Objective To observe traditional Chinese medicine (TCM) Huoxue Tongmai capsules (HXTMC) for the regulation of small molecule metabolites in plasma of patients with coronary heart disease and TCM blood stasis syndrome. Methods A prospective study was conducted in which 136 patients with coronary heart disease and blood stasis syndrome treated in Dagang district in Tianjin from January 2009 to December 2013 were selected and randomly divided into two groups:control group (68 cases) and HXTMC group (68 cases). The control group received the conventional oral therapy with nitrates, β receptor blockers, calcium antagonists, enteric coated aspirin, etc, and the HXTMC group received the conventional therapy and additionally oral administration of HXTMC, 4 capsules each time (each capsule 0.25 g), trice a day, 30 days constituting a therapeutic course, 3 courses in total. According to the standard of curative effect evaluation of angina pectoris in coronary heart disease, the clinic total curative effects of angina pectoris and electrocardiogram (ECG) were evaluated. The concentrations of copeptin, tumor necrosis factor-α(TNF-α) and interleukin-10 (IL-10) in the plasma were tested by enzyme-linked immunosorbent assay (ELISA), and the TNF-α/IL-10 ratio was calculated. Results The total clinical effective rates of patients and the ECG in HXTMC group were significantly higher than those of the control group [clinic total effective rates:89.71%(61/68) vs. 80.88%(55/68), ECG total effective rates:57.35%(39/68) vs. 48.53%(33/68), both P<0.05]. Concentration of copeptin and TNF-α/IL-10 ratio in the plasma after treatment of the both groups were significantly lower than those before treatment, and the changes were more obvious in HXTMC group [copeptin (ng/L): 0.22±0.04 vs. 0.31±0.05, TNF-α/IL-10 ratio:0.49±0.11 vs. 0.65±0.09, both P<0.05]. Conclusion Addition of HXTMC to conventional therapy for treatment of patients with coronary heart disease accompanied by blood stasis syndrome can lower the plasma level of copeptin and TNF-α/IL-10 ratio, thus it may improve the clinical curative effects of the patients.%目的：观察活血通脉胶囊对冠心病心血瘀阻证患者血浆小分子代谢产物的调节作用。方法采用前瞻性研究方法，选择2009年1月至2013年12月在天津市大港地区就诊的136例冠心病心血瘀阻证患者，按简单随机抽样方法分成两组。对照组（68例）采用硝酸酯类、β受体阻滞剂、钙离子拮抗剂及肠溶阿司匹林等常规疗法；活血通脉胶囊组（68例）在常规治疗基础上给予活血通脉胶囊，每次4粒（每粒0.25 g），每日3次，30 d为1个疗程，共3个疗程。评定两组治疗后临床疗效和心电图疗效；采用酶联免疫吸附试验（ELISA）检测血浆和肽素、肿瘤坏死因子-α（TNF-α）及白细胞介素-10（IL-10）水平，计算TNF-α/IL-10比值。结果活血通脉胶囊组临床疗效及心电图疗效均明显高于对照组〔临床总有效率：89.71%（61/68）比80.88%（55/68）；心电图总有效率：57.35%（39/68）比48.53%（33/68），均P＜0.05〕。两组治疗后和肽素及TNF-α/IL-10比值均较治疗前明显降低，且以活血通脉胶囊组降低更显著〔和肽素（ng/L）：0.22±0.04比0.31±0.05，TNF-α/IL-10比值：0.49±0.11比0.65±0.09，均P＜0.05〕。结论在常规疗法基础上加用活血通脉胶囊能通过降低和肽素水平及TNF/IL-10比值来改善冠心病心血瘀阻证患者的治疗效果。
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