Nicholls D P, Harron D W, McAinsh J, Castle W M, Barker N P, Shanks R G
Br J Clin Pharmacol. 1982 Nov;14(5):727-32. doi: 10.1111/j.1365-2125.1982.tb04964.x.
1 The effect of long-acting (LA) propranolol, LA propranolol and bendrofluazide, and a new combined formulation of LA propranolol/bendrofluazide (Inderex) on exercise tachycardia was studied in ten normal volunteers. 2 The preparations were given in random order, double-blind, on three separate study weeks. Observations were made 0, 1, 3, 6, 8, 24, 33 and 48 h after drug administration. 3 The three preparations produced a significant reduction in exercise tachycardia up to 48 h after drug administration, and the effects of the three preparations were not significantly different from each other. 4 Following LA propranolol, LA propranolol and bendrofluazide, and the combined formulation the mean reductions in exercise heart rate 24 h after drug administration were 16.7 +/- 2.1%, 13.0 +/- 1.8% and 16.2 +/- 1.7% respectively. 5 Plasma levels of propranolol and bendrofluazide were measured at 0, 1, 2, 3, 6, 8, 10, 12, 24, 33 and 48 h after dose administration. 6 There was no significant difference in plasma propranolol levels, Cmax propranolol or AUCo-x following the three preparations. The mean apparent t1/2 beta of propranolol after LA propranolol alone was significantly shorter than following the other two preparations (P less than 0.05), but this was not associated with a different pharmacodynamic response. 7 There was no significant difference in the pharmacokinetic parameters of bendrofluazide following the two preparations containing bendrofluazide. No bendrofluazide was detected in plasma after LA propranolol alone. 8 The new combined formulation produces similar pharmacodynamic and pharmacokinetic responses to LA propranolol and bendrofluazide given separately, and to LA propranolol given alone, and so may be of value in the treatment of hypertension.
在10名正常志愿者中研究了长效(LA)普萘洛尔、LA普萘洛尔与苄氟噻嗪以及一种新的LA普萘洛尔/苄氟噻嗪联合制剂(Inderex)对运动性心动过速的影响。
这些制剂在三个不同的研究周以随机、双盲的顺序给药。在给药后0、1、3、6、8、24、33和48小时进行观察。
这三种制剂在给药后长达48小时均能显著降低运动性心动过速,且三种制剂的效果彼此无显著差异。
服用LA普萘洛尔、LA普萘洛尔与苄氟噻嗪以及联合制剂后,给药后24小时运动心率的平均降低分别为16.7±2.1%、13.0±1.8%和16.2±1.7%。
在给药后0、1、2、3、6、8、10、12、24、33和48小时测量普萘洛尔和苄氟噻嗪的血浆水平。
三种制剂后的血浆普萘洛尔水平、普萘洛尔Cmax或AUCo-x无显著差异。单独使用LA普萘洛尔后普萘洛尔的平均表观t1/2β显著短于其他两种制剂(P<0.05),但这与不同的药效学反应无关。
两种含苄氟噻嗪制剂后的苄氟噻嗪药代动力学参数无显著差异。单独使用LA普萘洛尔后血浆中未检测到苄氟噻嗪。
新的联合制剂产生的药效学和药代动力学反应与单独给予LA普萘洛尔和苄氟噻嗪以及单独给予LA普萘洛尔相似,因此可能对高血压治疗有价值。