Cogo A, Chieffo A, Farinatti M, Ciaccia A
Institute of Infectious and Respiratory Diseases, University of Ferrara, Italy.
Arzneimittelforschung. 1996 Apr;46(4):385-8.
The aim of this study was to functionally evaluate the decongestant effect of a topical intranasal drug (Rhinofluimucil consisting of tuaminoheptane sulphate (CAS 6411-75-2, THS), a vasoconstrictor, combined with N-acetyl-cysteine (CAS 616-91-1, NAC). This was a double-blind randomized study, versus both xylometazoline and placebo. 18 subjects (8M and 10F, aged 20-47 years), unaffected by any rhinitic pathology, underwent anterior rhinomanometry. Following the basal evaluation (T0), subjects were randomly divided into three groups and subjected, in a double-blind manner, to nasal instillations (2 puffs per nostril) of THS/NAC (R), xylometazoline (O) and saline solution (P), respectively. Rhinomanometry was repeated after 5, 10 and 20 min (T5, T10, T20). Resistance and flow were measured in both nostrils at a pressure gradient of 150 Pa. After R and O nasal resistance significantly decreased from 0.30 Pa to 0.19 Pa and from 0.31 Pa to 0.17 Pa, respectively, and flow significantly increased; no effects were observed with placebo. In this study, THS/NAC showed rapid decongestant properties, with a significant decrease of resistance and increase of inspiratory flow. The same finding was observed with xylometazoline, but not with the placebo. The decongestant effect was rapid: it could already be observed at T5, and remained constant up to T20 without any rebound effect.
本研究的目的是对一种局部鼻内药物(由血管收缩剂硫酸吐昔洛韦(CAS 6411-75-2,THS)与N-乙酰半胱氨酸(CAS 616-91-1,NAC)组成的利诺复明)的减充血作用进行功能评估。这是一项双盲随机研究,与赛洛唑啉和安慰剂进行对比。18名未患任何鼻炎病理疾病的受试者(8名男性和10名女性,年龄20-47岁)接受了前鼻测压法检查。在基础评估(T0)之后,受试者被随机分为三组,并以双盲方式分别接受THS/NAC(R)、赛洛唑啉(O)和盐溶液(P)的滴鼻治疗(每侧鼻孔2喷)。在5、10和20分钟后(T5、T10、T20)重复进行前鼻测压法检查。在150 Pa的压力梯度下测量双侧鼻孔的阻力和流量。在使用R和O滴鼻后,鼻阻力分别从0.30 Pa显著降至0.19 Pa和从0.31 Pa显著降至0.17 Pa,并且流量显著增加;使用安慰剂未观察到任何效果。在本研究中,THS/NAC显示出快速的减充血特性,阻力显著降低且吸气流量增加。赛洛唑啉也观察到了相同的结果,但安慰剂组未观察到。减充血作用迅速:在T5时即可观察到,并且在T20之前保持不变,没有任何反跳效应。