中文摘要
中医学对冠心病(胸痹)的认知有两千多年历史,属于中医药治疗优势病种之一。现今国家基本药物目录收载的治疗冠心病系列中成药品种,占有大量医疗资源,在日常医疗中被广泛使用。项目拟借鉴临床转化研究思路,采用临床流行病学研究技术,针对天津辖区范围内服用基药药品治疗冠心病的人群,借助数据采集和项目管理两个IT平台、严格的临床试验质量控制体系,先通过病例查阅方式,开展以发生AMI和冠心病死亡为结局的回顾性病例对照研究;基于此,针对未发生过AMI的冠心病患者,通过跟踪访视3年以上,开展前瞻性的队列研究验证回顾性研究结论。结论一致的回顾性病例对照研究加前瞻性队列研究形成证据体,构成Ia级最高级别证据,弥补中医药疗效证据不足的现状,证明合理使用中成药可以延缓冠心病进程;形成一种既符合中医药自身特点,又符合临床实际,能发现中医药固有的优势特点,证据级别高且不拘泥于随机对照设计的临床研究模式。
英文摘要
More than 2000 years ago,traditional Chinese medicine (TCM) knew the coronary heart disease(CHD). TCM is good at treating CHD. Many effective TCM drugs are included in the state basic drug list, that occupies lots of medical resource, and being administered by many CHD patients. According to the thinking of clinical translational research, in this study, we will apply clinical epidemiological technique to evaluate effectiveness of CHD drugs recorded in state basic drug list, through data collect and project management IT platform and advanced clinical trial quality control system. Firstly case-controls study will be carried out on the CHD patient with TCM drug through checking patient case report. Secondly cohort study will be carried out on the new CHD patient with TCM drug through visit of more than 3 years. The two studies which results are similar make up a I grade proof to improve TCM can delay the progress of CHD, in order to illustrate the effectiveness of TCM drugs on the CHD and to set up a clinical research model not be limited to randomized control trial that can find the character and advantage of TCM, match with the situation of the clinical real word and be a high grade clinical proof.
