Miller J
J Clin Pharmacol J New Drugs. 1967 Jan-Feb;7(1):34-40. doi: 10.1002/j.1552-4604.1967.tb00027.x.
Metaproterenol (Alupent), a new bronchodilator, was administered in oral and metered aerosol forms to 134 patients with bronchial asthma in three separate studies: (1) a placebo-controlled trial of single doses of aerosol, (2) a long-term uncontrolled clinical trial of the aerosol, and (3) a long-term uncontrolled clinical trial of the oral tablet. In the first study, statistical analysis of results in 31 patients showed that a single dose of metaproterenol aerosol was significantly superior to placebo aerosol in improving the pulmonary function as measured by forced expiratory volume (P less than 0.01) and maximum mid-expiratory flow rate (P less than 0.05). In the two uncontrolled, long-term clinical trials, 37 patients were treated with metaproterenol aerosol for an average of about four months, and 66 other patients received the drug orally for an average of about three weeks, respectively. The daily dose was one or two doses of aerosol, approximately 0.65 mg. per dose, taken as required several times daily; or 20 to 80 mg. of metaproterenol tablets daily orally. Satisfactory clinical response was seen in 29 (78.4 per cent) of the patients on aerosol and in 45 (68.2 per cent) of the patients on oral therapy. On the aerosol, nine patients (24.3 per cent) experienced mild tachycardia. On oral medication, side effects developed in 16 patients (24.2 per cent). Reactions, mostly nervousness and tachycardia, were mild and usually could be controlled by reducing the dosage. Only two patients (3 per cent) discontinued the drug. Laboratory tests carried out during the aerosol trial and at the end of the oral study revealed no drug-related abnormalities.(ABSTRACT TRUNCATED AT 250 WORDS)
间羟异丙肾上腺素(Alupent)是一种新型支气管扩张剂,在三项独立研究中,以口服和定量气雾剂形式给予134例支气管哮喘患者:(1)单剂量气雾剂的安慰剂对照试验;(2)气雾剂的长期非对照临床试验;(3)口服片剂的长期非对照临床试验。在第一项研究中,对31例患者的结果进行统计分析表明,单剂量间羟异丙肾上腺素气雾剂在改善肺功能方面显著优于安慰剂气雾剂,以用力呼气量(P<0.01)和最大呼气中期流速(P<0.05)衡量。在两项非对照的长期临床试验中,37例患者接受间羟异丙肾上腺素气雾剂治疗,平均约四个月,另外66例患者分别口服该药,平均约三周。日剂量为一或两剂气雾剂,每剂约0.65毫克,根据需要每日服用数次;或每日口服20至80毫克间羟异丙肾上腺素片。接受气雾剂治疗的患者中有29例(78.4%)出现满意的临床反应,接受口服治疗的患者中有45例(68.2%)。使用气雾剂时,9例患者(24.3%)出现轻度心动过速。口服药物治疗时,16例患者(24.2%)出现副作用。反应大多为紧张和心动过速,症状较轻,通常可通过减少剂量控制。只有2例患者(3%)停药。气雾剂试验期间和口服研究结束时进行的实验室检查未发现与药物相关的异常情况。(摘要截取自250字)