Dahlöf C, Dimenäs E
Gothenburg Medical Research Centre AB, Gothenburg, Sweden.
Eur J Clin Pharmacol. 1992;43(4):375-9. doi: 10.1007/BF02220612.
Two randomised, double-blind, cross-over studies in healthy volunteers given captopril 50 mg b.d. (n = 37; Study I) or enalapril 20 mg o.d. (n = 40; Study 2) and placebo for 2 weeks have been done to examine general well-being. Subjective experiences were evaluated using the standardised, Minor Symptoms Evaluation-profile (MSEP), which was completed during Run-in and on Days 1, 4, 7 and 14 in the morning. In comparison to placebo and the Run-in period, neither captopril nor enalapril affected the MSEP dimensions of Vitality, Contentment and Sleep. Captopril treatment was also assessed by applying the Quality of Life Clinical Questionnaire during Run-in and on Days 7 and 14. No improvement in the quality of life was demonstrated during treatment in comparison with the placebo or the Run-in period. Thus, no mood elevating effect of the ACE-inhibitors captopril and enalapril was demonstrated in healthy volunteers. Cough, which is believed to be a common adverse effect of ACE-inhibitors, was no more frequent during the treatment with captopril or enalapril than with placebo. It is concluded, that short-term treatment with captopril or enalapril is not perceived differently by healthy volunteers than placebo or no treatment at all. Furthermore, the cough associated with ACE-inhibition may be dependent on the duration of treatment, and two weeks was apparently too short for it to emerge.
已开展两项随机、双盲、交叉研究,对健康志愿者进行为期2周的治疗,其中一项研究(研究I)给予卡托普利50毫克,每日两次(n = 37),另一项研究(研究2)给予依那普利20毫克,每日一次(n = 40),并设置安慰剂对照,以检验总体健康状况。使用标准化的轻微症状评估量表(MSEP)评估主观体验,该量表在导入期以及第1、4、7和14天上午完成。与安慰剂和导入期相比,卡托普利和依那普利均未影响活力、满足感和睡眠等MSEP维度。还通过在导入期以及第7和14天应用生活质量临床问卷对卡托普利治疗进行了评估。与安慰剂或导入期相比,治疗期间生活质量未显示出改善。因此,在健康志愿者中未证实血管紧张素转换酶抑制剂卡托普利和依那普利具有情绪提升作用。咳嗽被认为是血管紧张素转换酶抑制剂的常见不良反应,在卡托普利或依那普利治疗期间,咳嗽的发生率并不高于安慰剂。得出的结论是,健康志愿者对卡托普利或依那普利的短期治疗与安慰剂或不治疗并无不同的感受。此外,与血管紧张素转换酶抑制相关的咳嗽可能取决于治疗持续时间,两周的时间显然太短,不足以引发咳嗽。