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[JAMA Intern Med作者回复]:皮质类固醇在治疗COVID-19中的不确定作用
2020年08月27日 研究点评, 进展交流 暂无评论

翻译:陈燕

Comment & Response August 3, 2020

The Uncertain Role of Corticosteroids in the Treatment of COVID-19—Reply

Yuanlin Song, Chaomin Wu, Xiaoyan Chen

JAMA Intern Med. Published online August 3, 2020. doi:10.1001/jamainternmed.2020.2435

In Reply In response to the concerns about survival bias and the findings regarding methylprednisolone in our Original Investigation,1 we treated methylprednisolone use as a time-dependent variable with the Cox model in the same subgroup of 84 patients. The hazard ratio of methylprednisolone use for death was 0.52 (95% CI, 0.27-1.02; P = .06), suggesting a trend toward a lower mortality.

基于原始调查中对生存偏倚和甲强龙的调查结果的担忧,我们在由84名患者组成的相同亚组中应用COX模型把甲强龙的使用看作时间依赖性变化。甲强龙的死亡风险比是0.52(95%可信区间 0.27-1.02;P=0.06),暗示甲强龙的应用有降低死亡率的趋势。

Similarly, Ellsworth et al indicated that there was no difference in mortality between patients with acute respiratory distress syndrome who received methylprednisolone (23 of 50 [46%]) and those who did not (21 of 34 [62%]; 95% CI, –40% to 8%; P = .23). There was a trend toward a better outcome, and the nonsignificant P value might indicate that this subgroup analysis was underpowered. We followed up with patients to hospital discharge or death. We agree that the follow-up might be substantially shorter than needed to observe steroid adverse effects. As we discussed,1 the findings in our cohort study should be interpreted with caution because of potential bias, residual confounding, and the small sample size.

相似地,Ellsworth等人研究表明对于急性呼吸窘迫综合征的病人接受(50人中23人,46%)和未接受(34人中21人,62%)甲泼尼龙治疗的病死率没有差异(95%可信区间 -40%至8%;P=0.23)。我们倾向于更好的研究结果,没有意义的P值可能暗示此亚组人群分析缺少效力。我们追踪了出院或者死亡的病人。我们赞成观察类固醇的副作用的实质上随访时间可能比需要的时间更短。如我们讨论过的一样,由于潜在偏倚、残余的混杂因素和小样本的原因,队列研究的结果应该被谨慎解释。

The role of corticosteroids in treating acute respiratory distress syndrome remains controversial and inconclusive.2 For patients with coronavirus disease 2019 (COVID-19), there are insufficient data to recommend for or against the use of systemic corticosteroids.3 Although our findings about methylprednisolone use contribute to the evidence base for the systemic corticosteroids in patients with COVID-19 and acute respiratory distress syndrome, well-designed double-blinded randomized clinical trials are needed.

糖皮质激素治疗急性呼吸窘迫综合征的作用仍是有争议和不确定的。对于新型冠状病毒肺炎的患者,没有充分的数据来推荐或反对全身性应用糖皮质激素。尽管我们对甲泼尼龙的研究结果有助于为新型冠状病毒肺炎和急性呼吸窘迫综合征患者的全身性糖皮质激素的应用提供证据基础,但是需要进一步实施良好设计的双盲随机临床试验。

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