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伴有口腔地塞米松辅助治疗的非 ICU 社区获得性肺炎住院患者:一项随机临床试验。

Adjunctive treatment with oral dexamethasone in non-ICU patients hospitalised with community-acquired pneumonia: a randomised clinical trial.

机构信息

Dept of Internal Medicine, St Antonius Hospital, Nieuwegein, The Netherlands

Dept of Internal Medicine, St Antonius Hospital, Nieuwegein, The Netherlands.

出版信息

Eur Respir J. 2021 Aug 12;58(2). doi: 10.1183/13993003.02535-2020. Print 2021 Aug.

Abstract

BACKGROUND

Adjunctive intravenous corticosteroid treatment has been shown to reduce length of stay (LOS) in adults hospitalised with community-acquired pneumonia (CAP). We aimed to assess the effect of oral dexamethasone on LOS and whether this effect is disease severity dependent.

METHODS

In this multicentre, stratified randomised, double-blind, placebo-controlled trial, immunocompetent adults with CAP were randomly assigned (1:1 ratio) to receive oral dexamethasone (6 mg once daily) or placebo for 4 days in four teaching hospitals in the Netherlands. Randomisation (blocks of four) was stratified by CAP severity (pneumonia severity index class I-III and IV-V). The primary outcome was LOS.

RESULTS

Between December 2012 and November 2018, 401 patients were randomised to receive dexamethasone (n=203) or placebo (n=198). Median LOS was shorter in the dexamethasone group (4.5 days, 95% CI 4.0-5.0 days) than in the placebo group (5.0 days, 95% CI 4.6-5.4 days; p=0.033). Within both CAP severity subgroups, differences in LOS between treatment groups were not statistically significant. The secondary ICU admission rate was lower in the dexamethasone arm (5 (3%) 14 (7%); p=0.030); 30-day mortality did not differ between groups. In the dexamethasone group the rate of hospital readmission tended to be higher (20 (10%) 9 (5%); p=0.051) and hyperglycaemia (14 (7%) 1 (1%); p=0.001) was more prevalent.

CONCLUSION

Oral dexamethasone reduced LOS and ICU admission rate in adults hospitalised with CAP. It remains unclear for which patients the risk-benefit ratio is optimal.

摘要

背景

辅助静脉用皮质类固醇治疗已被证明可缩短社区获得性肺炎(CAP)住院患者的住院时间(LOS)。我们旨在评估口服地塞米松对 LOS 的影响,以及这种影响是否取决于疾病严重程度。

方法

在这项多中心、分层随机、双盲、安慰剂对照试验中,免疫功能正常的 CAP 成人患者被随机分配(1:1 比例)接受口服地塞米松(6mg 每日一次)或安慰剂治疗,为期 4 天,在荷兰的四家教学医院进行。随机分组(每 4 例一组)按 CAP 严重程度分层(肺炎严重指数 I-III 级和 IV-V 级)。主要结局是 LOS。

结果

2012 年 12 月至 2018 年 11 月,401 例患者被随机分为地塞米松组(n=203)或安慰剂组(n=198)。地塞米松组的 LOS 中位数较短(4.5 天,95%CI 4.0-5.0 天),安慰剂组为 5.0 天(95%CI 4.6-5.4 天;p=0.033)。在两个 CAP 严重程度亚组中,治疗组之间 LOS 的差异无统计学意义。地塞米松组的 ICU 入院率较低(5(3%) 14(7%);p=0.030);两组 30 天死亡率无差异。地塞米松组的再入院率有升高趋势(20(10%) 9(5%);p=0.051),且高血糖症更为常见(14(7%) 1(1%);p=0.001)。

结论

口服地塞米松可缩短 CAP 住院成人患者的 LOS 和 ICU 入院率。哪种患者的风险-效益比最佳尚不清楚。

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