窝沟封闭剂临床试验设计的考虑要点

Considerations of clinical trials design on pit and fissure sealants

目的通过设计评价窝沟封闭剂临床疗效的随机对照试验,探讨同类试验方案规范性设计要点,为设计证据等级高、结果可靠性强的临床试验方案提供建议。方法参阅循证医学等级高的窝沟封闭剂临床疗效文献和临床流行病学研究相关文献,从研究对象选择、评价指标确定、对照设置、假设检验类型、样本量估算、统计学方法、质量控制、伦理程序等方面进行分析和阐述。结果临床试验设计应根据研究目的,充分结合临床背景制定研究方案;根据研究药物或材料特性选择合适评价指标,对照设置,确定样本量,假设检验类型以及正确的统计分析方法;只有规范设计临床试验,才能在尽量节省人力、物力、时间的前提下得到可靠的试验结果进而推广。结论试验设计是试验过程实施的依据,是试验数据分析的前提。规范临床试验设计,深入研究方法学,制定完善的设计方案是促使科研工作经济高效、准确可靠,提高科研成果质量的重要保证。

Objective To investigate the standard of analogous clinical trial design points by means of designing randomized controlled trial to evaluate the clinical effectiveness of pit and fissure sealants, which provided a basis for the high quality clinical trial design. Methods Reading high quality evidence-based medicine literature on sealant clinical curative effect and clinical epidemiological literature for reference, this study was analyzed and expounded from the following respect：Efficacy of indicators, hypothesis testing type, control, subject choice, calculation of sample size,statistical methods, and quality control, and the ethical procedure. Results Clinical trials design should be fully combined with the objective and clinical background. The drug or material properties should be taken into account to choose appropriate efficacy of indicators, control, sample size hypothesis testing types and statistic method. Only when clinical trials were standardly designed can reliable results be obtained and then generalized in the condition of saving resources and time. Conclusion It is concluded that the clinical trial design was the basis of the implementation of trial and the precondition of the data analysis. Standardizing clinical trial design, studying methodology meticulously and making a perfect design are important guarantee, which can improve the quality of scientific research achievements and make scientific research efficient, accurate and reliable.