given in 44 (51%) of the cases; antihistamines were administered in 35 (41%); corticosteroids, in 20 (23%); and epinephrine, in 1 (1%). Two patients were hospitalized but none had airway compromise.
Enalapril-related angioedema is uncommon. Although it is most likely to occur early after initiation of therapy, it may occur at any time. It is more likely to occur in black patients, those older than 65 years, and those with a history of drug rash or seasonal allergies. Fatal angioedema or angioedema requiring airway protection did not occur in this study.
血管性水肿是血管紧张素转换酶抑制剂治疗中一种罕见但可能严重的不良事件。然而，尚无前瞻性对照研究报道其发病率及临床特征。
我们在一项针对12557例高血压患者的随机、双盲、对照试验中研究血管性水肿的发生情况，这些患者接受每日5至40毫克马来酸依那普利治疗，血管性水肿由专家委员会进行前瞻性确定和判定。
86例（0.68%）受试者发生血管性水肿。逐步逻辑回归分析确定黑人种族（比值比[OR]，2.88；95%置信区间[CI]，1.72 - 4.82）、药疹病史（OR，3.78；95%CI，1.80 - 7.92）、年龄大于65岁（OR，1.60；95%CI，1.02 - 2.53）以及季节性过敏（OR，1.79；95%CI，1.06 - 3.00）为血管性水肿的独立危险因素。治疗开始后血管性水肿的发病率较高（每月3.6/1000例患者），随后降至每月0.4/1000例患者。44例（51%）病例未进行治疗；35例（41%）给予抗组胺药；20例（23%）给予皮质类固醇；1例（1%）给予肾上腺素。2例患者住院，但均无气道梗阻。
依那普利相关的血管性水肿并不常见。虽然最有可能在治疗开始后早期发生，但也可能在任何时间出现。在黑人患者、年龄大于65岁的患者以及有药疹或季节性过敏史的患者中更易发生。本研究中未发生致命性血管性水肿或需要气道保护的血管性水肿。
