益气活血中药方联合双联抗血小板西药治疗气虚血瘀型冠心病的历史性对照研究

Historical Control Study on Yiqi Huoxue Decoction(益气活血方) Combined with Dual Anti-Platelet Western Medicine in Treating Coronary Heart Disease with Qi Deficiency and Blood Stasis Syndrome

目的观察益气活血中药方联合双联抗血小板(双抗)西药治疗气虚血瘀型冠心病患者的临床疗效。方法采用历史性对照研究,治疗组为2013年11月至2015年12月门诊治疗的50例气虚血瘀型冠心病患者,对照组选取2010年12月至2012年1月门诊服用双抗西药常规治疗(阿司匹林肠溶片每日100 mg口服+硫酸氢氯吡格雷片每日75 mg口服)的气虚血瘀型冠心病患者50例。治疗组在服用双抗西药常规治疗基础上加用益气活血中药,每日1剂。观察两组患者治疗前及治疗4周、3个月后血小板最大聚集率、心绞痛评分、气虚血瘀证候评分及血瘀证评分,治疗前、治疗3个月后及6个月随访时消化道不良反应例数及积分变化。结果与治疗前比较,治疗组治疗4周、3个月后患者血小板最大聚集率、心绞痛评分、气虚血瘀证候评分、血瘀证评分降低(P<0.05或P<0.01);与治疗4周后比较,治疗组治疗3个月后心绞痛评分、气虚血瘀证候评分、血瘀证评分降低更明显(P<0.05);随访6个月时治疗组消化道不良反应积分增高(P<0.01)。与对照组同时间比较,治疗组治疗4周、3个月后血小板聚集率、心绞痛评分、气虚血瘀证候评分、血瘀证评分降低(P<0.05或P<0.01),治疗3个月后、6个月随访时消化道不良反应积分减少(P<0.05)。结论益气活血中药方联合双抗西药治疗可进一步降低血小板聚集率,改善临床症状,减少双抗西药所致的消化道不良反应。

Objective To observe clinical curative effect of Yiqi Huoxue Decoction combined with dual antiplatelet western medicine in treating coronary heart disease with Qi deficiency and blood stasis syndrome. Methods Historical control was conducted as study design. The treatment group included 50 outpatients with coronary heart disease with Qi deficiency and blood stasis syndrome treated from November 2013 to December 2015. The control group consisted of 50 outpatients with coronary heart disease with Qi deficiency and blood stasis syndrome accepting dual anti-platelet western medicine conventional therapy （Aspirin Enteric-coated Tablets 100 mg per day orally ＋ Clopidogrel Hydrogen Sulphate Tablets 75 mg per day orally） from December 2010 to January 2012. The treatment group used Chinese medicine of tonifying Qi and activating blood additionally on the basis of conventional therapy of dual anti-platelet western medicine, one dose per day. Maximum platelet aggregation rate, angina scores, Qi deficiency and blood stasis syndrome scores and blood stasis syndrome scores of patients in the two groups before treatment and four weeks and three months after treatment, and number of gastrointestinal adverse reaction cases and score variation before treatment, in the follow-up visit 3 months and 6 months after treatment were observed. Results Compared with that before treatment, maximum platelet aggregation rate, angina scores, Qi deficiency and blood stasis syndrome scores and blood stasis syndrome scores of patients in the treatment group decreased four weeks and three months after treatment （ P 〈 0.05 or P 〈 0.01 ） ; compared with four weeks after treatment, angina scores, Qi deficiency and blood stasis syndrome scores and blood stasis syndrome scores of patients in the treatment group decreased more remarkably three months after treatment （ P 〈 0. 05 ） ; in the 6 months follow-up visit after treatment, gastrointestinal adverse reaction integral in the treatment group increased （P 〈 0. 01 ）. Compared with the control group at the same time point, maximum platelet aggregation rate, angina scores, Qi deficiency and blood stasis syndrome scores and blood stasis syndrome scores of patients decreased four weeks and three months after treatment （P 〈0. 05 or P 〈0. 01 ） , and gastrointestinal adverse reaction integral decreased in the 3 and 6 months follow-up visit after treatment in the treatment group （P 〈 0.05 ）. Conclusion Yiqi Huoxue Decoction combined with dual anti-platelet western medicine could further decrease platelet aggregation rate, improve clinical symptom and decrease gastrointestinal adverse reactions induced by dual anti-platelet western medicine.