Chalmers D, Dombey S L, Lawson D H
Medical & Scientific Affairs, E.R. Squibb & Sons Ltd., Hounslow, Middlesex.
Br J Clin Pharmacol. 1987 Sep;24(3):343-9. doi: 10.1111/j.1365-2125.1987.tb03179.x.
1 The methodology and interim results of a post marketing surveillance of captopril, the first orally active angiotensin converting enzyme inhibitor are presented. 2 Utilising viewdata technology, details of hypertensive patients were entered directly into a mainframe computer. This allowed day to day monitoring of events; a facility not available with paper-based methods. 3 The design of the study allowed analysis of results including some details of efficacy, concomitant therapy, any disease symptoms and reasons for withdrawal. These factors could be categorised according to sex and age. 4 This preliminary report is based on the first 13,295 patients entered from July 1983 with follow-up until January 1985. The results of the study confirm the safety of captopril in the patients studied.
1 本文介绍了首个口服活性血管紧张素转换酶抑制剂卡托普利上市后监测的方法和中期结果。2 利用可视数据技术,高血压患者的详细信息直接输入大型计算机。这使得能够对事件进行日常监测,这是基于纸质方法所没有的便利。3 该研究的设计允许对结果进行分析,包括疗效的一些细节、联合治疗、任何疾病症状以及停药原因。这些因素可按性别和年龄进行分类。4 这份初步报告基于1983年7月至1985年1月录入的首批13295例患者,研究结果证实了卡托普利在所研究患者中的安全性。