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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
徐一兰1, 高杉1, 邓兵2, 毛美娇2, 杜廷海3, 李彬3, 杨宝平4, 于研4, 张虹5, 张世姝5, 毛静远6, 王贤良6, 徐强7, 张蕾8, 宋光明8, 田莉8, 王丽9, 闫丹丹1, 李琳1, 高树明1, 潘晔1, 蔡雪朦1, 王朔1, 李晓枫1, 艾乐10, 胡镜清11, 边育红1, 于春泉1
1.天津中医药大学, 天津 300193;2.上海中医药大学附属龙华医院, 上海 200032;3.河南中医药大学第一附属医院, 郑州 136300;4.甘肃省中医院, 兰州 730699;5.天津市南开医院, 天津 300100;6.天津中医药大学第一附属医院, 天津 300193;7.天津中医药大学第二附属医院, 天津 300150;8.天津市武清区中医医院, 天津 301700;9.天津市第二人民医院, 天津 300192;10.天津中新药业集团股份有限公司乐仁堂制药厂, 天津 300112;11.中国中医科学院中医基础理论研究所, 北京 100700
摘要:
[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。
关键词:  冠心病稳定性心绞痛  痰瘀互结证  临床生化  多中心  精细化
DOI:10.11656/j.issn.1672-1519.2018.11.03
分类号:R541.4
基金项目:国家重点基础研究发展计划(973计划)项目(2014CB542902)。
Clinical and biochemical basic research of the phlegm and blood stasis syndrome of coronary heart disease stable angina treated with Danlou Tablet
XU Yilan1, GAO Shan1, DENG Bing2, MAO Meijiao2, DU Tinghai3, LI Bin3, YANG Baoping4, YU Yan4, ZHANG Hong5, ZHANG Shishu5, MAO Jingyuan6, WANG Xianliang6, XU Qiang7, ZHANG Lei8, SONG Guangming8, TIAN Li8, WANG Li9, YAN Dandan1, LI Lin1, GAO Shuming1, PAN Ye1, CAI Xuemeng1, WANG Shuo1, LI Xiaofeng1, AI Le10, HU Jingqing11, BIAN Yuhong1, YU Chunquan1
1.Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;2.Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032, China;3.The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou 136300, China;4.Gansu Provincial Hospital of Traditional Chinese medicine, Lanzhou 730699, China;5.Tianjin Nankai Hospital, Tianjin 300100, China;6.The First Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;7.The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300150, China;8.Tianjin Wuqing Hospital of Traditional Chinese Medicine, Tianjin 301700, China;9.Tianjin Second People Hospital, Tianjin 300192, China;10.Tianjin Zhongxin Pharmaceutical Group Limited by Share Ltd Lerentang Pharmaceutical Factory, Tianjin 300112, China;11.Institute of Basic Theory of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China
Abstract:
[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.
Key words:  coronary heart disease stable angina pectoris  phlegm and blood stasis syndrome  clinical biochemistry  multi-centers  refine
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