Stalman W, van Essen G A, van der Graaf Y, de Melker R A
Department of General Practice, University of Utrecht, The Netherlands.
Fam Pract. 1997 Apr;14(2):124-9. doi: 10.1093/fampra/14.2.124.
In general practice, acute sinusitis is frequently diagnosed and treated with antibiotics.
This study aimed to determine the evidence for the effectiveness of antibiotic treatment in acute maxillary sinusitis in adults by assessing the methodological quality of placebo-controlled double-blind randomized trials.
An evaluation by four raters through a 35-item scoring-scale for internal and external validity of all placebo-controlled double-blind randomized trials on acute sinusitis found between January 1966 and July 1996.
Eighty-five trials were excluded because they were not placebo-controlled, double-blind, randomized, or were carried out in patients with chronic sinusitis or in children. The three remaining trials were performed in different populations (one in general practice) between 1973 and 1978. Only one study claimed superiority of antibiotic treatment. Different inclusion criteria and major outcome measures were used by the authors. The reliability of major outcome events was reported poorly or not at all and in two studies outcome measures were clinically inappropriate. The studies scored 30-62% of the maximum attainable score for internal validity and 10-20% for external validity.
The effectiveness of antibiotic treatment in acute maxillary sinusitis in a general practice population is not based sufficiently on evidence.
在一般医疗实践中，急性鼻窦炎常使用抗生素进行诊断和治疗。
本研究旨在通过评估安慰剂对照双盲随机试验的方法学质量，确定抗生素治疗成人急性上颌窦炎有效性的证据。
由四位评估者通过一个35项评分量表，对1966年1月至1996年7月间发现的所有关于急性鼻窦炎的安慰剂对照双盲随机试验的内部和外部有效性进行评估。
85项试验被排除，原因是它们未采用安慰剂对照、双盲、随机设计，或是在慢性鼻窦炎患者或儿童中进行。其余三项试验于1973年至1978年间在不同人群中开展（其中一项在一般医疗实践中）。只有一项研究声称抗生素治疗具有优越性。作者们使用了不同的纳入标准和主要结局指标。主要结局事件的可靠性报告不佳或根本未报告，且在两项研究中结局指标在临床上不恰当。这些研究的内部有效性得分占可达到的最高分数的30% - 62%，外部有效性得分占10% - 20%。
在一般医疗实践人群中，抗生素治疗急性上颌窦炎的有效性缺乏充分的证据支持。
