PT -期刊文章盟Wang凯盟,出身低微的马尔科姆·g . AU -摩尔,迈克尔AU -干草,阿拉斯泰尔•d . AU -吨沙龙AU -加拉,阿诗玛河AU - Grabey离小岛很近,詹娜盟卡佛,特里西娅AU -佩雷拉,拉斐尔AU - Yu Ly-Mee盟——Mollison吉尔盟,小保罗盟——农民,Andrew AU -巴特勒,克里斯托弗·c . AU - Harnden安东尼TI -风险的早期使用抗生素的儿童流感样疾病(奇):双盲随机安慰剂对照试验AID - 10.1188 /13993003.02819-2020 DP - 2021年10月01日TA -欧洲呼吸杂志PG - 2002819 VI - 58 IP - 4 4099 - //www.qdcxjkg.com/content/58/4/2002819.short 4100 - //www.qdcxjkg.com/content/58/4/2002819.full SO - Eur Respir J2021年10月01日;英国政府储备复方阿莫昔拉夫(co-amoxiclav),以治疗流感大流行期间的细菌并发症。这项实用试验研究了早期联合阿莫昔拉夫的使用是否减少了在初级或门诊护理中出现流感样疾病(ILI)的“危险”儿童因临床恶化而再次咨询。方法发病5天内出现ILI的6个月至12岁“高危”儿童随机分配口服复方阿莫昔拉夫400/57或安慰剂,每日2次,连续5天(剂量根据年龄±体重)。“高危”群体包括患有呼吸系统、心脏和神经系统疾病的儿童。随机分组按地区分层,并使用非确定性最小化算法来平衡年龄和当前季节性流感疫苗接种状态。我们的目标样本量为650名儿童,这将使我们能够检测到由于临床恶化而重新咨询的儿童比例从40%下降到26%,具有90%的功率和5%的双尾alpha误差(包括25%的随访损失和1.041的膨胀因子)。参与者、护理人员和调查人员对治疗分配不知情。意向治疗分析包括所有随机受试者,在28天内由于临床恶化而再次咨询的主要结果数据。 Safety analysis included all randomised participants. Trial registration: ISRCTN 70714783. EudraCT 2013-002822-21.Results We recruited 271 children between February 11, 2015 and April 20, 2018. Primary outcome data were available for 265 children. Only 61 out of 265 children (23.0%) reconsulted due to clinical deterioration. No evidence of a treatment effect was observed for reconsultation due to clinical deterioration (33 out of 133 for co-amoxiclav (24.8%) and 28 out of 132 (21.2%) for placebo; adjusted risk ratio (RR) 1.16, 95% confidence interval (CI) 0.75–1.80). There was also no evidence of a difference between groups in the proportion of children for whom one or more adverse events (AEs) were reported (32 out of 136 (23.5%) for co-amoxiclav and 22 out of 135 (16.3%) for placebo; adjusted RR 1.45, 95% CI 0.90–2.34). In total, 66 AEs were reported (co-amoxiclav, n=37; placebo, n=29). Nine serious AEs were reported per group, although none were considered related to study medication.Conclusion Our trial did not find evidence that treatment with co-amoxiclav reduces risk of reconsultation due to clinical deterioration in “at risk” children who present early with ILI during influenza season. Our findings therefore do not support early co-amoxiclav use in children with seasonal ILI.This trial did not find evidence that early co-amoxiclav use reduces reconsultation due to clinical deterioration in “at risk” children who present with influenza-like illness during influenza season https://bit.ly/3stZwnn