基于ISCHEMIA研究探讨中医药治疗稳定性冠心病的优势与研究设计的优化  

Advantages of Traditional Chinese Medicine in the Treatment of Stable Coronary Heart Disease and the Optimization of Research Design:based on the ISCHEMIA Study

作　　者：于林童 马晓娟[2] 段文慧[2] 陶诗怡 林谦 史大卓[2] YU Lintong;MA Xiaojuan;DUAN Wenhui;TAO Shiyi;LIN Qian;SHI Dazhuo(Beijing University of Chinese Medicine,Beijing,100029;Xiyuan Hospital,China Academy of Chinese Medical Sciences;Dongzhimen Hospital,Beijing University of Chinese Medicine)

机构地区：[1]北京中医药大学,北京市100029 [2]中国中医科学院西苑医院 [3]北京中医药大学东直门医院

出　　处：《中医杂志》2022年第7期608-611,617,共5页Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(81774141);国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202007)。

摘　　要：对稳定性冠心病患者采用最佳药物治疗基础上的侵入性治疗策略能否进一步降低心血管事件发生率仍是目前研究的热点。ISCHEMIA研究显示,在服用药物和改变生活方式的基础上进行侵入性治疗并不能进一步改善稳定性冠心病患者的预后;而对有胸痛的患者,侵入性治疗可以改善其症状,但症状较轻者获益不明显。该结论在指导现代医学临床决策的同时也为中医药治疗稳定性冠心病带来启示,即中医药具有改善症状及提高患者生活质量的优势,且有望降低患者心血管残余风险并解决其血运重建后的临床相关问题;同时ISCHEMIA研究设计方法及思路对于中医药临床试验的研究设计及规范报告也具有一定的借鉴意义。在今后的中医药临床试验中应进一步探索中医药对中-重度稳定性冠心病患者的干预效果,同时依据提前设计的方案,加强治疗期间患者的高危风险的监测与评估,还应严格遵循循证医学的试验设计原则和报告标准,提高中医药临床试验的报告质量。It has always been a hot issue whether the addition of invasive therapy to the optimal drug therapy can further reduce the risk of cardiovascular events. The ISCHEMIA study showed that invasive therapy based on medication and lifestyle changes could not further improve prognosis in patients with stable coronary heart disease(SCHD).For patients with chest pain,invasive therapy could improve symptoms,but the benefit was not significant in mild cases. The conclusion that traditional Chinese medicine(TCM)has the advantages of improving symptoms and quality of life,and may be used to reduce the residual cardiovascular risk of patients with SCHD and solve certain clinical problems after revascularization,brings enlightenment for clinical decision in modern medicine as well as treatment of SCHD with TCM. Simultaneously,the ideas and methods used in the ISCHEMIA research provide references for future study design and reporting. The effect of TCM on mild or severe SCHD should be further explored in future TCM trials,and the protocol should be designed before conduct. Moreover,the monitoring and evaluation of high-risk factors of patients during treatment should be strengthened. The guidelines and checklists for trial design and reporting in evidence-based medicine should be strictly followed to improve the quality of TCM trials.

关 键 词：稳定性冠心病 ISCHEMIA研究 侵入性治疗 血运重建 心血管事件 

分 类 号：R259[医药卫生—中西医结合]