地塞米松与甲基强的松龙治疗重症哮喘：一个单中心、开放标签、平行组的临床试验
2023/04/21
摘要
背景：使用地塞米松治疗小儿重症哮喘的证据是有限的。我们试图比较地塞米松与甲基强的松龙在小儿重症监护室（PICU）住院的重症哮喘患儿中的临床疗效和安全性。
方法：一项针对2019年4月至2021 12月在PICU住院治疗的5-17岁危重哮喘儿童的前瞻性、单中心、开放标签、双臂、平行组、非随机试验，同意分别以2:1的分配比例接受甲基强的松龙（标准护理）或地塞米松（干预）。干预组每6小时静脉注射地塞米松0.25 mg/kg/剂量（最大：15 mg/剂量），持续48小时，标准护理组每6 h静脉注射甲基强的松龙1 mg/kg/剂量，持续5天。研究终点是临床疗效（即住院时间[LOS]、持续沙丁胺醇持续时间和辅助哮喘干预的组合）和安全性（即皮质类固醇相关不良事件）。
结果：对92名参与者进行了分析，其中31人被分配到干预组，61人被分配给标准护理组。在人口统计学、临床特征或急性/慢性哮喘严重程度指数方面没有观察到差异。关于疗效和安全性终点，在住院服务水平、持续沙丁胺醇持续时间、辅助哮喘干预率或皮质类固醇相关不良事件方面没有差异。与干预组相比，标准护理组的参与者出院时更频繁地服用皮质类固醇（72%对13%，p<0.001）。
结论：在因危重哮喘住院的儿童中，地塞米松似乎是安全的，值得进一步调查，以充分评估临床疗效和与常用药物如甲基强的松龙相比的潜在优势。
Dexamethasone versus methylprednisolone for critical asthma: A single center, open-label, parallel-group clinical trial
Roddy, M. R., Sellers, A. R., Darville, K. K., Teppa-Sanchez, B., McKinley, S. D., Martin, M., Goldenberg, N. A., Nakagawa, T. A., & Sochet, A. A.
Abstract
BACKGROUND:Evidence for the use of dexamethasone for pediatric critical asthma is limited. We sought to compare the clinical efficacy and safety of dexamethasone versus methylprednisolone among children hospitalized in the pediatric intensive care unit (PICU) for critical asthma.
METHODS:A prospective, single center, open-label, two-arm, parallel-group, nonrandomized trial among children ages 5-17 years hospitalized within the PICU from April 2019 to December 2021 for critical asthma consented to receive methylprednisolone (standard care) or dexamethasone (intervention) at a 2:1 allocation ratio, respectively. The intervention arm received intravenous dexamethasone 0.25 mg/kg/dose (max: 15 mg/dose) every 6 h for 48 h and the standard care arm intravenous methylprednisolone 1 mg/kg/dose every 6 h (max dose: 60 mg/dose) for 5 days. Study endpoints were clinical efficacy (i.e., length of stay [LOS], continuous albuterol duration, and a composite of adjunctive asthma interventions) and safety (i.e., corticosteroid-related adverse events).
RESULTS:Ninety-two participants were analyzed of whom 31 were allocated to the intervention arm and 61 the standard care arm. No differences in demographics, clinical characteristics, or acute/chronic asthma severity indices were observed. Regarding efficacy and safety endpoints, no differences in hospital LOS, continuous albuterol duration, adjunctive asthma intervention rates, or corticosteroid-related adverse events were noted. Compared to the intervention arm, participants in the standard care arm more frequently were prescribed corticosteroids at discharge (72% vs. 13%, p < 0.001).
CONCLUSION:Among children hospitalized for critical asthma, dexamethasone appears safe and warrants further investigation to fully assess clinical efficacy and potential advantages over commonly applied agents such as methylprednisolone.
背景：使用地塞米松治疗小儿重症哮喘的证据是有限的。我们试图比较地塞米松与甲基强的松龙在小儿重症监护室（PICU）住院的重症哮喘患儿中的临床疗效和安全性。
方法：一项针对2019年4月至2021 12月在PICU住院治疗的5-17岁危重哮喘儿童的前瞻性、单中心、开放标签、双臂、平行组、非随机试验，同意分别以2:1的分配比例接受甲基强的松龙（标准护理）或地塞米松（干预）。干预组每6小时静脉注射地塞米松0.25 mg/kg/剂量（最大：15 mg/剂量），持续48小时，标准护理组每6 h静脉注射甲基强的松龙1 mg/kg/剂量，持续5天。研究终点是临床疗效（即住院时间[LOS]、持续沙丁胺醇持续时间和辅助哮喘干预的组合）和安全性（即皮质类固醇相关不良事件）。
结果：对92名参与者进行了分析，其中31人被分配到干预组，61人被分配给标准护理组。在人口统计学、临床特征或急性/慢性哮喘严重程度指数方面没有观察到差异。关于疗效和安全性终点，在住院服务水平、持续沙丁胺醇持续时间、辅助哮喘干预率或皮质类固醇相关不良事件方面没有差异。与干预组相比，标准护理组的参与者出院时更频繁地服用皮质类固醇（72%对13%，p<0.001）。
结论：在因危重哮喘住院的儿童中，地塞米松似乎是安全的，值得进一步调查，以充分评估临床疗效和与常用药物如甲基强的松龙相比的潜在优势。
(中日友好医院呼吸与危重症医学科 沈焜路 摘译 林江涛 审校)
(Pediatr Pulmonol. 2023 Mar 17; DOI: 10.1002/ppul.26386)
(Pediatr Pulmonol. 2023 Mar 17; DOI: 10.1002/ppul.26386)
Dexamethasone versus methylprednisolone for critical asthma: A single center, open-label, parallel-group clinical trial
Roddy, M. R., Sellers, A. R., Darville, K. K., Teppa-Sanchez, B., McKinley, S. D., Martin, M., Goldenberg, N. A., Nakagawa, T. A., & Sochet, A. A.
Abstract
BACKGROUND:Evidence for the use of dexamethasone for pediatric critical asthma is limited. We sought to compare the clinical efficacy and safety of dexamethasone versus methylprednisolone among children hospitalized in the pediatric intensive care unit (PICU) for critical asthma.
METHODS:A prospective, single center, open-label, two-arm, parallel-group, nonrandomized trial among children ages 5-17 years hospitalized within the PICU from April 2019 to December 2021 for critical asthma consented to receive methylprednisolone (standard care) or dexamethasone (intervention) at a 2:1 allocation ratio, respectively. The intervention arm received intravenous dexamethasone 0.25 mg/kg/dose (max: 15 mg/dose) every 6 h for 48 h and the standard care arm intravenous methylprednisolone 1 mg/kg/dose every 6 h (max dose: 60 mg/dose) for 5 days. Study endpoints were clinical efficacy (i.e., length of stay [LOS], continuous albuterol duration, and a composite of adjunctive asthma interventions) and safety (i.e., corticosteroid-related adverse events).
RESULTS:Ninety-two participants were analyzed of whom 31 were allocated to the intervention arm and 61 the standard care arm. No differences in demographics, clinical characteristics, or acute/chronic asthma severity indices were observed. Regarding efficacy and safety endpoints, no differences in hospital LOS, continuous albuterol duration, adjunctive asthma intervention rates, or corticosteroid-related adverse events were noted. Compared to the intervention arm, participants in the standard care arm more frequently were prescribed corticosteroids at discharge (72% vs. 13%, p < 0.001).
CONCLUSION:Among children hospitalized for critical asthma, dexamethasone appears safe and warrants further investigation to fully assess clinical efficacy and potential advantages over commonly applied agents such as methylprednisolone.
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Tezepelumab治疗重症、未控制哮喘的疗效：PATHWAY和NAVIGATOR研究的汇总分析
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应用ICS-福莫特罗或ICS-沙美特罗维持治疗的哮喘患者中按需福莫特罗的安全性和有效性
