摘要
目的 评价我国医学文献中耳鼻咽喉疾病防治性研究随机对照试验(randomized controlled trials,RCT)的质量,了解其是否能为临床实践提供可靠的决策证据,为改进和提高临床治疗试验的水平提供依据。方法 对我国可能刊登上述RCT的5种耳鼻咽喉科学期刊进行人工检索并根据国际循证医学标准对其中的RCT报告进行分析。结果查阅杂志287期,共含论著10471篇,检索出RCT报告81篇,并从研究对象的选择、样本含量、随机方法、组间可比性、试验措施、对照措施、盲法、疗效评价指标、干预措施临床效果的报道、随访及失访问题等几个方面进行分析。结论我国耳鼻喉科疾病防治性研究RCT数量不足,质量距循证医学标准还有较大距离,尚不能满足临床实践的需要。更多开展高质量RCT研究对于提高耳鼻喉科疾病的防治水平具有特别重要的意义。
Objective To evaluate the quality of randomized controlled trials in otorhinolarvngology in China and provide 10 comprehend the possihility of its contribution in providing reliable evidence in clinical practice; thus providing evidence to elevate the clinical treatment level. Methods Five Chinese clinical otorhinolaryngology journals were searched and randomized controlled trials were identified and analysed according to the standards of evidence-based medicine. Results Two hundred and eighty seven issues were referred to and eighty-one randomized controlled trials were identified and analysed. Of these randomized controlled trials, 34.57% (28/81 ) had definite diagnostic standards, 38.27% (31/81 ) had inclusion standards and 33.33% (27/81) had exclusion standards ; only 1 .23% (1/81) got the approval of the participants; 40.74% (33/81 ) had moderate sample size; 3.70% (3/81) had large sample size and no one mentioned sample size estimation;81 .48% (66/81 ) didn't report the method of randomization and 38.27% (31/81 ) had baseline comparison; 18.52% (15/81 ) didn' t define the control interventions and 8.64% (7/81) even didn' t explicate the experimental intcrventions-,32.10%(26/81) used blank comparison-, 86.42 %( 70/81 ) didn't use blindness; 37 .04% (30/81) didn't mention the adverse effects; 23.46% (19/81) used accredited standards to evaluate the outcomes; 11.11% (9/81) mentioned the loss of participants and only 1 .23% (1 /81) treated the loss with statistics methods. Conclusions The quantity and quality of the otorhinolaryngologic randomized controlled trials in present review can not meet the clinical need. Higher quality of randomized controlled trials are required to improve the level of prevention and the treatment of otorhinolaryngologic diseases.
