生物制剂在SARS-CoV-2感染严重哮喘患者中的安全性研究:一项前瞻性研究
2023/02/20
摘要
背景：哮喘指南建议在2019冠状病毒病(COVID-19)大流行期间继续使用生物制剂治疗。然而，在严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)患者中继续使用生物制剂治疗的研究很少。
目的：评估生物制剂在SARS-CoV-2感染患者中的安全性。
方法：一项试点、单中心、前瞻性研究。纳入了6岁及以上正在接受生物制剂治疗的严重哮喘患者，并确诊为SARS-CoV-2感染。根据Naranjo不良概率量表(NAPS)，对患者在不同时间点进行定期随访，随访时间长达3个月，以检测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：总的来说，我们纳入了21例患者(10例omalizumab治疗，9例dupilumab治疗，2例mepolizumab治疗)。只有一名患者报告了两起局部不良事件。无其他不良事件报告。21例患者中有20例病程轻，未观察到不良结局。
结论：我们的研究表明，在SARS-CoV-2感染患者中，生物疗法可以安全按时给予预定剂量，因为治疗没有导致不良事件或结局。
Safety of biologics in severe asthmatic patients with SARS-CoV-2 infection: A prospective study
S. Manti, A. Giallongo, G. Pecora, G. F. Parisi, M. Papale, E. Mule, et al.
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.
CONCLUSIONS: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.
背景：哮喘指南建议在2019冠状病毒病(COVID-19)大流行期间继续使用生物制剂治疗。然而，在严重急性呼吸综合征冠状病毒2 (SARS-CoV-2)患者中继续使用生物制剂治疗的研究很少。
目的：评估生物制剂在SARS-CoV-2感染患者中的安全性。
方法：一项试点、单中心、前瞻性研究。纳入了6岁及以上正在接受生物制剂治疗的严重哮喘患者，并确诊为SARS-CoV-2感染。根据Naranjo不良概率量表(NAPS)，对患者在不同时间点进行定期随访，随访时间长达3个月，以检测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：总的来说，我们纳入了21例患者(10例omalizumab治疗，9例dupilumab治疗，2例mepolizumab治疗)。只有一名患者报告了两起局部不良事件。无其他不良事件报告。21例患者中有20例病程轻，未观察到不良结局。
结论：我们的研究表明，在SARS-CoV-2感染患者中，生物疗法可以安全按时给予预定剂量，因为治疗没有导致不良事件或结局。
（中日友好医院呼吸与危重症医学科 李春晓 摘译 林江涛 审校）
（Pediatric Pulmonology 2023 DOI:10.1002/ppul.26298）
（Pediatric Pulmonology 2023 DOI:10.1002/ppul.26298）
Safety of biologics in severe asthmatic patients with SARS-CoV-2 infection: A prospective study
S. Manti, A. Giallongo, G. Pecora, G. F. Parisi, M. Papale, E. Mule, et al.
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.
CONCLUSIONS: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.
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贝那利珠单抗治疗OCS依赖性重症哮喘的疗效：真实世界研究2年治疗的效果
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补充石榴提取物是否能改善过敏性哮喘患者的临床症状？一项双盲、随机、安慰剂对照试验
