Graf P, Toll K, Palm J, Hallén H
Department of Otorhinolaryngology, Huddinge University Hospital, Karolinska Institute, Stockholm, Sweden.
Acta Otolaryngol. 1999;119(7):837-42. doi: 10.1080/00016489950180513.
Phenylpropanolamine (PPA) is widely used as a nasal decongestant administered orally in sustained release preparations and, in Sweden, the recommended dose nowadays is 50 mg twice daily for adults. The aim of this placebo-controlled, cross-over study was to determine the onset and duration of the decongestive effect of 50 and 100 mg PPA in 15 healthy subjects. All subjects arrived at the laboratory at 07.30 h. After an acclimatisation, the nasal mucosal baseline was established with rhinostereometry and the minimal cross-sectional area was measured using acoustic rhinometry. The systolic and diastolic blood pressures were also determined. Then all subjects were given their study drugs for the day and the measurements were repeated every hour for 8 h. This procedure was repeated for 3 days at 48 h intervals between the days. For purposes of comparison, the decongestive effect of oxymetazoline nasal spray was studied on a separate day. The decongestive effect of 100 mg PPA was similar to that of topical oxymetazoline. It develops after 1 h and lasts for approximately 6 h. The decongestive effect of oxymetazoline was significantly greater than that of 50 mg PPA and that of 100 mg PPA was significantly greater than that of 50 mg PPA using rhinostereometry, but not when using acoustic rhinometry. However, 50 mg PPA had no significant decongestive effect, compared with placebo, with rhinostereometry or acoustic rhinometry. In the first 3 h after administration of PPA, there was a dose-response increase in the systolic and diastolic blood pressures, which then returned to baseline. In conclusion, this study shows that PPA in double the recommended dose, i.e. 100 mg, has a significant decongestive effect on the nasal mucosa in healthy subjects. However, when the dose of PPA is increased the systolic and diastolic blood pressures also increase.
苯丙醇胺（PPA）作为一种口服缓释制剂的鼻减充血剂被广泛使用，在瑞典，目前推荐的成人剂量是每日两次，每次50毫克。这项安慰剂对照的交叉研究旨在确定15名健康受试者服用50毫克和100毫克PPA后减充血作用的起效时间和持续时间。所有受试者于07:30到达实验室。经过适应性调整后，使用鼻立体测量法建立鼻黏膜基线，并使用声学鼻测量法测量最小横截面积。还测定了收缩压和舒张压。然后给所有受试者当天的研究药物，并在8小时内每小时重复测量一次。此过程在3天内以48小时的间隔重复进行。为了进行比较，在单独的一天研究了羟甲唑啉鼻喷雾剂的减充血作用。100毫克PPA的减充血作用与局部使用羟甲唑啉相似。它在1小时后起效，持续约6小时。使用鼻立体测量法时，羟甲唑啉的减充血作用明显大于50毫克PPA，100毫克PPA的减充血作用明显大于50毫克PPA，但使用声学鼻测量法时并非如此。然而，与安慰剂相比，50毫克PPA使用鼻立体测量法或声学鼻测量法均无明显的减充血作用。在服用PPA后的前3小时内，收缩压和舒张压呈剂量反应性升高，然后恢复到基线水平。总之，本研究表明，推荐剂量加倍即100毫克的PPA对健康受试者的鼻黏膜有显著的减充血作用。然而，当PPA剂量增加时，收缩压和舒张压也会升高。
