akinohanayuki ブログ

学位を持っても、センスのない、感染制御専門薬剤師のブログ.  I have Ph.D. but less sense ID pharmacist.

Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial.

Effect of corticosteroids on treatment failure among hospitalized patients with severe community-acquired pneumonia and high inflammatory response: a randomized clinical trial.

www.ncbi.nlm.nih.gov

2015年JAMAに報告された、スペイン3施設による成人の重症な市中肺炎に対するメチルプレドニゾロンvsプラセボのRCT.

 

 

 

P : patients with both severe community-acquired pneumoniaand a high inflammatory response, which was defined as a level of C-reactive protein greater than 150 mg/L at admission

E : intravenous bolus of 0.5 mg/kg per 12 hours of methylprednisolone (n = 61) for 5 days started within 36 hours of hospital admission.

C : placebo (n = 59)

O :

There was less treatment failure among patients from the methylprednisolone group (8 patients [13%]) compared with the placebo group (18 patients [31%]) (P = .02), with a difference between groups of 18% (95% CI, 3% to 32%).

Corticosteroid treatment reduced the risk of treatment failure (odds ratio, 0.34 [95% CI, 0.14 to 0.87]; P = .02).

In-hospital mortality did not differ between the 2 groups (6 patients [10%] in the methylprednisolone group vs 9 patients [15%] in the placebo group; P = .37); the difference between groups was 5% (95% CI, -6% to 17%).

Hyperglycemia occurred in 11 patients (18%) in the methylprednisolone group and in 7 patients (12%) in the placebo group (P = .34).

T : Multicenter, randomized, double-blind, placebo-controlled trial.

 

TRIAL REGISTRATION:

 

Corticoids in Severe Community-Acquired Pneumonia (CAP) - Full Text View - ClinicalTrials.gov

limitation

Another major limitation is the long duration of the study because the care of patients could have evolved during this time or many intervening diseases might have influenced the results. However, our protocol for managing patients with 

community-acquired pneumonia did not change during these years. We excluded patients with H1N1 influenza.

Time to the first antibiotic dosage was similar in both groups. In addition, we adjusted for the year of admission in the corresponding statistical models. Last, the small differ- ence in the number of events (a difference of only 10 pa- tients) indicates the need for study replication. A new trial is currently ongoing.

 

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感想

重症CAPの初期治療にいいかも。しかし、心不全との鑑別が重要。

インパクトは限定的です。絶対必要条件にはなりにくいと思います。

研究期間は8年かかっており、限界の1番目記載は苦しい告白です。

 

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