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拉贝洛尔用于老年原发性高血压患者的评估。

Evaluation of labetalol in elderly patients with essential hypertension.

作者信息

Giles T D, Weber M, Bartels D W, Gregory M C, Burris J F, Due D, Sirgo M A

机构信息

Tulane Medical Center, School of Medicine, New Orleans, LA.

出版信息

J Clin Pharmacol. 1991 Jun;31(6):556-60. doi: 10.1002/j.1552-4604.1991.tb03737.x.

Abstract

Labetalol was evaluated in a multicenter, placebo-controlled study of elderly patients (greater than or equal to 60 years) with mild to moderate essential hypertension. After a placebo-washout period, doses were titrated from 100 mg BID to a maximum of 400 mg BID over a 6-week period. Once blood pressure control (standing diastolic blood pressure [SDBP] less than 90 mm Hg and greater than or equal to 10 mm Hg reduction from baseline) was achieved or the maximum allowable dosage had been given, the dosage remained the same until the end of the study. The titration phase was followed by a 4-week maintenance period. Blood pressure control was achieved in 37/54 (69%) of the patients who were treated with labetalol compared with 21/58 (36%) of the patients who received placebo (P less than .001). Twenty-nine (78%) of those controlled on labetalol responded to doses of 200 mg or less BID, and there was no significant difference between groups with respect to orthostatic blood pressure changes. Adverse experiences were generally mild and occurred with similar frequency in the labetalol and placebo groups; six patients who received labetalol and five who received placebo withdrew from the study due to adverse experiences, but in only one case (labetalol) was the adverse experience considered drug-related. In summary, labetalol effectively and safely lowered diastolic blood pressure in the elderly without producing significant orthostatic changes.

摘要

在一项针对年龄≥60岁的轻至中度原发性高血压老年患者的多中心、安慰剂对照研究中对拉贝洛尔进行了评估。经过一个安慰剂洗脱期后,在6周内将剂量从每日两次,每次100毫克滴定至最大每日两次,每次400毫克。一旦实现血压控制(站立位舒张压[SDBP]<90毫米汞柱且较基线降低≥10毫米汞柱)或已给予最大允许剂量,剂量在研究结束前保持不变。滴定阶段之后是为期4周的维持期。接受拉贝洛尔治疗的患者中有37/54(69%)实现了血压控制,而接受安慰剂治疗的患者中有21/58(36%)实现了血压控制(P<0.001)。在拉贝洛尔治疗下血压得到控制的患者中,29例(78%)对每日两次200毫克或更低剂量有反应,且两组在直立性血压变化方面无显著差异。不良事件一般较轻,在拉贝洛尔组和安慰剂组中发生频率相似;6例接受拉贝洛尔治疗的患者和5例接受安慰剂治疗的患者因不良事件退出研究,但只有1例(拉贝洛尔)的不良事件被认为与药物相关。总之,拉贝洛尔能有效且安全地降低老年人的舒张压,且不会产生明显的直立性变化。

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