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左氧氟沙星吸入溶液在真实世界环境中囊性纤维化患者中的临床影响。

Clinical impact of levofloxacin inhalation solution in cystic fibrosis patients in a real-world setting.

机构信息

Department of Pediatric Pulmonology, Immunology and Intensive Care Medicine, Division of Cystic Fibrosis, Charité - Universitätsmedizin, Augustenburger Platz 1, 13353 Berlin, Germany.

出版信息

J Cyst Fibros. 2021 Nov;20(6):1035-1039. doi: 10.1016/j.jcf.2021.03.002. Epub 2021 Jun 5.

Abstract

BACKGROUND

Levofloxacin inhalation solution is the most recently approved inhaled antibiotic in Europe and Canada for adult cystic fibrosis patients. Its efficacy and safety have been assessed in randomized controlled trials. Our aim was to evaluate real life experience and outcomes in our treatment centre.

METHODS

We evaluated the efficacy of inhaled levofloxacin solution in 86 patients with cystic fibrosis in terms of the following outcome parameters: changes in %-predicted forced expiratory volume in one second (FEV), body-mass index (BMI), and exacerbation rate. We conducted an intraindividual analysis of patients who received levofloxacin inhalation solution twice daily 240 mg for at least 4 weeks.

RESULTS

Change in FEV% predicted for the treatment period was +2.27% (p=0.0027) after 4 weeks. There was no change in BMI for overall group, but exacerbation rate compared to one year before initiation of inhaled levofloxacin decreased significantly (p=0.0024) after 1 year of treatment (3.23 ± 1.39 versus 2.71 ± 1.58).

CONCLUSIONS

In patients with cystic fibrosis, inhaled levofloxacin solution has the potential to improve FEV and to reduce the number of bronchopulmonary exacerbations.

摘要

背景

左氧氟沙星吸入溶液是最近在欧洲和加拿大批准用于成年囊性纤维化患者的吸入抗生素。其疗效和安全性已在随机对照试验中进行了评估。我们的目的是在我们的治疗中心评估真实世界的经验和结果。

方法

我们评估了 86 例囊性纤维化患者使用吸入左氧氟沙星溶液的疗效,以下列结果参数为指标:用力呼气量(FEV)预测百分比的变化、体重指数(BMI)和加重率。我们对接受每日两次 240 毫克左氧氟沙星吸入溶液治疗至少 4 周的患者进行了个体内分析。

结果

治疗期间 FEV%预测值的变化为+2.27%(p=0.0027),4 周后。总体组 BMI 无变化,但与吸入左氧氟沙星溶液治疗前 1 年相比,治疗 1 年后加重率显著下降(p=0.0024)(3.23±1.39 比 2.71±1.58)。

结论

在囊性纤维化患者中,吸入左氧氟沙星溶液有可能改善 FEV 并减少支气管肺部加重的次数。

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