丹蒌方干预冠心病稳定性心绞痛痰瘀互结证的临床生化基础研究

Clinical and biochemical basic research of the phlegm and blood stasis syndrome of coronary heart disease stable angina treated with Danlou Tablet

[目的]通过多中心、精细化的临床研究,旨在通过对比丹蒌方干预冠心病稳定性心绞痛痰瘀互结证患者和健康人的临床生化指标,探究其临床生化基础。[方法]从全国7家临床研究中心共入组受试者82例,脱失4例,最终入组冠心病痰瘀互结证患者38例,在西医常规治疗的基础上加服中药丹蒌片治疗,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]冠心病痰瘀互结证与高密度脂蛋白胆固醇(HDL-C)、基质金属蛋白酶9(MMP9)、活化部分凝血活酶时间(APTT)相关性较大,通过丹蒌方的治疗可降低患者炎症因子水平,改善血管内皮损伤情况。[结论]丹蒌方干预冠心病稳定性心绞痛痰瘀互结证的机制与调节内皮损伤、脂质代谢、炎症因子、凝血功能、金属蛋白酶有关,可为下一步研究提供参考依据。

[Objective] To explore the phlegm and blood stasis syndrome of coronary heart disease treated with Danlou Tablets by clinical biochemical basis through comparing the strict screening of coronary heart disease stable angina mutually by phlegm and blood stasis clinical and biochemical indexes of patients and healthy people with the multicenter and fineness clinical research.[Methods] From the seven clinical research centers, 82 cases were selected to the observation, with 4 cases deletion, 38 patients of coronary heart disease with phlegm and blood stasis syndrome, on the basis of conventional Western medicine therapy and Danlou tablet treatment, and 40 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, was detected in patients with coronary heart disease （CHD） level 0, 8, 12 weeks, healthy people group testing week 0 level.[Results] The phlegm and blood stasis syndrome of coronary heart disease has correlation with HDL-C, MMP9 and APTT. The treatment of trichosanthes decoction can reduce the level of inflammatory factors and improve the vascular endothelial injury.[Conclusion] The mechanism of Danlou Tablets on treating stable angina pectoris of coronary heart disease with phlegm and blood stasis syndrome is related to the regulation of endothelial injury, lipid metabolism, inflammatory factors, coagulation function and metalloproteinase. It can provide reference for further research.