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阿替洛尔、依那普利和伊拉地平在老年高血压女性中的疗效与安全性。

Efficacy and safety of atenolol, enalapril, and isradipine in elderly hypertensive women.

作者信息

Perry H M, Hall W D, Benz J R, Bartels D W, Kostis J B, Townsend R R, Due D L, Peng A, Sirgo M

机构信息

Department of Medicine, Washington University School of Medicine, St. Louis, Missouri 63110.

出版信息

Am J Med. 1994 Jan;96(1):77-86. doi: 10.1016/0002-9343(94)90118-x.

Abstract

PURPOSE

This trial was designed to evaluate the efficacy and safety of three different classes of antihypertensive agents in elderly women.

PATIENTS AND METHODS

The trial had three phases: 4 to 8 weeks of placebo, 6 weeks of titration, and 16 weeks of maintenance. White women between 60 and 80 years old with sitting diastolic blood pressures (DBPs) from 95 through 114 mm Hg treated with placebo were evaluated by history, physical examination, laboratory studies, and quality-of-life interview. After double-blind randomization with low-dose atenolol, enalapril, or isradipine, the dose was increased stepwise and hydrochlorothiazide added as needed to achieve goal DBP (less than 90 mm Hg and greater than 10 mm Hg below baseline). During maintenance, patients not at goal were "stepped up," and patients with uncontrolled DBP at maximum dosage were removed from the study. The pretreatment (baseline) blood pressure of the 315 randomized participants averaged 161/100 mm Hg; 92% had been treated previously for hypertension, 15% had diabetes mellitus, 11% smoked, and 38% consumed alcohol.

RESULTS

For 245 patients completing the trial, the average decrease in blood pressure during treatment was 18.2/15.6 mm Hg. Antihypertensive efficacy was similar for the monotherapy drug regimens, with 84%, 71%, and 80% of patients receiving atenolol, enalapril, and isradipine, respectively, achieving DBP goal. Of the 70 patients who did not complete the trial, 42 left because of symptoms and 19 because of uncontrolled DBP. No important, unexpected drug-induced changes in symptoms or blood chemistries were noted. Symptom frequency differed little among the three dosage levels, becoming maximal by the second visit at the same dosage level.

CONCLUSION

All three drugs lowered DBP comparably, and none produced alarming effects. Thirteen percent of patients left the study because of symptoms.

摘要

目的

本试验旨在评估三类不同的抗高血压药物对老年女性的疗效和安全性。

患者与方法

试验分为三个阶段:4至8周的安慰剂治疗期、6周的滴定期和16周的维持期。对年龄在60至80岁、坐位舒张压(DBP)为95至114毫米汞柱且接受安慰剂治疗的白人女性进行病史、体格检查、实验室检查及生活质量访谈评估。在双盲随机分组后给予低剂量阿替洛尔、依那普利或伊拉地平,然后逐步增加剂量,并根据需要添加氢氯噻嗪以达到目标DBP(低于90毫米汞柱且比基线低10毫米汞柱以上)。在维持期,未达目标的患者“逐步升级”治疗,而在最大剂量时DBP仍未得到控制的患者退出研究。315名随机分组参与者的治疗前(基线)血压平均为161/100毫米汞柱;92%的患者既往接受过高血压治疗,15%患有糖尿病,11%吸烟,38%饮酒。

结果

对于245名完成试验的患者,治疗期间血压平均下降18.2/15.6毫米汞柱。单一疗法药物方案的降压疗效相似,接受阿替洛尔、依那普利和伊拉地平治疗的患者分别有84%、71%和80%达到DBP目标。在70名未完成试验的患者中,42名因症状退出,19名因DBP未得到控制退出。未观察到重要的、意外的药物引起的症状或血液化学变化。三种剂量水平之间症状频率差异不大,在相同剂量水平的第二次就诊时达到最高。

结论

三种药物降低DBP的效果相当,且均未产生令人担忧的影响。13%的患者因症状退出研究。

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