Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial

Dexamethasone and length of hospital stay in patients with community-acquired pneumonia: a randomised, double-blind, placebo-controlled trial
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DOI:
10.1016/s0140-6736(11)60607-7
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发表时间:
2011-06-11
期刊:
影响因子:
168.9
通讯作者:
Biesma, Douwe H.
Biesma, Douwe H.
中科院分区:
医学1区
文献类型:
--
作者:
Meijvis, Sabine C. A.;Hardeman, Hans;Biesma, Douwe H.

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在抗生素治疗的基础上加用皮质类固醇是否对未入住重症监护病房的社区获得性肺炎患者有益尚不清楚。我们的目的是评估增加地塞米松对这组患者住院时间的影响,这可能会通过抑制全身炎症而导致肺炎的早期消退。我们随机分配到荷兰两家教学医院急诊室就诊的18岁或以上确诊为社区获得性肺炎的成年人接受静脉注射地塞米松(5 mg,每日一次)或安慰剂治疗4天。如果患者免疫功能低下,需要立即转移到重症监护室,或已经接受皮质类固醇或免疫抑制药物,则不符合资格。我们采用计算机化随机分配序列,将患者以一对一的方式随机分配至治疗组,每组20人。主要结局是所有入组患者的住院时间。该研究注册于ClinicalTrials.gov,编号NCT 00471640。结果在2007年11月至2010年9月期间,我们招募了304名患者,并将153名随机分配至安慰剂组,151名随机分配至地塞米松组。304例入组患者中有143例(47%)患有肺炎严重程度指数4-5级的肺炎(地塞米松组79例[52%]患者和对照组64例[42%]患者)。地塞米松组的中位住院时间为6.5天(IQR 5.0-9.0),而安慰剂组为7.5天(5.3-11.5)(中位住院时间差异的95%CI 0-2天; p=0.0480)。尽管地塞米松组151例患者中有67例(44%)有高血糖,而对照组153例患者中有35例(23%)有高血糖,但住院死亡率和严重不良事件并不常见,两组之间的发生率没有差异(p
Background Whether addition of corticosteroids to antibiotic treatment benefits patients with community-acquired pneumonia who are not in intensive care units is unclear. We aimed to assess effect of addition of dexamethasone on length of stay in this group, which might result in earlier resolution of pneumonia through dampening of systemic inflammation.Methods In our double-blind, placebo-controlled trial, we randomly assigned adults aged 18 years or older with confirmed community-acquired pneumonia who presented to emergency departments of two teaching hospitals in the Netherlands to receive intravenous dexamethasone (5 mg once a day) or placebo for 4 days from admission. Patients were ineligible if they were immunocompromised, needed immediate transfer to an intensive-care unit, or were already receiving corticosteroids or immunosuppressive drugs. We randomly allocated patients on a one-to-one basis to treatment groups with a computerised randomisation allocation sequence in blocks of 20. The primary outcome was length of hospital stay in all enrolled patients. This study is registered with ClinicalTrials.gov, number NCT00471640.Findings Between November, 2007, and September, 2010, we enrolled 304 patients and randomly allocated 153 to the placebo group and 151 to the dexamethasone group. 143 (47%) of 304 enrolled patients had pneumonia of pneumonia severity index class 4-5 (79 [52%] patients in the dexamethasone group and 64 [42%] controls). Median length of stay was 6.5 days (IQR 5.0-9.0) in the dexamethasone group compared with 7.5 days (5.3-11.5) in the placebo group (95% CI of difference in medians 0-2 days; p=0.0480). In-hospital mortality and severe adverse events were infrequent and rates did not differ between groups, although 67 (44%) of 151 patients in the dexamethasone group had hyperglycaemia compared with 35 (23%) of 153 controls (p