在轻度持续性哮喘的儿童中使用对乙酰氨基酚和布洛芬的对比
2017/07/12
摘要
背景：研究表明，儿童经常使用对乙酰氨基酚会引起哮喘相关的并发症，导致有些医生建议哮喘小儿避免使用对乙酰氨基酚；然而，目前并没有合理的试验设计来评价儿童群体中的这种现象。
方法：在一项多中心、前瞻性、随机、双盲、平行对照试验中，我们纳入了患有轻度持续性哮喘的300名幼儿（年龄为12至59个月），当他们需要缓解发热或疼痛的症状时使他们分别接受对乙酰氨基酚或布洛芬治疗，疗程为48周内。主要结果是需要应用全身糖皮质激素治疗的哮喘急性发作的次数。两个治疗组的幼儿都接受了同步的规范的哮喘控制治疗。
结果：参与者平均接受5.5剂量（四分位距为1-15）的试验药物；接受药物治疗的剂量的中位数无明显组间差异（P = 0.47）。两组之间哮喘急性发作次数没有显著差异，在随后的46周随访里，接受对乙酰氨基酚和布洛芬的每位受试者平均发作次数为0.81和0.87（对乙酰氨基酚组比布洛芬组的相对哮喘加重率为0.94；95%置信区间，0.69-1.28；P = 0.67）。在对乙酰氨基酚组，49%的参与者都至少有一次哮喘发作，21%的参与者至少有两次，而布洛芬组分别为47%和24%。同样，对乙酰氨基酚和布洛芬组之间的哮喘控制天数比例（分别为85.8%和86.8%；P = 0.50），沙丁胺醇的使用次数（分别2.8/周和3.2次/周；P = 0.69），因哮喘而发生的计划外的医疗卫生使用次数（分别为每个受试者0.75和0.76次；P = 0.94），或不良事件的发生次数均无显著性差异。
结论：在轻度持续性哮喘的儿童中，按需使用对乙酰氨基酚哮喘急性发作的发病率以及哮喘控制状况与布洛芬没有显著差异。（由美国国立卫生研究院资助；AVICA ClinicalTrials.gov，nct01606319。）
Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma
W.J. Sheehan, D.T. Mauger, I.M. Paul, J.N. Moy, S.J. Boehmer, S.J. Szefler, A.M. Fitzpatrick, D.J. Jackson, L.B. Bacharier, M.D. Cabana, R. Covar, F. Holguin, R.F. Lemanske Jr., F.D. Martinez, J.A. Pongracic, A. Beigelman, S.N. Baxi, M. Benson, K. Blake, J.F. Chmiel, C.L. Daines, M.O. Daines, J.M. Gaffin, D.A. Gentile, W.A. Gower, E. Israel, H.V. Kumar, J.E. Lang, S.C. Lazarus, J.J. Lima, N. Ly, J. Marbin, W.J. Morgan, R.E. Myers, J.T. Olin, S.P. Peters, H.H. Raissy, R.G. Robison, K. Ross, C.A. Sorkness, S.M. Thyne, M.E. Wechsler, and W. Phipatanakul for the NIH/NHLBI AsthmaNet*.
Abstract
BACKGROUND:Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking.
METHODS:In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both treatment groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial.
RESULTS:Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P = 0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P = 0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P = 0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P = 0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P = 0.94), or adverse events.
CONCLUSIONS:Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.)
背景：研究表明，儿童经常使用对乙酰氨基酚会引起哮喘相关的并发症，导致有些医生建议哮喘小儿避免使用对乙酰氨基酚；然而，目前并没有合理的试验设计来评价儿童群体中的这种现象。
方法：在一项多中心、前瞻性、随机、双盲、平行对照试验中，我们纳入了患有轻度持续性哮喘的300名幼儿（年龄为12至59个月），当他们需要缓解发热或疼痛的症状时使他们分别接受对乙酰氨基酚或布洛芬治疗，疗程为48周内。主要结果是需要应用全身糖皮质激素治疗的哮喘急性发作的次数。两个治疗组的幼儿都接受了同步的规范的哮喘控制治疗。
结果：参与者平均接受5.5剂量（四分位距为1-15）的试验药物；接受药物治疗的剂量的中位数无明显组间差异（P = 0.47）。两组之间哮喘急性发作次数没有显著差异，在随后的46周随访里，接受对乙酰氨基酚和布洛芬的每位受试者平均发作次数为0.81和0.87（对乙酰氨基酚组比布洛芬组的相对哮喘加重率为0.94；95%置信区间，0.69-1.28；P = 0.67）。在对乙酰氨基酚组，49%的参与者都至少有一次哮喘发作，21%的参与者至少有两次，而布洛芬组分别为47%和24%。同样，对乙酰氨基酚和布洛芬组之间的哮喘控制天数比例（分别为85.8%和86.8%；P = 0.50），沙丁胺醇的使用次数（分别2.8/周和3.2次/周；P = 0.69），因哮喘而发生的计划外的医疗卫生使用次数（分别为每个受试者0.75和0.76次；P = 0.94），或不良事件的发生次数均无显著性差异。
结论：在轻度持续性哮喘的儿童中，按需使用对乙酰氨基酚哮喘急性发作的发病率以及哮喘控制状况与布洛芬没有显著差异。（由美国国立卫生研究院资助；AVICA ClinicalTrials.gov，nct01606319。）
(中日友好医院医院呼吸与危重症医学科 李笑艳摘译 林江涛审校)
(N Engl J Med. 2016 August 18; 375(7): 619–630. doi:10.1056/NEJMoa1515990.)
(N Engl J Med. 2016 August 18; 375(7): 619–630. doi:10.1056/NEJMoa1515990.)
Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma
W.J. Sheehan, D.T. Mauger, I.M. Paul, J.N. Moy, S.J. Boehmer, S.J. Szefler, A.M. Fitzpatrick, D.J. Jackson, L.B. Bacharier, M.D. Cabana, R. Covar, F. Holguin, R.F. Lemanske Jr., F.D. Martinez, J.A. Pongracic, A. Beigelman, S.N. Baxi, M. Benson, K. Blake, J.F. Chmiel, C.L. Daines, M.O. Daines, J.M. Gaffin, D.A. Gentile, W.A. Gower, E. Israel, H.V. Kumar, J.E. Lang, S.C. Lazarus, J.J. Lima, N. Ly, J. Marbin, W.J. Morgan, R.E. Myers, J.T. Olin, S.P. Peters, H.H. Raissy, R.G. Robison, K. Ross, C.A. Sorkness, S.M. Thyne, M.E. Wechsler, and W. Phipatanakul for the NIH/NHLBI AsthmaNet*.
Abstract
BACKGROUND:Studies have suggested an association between frequent acetaminophen use and asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with asthma; however, appropriately designed trials evaluating this association in children are lacking.
METHODS:In a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with mild persistent asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both treatment groups received standardized asthma-controller therapies that were used in a simultaneous, factorially linked trial.
RESULTS:Participants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group difference in the median number of doses received (P = 0.47). The number of asthma exacerbations did not differ significantly between the two groups, with a mean of 0.81 per participant with acetaminophen and 0.87 per participant with ibuprofen over 46 weeks of follow-up (relative rate of asthma exacerbations in the acetaminophen group vs. the ibuprofen group, 0.94; 95% confidence interval, 0.69 to 1.28; P = 0.67). In the acetaminophen group, 49% of participants had at least one asthma exacerbation and 21% had at least two, as compared with 47% and 24%, respectively, in the ibuprofen group. Similarly, no significant differences were detected between acetaminophen and ibuprofen with respect to the percentage of asthma-control days (85.8% and 86.8%, respectively; P = 0.50), use of an albuterol rescue inhaler (2.8 and 3.0 inhalations per week, respectively; P = 0.69), unscheduled health care utilization for asthma (0.75 and 0.76 episodes per participant, respectively; P = 0.94), or adverse events.
CONCLUSIONS:Among young children with mild persistent asthma, as-needed use of acetaminophen was not shown to be associated with a higher incidence of asthma exacerbations or worse asthma control than was as-needed use of ibuprofen. (Funded by the National Institutes of Health; AVICA ClinicalTrials.gov number, NCT01606319.)
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酪氨酸激酶抑制剂伊马替尼对重度难治性哮喘患者的作用
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Benralizumab在重症哮喘治疗中的激素节减效应
