摘要
[目的]通过多中心、精细化的临床研究,旨在对比通脉养心丸干预的冠心病稳定性心绞痛气阴两虚证患者和健康人的临床生化指标,探讨其临床生化基础。[方法]从全国7家临床研究中心共入组受试者82例,其中脱失3例,最终纳入冠心病气阴两虚证患者39例,在西医常规治疗的基础上加服中药通脉养心丸治疗,健康人40例不予干预。分别检测内皮细胞损伤、脂质代谢、黏附分子、炎症介质、金属蛋白酶、同型半胱氨酸和凝血功能共7类28项指标,冠心病患者分别检测0、8、12周水平,健康人检测第0周水平。[结果]冠心病气阴两虚证与载脂蛋白B、低密度脂蛋白、血管紧张素Ⅱ相关性较大,经过通脉养心丸的治疗,血管紧张素Ⅰ、血浆内皮素升高,可溶性CD40配体水平下降(P<0.05)。整体炎症因子水平有下降趋势。[结论]通脉养心丸调控冠心病稳定性心绞痛气阴两虚证的生化基础与内皮损伤、脂质代谢、炎症因子有关,可为进一步研究提供参考依据。
[Objective] To explore the qi and yin deficiency syndrome of coronary heart disease by clinical biochemical basis through comparing the strict screening of coronary heart disease stable angina pectoris by clinical and biochemical indexes of patients and healthy people with the multicenter, small sample and fineness clinical research. [Methods] From the seven clinical research centers, 82 cases were selected to the observation. With 3 cases deletion, 79 cases were eventually into the subjects, including 39 cases of qi and yin deficiency syndrome, which were treated with traditional Chinese medicine on the basis of the routine treatment of Western medicine, and40 healthy people were not involved in the treatment. Endothelial cell injury was detected, lipid metabolism, adhesion molecules and inflammatory mediators, metalloproteinases, homocysteine and blood coagulation function 7 class 28 indicators, were detected in patients with coronary heart disease(CHD) level 0, 8, 12 weeks, healthy people group testing at 0 week. [Results] The correlation between qi and yin deficiency syndrome of CHD and ApoB, LDL-C, AngⅡ was larger. After treatment of Tongmai Yangxin Pills, the level of AngⅠ, ET and sCD40 L level were decreased(P<0.05). Overall levels of inflammatory cytokines tended to decrease. [Conclusion] The biochemical basis of Tongmai Yangxin Pills for the regulation of stable angina pectoris with CHD qi and yin deficiency syndrome is related to endothelial injury, lipid metabolism and inflammatory factors, which can provide reference for the next study.
引文
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