Schiøtz P O, Jørgensen M, Flensborg E W, Faerø O, Husby S, Høiby N, Jacobsen S V, Nielsen H, Svehag S E
Acta Paediatr Scand. 1983 Mar;72(2):283-7. doi: 10.1111/j.1651-2227.1983.tb09712.x.
A double blind controlled trial of Becotide (beclomethasone diproprionate) inhalations was carried out for treating cystic fibrosis patients with chronic P. aeruginosa lung infection to determine its efficacy and safety. The aim of the treatment was to diminish the inflammatory response in the lungs of these patients, a response which is initiated by an allergic type III reaction. Pulmonary inflammation was evaluated by measurements of proteolytic activity, albumin concentration and immune complex activity in the sputum sol-phase before, during, and after the 16 weeks the trial lasted. 26 cystic fibrosis patients participated (13 received Becotide and 13 placebo) and the results showed that local steroids have no effect on the inflammatory response in the lungs of cystic fibrosis patients with chronic P. aeruginosa lung infection. No adverse effects were demonstrated. There was, however, a significant increase in the inflammatory parameters for all 26 cystic fibrosis patients when the trial period was over, compared to the insidious pulmonary destruction which takes place in the lungs of these patients, and it corresponded to a significant decrease (p less than 0.05) in forced vital capacity which took place at the same time. Therefore, chronic P. aeruginosa lung infection in these patients should be treated as efficiently as possible.
开展了一项关于必可酮（丙酸倍氯米松）吸入剂的双盲对照试验，用于治疗患有慢性铜绿假单胞菌肺部感染的囊性纤维化患者，以确定其疗效和安全性。治疗的目的是减轻这些患者肺部的炎症反应，这种反应是由过敏性III型反应引发的。在为期16周的试验之前、期间和之后，通过测量痰液液相中的蛋白水解活性、白蛋白浓度和免疫复合物活性来评估肺部炎症。26名囊性纤维化患者参与试验（13名接受必可酮治疗，13名接受安慰剂治疗），结果表明局部使用类固醇对患有慢性铜绿假单胞菌肺部感染的囊性纤维化患者肺部的炎症反应没有影响。未显示出不良反应。然而，与这些患者肺部发生的隐匿性肺破坏相比，在试验期结束时，所有26名囊性纤维化患者的炎症参数均显著增加，并且这与同时发生的用力肺活量显著下降（p小于0.05）相对应。因此，应尽可能有效地治疗这些患者的慢性铜绿假单胞菌肺部感染。
