Pizarro M, Lima M J, Domingues J, Gouveia A C, Monteiro A, Carrageta M, de Freitas A F
Serviço de Medicina 2, Hospital de S. Joäo, Porto.
Rev Port Cardiol. 1996 Jun;15(6):495-7, 460.
The aim of this double-blind randomized placebo-controlled study was to evaluate the antihypertensive and safety of fosinopril in mild essential hypertension. After a 2-week placebo period, patients received either placebo or fosinopril 20 mg, once daily. Thirty-four patients finished the study (18 patients in the placebo group and 16 patients in the fosinopril group). Systolic blood pressure decreased from 160.1 +/- 22.1 mmHg to 156.0 +/- 24.2 in the placebo group (NS) and from 151.8 +/- 14.0 mmHg to 141.5 +/- 14.5 in the fosinopril group (p < 0.005); diastolic blood pressure decreased from 100.1 +/- 2.4 mmHg to 94.3 +/- 7.4 mmHg in the placebo group (p < 0.005) and from 100.8 +/- 4.8 mmHg to 88.1 +/- 9.0 mmHg in the fosinopril group (p < 0.001). Mean decrease in diastolic blood pressure was 5.7 mmHg in the placebo group and 12.6 mmHg in the fosinopril group (p < 0.05). A statistically significant difference was seen between the percentage of controlled patients in the two groups: 16.6% in the placebo group vs 56.2% in the fosinopril group (p < 0.05). No statistically significant difference in biochemical parameters was seen between the two groups. Tolerance was good and no patients were withdrawn from the study for adverse events.
这项双盲随机安慰剂对照研究的目的是评估福辛普利对轻度原发性高血压的降压效果及安全性。经过2周的安慰剂期后，患者每日一次接受安慰剂或20毫克福辛普利治疗。34名患者完成了研究（安慰剂组18例，福辛普利组16例）。安慰剂组收缩压从160.1±22.1毫米汞柱降至156.0±24.2毫米汞柱（无统计学意义），福辛普利组从151.8±14.0毫米汞柱降至141.5±14.5毫米汞柱（p<0.005）；安慰剂组舒张压从100.1±2.4毫米汞柱降至94.3±7.4毫米汞柱（p<0.005），福辛普利组从100.8±4.8毫米汞柱降至88.1±9.0毫米汞柱（p<0.001）。安慰剂组舒张压平均下降5.7毫米汞柱，福辛普利组为12.6毫米汞柱（p<0.05）。两组患者血压得到控制的百分比存在统计学显著差异：安慰剂组为16.6%，福辛普利组为56.2%（p<0.05）。两组生化指标无统计学显著差异。耐受性良好，无患者因不良事件退出研究。
