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阿莫西林与复方新诺明用于儿童疑似病毒性呼吸道感染:安慰剂对照试验

Amoxycillin and co-trimoxazole in presumed viral respiratory infections of childhood: placebo-controlled trial.

作者信息

Taylor B, Abbott G D, Kerr M M, Fergusson D M

出版信息

Br Med J. 1977 Aug 27;2(6086):552-4. doi: 10.1136/bmj.2.6086.552.

Abstract

A double-blind randomized controlled trial of amoxycillin, co-trimoxazole, and placebo was conducted on 197 children presenting with presumed viral respiratory infections. Routine throat swabs were taken to exclude streptococcal diseases. The three disease categories studied--nasopharyngitis, pharyngotonsillitis, and bronchitis (including laryngotracheobronchitis)--showed a generally similar pattern of resolution irrespective of treatment. Nevertheless, seven out of 66 children receiving placebo were withdrawn from the trial with unremitting symptoms or complications thought to require antimicrobial treatment. Only two of 56 children receiving amoxycillin and none of 75 receiving co-trimoxazole were withdrawn. Three other children receiving amoxycillin and three receiving placebo were seen during the trial but further treatment was not thought to be necessary. Thus the return consultation rate in children receiving placebo therapy was 15% compared with 4% for those receiving antimicrobial treatment. Antimicrobial treatment was associated with less nasal discharge on the eighth day of treatment. Placebo treatment allowed an earlier return to normal activity. There was a high incidence of possible side effects on all regimens including placebo. It is concluded that the benefits of antimicrobial treatment in presumed viral respiratory infections are marginal, and they should not be routinely prescribed for these conditions.

摘要

对197名疑似患有病毒性呼吸道感染的儿童进行了一项阿莫西林、复方新诺明和安慰剂的双盲随机对照试验。采集常规咽拭子以排除链球菌疾病。所研究的三类疾病——鼻咽炎、咽扁桃体炎和支气管炎(包括喉气管支气管炎)——无论接受何种治疗,其总体缓解模式相似。然而,66名接受安慰剂治疗的儿童中有7名因持续症状或被认为需要抗菌治疗的并发症而退出试验。接受阿莫西林治疗的56名儿童中只有2名退出,接受复方新诺明治疗的75名儿童中无人退出。在试验期间还观察到另外3名接受阿莫西林治疗的儿童和3名接受安慰剂治疗的儿童,但认为无需进一步治疗。因此,接受安慰剂治疗的儿童复诊率为15%,而接受抗菌治疗的儿童为4%。抗菌治疗在治疗的第8天与较少的鼻涕有关。安慰剂治疗能使儿童更早恢复正常活动。包括安慰剂在内的所有治疗方案都有较高的可能副作用发生率。得出的结论是,抗菌治疗在疑似病毒性呼吸道感染中的益处微乎其微,不应针对这些病症常规开处方。

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