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Long‐term safety of budesonide nasal aerosol: a 5.5‐year follow‐up study

机译:布地奈德鼻气雾剂的长期安全性:一项为期 5.5 年的随访研究

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SummaryThe effects of prolonged treatment with intranasally applied budesonide was studied in twenty‐four patients with perennial allergic or non‐allergic rhinitis. Patients on continuous treatment were followed up for 5.5 years. At entry and follow‐up visits, rhinoscopic findings, nasal symptom scores, blood chemistry, haematology, urine analysis and determination of plasma cortisol levels, before and after stimulation with ACTH (Synacthen®, Ciba‐Geigy AG, Basel, Switzerland), were registered. Biopsies of the nasal mucosa were taken before entry into the study, after 1 year of treatment, and after varying time intervals ranging from 2.5 to 5.5 years during the treatment. The biopsy specimens were examined blindly by an independent pathologist. The analyses revealed no histopathological changes in the nasal mucosa. All nasal symptom parameters assessed by the patients were significantly reduced from the baseline during the entire follow‐up period. No clinically significant changes in the haematological and blood chemistry parameters were observed. Plasma cortisol analyses before and after challenge with ACTH revealed no influence on the hypothalamic pituitary adrenal (HPA) axis. The present study suggests that intranasal budesonide in the dose of 200–400 μg/day is also a safe treatment for prolonged treatment of peren
机译:摘要在24例常年性过敏性或非过敏性鼻炎患者中研究了长期鼻内应用布地奈德治疗的效果。对持续治疗的患者进行5.5年的随访。在入组和随访时,记录了 ACTH 刺激前后的鼻镜检查结果、鼻部症状评分、血液化学、血液学、尿液分析和血浆皮质醇水平的测定(Synacthen,Ciba-Geigy® AG,瑞士巴塞尔)。在进入研究之前、治疗 1 年后以及治疗期间 2.5 至 5.5 年的不同时间间隔后,对鼻粘膜进行活检。活检标本由独立病理学家盲目检查。分析显示鼻粘膜没有组织病理学变化。在整个随访期间,患者评估的所有鼻部症状参数均较基线显着降低。未观察到血液学和血液化学参数的临床显着变化。ACTH 激发前后的血浆皮质醇分析显示对下丘脑垂体肾上腺 (HPA) 轴没有影响。本研究表明,剂量为 200-400 μg/天的鼻内布地奈德也是长期治疗培生酮的安全治疗方法

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