中药复方个体化干预冠心病稳定型心绞痛的多中心随机对照试验  

Efficacy and safety of Chinese medical differentiation treatment for patients with stable angina pectoris: A multicenter, randomized, controlled trial

作　　者：陈智慧[1] 张哲[2] 杨关林[1] 裴宇鹏[1] 张会永[2] 贾连群[1] 王洋[2] 邱倩 刘光颖[4] CHEN Zhi-hui;ZHANG Zhe;YANG Guan-lin;PEI Yu-peng;ZHANG Hui-yong;JIA Lian-qun;WANG Yang;QIU Qian;LIU Guang-ying(Liaoning University of Traditional Chinese Medicine,Shenyang 110847,China;The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,China;Dalian Chinese Medical Hospital,Dalian 116000,China;The First Affiliated Hospital of China Medical University,Shenyang 110000,China)

机构地区：[1]辽宁中医药大学,沈阳110847 [2]辽宁中医药大学附属医院,沈阳110032 [3]大连市中医院,大连116000 [4]中国医科大学附属第一医院,沈阳110000

出　　处：《中华中医药杂志》2021年第9期5635-5639,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家科技部“重大新药创制”专项课题(No.2009ZX09502-29)。

摘　　要：目的:评价中医药个体化辨证论治干预冠心病稳定型心绞痛的有效性与安全性。方法:设计随机对照试验,以冠心病心绞痛患者为研究对象,辨证选取该人群中气虚血瘀证和痰瘀互结证两个证候类型的患者纳入研究,干预8周,观察其有效性与安全性。结果:试验组和对照组共纳入480例受试者,采用全分析集数据集分析,两组基线可比。心绞痛发作情况和生活质量得到显著改善,与对照组比较,气虚血瘀证试验组在中医证候疗效评价量表中以患者的治疗满意度维度改善最为显著(P<0.05),痰瘀互结证试验组在运动耐量与中医证候两个维度改善最为显著(P<0.05)。两组受试者均未发生心血管死亡等终点结局事件。结论:采用中医个体化辨证治疗冠心病心绞痛安全有效,在反映患者整体功能状态的中医证候、反映患者生活质量的运动耐量和治疗满意度方面具有显著优势。Objective: To evaluate the efficacy and safety of Chinese medical differentiation treatment for patients with stable angina pectoris. Methods: A randomized controlled clinical trial was designed, the angina pectoris patients were recruited as study subjects. On the basis of Chinese medical differentiation treatment principle, patients with qi deficiency and blood stasis as well as phlegm and blood stasis were included in this study. The efficacy and safety were observed after 8 weeks of intervention.Results: A total of 480 patients were included, with 240 being assigned to experimental group and placebo group respectively including phlegm and blood stasis syndrome and qi deficiency and blood stasis syndrome in each group. All the data was analyzed by FAS, the basic line was equally and with no significant difference. Angina pectoris attack and quality of life were significantly improved. Compared with the control group, the ‘treatment satisfaction’ dimension of patients in the qi deficiency and blood stasis syndrome test group was the most significant improvement(P<0.05) in the TCM syndrome efficacy evaluation scale, and the ‘exercise tolerance’ and ‘TCM syndrome’ dimension of subjects in the phlegm-stasis syndrome test group were the most significant improvement(P<0.05). No end points such as cardiovascular death occurred in the two groups. Conclusion: On the basis of Chinese medical differentiation treatment in patients with angina pectoris is effective and safe, but a more suitable clinical effectiveness evaluation methods to deeply learn Chinese medical differentiation is greatly in need.

关 键 词：冠心病心绞痛 随机对照试验 中医药 疗效评价 

分 类 号：R259[医药卫生—中西医结合]