Riker J B, Cacace L G
Chest. 1980 Nov;78(5):723-5. doi: 10.1378/chest.78.5.723.
A 5 percent solution of metaproterenol sulfate (Alupent) and a fixed-combination solution of isoetharine and phenylephrine were compared in a single-dose double-blind study in a total of 27 patients with reversible bronchospastic disease. The patients were assigned to parallel groups for treatment and received the usual dose of 0.3 ml of metaproterenol and 0.5 ml of the isoetharine-phenylephrine solution via equipment for intermittent positive-pressure breathing. Tests of pulmonary function, blood pressure, and pulse rate were performed before the treatment and at intervals of 30 minutes to six hours after administration. The duration of effect (defined as an increase over baseline in the forced expiratory volume in one second [FEV1] of at least 15 percent) of metaproterenol averaged four hours, as compared with one hour for the reference solution. The overall response of FEV1 to metaproterenol was significantly (P = 0.01) superior to the response to the isoetharine-phenylephrine solution. Metaproterenol also surpassed the reference drug in terms of increases in the mean forced expiratory flow during the middle half of the forced vital capacity (FEF-25-75%) to a degree approaching statistical significance. Changes in blood pressure and pulse rate were clinically insignificant with both drugs, and the total number of adverse experiences was substantially the same with both solutions.
在一项针对27例可逆性支气管痉挛疾病患者的单剂量双盲研究中,对5%的硫酸间羟异丙肾上腺素溶液(Alupent)和异他林与去氧肾上腺素的固定复方溶液进行了比较。患者被分为平行组接受治疗,通过间歇性正压呼吸设备分别给予常规剂量的0.3 ml间羟异丙肾上腺素和0.5 ml异他林 - 去氧肾上腺素溶液。在治疗前以及给药后30分钟至6小时的间隔时间进行肺功能、血压和脉搏率测试。间羟异丙肾上腺素的起效持续时间(定义为一秒用力呼气量[FEV1]较基线增加至少15%)平均为4小时,而对照溶液为1小时。FEV1对间羟异丙肾上腺素的总体反应显著(P = 0.01)优于对异他林 - 去氧肾上腺素溶液的反应。在用力肺活量中间一半时段的平均用力呼气流量(FEF - 25 - 75%)增加方面,间羟异丙肾上腺素也超过了对照药物,达到接近统计学显著性的程度。两种药物引起的血压和脉搏率变化在临床上均无显著意义,并且两种溶液的不良事件总数基本相同。