Sridhara B S, Thomas P, Lahiri A, Raftery E B
Department of Cardiology, Northwick Park Hospital, Harrow, Middlesex, UK.
Eur J Clin Pharmacol. 1994;46(5):427-30. doi: 10.1007/BF00191905.
The aim of the study was to examine the efficacy of a new controlled release formulation of diltiazem administered in a twice-daily dose in patients with essential hypertension using 24 hour intra-arterial ambulatory blood pressure monitoring. Sixteen patients (2 female) of mean age 53 years with mild to moderate essential hypertension, defined as a supine resting diastolic cuff blood pressure > or = 95 mm Hg, were recruited to a sequential dose ranging study of controlled release (CR) diltiazem. After a six week run-in period without any anti-hypertensive medication, intraarterial blood pressure monitoring with 60 degrees tilt, isometric handgrip and bicycle exercise testing were performed. Patients were then treated for one week with CR diltiazem 120 mg b.i.d. If supine resting diastolic cuff blood pressure fell by < 10 mm Hg compared to the last run-in value and remained > 90 mm Hg, the dose was increased to 240 mg b.i.d. for a week, and if necessary to 360 mg b.i.d. for a week. Patients continued for further one month on the dose of CR diltiazem at which they achieved target blood pressure reduction. At the end of this maintenance treatment, 24 hour intra-arterial blood pressure monitoring was repeated. Twelve patients were satisfactorily controlled on 120 mg b.i.d. CR diltiazem, three on 240 mg twice daily and one on 360 mg twice daily. During rest and exercise, blood pressure and heart rate were significantly lower after treatment with CR diltiazem than before treatment.(ABSTRACT TRUNCATED AT 250 WORDS)
本研究的目的是使用24小时动态动脉血压监测,来检验一种新型的地尔硫䓬控释制剂,以每日两次给药方案治疗原发性高血压患者的疗效。招募了16例平均年龄53岁的患者(2例女性),患有轻度至中度原发性高血压,定义为仰卧位静息舒张压袖带血压≥95 mmHg,进行地尔硫䓬控释制剂的序贯剂量递增研究。在为期六周的洗脱期且未服用任何抗高血压药物后,进行60度倾斜、等长握力和自行车运动测试时的动脉内血压监测。然后患者接受120 mg bid的地尔硫䓬控释制剂治疗一周。如果仰卧位静息舒张压袖带血压与上次洗脱期值相比下降<10 mmHg且仍>90 mmHg,则剂量增加至240 mg bid,持续一周,必要时增加至360 mg bid,持续一周。患者继续使用能实现目标血压降低的地尔硫䓬控释制剂剂量治疗一个月。在维持治疗结束时,重复进行24小时动脉内血压监测。12例患者使用120 mg bid的地尔硫䓬控释制剂得到满意控制,3例使用每日两次240 mg,1例使用每日两次360 mg。在休息和运动期间,地尔硫䓬控释制剂治疗后的血压和心率显著低于治疗前。(摘要截断于250字)