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糖皮质激素治疗社区获得性肺炎的疗效:一项随机双盲临床试验。

Efficacy of corticosteroids in community-acquired pneumonia: a randomized double-blinded clinical trial.

机构信息

Department of Pulmonary Diseases, Medical Centre Alkmaar, Wilhelminalaan 15, 1812 JD Alkmaar, The Netherlands.

出版信息

Am J Respir Crit Care Med. 2010 May 1;181(9):975-82. doi: 10.1164/rccm.200905-0808OC. Epub 2010 Feb 4.

DOI:10.1164/rccm.200905-0808OC
PMID:20133929
Abstract

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.

摘要

背景

一些研究表明,皮质类固醇激素对社区获得性肺炎(CAP)患者有益,可能通过减轻局部和全身抗炎宿主反应。

目的

评估辅助泼尼松龙治疗住院 CAP 患者的疗效。

方法

使用标准临床和影像学标准,对临床和影像学诊断为 CAP 的住院患者进行随机分组,接受泼尼松龙 40mg 治疗 7 天或安慰剂,同时接受抗生素治疗。主要结局为第 7 天临床治愈。次要结局为第 30 天临床治愈、住院时间、临床稳定时间、退热时间和 C 反应蛋白。使用 CURB-65(评估社区获得性肺炎严重程度的严重指数,包括意识障碍、血尿素氮、呼吸频率、血压和年龄≥65 岁)和肺炎严重指数对疾病严重程度进行评分。

测量和主要结果

共纳入 213 例患者。54 例(25.4%)患者 CURB-65 评分>2,93 例(43.7%)患者肺炎严重指数分级为 IV-V 级。泼尼松龙组第 7 天和第 30 天的临床治愈率分别为 84/104(80.8%)和 69/104(66.3%),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。对严重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,19.2%)较安慰剂组(10 例,6.4%)更常见晚期失败(入院后 72 小时以上)(P=0.04)。两组不良反应均较少且无差异。

结论

泼尼松龙(每日 40mg,连用 1 周)不能改善住院 CAP 患者的结局。不能排除对更严重疾病患者有益的可能性。由于其与晚期失败增加相关且缺乏疗效,泼尼松龙不应用于 CAP 的常规辅助治疗。

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