Efficacy of Corticosteroids in Community-acquired Pneumonia A Randomized Double-Blinded Clinical Trial

Efficacy of Corticosteroids in Community-acquired Pneumonia A Randomized Double-Blinded Clinical Trial
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DOI:
10.1164/rccm.200905-0808oc
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发表时间:
2010-05-01
影响因子:
24.7
通讯作者:
Boersma, Wim G.
Boersma, Wim G.
中科院分区:
医学1区
文献类型:
--
作者:
Snijders, Dominic;Daniels, Johannes M. A.;Boersma, Wim G.

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基本原理:一些研究表明,皮质类固醇激素对社区获得性肺炎(CAP)患者的有益作用,可能是通过减少局部和全身的抗宿主反应。目的:评估社区获得性肺炎住院患者使用泼尼松龙治疗的疗效。使用标准临床和放射学标准进行临床和放射学诊断为CAP的住院患者,随机接受40 mg泼尼松龙7天或安慰剂,沿着抗生素。主要结局为第7天的临床治愈。次要结局为第30天的临床治愈、住院时间、达到临床稳定的时间、退热和C反应蛋白。疾病严重程度采用CURB-65(社区获得性肺炎的严重程度指数,评估意识模糊、血尿素氮、呼吸频率、血压和年龄65岁或以上)和肺炎严重程度指数进行评分。五十四(25.4%)患者的CURB-65评分大于2,和93(43.7%)患者的肺炎严重程度指数为IV-V级。第7天和第30天的临床治愈率为84/104泼尼松龙组和安慰剂组分别为93/109(85.3%)和84/109(77.1%)(P = 0.38和P = 0.08)。与安慰剂组相比,泼尼松龙组患者退热更快,血清C反应蛋白水平下降更快。重症肺炎患者的亚组分析未显示临床结局的差异。泼尼松龙组(20例患者,19.2%)的晚期失败(入院后>72小时)比安慰剂组(10例患者,6.4%; P = 0.04)更常见。不良事件很少,没有两个groups.Conclusions之间的差异:泼尼松龙(在40毫克),每天一次,为期一周,并没有改善住院的CAP患者的结果。不能排除在病情更严重的患者中的获益。由于其与晚期失败增加和缺乏疗效的相关性,不应推荐泼尼松龙作为CAP的常规连续治疗。
Rationale: Some studies have shown a beneficial effect of corticosteroids in patients with community-acquired pneumonia (CAP), possibly by diminishing local and systemic antiinflammatory host response.Objectives: To assess the efficacy of adjunctive prednisolone treatment in patients hospitalized with CAP.Methods: Hospitalized patients, clinically and radiologically diagnosed with CAP using standard clinical and radiological criteria, were randomized to receive 40 mg prednisolone for 7 days or placebo, along with antibiotics. Primary outcome was clinical cure at Day 7. Secondary outcomes were clinical cure at Day 30, length of stay, time to clinical stability, defervescence, and C-reactive protein. Disease severity was scored using CURB-65 (a severity index for community-acquired pneumonia evaluating Confusion, blood Urea nitrogen, Respiratory rate, Blood pressure, and age 65 or older) and Pneumonia Severity Index.Measurements and Main Results: We enrolled 213 patients. Fifty-four (25.4%) patients had a CURB-65 score greater than 2, and 93 (43.7%) patients were in Pneumonia Severity Index class IV-V. Clinical cure at Days 7 and 30 was 84/104 (80.8%) and 69/104 (66.3%) in the prednisolone group and 93/109 (85.3%) and 84/109 (77.1%) in the placebo group (P = 0.38 and P = 0.08). Patients on prednisolone had faster defervescence and faster decline in serum C-reactive protein levels compared with placebo. Subanalysis of patients with severe pneumonia did not show differences in clinical outcome. Late failure (>72 h after admittance) was more common in the prednisolone group (20 patients, 19.2%) than in the placebo group (10 patients, 6.4%; P = 0.04). Adverse events were few and not different between the two groups.Conclusions: Prednisolone (at 40 mg) once daily for a week does not improve outcome in hospitalized patients with CAP. A benefit in more severely ill patients cannot be excluded. Because of its association with increased late failure and lack of efficacy prednisolone should not be recommended as routine adjunctive treatment in CAP.