2連問
あなたが当直をしていると、昨日から咳嗽・発熱が出現したと訴える歳男性が来院しました。
調べるとCOVID19抗原検査が陽性となり、COVID19と診断しました。
男性は糖尿病の持病を持っていたことから、治療を行うべきかどうか迷ったあなたは、以下の論文を探しあてました。
以下の問題に答えなさい。
【論文はあとあと調べたところ NEJM(https://nejm.org/doi/full/10.1056/NEJMoa2107934)でした】
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BACKGROUND
Coronavirus disease 2019 (Covid-19) disproportionately results in hospitalization or death in older patients and those with underlying conditions. Sotrovimab is a pan-sarbecovirus monoclonal antibody that was designed to prevent progression of Covid-19 in high-risk patients early in the course of disease.
METHODS
Adult patients (≥18 years of age) who had a positive result on reverse-transcriptase–polymerase-chain-reaction or antigen SARS-CoV-2 testing and an onset of Covid-19 symptoms within the previous 5 days were screened for eligibility; screening was performed within 24 hours before the administration of sotrovimab or placebo. The patients were at high risk for progression of Covid-19 because of older age (≥55 years) or because they had at least one of the following risk factors: diabetes for which medication was warranted, obesity (body-mass index [BMI; the weight in kilograms divided by the square of the height in meters], >30), chronic kidney disease (estimated glomerular filtration rate, <60 ml per minute per 1.73 m2 of body-surface area),23 congestive heart failure (New York Heart Association class II, III, or IV), chronic obstructive pulmonary disease, and moderate-to-severe asthma.24 Patients with already severe Covid-19, defined as shortness of breath at rest, an oxygen saturation below 94%, or the use of supplemental oxygen, were excluded. Full inclusion and exclusion criteria are described in the Supplementary Methods section in the Supplementary Appendix.
RESULTS
In this prespecified interim analysis, which included an intention-to-treat population of 583 patients (291 in the sotrovimab group and 292 in the placebo group), 3 patients (1%) in the sotrovimab group, as compared with 21 patients (7%) in the placebo group, had disease progression leading to hospitalization or death (relative risk reduction, 85%; 97.24% confidence interval, 44 to 96; P=0.002). In the placebo group, 5 patients were admitted to the intensive care unit, including 1 who died by day 29. Safety was assessed in 868 patients (430 in the sotrovimab group and 438 in the placebo group). Adverse events were reported by 17% of the patients in the sotrovimab group and 19% of those in the placebo group; serious adverse events were less common with sotrovimab than with placebo (in 2% and 6% of the patients, respectively).
CONCLUSIONS
Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. No safety signals were identified. (Funded by Vir Biotechnology and GlaxoSmithKline; COMET-ICE ClinicalTrials.gov number, NCT04545060. opens in new tab.)
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