摘要
建立将比较效果研究模式引入中医临床评价体系的研究方案,采用医院注册登记研究的方式,对真实情况下应用丹红注射液患者的诊断、治疗、疗效和安全性情况进行记录;数据调查完成后,根据不同的分析目的,将数据自然分成若干组进行比较分析。对该研究方案的研究目的、试验设计、分组及对照组的选择、病例入选、合并用药、观察指标、随访、数据管理、伦理问题等内容进行重点解读。
The research program of introducing comparative effectiveness research into TCM clinical evaluation system was established. The diagnosis, treatment, efficacy and safety of patients who received Danhong Injection （丹红注射液） were recorded with hospital registration study method. The data was naturally divided into several groups and compared. The research purpose, experimental design, selection of subgroup, control group and patients, eoneomitantmedications, observed indicators, follow-up, data management and ethical issues were interpreted in this article.
出处
《中医杂志》
CSCD
北大核心
2014年第5期379-382,共4页
Journal of Traditional Chinese Medicine
基金
"十二五"国家科技重大专项"重大新药创制"资助项目(2011ZX09302-006-01)
关键词
比较效果研究
丹红注射液
医院注册登记研究
中医临床评价方案
comparative effectiveness research
Danhong Injection （丹红注射液）
hospital registration study
TCMclinical evaluation program
