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血管紧张素转换酶抑制剂所致咳嗽的再现性:一项双盲随机研究。

Reproducibility of angiotensin converting enzyme inhibitor induced cough: a double-blind randomised study.

作者信息

Charlon V, Dollow S, Fidel J, Hoglund C, Honkanen T, Kobrin I, McEwan J, McInnes G, Viskoper J R, Woo K S

机构信息

Roche Products Limited, Maidenhead, Berks.

出版信息

Br J Clin Pharmacol. 1995 Feb;39(2):125-9. doi: 10.1111/j.1365-2125.1995.tb04418.x.

Abstract
  1. The reproducibility of angiotensin converting enzyme inhibitor induced cough was examined in a double-blind cross over study in patients previously shown to have exhibited this side effect. 2. Ninety-seven patients who had experienced angiotensin converting enzyme inhibitor cough within the last 2 years were challenged with enalapril 20 mg daily for 4 weeks to establish eligibility. Eighty-eight of 97 (91%) patients experienced a repeat of their cough symptoms. Sixty-four patients entered the double-blind part of the study where they were treated with enalapril 20 mg and a renin inhibitor for up to 4 weeks in random order. These periods were separated by a minimum 4 week placebo wash out. 3. Of 59 evaluable patients who received enalapril a second time, 37 (62.7%) experienced cough again. Of 62 patients on the renin inhibitor 16 (25.8%) experienced cough, however as it was not equi-efficacious to enalapril no valid comparison could be made. 4. Angiotensin converting enzyme inhibitor cough is not reproducible within patients, as other factors are involved in the aetiology. Objective testing with blinded assessment together with symptom reporting, would give a more accurate measure of the incidence, and mechanism of this side effect.
摘要
  1. 在一项双盲交叉研究中,对先前已出现这种副作用的患者进行了血管紧张素转换酶抑制剂诱发咳嗽的再现性研究。2. 对过去2年内曾经历过血管紧张素转换酶抑制剂引起咳嗽的97例患者,每日给予依那普利20 mg,持续4周,以确定其是否符合条件。97例患者中有88例(91%)再次出现咳嗽症状。64例患者进入研究的双盲部分,他们被随机给予依那普利20 mg和一种肾素抑制剂,治疗长达4周。这些治疗期之间至少有4周的安慰剂洗脱期。3. 在59例再次接受依那普利治疗的可评估患者中,37例(62.7%)再次出现咳嗽。在62例使用肾素抑制剂的患者中,16例(25.8%)出现咳嗽,但由于其疗效与依那普利不相等,无法进行有效比较。4. 血管紧张素转换酶抑制剂引起的咳嗽在患者个体内不可再现,因为病因涉及其他因素。采用盲法评估的客观检测方法结合症状报告,将能更准确地衡量这种副作用的发生率和机制。

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