布地奈德与沙丁胺醇作为轻度哮喘儿童（CARE）缓解剂治疗的比较：一项为期52周的开放标签、多中心、优越性、随机对照试验
2025/10/31
摘要
背景：与短效β2受体激动剂（SABA）单药治疗相比，联合吸入皮质类固醇-福莫特罗缓解剂单药治疗可降低成人哮喘发作率。其在儿童中的相对疗效尚未确定。
方法：CARE是一项为期52周的开放标签、平行组、多中心、优势、随机对照试验，在新西兰的15个临床试验地点使用SABA缓解剂单药治疗5-15岁哮喘儿童。参与者按1:1随机分配，分别接受布地奈德（50μg）-福莫特罗（3μg）、按需吸入2吸，或沙丁胺醇（100μg）、按需吸入2吸。主要结局是每位受试者的年哮喘发作率。该试验已在澳大利亚新西兰临床试验注册处注册，注册编号为ACTRN12620001091998。
结果：从2021年1月28日到2023年6月23日，本研究共评估了382名受试者的试验资格，并随机分配360名（94%）受试者接受治疗（布地奈德-福莫特罗组179名[50%]，沙丁胺醇组181名[50%]）。布地奈德-福莫特罗组的年哮喘发作率低于沙丁胺醇组，每名受试者每年的集群调整率为0.23比0.41（相对比率0.55[95%CI 0.35-0.86]；p=0.012）。布地奈德-福莫特罗组至少发生一次不良事件的受试者人数为162人（91%），沙丁胺醇组为167人（92%）（比值比0.79 [95%CI 0.35-1.79]）。
结论：在5-15岁轻度哮喘儿童中，布地奈德-福莫特罗缓解剂单一疗法在预防哮喘发作方面优于沙丁胺醇，安全性相似。
Budesonide-formoterol versus salbutamol as reliever therapy in children with mild asthma (CARE) a 52-week, open-label, multicentre, superiority, randomised controlled trial.
Hatter L, Holliday M, Oldfield K, Kearns C, Barry T, Black M, Bruce P, Colman A, Dickinson E, Eathorne A, Harwood M, Hills T, Lamb R, Kerse K, Krishnamoorthy S, Martindale J, Semprini A, Shortt N, McNamara D, Byrnes CA, Dalziel SR, Bush A, Weatherall M, Beasley R; CARE study team.
Abstract
BACKGROUND:Combination inhaled corticosteroid-formoterol reliever monotherapy reduces the rate of asthma attacks compared to short-acting β2-agonist (SABA) reliever monotherapy in adults. Its comparative efficacy in children has not been established.
METHODS:CARE was a 52-week, open-label, parallel-group, multicentre, superiority, randomised controlled trial in children aged 5-15 years with asthma using SABA reliever monotherapy at 15 clinical trials sites in New Zealand. Participants were randomly assigned (1:1) to either budesonide 50 μg-formoterol 3 μg, two actuations as needed, or salbutamol 100 μg, two actuations as needed. The primary outcome was asthma attacks as rate per participant per year. This trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN12620001091998.
RESULTS:From Jan 28, 2021, to June 23, 2023, we assessed 382 participants for eligibility. We randomly assigned 360 (94%) participants to treatment (179 [50%] to the budesonide-formoterol group and 181 [50%] to the salbutamol group). The annualised rate of asthma attacks was lower in the budesonide-formoterol group than in the salbutamol group-cluster-adjusted rates 0·23 versus 0·41 per participant per year (relative rate 0·55 [95% CI 0·35-0·86]; p=0·012). The number of participants with at least one adverse event was 162 (91%) in the budesonide-formoterol group and 167 (92%) in the salbutamol group (odds ratio 0·79 [95% CI 0·35-1·79]).
CONCLUSION: In children aged 5-15 years with mild asthma, budesonide-formoterol reliever monotherapy is superior to salbutamol for preventing asthma attacks, with a similar safety profile.
背景：与短效β2受体激动剂（SABA）单药治疗相比，联合吸入皮质类固醇-福莫特罗缓解剂单药治疗可降低成人哮喘发作率。其在儿童中的相对疗效尚未确定。
方法：CARE是一项为期52周的开放标签、平行组、多中心、优势、随机对照试验，在新西兰的15个临床试验地点使用SABA缓解剂单药治疗5-15岁哮喘儿童。参与者按1:1随机分配，分别接受布地奈德（50μg）-福莫特罗（3μg）、按需吸入2吸，或沙丁胺醇（100μg）、按需吸入2吸。主要结局是每位受试者的年哮喘发作率。该试验已在澳大利亚新西兰临床试验注册处注册，注册编号为ACTRN12620001091998。
结果：从2021年1月28日到2023年6月23日，本研究共评估了382名受试者的试验资格，并随机分配360名（94%）受试者接受治疗（布地奈德-福莫特罗组179名[50%]，沙丁胺醇组181名[50%]）。布地奈德-福莫特罗组的年哮喘发作率低于沙丁胺醇组，每名受试者每年的集群调整率为0.23比0.41（相对比率0.55[95%CI 0.35-0.86]；p=0.012）。布地奈德-福莫特罗组至少发生一次不良事件的受试者人数为162人（91%），沙丁胺醇组为167人（92%）（比值比0.79 [95%CI 0.35-1.79]）。
结论：在5-15岁轻度哮喘儿童中，布地奈德-福莫特罗缓解剂单一疗法在预防哮喘发作方面优于沙丁胺醇，安全性相似。
（中日友好医院呼吸与危重症医学科 张婧媛 摘译 林江涛 审校）
（Lancet. 2025;406(10511):1473-1483. doi:10.1016/S0140-6736(25)00861-X）
（Lancet. 2025;406(10511):1473-1483. doi:10.1016/S0140-6736(25)00861-X）
Budesonide-formoterol versus salbutamol as reliever therapy in children with mild asthma (CARE) a 52-week, open-label, multicentre, superiority, randomised controlled trial.
Hatter L, Holliday M, Oldfield K, Kearns C, Barry T, Black M, Bruce P, Colman A, Dickinson E, Eathorne A, Harwood M, Hills T, Lamb R, Kerse K, Krishnamoorthy S, Martindale J, Semprini A, Shortt N, McNamara D, Byrnes CA, Dalziel SR, Bush A, Weatherall M, Beasley R; CARE study team.
Abstract
BACKGROUND:Combination inhaled corticosteroid-formoterol reliever monotherapy reduces the rate of asthma attacks compared to short-acting β2-agonist (SABA) reliever monotherapy in adults. Its comparative efficacy in children has not been established.
METHODS:CARE was a 52-week, open-label, parallel-group, multicentre, superiority, randomised controlled trial in children aged 5-15 years with asthma using SABA reliever monotherapy at 15 clinical trials sites in New Zealand. Participants were randomly assigned (1:1) to either budesonide 50 μg-formoterol 3 μg, two actuations as needed, or salbutamol 100 μg, two actuations as needed. The primary outcome was asthma attacks as rate per participant per year. This trial was registered with the Australian New Zealand Clinical Trials Registry, ACTRN12620001091998.
RESULTS:From Jan 28, 2021, to June 23, 2023, we assessed 382 participants for eligibility. We randomly assigned 360 (94%) participants to treatment (179 [50%] to the budesonide-formoterol group and 181 [50%] to the salbutamol group). The annualised rate of asthma attacks was lower in the budesonide-formoterol group than in the salbutamol group-cluster-adjusted rates 0·23 versus 0·41 per participant per year (relative rate 0·55 [95% CI 0·35-0·86]; p=0·012). The number of participants with at least one adverse event was 162 (91%) in the budesonide-formoterol group and 167 (92%) in the salbutamol group (odds ratio 0·79 [95% CI 0·35-1·79]).
CONCLUSION: In children aged 5-15 years with mild asthma, budesonide-formoterol reliever monotherapy is superior to salbutamol for preventing asthma attacks, with a similar safety profile.
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