Marchant C, Shurin P A
Rev Infect Dis. 1982 Mar-Apr;4(2):506-13. doi: 10.1093/clinids/4.2.506.
Twenty-five published trials of antibacterial therapy for acute otitis media were reviewed according to 13 methodologic standards for the design of clinical trials. Randomized, controlled trials, often with the double-blind technique, have been widely applied to assess efficacy. Bias can be further avoided by prognostic stratification according to known risk factors and by the measurement and analysis of patient compliance with treatment. A less frequently recognized problem is the insensitive trial. Bacteriologic diagnosis of the middle ear exudate before therapy can improve the sensitivity of clinical trials. The eradication of pathogens from the middle ear may be a more sensitive measure of outcome than the reduction of ear effusion. The analysis of type II statistical error should be included in trials that reveal no difference between antibacterial agents. The evaluation of new antibacterial agents for this important health problem requires rigorous research design.
根据13项临床试验设计的方法学标准，对25项已发表的急性中耳炎抗菌治疗试验进行了综述。随机对照试验，通常采用双盲技术，已被广泛应用于评估疗效。根据已知风险因素进行预后分层，以及测量和分析患者对治疗的依从性，可以进一步避免偏差。一个较少被认识到的问题是不敏感试验。治疗前对中耳渗出液进行细菌学诊断可以提高临床试验的敏感性。从中耳清除病原体可能是比减少耳积液更敏感的疗效衡量指标。在抗菌药物之间未显示出差异的试验中，应包括对II型统计误差的分析。对这一重要健康问题的新型抗菌药物进行评估需要严格的研究设计。
