Chien Kuo-Liong, Huang Por-Jau, Chen Ming-Fong, Chiang Fu-Tien, Lai Ling-Ping, Lee Yuan-Teh
Department of Internal Medicine (Cardiology), University Hospital, National Taiwan University College of Medicine, No. 7 Chuang-San South Road, Taipei 100, Taiwan.
Cardiovasc Drugs Ther. 2002 May;16(3):221-6. doi: 10.1023/a:1020648405680.
Although the role of angiotensin-converting enzyme (ACE) inhibitors for the treatment of hypertension has been well established, no data has been generated regarding the influence of ACE inhibitors for health-related quality-of-life (QOL) dimensions for Chinese patients.
A double-blind, active-control, randomized clinical trial was used to compare the effects of two ACE inhibitors, imidapril and captopril, on quality-of-life dimensions in one outpatient clinic in one tertiary clinical-care facility. After a 2-3 week washout period with placebo, 59 patients with mild-to-moderate hypertension were randomly assigned to receive imidapril (5 to 10 mg per day) or captopril (25 to 50 mg twice per day) for 12 weeks. Patients completed the Short-form 36 (SF 36) health survey questionnaire, which evaluates 8 QOL dimensions, just before treatment, during the 8th week, and at the end of treatment (12th week). ANOVA for repeated measures was used to analyze the QOL-score changes over time and compare treatments, and to assess the interaction of treatment duration and group on these scores.
No significant differences were demonstrated for changes in blood-pressure, frequency of adverse effects and withdrawal of patients from the study comparing the two drugs. Significant improvement, however, was demonstrated for mental-component summary scores after 12 weeks of treatment for both drugs (P = 0.029). No significant differences were established for individual QOL dimensions comparing the two drugs. A significantly higher baseline systolic blood pressure was found in the participants who did not complete the questionnaire than in those who did.
Similar and significant improvements were determined for the mental-component QOL summary scores for the two ACE inhibitors, imidapril and captopril, and no significant differences were demonstrated comparing treatments.
尽管血管紧张素转换酶（ACE）抑制剂治疗高血压的作用已得到充分证实，但尚未有关于ACE抑制剂对中国患者健康相关生活质量（QOL）维度影响的数据。
采用双盲、活性对照、随机临床试验，在一家三级临床护理机构的一个门诊诊所比较两种ACE抑制剂咪达普利和卡托普利对生活质量维度的影响。在使用安慰剂进行2-3周的洗脱期后，59例轻度至中度高血压患者被随机分配接受咪达普利（每日5至10毫克）或卡托普利（每日25至50毫克，分两次服用），为期12周。患者在治疗前、第8周和治疗结束时（第12周）完成简短健康调查问卷（SF-36），该问卷评估8个生活质量维度。采用重复测量方差分析来分析生活质量评分随时间的变化并比较治疗效果，以及评估治疗持续时间和组间对这些评分的交互作用。
比较两种药物时未发现血压变化、不良反应发生率和患者退出研究方面的显著差异。然而，两种药物治疗12周后，精神健康综合评分均有显著改善（P = 0.029）。比较两种药物时，各生活质量维度未发现显著差异。未完成问卷的参与者的基线收缩压显著高于完成问卷的参与者。
两种ACE抑制剂咪达普利和卡托普利的精神健康生活质量综合评分有相似且显著的改善，比较治疗效果未发现显著差异。
