Fernández González R, García Robles R, Rodríguez Pérez J C, Gómez Pajuelo C, Moreno Carretero E
Dpto. Médico. Laboratorios Knoll, S. A. Avda. de Burgos, 91 28050, Madrid.
Nefrologia. 2001 Sep-Oct;21(5):456-63.
The aim of this study was to analyse the effect of the ACE-1, Trandolapril, alone or with Verapamil on blood pressure, albuminuria and metabolic profile in type 2 diabetic patients with hypertension and albuminuria. It was an open multicenter, consecutive and prospective study conducted in 281 patients. There was a four-week wash-out period of antihypertensive drugs, after which we carried out a measurement over a 24-h period of the urinary excretion of albumina (UEA). Blood pressure was recorded after at least 5 minutes of rest in the sitting position at 1 to 3 minute intervals with a mercury sphygmomanometer in good condition. Average BP was obtained from three consecutive readings. Within treatment changes were analysed using descriptive statistics and t-tests on the change from baseline. Analysis of variance, chi-square and Mc Nemar tests were also used. If after 8 weeks of treatment with Trandolapril 2 mg o.q.d. the patients were non-responders (mean blood pressure reduction of 5 mmHg or less) or their blood pressure remained uncontrolled (blood pressure > or = 140/90 mmHg), Verapamil 180 mg o.q.d. was added. Two hundred and thirty patients completed the 12 weeks study. Population included 157 (55.9%) males with an average of 61.7 +/- 9.2 years. Baseline measurements were systolic 165.4 +/- 14.6 and diastolic 94.8 +/- 8.5 mmHg blood pressures, fasting glucose 162.7 +/- 43.9 mg/dL, glycosylated hemoglobin (HbAlc) 6.8 +/- 1.2%, and albuminuria 520.9 +/- 602 mg/day. UEA fell significantly (p < 0.001) after treatment to 177.9 +/- 24.3 mg/day (CI 95%, 129.9 to 225.8). The percent reduction reached 29.6%. Albuminuria was lower than 30 mg/day in 47 patients. Blood pressure was completely controlled in 125 (54%) patients. Glucemia fell significantly (p < 0.001) to 153.2 +/- 42.7 mg/dL, and the HbAlc to 6.5 +/- 1.3% (p = 0.012). In summary, in those diabetic type 2 patients with arterial hypertension and proteinuria, Trandolapril alone or associated with Verapamil significant lowered albuminuria and blood pressure facilitated the control or their metabolic profile.
本研究旨在分析血管紧张素转换酶-1(ACE-1)抑制剂群多普利单独使用或与维拉帕米联合使用对伴有高血压和蛋白尿的2型糖尿病患者的血压、蛋白尿及代谢指标的影响。这是一项开放性多中心、连续性前瞻性研究,共纳入281例患者。患者停用抗高血压药物4周,之后进行24小时尿白蛋白排泄量(UEA)测定。使用状况良好的汞柱式血压计,患者坐位休息至少5分钟后,每隔1至3分钟记录一次血压,连续记录3次,取平均值作为平均血压。采用描述性统计和基于基线变化的t检验分析治疗期间的变化情况,同时还使用了方差分析(ANOVA)、卡方检验和Mc Nemar检验。若患者接受2毫克群多普利每日一次治疗8周后无反应(平均血压降低5毫米汞柱或更低)或血压仍未得到控制(血压≥140/90毫米汞柱),则加用180毫克维拉帕米每日一次。230例患者完成了为期12周的研究。研究人群包括157例(55.9%)男性,平均年龄61.7±9.2岁。基线测量时,收缩压为165.4±14.6毫米汞柱,舒张压为94.8±8.5毫米汞柱,空腹血糖为162.7±43.9毫克/分升,糖化血红蛋白(HbAlc)为6.8±1.2%,蛋白尿为520.9±602毫克/天。治疗后UEA显著下降(p<0.001),降至177.9±24.3毫克/天(95%置信区间,129.9至225.8),降低百分比达29.6%。47例患者的蛋白尿低于30毫克/天。125例(54%)患者的血压得到完全控制。血糖显著下降(p<0.001)至153.2±42.7毫克/分升,HbAlc降至6.5±1.3%(p = 0.012)。总之,对于伴有动脉高血压和蛋白尿的2型糖尿病患者,单独使用群多普利或联合维拉帕米可显著降低蛋白尿和血压,有助于控制其代谢指标。