Renovanz V K
Arzneimittelforschung. 1975 Apr;25(4):646-52.
In the beginning objects and problems of clinical pharmacology were outlined. Results from experimental studies in animals with the metabolite VIII of bromhexine (N-[trans-4-hydroxy-cyclohexyl]=[2-amino-3,5-dibromo-benzyl]-amine, Ambroxol (NA 842)) are described in order to contribute to the understanding of this substance's mode of action. Hence NA 872 is an expectorant which fully meets all requirements expected from this category of druggs -- increase in sputum amount, easement in breathing, reducing the viscosity, and depression of coughing. The dose-effect rate of the substance was tested in 54 adults and 32 children. The average dose of 45.0 mg/kg for adults was determined as sufficient for the majority of patients. In the following test in 124 patients on dose tolerance and efficacy, the substance proved to be tolerated extremely well, to cause no adverse side effects while achieving good effects particularly with regard to improvement of expectoration. There was no casual relationship between some occurring changes in laboratory data and the application of the substance.
一开始概述了临床药理学的研究对象和问题。为有助于理解氨溴索（N-[反式-4-羟基环己基]-[2-氨基-3,5-二溴苄基]胺，NA 842）的代谢物VIII在动物实验研究中的结果，进行了相关描述。因此，NA 872是一种祛痰剂，完全符合这类药物的所有预期要求——增加痰液量、缓解呼吸、降低黏稠度以及抑制咳嗽。在54名成人和32名儿童中测试了该物质的剂量效应率。确定成人45.0 mg/kg的平均剂量对大多数患者来说足够。在随后对124名患者进行的剂量耐受性和疗效测试中，该物质被证明耐受性极佳，在取得良好效果尤其是改善咳痰方面未引起不良副作用。实验室数据中出现的一些变化与该物质的应用之间没有因果关系。
