Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.

Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma.
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DOI:
10.1056/nejmoa1515990
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发表时间:
2016-08-18
期刊:
The New England journal of medicine
影响因子:
--
通讯作者:
NIH/NHLBI AsthmaNet
NIH/NHLBI AsthmaNet
中科院分区:
其他
文献类型:
--
作者:
Sheehan WJ;Mauger DT;Paul IM;Moy JN;Boehmer SJ;Szefler SJ;Fitzpatrick AM;Jackson DJ;Bacharier LB;Cabana MD;Covar R;Holguin F;Lemanske RF Jr;Martinez FD;Pongracic JA;Beigelman A;Baxi SN;Benson M;Blake K;Chmiel JF;Daines CL;Daines MO;Gaffin JM;Gentile DA;Gower WA;Israel E;Kumar HV;Lang JE;Lazarus SC;Lima JJ;Ly N;Marbin J;Morgan WJ;Myers RE;Olin JT;Peters SP;Raissy HH;Robison RG;Ross K;Sorkness CA;Thyne SM;Wechsler ME;Phipatanakul W;NIH/NHLBI AsthmaNet

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研究表明,频繁使用对乙酰氨基酚与儿童哮喘相关并发症之间存在关联,因此一些医生建议哮喘儿童避免使用对乙酰氨基酚;然而,缺乏适当设计的试验来评估儿童中的这种关联。在一项多中心、前瞻性、随机、双盲、平行组试验中,我们招募了 300 名患有轻度持续性哮喘的儿童(年龄范围为 12 至 59 个月),并让他们在需要时接受对乙酰氨基酚或布洛芬治疗,以在 48 周内缓解发烧或疼痛。主要结果是导致全身性糖皮质激素治疗的哮喘发作次数。两个治疗组的儿童都接受了标准化的哮喘控制疗法,这些疗法用于同时进行的因子关联试验。参与者平均接受了 5.5 剂试验药物(四分位数范围,1.0 至 15.0);接受剂量的中位数没有显着组间差异(P = 0.47)。两组之间的哮喘发作次数没有显着差异,在 46 周的随访期间,每位服用对乙酰氨基酚的参与者平均为 0.81 次,每位服用布洛芬的参与者平均为 0.87 次(对乙酰氨基酚组与布洛芬组的哮喘发作相对发生率为 0.94;95% 置信区间为 0.69 至 1.28;P = 0.67)。在对乙酰氨基酚组中,49% 的参与者至少出现过一次哮喘发作,21% 的参与者至少出现过两次,而布洛芬组中这一比例分别为 47% 和 24%。同样,对乙酰氨基酚和布洛芬在哮喘控制天数百分比(分别为 85.8% 和 86.8%;P = 0.50)、沙丁胺醇救援吸入器的使用(分别为每周 2.8 次和 3.0 次吸入;P = 0.69)、未安排的哮喘医疗保健利用(每位参与者分别为 0.75 次和 0.76 次发作;P = 0.69)方面没有检测到显着差异。 P = 0.94),或不良事件。在患有轻度持续性哮喘的幼儿中,与按需使用布洛芬相比,按需使用对乙酰氨基酚并未显示出与更高的哮喘发作发生率或较差的哮喘控制相关。 (由美国国立卫生研究院资助;AVICA ClinicalTrials.gov 编号,NCT01606319。)
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. 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. 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. 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.)