Diwan J, Dhand R, Jindal S K, Malik S K, Sharma P L
Int J Clin Pharmacol Ther Toxicol. 1982 Aug;20(8):373-5.
The efficacy and safety of a new centrally acting antitussive agent, isoaminile citrate, was compared with that of chlophedianol hydrochloride in a double-blind, randomized interpatient study. A total of 66 patients participated, two and four patients were lost to follow-up with isoaminile and chlophedianol, respectively. In the experimentally induced cough in 12 normal human subjects, isoaminile (40 mg) was as effective as chlophedianol (20 mg), but its duration of action was somewhat longer. One subject developed allergic skin rash with chlophedianol and was withdrawn from the study. In 60 patients with cough associated with chest diseases, isoaminile (40 mg, 3 x daily) was as effective as chlophedianol (20 mg, 3 x daily) in suppressing cough as judged from the 3-h and 24-h cough counts. The increase in PEFR at day 7 of treatment was somewhat more marked with chlophedianol as compared with isoaminile. None of the drugs interfered with the expectoration process. The side effects observed were few, mild in nature, and did not require a decrease in dose or withdrawal of treatment in any of the patients. Isoaminile citrate was concluded to be an effective and relatively safe antitussive agent. Isoaminile citrate, alpha(isopropyl)-alpha-(beta-dimethylaminoproyl) phenylacetonitrile citrate, is a centrally acting antitussive agent. In animal experiments this drug was as efficacious as codeine but was devoid of any respiratory depressant effect [Krause 1958, Kuroda et al. 1971]. This controlled double-randomized interpatient study was designed to test the comparative efficacy and safety of isoaminile and chlophedianol, another centrally acting antitussive, in humans.
在一项双盲、随机的患者间研究中，将一种新型中枢性镇咳药枸橼酸异米尼尔的疗效和安全性与盐酸氯苯达诺进行了比较。共有66例患者参与研究，使用枸橼酸异米尼尔和盐酸氯苯达诺治疗时分别有2例和4例患者失访。在12名正常人体的实验性诱导咳嗽中，枸橼酸异米尼尔（40毫克）与盐酸氯苯达诺（20毫克）效果相当，但作用持续时间稍长。1名受试者使用盐酸氯苯达诺后出现过敏性皮疹，退出研究。在60例患有胸部疾病并伴有咳嗽的患者中，从3小时和24小时的咳嗽次数判断，枸橼酸异米尼尔（40毫克，每日3次）在抑制咳嗽方面与盐酸氯苯达诺（20毫克，每日3次）效果相当。与枸橼酸异米尼尔相比，治疗第7天时盐酸氯苯达诺使呼气峰流速（PEFR）的增加更为明显。两种药物均未干扰咳痰过程。观察到的副作用较少，性质轻微，所有患者均无需减少剂量或停止治疗。结论是枸橼酸异米尼尔是一种有效且相对安全的镇咳药。枸橼酸异米尼尔，α-（异丙基）-α-（β-二甲基氨基丙基）苯乙腈枸橼酸盐，是一种中枢性镇咳药。在动物实验中，该药与可待因效果相当，但无任何呼吸抑制作用[克劳斯，1958年；黑田等人，1971年]。这项对照双随机患者间研究旨在测试枸橼酸异米尼尔与另一种中枢性镇咳药盐酸氯苯达诺在人体中的相对疗效和安全性。
