目录摘要............................................................................................................................................1英文缩略词.................................................................................................................................4前言............................................................................................................................................5临床研究..................................................................................................................................71研究对象..........................................................................................................................71.1病例来源...............................................................................................................71.2诊断标准...............................................................................................................71.3纳入标准...............................................................................................................71.4排除标准...............................................................................................................71.5剔除标准...............................................................................................................81.6脱落标准...............................................................................................................81.7中止试验标准.......................................................................................................81.8签署伦理审查知情同意书...................................................................................82研究方法..........................................................................................................................92.1样本量估计...........................................................................................................92.2分组方法...............................................................................................................92.3治疗方案...............................................................................................................92.4质量控制.............................................................................................................102.5观察指标.............................................................................................................102.6疗效评价.............................................................................................................102.7安全性评价标准.................................................................................................112.8统计学处理.........................................................................................................112.9技术路线图.........................................................................................................123研究结果........................................................................................................................133.1一般资料.............................................................................................................133.2治疗前两组比较.................................................................................................133.3治疗前后比较.........................................................
