摘要
目的 评价中国医学文献中耳鼻咽喉疾病防治性研究随机对照试验 (randomizedcontrolledtrials,RCT)的质量 ,为改进和提高临床治疗试验的水平提供依据。方法 对中国可能刊登上述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 2 87期 ,共含论著 10 471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 中国耳鼻喉科疾病防治性研究RCT数量不足 ,临床研究的水平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。
Objective To evaluate the quality of randomized controlled trials (RCT) in otorhinolaryngology in China and offer evidence for the improvement of RCT. Methods Five kinds of Chinese journals of clinical otorhinolaryngology were searched, and RCTs were identified and analyzed according to the standards of Evidence Based Medicine. Results Two hundred and eighty seven issues were referred to, and eighty-one RCTs were finally identified and analyzed. Of these RCTs, 34.57% (28/81) had definite diagnostic standards, 38.27% (31/81) had including standards and 33.33% (27/81) had excluding 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 non of them 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 intervention; 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 following-up and only 1.23% (1/81) treated the loss with statistics methods. Conclusion The quantity and quality of otorhinolaryngological RCTs couldn′t meet the clinical need. More high quality RCTs are required to improve the level of prevention and cure of otorhinolaryngologic diseases.
出处
《中华耳鼻咽喉科杂志》
CAS
CSCD
北大核心
2002年第1期60-63,共4页
Chinese Journal of Otorhinolaryngology
关键词
流行病学
研究
耳鼻咽喉科学
随要对照试验
Epidemiologic studies
Otolaryngology
Randomized controlled trials
