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维拉帕米缓释片/群多普利联合治疗老年高血压患者。德国维拉群多高血压研究组。

Verapamil SR/trandolapril combination therapy for the elderly hypertensive patient. German VeraTran Hypertension Study Group.

作者信息

Holzgreve H, Compagnone D, Zilles P

机构信息

Medizinische Polikinik, Universität München, Germany.

出版信息

J Hum Hypertens. 1999 Jan;13(1):61-7. doi: 10.1038/sj.jhh.1000728.

Abstract

A total of 254 elderly hypertensive patients (71 men and 183 women aged between 63 and 92 years, diastolic blood pressure (DBP) 95-115 mm Hg inclusive) were treated with the fixed combination of verapamil SR/trandolapril following a 4-week single-blind placebo run-in period. Treatment was started with a response dependent 3-step dose titration period. All patients were initiated at dose step 1 (verapamil SR/trandolapril 120/0.5 mg o.d.) and if not normalised (DBP <90 mm Hg) titrated at 4-weekly intervals over dose step 2 (verapamil SR/trandolapril 180/1 mg o.d.) to dose step 3 (verapamil SR/trandolapril 180/2 mg o.d.) during the first 12 weeks. After 3 months of treatment all patients not normalised were excluded from further participation in the study. The total duration of the treatment period was 6 months. Routine safety investigations were performed prior, during and on completion of the treatment period. Verapamil SR/trandolapril was highly effective in reducing blood pressure. At individual last visit during active treatment (also taking the non-responders into account), the mean reduction in SBP/DBP was 21.9/17.1 mm Hg (95% CI 19.8-24.1/16.1-18.1 mm Hg), with most of this reduction occurring during the first 3 months of treatment. After 6 months, 81.9% of the patients enrolled showed normalisation of DBP (<90 mm Hg) and 85% were responders (normalisation and/or reduction in DBP by at least 10 mm Hg). Normalisation and responder rates appeared to be comparable when stratified by age subgroups (63-69, 70-79 and > or =80 years) and were all greater than 80%. Verapamil SR/trandolapril was very well tolerated and there was no evidence of any clinically relevant changes in routine laboratory safety variables or resting ECG. In conclusion, the fixed dose combination of verapamil SR/trandolapril is an effective and safe alternative treatment for the elderly hypertensive patient.

摘要

在为期4周的单盲安慰剂导入期后,共254例老年高血压患者(71例男性,183例女性,年龄在63至92岁之间,舒张压(DBP)95 - 115 mmHg(含))接受了维拉帕米缓释片/群多普利的固定复方制剂治疗。治疗始于一个依反应而定的3步剂量滴定期。所有患者均从剂量步骤1(维拉帕米缓释片/群多普利120/0.5 mg每日一次)开始治疗,若血压未恢复正常(DBP <90 mmHg),则在最初12周内每隔4周依次滴定至剂量步骤2(维拉帕米缓释片/群多普利180/1 mg每日一次)和剂量步骤3(维拉帕米缓释片/群多普利180/2 mg每日一次)。治疗3个月后,所有血压未恢复正常的患者被排除在进一步研究之外。治疗期总时长为6个月。在治疗期之前、期间及结束时均进行了常规安全性调查。维拉帕米缓释片/群多普利在降低血压方面非常有效。在积极治疗期间的最后一次个体访视时(也将无反应者考虑在内),收缩压/舒张压的平均降幅为21.9/17.1 mmHg(95%可信区间19.8 - 24.1/16.1 - 18.1 mmHg),其中大部分降幅发生在治疗的前3个月。6个月后,纳入研究的患者中81.9%的患者舒张压恢复正常(<90 mmHg),85%的患者有反应(舒张压恢复正常和/或降低至少10 mmHg)。按年龄亚组(63 - 69岁、70 - 79岁和≥8岁)分层时,恢复正常率和有反应率似乎相当,且均大于80%。维拉帕米缓释片/群多普利耐受性良好,没有证据表明常规实验室安全性变量或静息心电图有任何临床相关变化。总之,维拉帕米缓释片/群多普利的固定剂量复方制剂是老年高血压患者一种有效且安全的替代治疗方法。

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