Gotfried Mark H, Jung Rose, Messick Chad R, Rubinstein Israel, Garey Kevin W, Rodvold Keith A, Danziger Larry H
Pulmonary Associates, University of Arizona, Phoenix, Arizona, USA ; Department of Pharmacy Practice, University of Illinois at Chicago, Chicago, Illinois , USA.
Department of Clinical Pharmacy, University of Colorado Health Science Center, Denver Colorado, USA.
Curr Ther Res Clin Exp. 2004 Jan;65(1):1-12. doi: 10.1016/S0011-393X(04)90000-8.
Although corticosteroids such as prednisone are efficacious for the treatment of severe asthma, chronic administration of oral corticosteroid therapy is associated with significant adverse effects. Previous studies have shown that clarithromycin is effective in reducing bronchial hyperresponsiveness and allergen-induced bronchoconstriction. However, the effect of long-term clarithromycin therapy in patients with prednisone-dependent asthma is uncertain.
This study was conducted to determine the effects of oral clarithromycin on prednisone daily dosage, pulmonary function, quality of life (QOL), and asthmatic symptoms in patients with corticosteroid-dependent asthma.
This 14-week, prospective, randomized, double-blind, placebo-controlled pilot study was conducted at Pulmonary Associates (Phoenix, Arizona) and the University of Illinois at Chicago Medical Center (Chicago, Illinois). Patients aged 18 to 75 years with an established diagnosis of asthma and who had been receiving ≥5 mg/d of prednisone for the preceding 6 months were enrolled. After a 4-week data-collection period, patients received clarithromycin 500 mg BID for 6 weeks, followed by a 4-week follow-up period. The effects of clarithromycin therapy on prednisone dosage requirements, pulmonary function (as assessed using spirometry), QOL, and asthmatic symptoms (nocturnal asthma, shortness of breath, chest discomfort, wheezing, and cough) were assessed.
Fourteen patients (9 men, 5 women; mean [SD] age, 62 [13] years) completed the study and were included in the final analysis. One patient withdrew from the study due to clarithromycin-related nausea. After 6 weeks of clarithromycin therapy, patients were able to tolerate a significant reduction in mean (SD) prednisone dosage from baseline (30% [18%]; P- 0.020). Pulmonary function, QOL, and asthmatic symptoms did not significantly worsen despite reduction in prednisone dose. All patients who completed the study tolerated clarithromycin therapy.
In this pilot study of patients with corticosteroid-dependent asthma, 6-week clarithromycin 500 mg BID was clinically effective in allowing a reduction in prednisone dosage, without worsening pulmonary function, QOL, or asthmatic symptoms. In addition, clarithromycin was well tolerated, with only 1 patient discontinuing therapy due to treatment-related nausea.
尽管泼尼松等皮质类固醇对重度哮喘的治疗有效，但长期口服皮质类固醇疗法会带来显著的不良反应。先前的研究表明，克拉霉素在降低支气管高反应性和变应原诱导的支气管收缩方面有效。然而，长期使用克拉霉素治疗依赖泼尼松的哮喘患者的效果尚不确定。
本研究旨在确定口服克拉霉素对依赖皮质类固醇哮喘患者的泼尼松每日剂量、肺功能、生活质量（QOL）和哮喘症状的影响。
这项为期14周的前瞻性、随机、双盲、安慰剂对照试验在亚利桑那州凤凰城的肺科协会和伊利诺伊大学芝加哥医学中心（伊利诺伊州芝加哥）进行。纳入年龄在18至75岁、已确诊哮喘且在过去6个月内接受≥5mg/d泼尼松治疗的患者。在为期4周的数据收集期后，患者接受6周的克拉霉素500mg每日两次治疗，随后是4周的随访期。评估克拉霉素治疗对泼尼松剂量需求、肺功能（使用肺活量测定法评估）、生活质量和哮喘症状（夜间哮喘、呼吸急促、胸部不适、喘息和咳嗽）的影响。
14名患者（9名男性，5名女性；平均[标准差]年龄，62[13]岁）完成了研究并纳入最终分析。1名患者因与克拉霉素相关的恶心退出研究。克拉霉素治疗6周后，患者能够耐受平均（标准差）泼尼松剂量从基线显著降低（30%[18%]；P = 0.020）。尽管泼尼松剂量降低，但肺功能、生活质量和哮喘症状并未显著恶化。所有完成研究的患者都耐受克拉霉素治疗。
在这项针对依赖皮质类固醇哮喘患者的试验研究中，6周的克拉霉素500mg每日两次在临床上有效，可降低泼尼松剂量，且不会使肺功能、生活质量或哮喘症状恶化。此外，克拉霉素耐受性良好，只有1名患者因治疗相关的恶心而停止治疗。
