门诊学前儿童在非复杂社区获得的肺炎治疗:低剂量或高剂量阿莫西林3 - 7天的比较。英国capit RCT的结果

Gruppo di lettura di Parma
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引用次数: 0

摘要

学龄前ED出院儿童无并发症社区获得性肺炎的治疗:低剂量与高剂量阿莫西林3天或7天的比较这项研究是第一个在西方国家进行的使用3天治疗无并发症社区获得性肺炎(CAP)的研究,该研究已经在中低收入国家进行了多次试验。本研究在英国进行,是一项具有良好方法学质量的双盲随机对照试验。该研究比较了4种不同治疗方案的剂量(高或低)和持续时间(3或7天)与安慰剂的疗效,治疗了824名6个月以上、体重在6至24kg之间的CAP患儿,这些患儿从急诊室或医院出院。在所有方案中,约有12%的病例需要在随机分组后28天内对新呼吸道感染进行进一步抗生素治疗;5%的入组儿童发生严重不良事件,需要住院治疗。两组均表现出非劣效性,剂量和持续时间之间没有显著的相互作用。在入组时症状较严重的亚组(即至少有两项胸廓生理参数改变的亚组)中,17.3%的低剂量组与13.5%的高剂量组在第28天前需要额外的抗生素治疗,但差异无统计学意义。讨论了与非劣效性设计和研究人群组成有关的限制,这些限制了结果的可转移性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Terapia per la polmonite acquisita in comunità non complicata in bambini in età prescolare dimessi a domicilio: confronto tra Amoxicillina a basso o alto dosaggio per 3 o 7 giorni. I risultati del RCT inglese CAP-IT
Therapy for uncomplicated community-acquired pneumonia in preschool children discharged from ED: comparison of low-dose or high-dose Amoxicillin for 3 or 7 days. Results of the English RCT CAP-IT This study is the first one performed in Western countries that used a 3-day therapy for uncomplicated community-acquired pneumonia (CAP), already tested several times in low- and medium-income countries. This study, carried out in UK, is a double-blind RCT of good methodological quality. The study compared the efficacy of 4 different therapeutic regimens by dose (high or low) and by duration (3 or 7 days) versus placebo, in the treatment of 824 children older than 6 months and weighing between 6 and 24kg with CAP, discharged from emergency room or hospital. Approximately 12% of cases across all regimens require further antibiotic therapy for a new respiratory infection within 28 days from randomization; 5% of children enrolled experienced a severe adverse event requiring hospitalization. Both groups demonstrated noninferiority with no significant interaction between doses and duration. In the subgroup with more severe symptoms at enrolment (i.e., those with at least two altered thoracic physiologic parameters) 17.3% of recipients of a lower dose versus 13.5% of those treated with the higher dose require additional antibiotic therapy by 28th day, but the difference is not statistically significant. The limitations related to the non-inferiority design and the composition of the studied population, which limit the transferability of the results, are discussed.
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