依那普利的上市后监测。I：处方事件监测结果。
Postmarketing surveillance of enalapril. I: Results of prescription-event monitoring.
作者信息
Inman W H, Rawson N S, Wilton L V, Pearce G L, Speirs C J
机构信息
Drug Safety Research Unit, Botley, Southampton.
出版信息
BMJ. 1988 Oct 1;297(6652):826-9. doi: 10.1136/bmj.297.6652.826.
To identify and measure the incidence of adverse effects of the angiotensin converting enzyme inhibitor enalapril 13,713 patients were studied for one year by prescription-event monitoring. Precise information about the duration of treatment was available for 12,543 patients. The frequency of many events was calculated, including dizziness (483 patients; 3.9%), persistent dry cough (360; 2.9%), headache (310; 2.5%) hypotension (218; 1.7%), and syncope (155; 1.2%). Less common reactions included angioedema, urticaria, and muscle cramps. Altogether 1098 (8%) patients died and the notes of 913 of them (83%) were obtained for detailed scrutiny. With the exception of a few patients with renal failure who deteriorated during treatment (reported on separately), no death was attributed to enalapril. Enalapril was considered to be effective, even in patients with advanced cardiac failure. These results for enalapril are reassuring and provide further evidence of the value of prescription-event monitoring.
为了识别和测量血管紧张素转换酶抑制剂依那普利的不良反应发生率，通过处方事件监测对13713名患者进行了为期一年的研究。12543名患者有关于治疗持续时间的精确信息。计算了许多事件的发生率，包括头晕（483例患者；3.9%）、持续性干咳（360例；2.9%）、头痛（310例；2.5%）、低血压（218例；1.7%）和晕厥（155例；1.2%）。较不常见的反应包括血管性水肿、荨麻疹和肌肉痉挛。共有1098名（8%）患者死亡，其中913名（83%）患者的病历被获取以进行详细审查。除了少数在治疗期间病情恶化的肾衰竭患者（另行报告）外，没有死亡归因于依那普利。依那普利被认为是有效的，即使在晚期心力衰竭患者中也是如此。依那普利的这些结果令人放心，并为处方事件监测的价值提供了进一步的证据。
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