Bulpitt C J, Fletcher A E, Dössegger L, Neiss A, Nielsen T, Viergutz S
Epidemiology Research Unit, Hammersmith Hospital, Imperial College of Medicine, London, UK.
Heart. 1998 Jun;79(6):593-8. doi: 10.1136/hrt.79.6.593.
To measure quality of life (QOL) in patients with mild to moderate heart failure treated with angiotensin converting enzyme (ACE) inhibitors cilazapril or captopril.
Randomised, double blind, placebo controlled, parallel groups trial.
367 patients with New York Heart Association (NYHA) heart failure class II (62%), III (36%) or IV (1%).
Patients were randomised to receive cilazapril 1 mg daily (n = 191) or captopril 25 mg three times daily (n = 90) for 24 weeks, or placebo for 12 weeks followed by cilazapril 1 mg daily for a further 12 weeks (n = 86). If patients had not responded after four weeks cilazapril was increased to 2.5 mg daily and captopril to 50 mg three times daily. QOL was assessed at baseline, 12, and 24 weeks using the sickness impact profile (SIP), the profile of mood states (POMS), the Mahler index of dyspnoea-fatigue, and a health status index (HSI).
The physical dimension of the SIP averaged 7 units at baseline and improved after 12 weeks by 2.24 units in the cilazapril group, 2.38 units in the captopril group, and 1.51 units in the placebo group. The difference between drug and placebo was therefore 0.73 units (95% CI -0.86 to 2.32) for cilazapril, and 0.87 units (95% CI -0.96 to 2.70) for captopril, with small non-significant effect sizes (a statistical method for estimating the importance of a treatment related change) of 0.12 and 0.14. Similar results were observed for the total POMS and HSI scores. Although QOL improved more on the ACE inhibitors than on placebo, the effect sizes were not significant (< or = 0.26).
Improvements in QOL in mild to moderate heart failure were small when treated with cilazapril or captopril compared with placebo.
评估接受血管紧张素转换酶（ACE）抑制剂西拉普利或卡托普利治疗的轻至中度心力衰竭患者的生活质量（QOL）。
随机、双盲、安慰剂对照、平行组试验。
367例纽约心脏病协会（NYHA）心力衰竭Ⅱ级（62%）、Ⅲ级（36%）或Ⅳ级（1%）的患者。
患者被随机分为三组，分别接受每日1毫克西拉普利（n = 191）或每日三次每次25毫克卡托普利（n = 90）治疗24周，或先接受12周安慰剂治疗，随后再接受12周每日1毫克西拉普利治疗（n = 86）。如果患者在四周后无反应，西拉普利剂量增至每日2.5毫克，卡托普利剂量增至每日三次每次50毫克。在基线、12周和24周时，使用疾病影响量表（SIP）、情绪状态量表（POMS）、呼吸困难-疲劳马勒指数和健康状况指数（HSI）评估生活质量。
SIP的身体维度在基线时平均为7分，12周后，西拉普利组改善了2.24分，卡托普利组改善了2.38分，安慰剂组改善了1.51分。因此，西拉普利组药物与安慰剂之间的差异为0.73分（95%CI -0.86至2.32），卡托普利组为0.87分（95%CI -0.96至2.70），效应量较小且无统计学意义（一种估计治疗相关变化重要性的统计方法），分别为0.12和0.14。总POMS和HSI评分也观察到类似结果。虽然与安慰剂相比，ACE抑制剂使生活质量改善更多，但效应量不显著（≤0.26）。
与安慰剂相比，轻至中度心力衰竭患者使用西拉普利或卡托普利治疗时，生活质量的改善较小。
