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[HFA-倍氯米松二丙酸酯与丙酸氟替卡松对下呼吸道哮喘炎症抑制作用及对健康相关生活质量改善作用的多中心、开放标签、随机对照比较]

[A multicenter, open-label, randomized comparison of suppressive effects on asthmatic inflammation of lower airways and improved effects on health-related QOL between HFA-BDP and fluticasone propionate].

作者信息

Ohbayashi Hiroyuki, Adachi Mitsuru, Ichinose Masakazu, Ohta Ken, Kokubu Fumio, Sano Yasuyuki, Tamura Gen, Tohda Yuji, Hirata Kazuto, Yasuba Hirotaka

机构信息

Tohno Kousei Hospital, Japan.

出版信息

Arerugi. 2007 Jun;56(6):577-86.

PMID:17615501
Abstract

PURPOSE

It is important to evaluate the effects of hydrofluoroalkane-beclomethasone dipropionate (HFA-BDP), which shows predominant deposition in the lower airways, on asthmatic inflammation in the lower airways and the Quality of Life (QOL) of asthma patients, as compared with those of fluticasone propionate (FP) Diskus.

METHODS

Seventy-seven adult patients with mild persistent or more severe asthma who were being treated with FP for >/=3 months were randomly assigned to the HFA-BDP group and continued FP group. The differential count of eosinophils in the peripheral blood, the serum cortisol levels, and pulmonary function parameters were measured before the study and at 3 months after the start of the study treatment. The improvements in the Asthma Quality of Life Questionnaire (AQLQ) scores were also compared. Sputum samples collected by the induced expectoration method (inhalation of 10% saline for 15 min) were divided into the early-phase sputum samples obtained within 15 minutes of the inhalation and the late-phase sputum samples obtained later than 15 minutes after the inhalation, and the eosinophil count and eosinophil cationic protein (ECP) levels were measured.

RESULTS

In the HFA-BDP group (N=40), the differential count of eosinophils in the peripheral blood was significantly decreased as compared with that in the FP group (p=0.009), and the scores in all the domains of the AQLQ and the percentage improvement of the total score were significantly better as compared with those in FP group (p=0.033). The eosinophil count in the late-phase sputum samples (p=0.022) as well as the ECP level in the sputum samples showed more pronounced decreases in the HFA-BDP group as compared with those in the FP group. On the other hand, no significant changes were detected in the pulmonary function values.

CONCLUSION

Use of the HFA-BDP preparation can more effectively suppress residual inflammation in the lower airways and significantly improve the QOL as compared with use of the FP preparation of asthma patients. Examination of induced sputum samples allows detection of changes in the peripheral airways that cannot be detected by pulmonary function testing.

摘要

目的

与丙酸氟替卡松(FP)吸入装置相比,评估在下呼吸道主要沉积的氢氟烷烃 - 二丙酸倍氯米松(HFA - BDP)对下呼吸道哮喘炎症和哮喘患者生活质量(QOL)的影响具有重要意义。

方法

77例接受FP治疗≥3个月的轻度持续性或更严重哮喘成年患者被随机分为HFA - BDP组和继续使用FP组。在研究前和研究治疗开始后3个月测量外周血嗜酸性粒细胞分类计数、血清皮质醇水平和肺功能参数。还比较了哮喘生活质量问卷(AQLQ)评分的改善情况。通过诱导咳痰法(吸入10%盐水15分钟)收集的痰液样本分为吸入后15分钟内获得的早期痰液样本和吸入后15分钟后获得的晚期痰液样本,并测量嗜酸性粒细胞计数和嗜酸性粒细胞阳离子蛋白(ECP)水平。

结果

在HFA - BDP组(N = 40)中,外周血嗜酸性粒细胞分类计数与FP组相比显著降低(p = 0.009),AQLQ所有领域的评分以及总分的改善百分比与FP组相比显著更好(p = 0.033)。与FP组相比,HFA - BDP组晚期痰液样本中的嗜酸性粒细胞计数(p = 0.022)以及痰液样本中的ECP水平下降更为明显。另一方面,肺功能值未检测到显著变化。

结论

与使用FP制剂相比,使用HFA - BDP制剂可更有效地抑制下呼吸道残留炎症,并显著改善哮喘患者的生活质量。检查诱导痰液样本可检测到肺功能测试无法检测到的外周气道变化。

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