CAJ | 학술논문

目的介绍慢性活动性轻中度溃疡性结肠炎(UC)非劣效临床试验的试验设计要点.方法根据文献和欧盟关于溃疡性结肠炎新药研究指南,对溃疡性结肠炎非劣性临床研究所涉及到的标准阳性对照、非劣界值、主要疗效指标及剂量选择等关键性问题进行设计;以一个实例进行叙述,并模拟其部分试验数据进行定量评价.结果在活动期的轻中度溃疡性结肠炎的非劣性临床研究中,阳性对照药宜选择氨基水杨酸制,剂量为3 g·d~(-1),非劣界值应取15%,主要疗效指标评判标准采用临床疾病活动指数量表.结论本设计可为同类临床研究提供参考.
목적 개소만성활동성경중도궤양성결장염(UC)비렬효림상시험적시험설계요점.방법 근거문헌화구맹관우궤양성결장염신약연구지남,대궤양성결장염비렬성림상연구소섭급도적표준양성대조、비렬계치、주요료효지표급제량선택등관건성문제진행설계;이일개실례진행서술,병모의기부분시험수거진행정량평개.결과 재활동기적경중도궤양성결장염적비렬성림상연구중,양성대조약의선택안기수양산제,제량위3 g·d~(-1),비렬계치응취15%,주요료효지표평판표준채용림상질병활동지수량표.결론 본설계가위동류림상연구제공삼고.
Objective To introduce the design of a non-inferiority clinical trial for evaluating the mild-to-moderate active ulcerative coli-tis. Methods Based on international literature and the European guide-line on the development of new medicinal products for the treatment of ul-cerative colitis, a clinical trial was designed in involving with the positive control, non-inferiority margin, primary endpoint and the dose-finding within accepted efficacy and safety for a treatment of mild-to-moderate active ulcerative colitis. A real example of ulcerative colitis was intro-duced and its primary data were simulated for quantitative analysis. Re-sult For the non-inferiority clinical trial on mild-to-moderate active ulcerative colitis, the standard positive control should be aminosalicylic acid (5-ASA) with the dose of 3 g/day, the non-inferior margin is approximately 15%, and the CAI scale is recommended as primary end-point. Conclusion This study can provide some important information for similar clinical research.