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布地奈德在非囊性纤维化支气管扩张症患者中的疗效和安全性。

Budesonide efficacy and safety in patients with bronchiectasis not due to cystic fibrosis.

机构信息

Servei de Pneumologia, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Passeig Vall d'Hebron, 119-129, 08035, Barcelona, Catalonia, Spain.

出版信息

Int J Clin Pharm. 2012 Aug;34(4):644-50. doi: 10.1007/s11096-012-9659-6. Epub 2012 Jun 9.

Abstract

OBJECTIVE

The therapeutic benefit of inhaled corticoids in bronchiectasis not due to cystic fibrosis is still not well documented. The aim of the present study was to assess the efficacy and safety of inhaled corticoids in this disease.

SETTING

This study was conducted at a tertiary university hospital in the city of Barcelona, Catalonia, (Spain).

METHOD

A prospective, double-blind, parallel, placebo-masked study was conducted. Seventy-seven patients (40 women; mean age: 68 years) were randomly assigned to receive either 400 mcg budesonide twice daily or placebo and were regularly reviewed for six months.

RESULTS

Differences in forced vital capacity and forced expiratory volume in the first second between the beginning and end of the study were not significantly lower in the budesonide group than in the placebo group, either in absolute values [-17.4 (386.9) versus -21.4 (375.5)] or in percentages [-1.9(9.5) versus -2.8 (11.6)]. Microbiological criteria applied to evaluate changes between the beginning and end of the study showed no worsening in the budesonide group compared with the control group, whereas a non-significant improvement was obtained in 8.1 % of cases in the budesonide group compared to 3 % in the placebo group. Although significance was only achieved for sputum eosinophils (p = 0.021), a consistent tendency towards improvement was also observed in secondary end-points (symptoms, number and duration of exacerbations, quality of life, sputum cytology and interleukin-8) in the budesonide group.

CONCLUSION

Although further studies are required, inhaled corticoid treatment may be efficacious and safe in bronchiectasis not due to cystic fibrosis.

摘要

目的

吸入性皮质类固醇在非囊性纤维化支气管扩张症中的治疗益处尚未得到充分证实。本研究旨在评估吸入性皮质类固醇在该病中的疗效和安全性。

地点

该研究在西班牙加泰罗尼亚巴塞罗那市的一家三级大学医院进行。

方法

进行了一项前瞻性、双盲、平行、安慰剂对照的研究。77 名患者(40 名女性;平均年龄:68 岁)被随机分为布地奈德 400μg 每日两次或安慰剂组,并定期随访 6 个月。

结果

在研究开始和结束时,布地奈德组和安慰剂组之间用力肺活量和第一秒用力呼气量的差异无论是绝对值[-17.4(386.9)与-21.4(375.5)]还是百分比[-1.9(9.5)与-2.8(11.6)]均无显著差异。应用于评估研究开始和结束之间变化的微生物学标准显示,布地奈德组与对照组相比没有恶化,而布地奈德组的 8.1%病例有改善,安慰剂组则为 3%。虽然痰液中嗜酸性粒细胞的差异具有统计学意义(p=0.021),但布地奈德组的次要终点(症状、恶化次数、持续时间、生活质量、痰液细胞学和白细胞介素-8)也观察到一致的改善趋势。

结论

尽管需要进一步研究,但吸入性皮质类固醇治疗可能对非囊性纤维化支气管扩张症有效且安全。

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