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严重哮喘合并 SARS-CoV-2 感染患者使用生物制剂的安全性:一项前瞻性研究。

Safety of biologics in severe asthmatic patients with SARS-CoV-2 infection: A prospective study.

机构信息

Pediatric Respiratory Unit, Department of Clinical and Experimental Medicine, University of Catania, Catania, Italy.

Department of Human Pathology of Adult and Childhood Gaetano Barresi, Pediatric Unit, University of Messina, Messina, Italy.

出版信息

Pediatr Pulmonol. 2023 Apr;58(4):1085-1091. doi: 10.1002/ppul.26298. Epub 2023 Jan 13.

Abstract

BACKGROUND

Asthma guidelines have recommended continuing treatment with biologics during coronavirus disease 2019 (COVID-19) pandemic. However, a continuation of treatment with biologics in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been little investigated.

OBJECTIVE

To assess the safety of biologics in patients with SARS-CoV-2 infection.

METHODS

A pilot, monocentric, prospective study. Patients aged 6 years old and older with severe asthma on treatment with biologics and confirmed SARS-CoV-2 infection were enrolled. Patients were followed-up with periodic calls at different time points up to 3 months to detect any adverse effect and its relationship with biologic treatment according to the Naranjo Adverse Probability Scale (NAPS). The severity of SARS-CoV-2 infection and clinical outcome were also assessed.

RESULTS

Overall, we included 21 patients (10 on therapy with omalizumab, 9 with dupilumab, and 2 with mepolizumab). Only a patient-reported two local adverse events. No other adverse event was reported. Twenty out of 21 patients had a mild COVID-19 course, and no adverse outcome was observed.

CONCLUSION

We showed that the scheduled dose of the biologic therapy can be administered safely on time in patients with SARS-CoV-2 infection, as the treatment did not result in adverse events or outcomes.

摘要

背景

哮喘指南建议在 2019 年冠状病毒病(COVID-19)大流行期间继续使用生物制剂进行治疗。然而,针对严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)患者继续使用生物制剂的治疗方法尚未得到充分研究。

目的

评估 SARS-CoV-2 感染患者使用生物制剂的安全性。

方法

一项试点、单中心、前瞻性研究。纳入了正在接受生物制剂治疗且确诊 SARS-CoV-2 感染的年龄 6 岁及以上的重症哮喘患者。通过定期电话随访,在不同时间点随访患者 3 个月,以根据 Naranjo 不良反应概率量表(NAPS)检测任何不良反应及其与生物治疗的关系。还评估了 SARS-CoV-2 感染的严重程度和临床结局。

结果

总体而言,我们纳入了 21 例患者(10 例接受奥马珠单抗治疗,9 例接受度普利尤单抗治疗,2 例接受美泊利珠单抗治疗)。仅有 1 例患者报告了 2 例局部不良反应。未报告其他不良反应。21 例患者中有 20 例 COVID-19 病程较轻,未观察到不良结局。

结论

我们表明,SARS-CoV-2 感染患者可按时安全地给予生物制剂的既定剂量,因为治疗未导致不良反应或结局。

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