Hart W, Clarke R J
Reinier de Graaf Gasthuis, Delft, The Netherlands.
Postgrad Med J. 1993 Jun;69(812):450-5. doi: 10.1136/pgmj.69.812.450.
The efficacy of lisinopril 10-40 mg once daily was compared with that of nifedipine tablets 20-40 mg twice daily in a multicentre double-blind randomized parallel group study of 16 weeks duration involving 127 patients with mild to moderate hypertension. The groups randomized to lisinopril or to nifedipine were not significantly different with respect to any demographic variable. An analysis of the pooled data from all centres demonstrated a significantly greater fall in both lying and standing systolic blood pressure (SBP) on lisinopril than on nifedipine treatment (difference between treatments 7.70 +/- 3.34 mmHg; P = 0.02 and 10.2 +/- 3.30 mmHg; P = 0.003 for lying and standing SBP, respectively). However, this difference may be accounted for by the slightly higher mean SBP in the lisinopril treatment groups compared with the nifedipine group at the end of the placebo run-in period. Both treatments lowered lying and standing diastolic blood pressures (DBP) to the same extent and the response rates to the two treatments were the same. The effects of the two drugs on heart rate were indistinguishable from each other. There were six lisinopril and 12 nifedipine-treated patients withdrawn during randomized treatment (P = 0.22). Nineteen per cent of lisinopril patients reported an adverse event compared with 36% of nifedipine patients. The relative risk of an adverse event on lisinopril compared with nifedipine was 0.42 (confidence limits 1.027-0.172) a difference which approached statistical significance (P = 0.0573). Lisinopril produced a greater reduction in both lying and standing SBP than nifedipine and both were associated with equivalent reductions in DBP. Lisinopril may be better tolerate than nifedipine.
在一项为期16周的多中心双盲随机平行组研究中,将每日一次服用10 - 40毫克赖诺普利的疗效与每日两次服用20 - 40毫克硝苯地平片的疗效进行了比较,该研究涉及127例轻至中度高血压患者。随机分为赖诺普利组或硝苯地平组的患者在任何人口统计学变量方面均无显著差异。对所有中心的汇总数据进行分析表明,与硝苯地平治疗相比,赖诺普利治疗使卧位和立位收缩压(SBP)的下降幅度显著更大(治疗差异为7.70±3.34 mmHg;P = 0.02;卧位和立位SBP分别为10.2±3.30 mmHg;P = 0.003)。然而,这种差异可能是由于在安慰剂导入期结束时,赖诺普利治疗组的平均SBP略高于硝苯地平组。两种治疗均使卧位和立位舒张压(DBP)降低到相同程度,且对两种治疗的反应率相同。两种药物对心率的影响彼此无差异。在随机治疗期间,有6例接受赖诺普利治疗的患者和12例接受硝苯地平治疗的患者退出研究(P = 0.22)。19%的赖诺普利患者报告了不良事件,而硝苯地平患者为36%。与硝苯地平相比,赖诺普利发生不良事件的相对风险为0.42(置信区间1.027 - 0.172),这一差异接近统计学显著性(P = 0.0573)。赖诺普利比硝苯地平能使卧位和立位SBP有更大程度的降低,且两者对DBP的降低程度相当。赖诺普利的耐受性可能优于硝苯地平。