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吸入布地奈德与静脉注射甲泼尼龙治疗慢性阻塞性肺疾病急性加重期的随机对照多中心研究

A randomized, controlled multicentric study of inhaled budesonide and intravenous methylprednisolone in the treatment on acute exacerbation of chronic obstructive pulmonary disease.

作者信息

Ding Zhen, Li Xiu, Lu Youjin, Rong Guangsheng, Yang Ruiqing, Zhang Ruixia, Wang Guiqin, Wei Xiqiang, Ye Yongqing, Qian Zhaoxia, Liu Hongyan, Zhu Daifeng, Zhou Ruiqing, Zhu Kun, Ni Rongping, Xia Kui, Luo Nan, Pei Cong

机构信息

Department of Respiratory Medicine, The 3rd Hospital of Anhui Medical University, Hefei 1st People's Hospital, Hefei, Anhui, China.

Department of Respiratory Medicine, The 2nd Hospital of Anhui Medical University, Hefei, Anhui, China.

出版信息

Respir Med. 2016 Dec;121:39-47. doi: 10.1016/j.rmed.2016.10.013. Epub 2016 Oct 21.

Abstract

BACKGROUND

Almost all international guidelines recommend corticosteroids for management of exacerbations of chronic obstructive pulmonary disease (COPD), because it leads to improved outcomes of acute exacerbations of chronic obstructive pulmonary disease (AECOPD). Nevertheless, due to its side effects, there are still concerns regarding the use of systemic corticosteroid (SC). Inhaled corticosteroids (IC) can be used as an alternative to SC, while reducing the risk of occurrence of side effects.

PURPOSE

To measure the clinical efficacy and side effects of nebulized budesonide and systemic methylprednisolone in AECOPD.

METHODS

Valid data from 410 AECOPD patients in 10 hospitals was collected. Patients were randomly divided into 2 groups; budesonide group, treated with nebulized budesonide (2 mg 3 times/day); and methylprednisolone group, treated with intravenously injected methylprednisolone (40 mg/day). COPD assessment test (CAT), arterial blood gas analysis, hospitalization days, adverse effects, fasting blood glucose, serum creatinine, alanine aminotransferase levels, and blood drug were measured and analyzed in both groups.

RESULTS

Symptoms, pulmonary function and arterial blood gas analysis were significantly improved after treatment in both groups (P < 0.05), with no significant differences between them (P > 0.05), while incidence of adverse events in the budesonide group was lower (P < 0.05). No significant differences in CAT score, days of admission, blood gas analysis results and physiological and biochemical indexes were found between the two groups. Patients treated with methylprednisolone showed a higher degree of PaO level improvement.

CONCLUSION

Results show that inhalation of budesonide (2 mg 3 times/day) and systemic methylprednisolone (40 mg/day) had similar clinical outcome in AECOPD. In conclusion, inhaled budesonide is an alternative to systemic corticosteroids in AECOPD treatment.

摘要

背景

几乎所有国际指南都推荐使用皮质类固醇来治疗慢性阻塞性肺疾病(COPD)急性加重期,因为它能改善慢性阻塞性肺疾病急性加重(AECOPD)的预后。然而,由于其副作用,对于全身用皮质类固醇(SC)的使用仍存在担忧。吸入性皮质类固醇(IC)可作为SC的替代品,同时降低副作用发生风险。

目的

评估雾化布地奈德和全身用甲泼尼龙治疗AECOPD的临床疗效及副作用。

方法

收集了10家医院410例AECOPD患者的有效数据。患者被随机分为两组;布地奈德组,接受雾化布地奈德治疗(2毫克,每日3次);甲泼尼龙组,接受静脉注射甲泼尼龙治疗(40毫克/天)。对两组患者进行慢性阻塞性肺疾病评估测试(CAT)、动脉血气分析、住院天数、不良反应、空腹血糖、血清肌酐、丙氨酸转氨酶水平及血药浓度的测定与分析。

结果

两组治疗后症状、肺功能及动脉血气分析均有显著改善(P<0.05),两组间无显著差异(P>0.05),而布地奈德组不良事件发生率较低(P<0.05)。两组间CAT评分、住院天数、血气分析结果及生理生化指标无显著差异。接受甲泼尼龙治疗的患者PaO水平改善程度更高。

结论

结果表明,雾化吸入布地奈德(2毫克,每日3次)和全身用甲泼尼龙(40毫克/天)在AECOPD治疗中具有相似的临床疗效。总之,在AECOPD治疗中,吸入性布地奈德可替代全身用皮质类固醇。

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