NEJM:急性中耳炎患儿，抗菌治疗有效吗？
2011-12-10 NEJM NEJM
背景 对抗菌治疗在急性中耳炎患儿中的有效性仍有争议。 方法 在这项随机、双盲试验中， 年龄为6~35个月有急性中耳炎（采用严格的标准诊断）的患儿接受了阿莫西林―克拉维酸（161例患儿）治疗或安慰剂（158例患儿），共7天。主要转归是至治疗失败的时间，从首剂到第8天治疗结束随访时。治疗失败的定义是以患儿的总体状况（包括不良事件）和急性中耳炎的耳镜检查体征为基础的。 结果 治疗失败发生
背景 对抗菌治疗在急性中耳炎患儿中的有效性仍有争议。
方法 在这项随机、双盲试验中， 年龄为6~35个月有急性中耳炎（采用严格的标准诊断）的患儿接受了阿莫西林―克拉维酸（161例患儿）治疗或安慰剂（158例患儿），共7天。主要转归是至治疗失败的时间，从首剂到第8天治疗结束随访时。治疗失败的定义是以患儿的总体状况（包括不良事件）和急性中耳炎的耳镜检查体征为基础的。
结果 治疗失败发生于18.6%接受阿莫西林―克拉维酸治疗的患儿中，相比之下，发生于44.9%接受安慰剂的患儿中（P<0.001）。在首次安排的随访时（第3天）组间差异已经显而易见，此时13.7%接受阿莫西林―克拉维酸治疗的患儿发生了治疗失败，相比之下25.3%接受安慰剂的患儿发生了治疗失败。总体上，阿莫西林―克拉维酸使进展到治疗失败的情况减少了62%[风险比为0.38；95%可信区间（CI） 0.25~0.59，P<0.001]，并使需要挽救治疗的情况减少了81%（6.8% 对 33.5%，风险比为0.19；95% CI 0.10~0.36，P<0.001）。阿莫西林―克拉维酸组84.2%的患儿以及安慰剂组85.9%的患儿被分别给予镇痛药或解热药。阿莫西林― 克拉维酸组的不良事件显著比安慰剂组常见。阿莫西林―克拉维酸组共有47.8%的患儿发生了腹泻，相比之下安慰剂组有26.6% 的患儿发生了腹泻 （P<0.001）；各组分别有8.7%和3.2%的患儿出现了湿疹 （P=0.04）。
结论 与安慰剂相比，有急性中耳炎的患儿可从抗菌治疗中获益，尽管它们有更多的副作用。未来的研究应识别出有可能获得最大益处的患者，以便使不必要的抗菌治疗以及细菌耐药的发生减至最少。
下面是临床试验患儿的筛选流程，这也反映了临床试验的严谨性，值得学习。
原始出处：
BACKGROUND:
The efficacy of antimicrobial treatment in children with acute otitis media remains controversial.
METHODS:
In this randomized, double-blind trial, children 6 to 35 months of age with acute otitis media, diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media.
RESULTS:
Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P<0.001). The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001) and the need for rescue treatment by 81% (6.8% vs. 33.5%; hazard ratio, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group (P<0.001); 8.7% and 3.2% of the children in the respective groups had eczema (P=0.04).
CONCLUSIONS:
Children with acute otitis media benefit from antimicrobial treatment as compared with placebo, although they have more side effects. Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance. (Funded by the Foundation for Paediatric Research and others; ClinicalTrials.gov number, NCT00299455.).
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#抗菌治疗#
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#抗菌#
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#中耳炎#
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