病证结合治疗冠心病多中心随机对照临床研究

Comprehensive intervention of coronary heart disease based on combining disease with syndrome: a multicenter randomized controlled clinical study

目的评价病证结合模式干预冠状动脉粥样硬化性心脏病(冠心病)患者的临床疗效和长期预后。方法随机选择自2011年8月~2012年2月住院治疗的冠心病患者630例,随机分为病证结合治疗组(干预组,315例)和西医常规治疗组(对照组,315例)。干预组在西医常规治疗基础上根据不同中医症候加服中成药治疗,连服6个月,然后从临床症状、实验室检查结果以及不良预后方面评估两种治疗模式的疗效。结果与治疗前比较,治疗6个月后两组中医主症积分、焦虑和抑郁评分均显著降低,且与对照组相比,干预组上述三个评分降低幅度更大(P<0.05)。干预组中,使用心可舒片治疗的亚组患者有97例,与对照组相比,该亚组患者治疗6个月后焦虑和抑郁评分降低更明显(P<0.05)。与治疗前比较,两组患者血清超敏C反应蛋白(hs-CRP)水平及ADP、AA介导的血小板聚集率均显著降低;干预组上述三个指标降低幅度均较对照组更大(P<0.05)。2年随访中,干预组主要不良心血管事件(MACEs)发生率显著低于对照组(P<0.05)。结论中西医病症结合模式能够改善冠心病患者中医症候,有抗炎,降低血小板聚集率,调节情志等作用,并且可改善患者远期预后。

Objective To evaluate the clinical efficacy and long-term prognosis of patients with coronary heart disease (CHD) treated by combining disease with syndrome. Methods 610 CHD patients from February 2012 to August 2011were randomly divided into disease and syndrome combination treatment group (intervention group,315 patients) and routine treatment group with western medicine (control group, 315 patients). The intervention group was received traditional Chinese medicine treatment for 6 months on the basis of routine western medicine according to different Chinese medicine syndrome. The efficacy of the two treatment modalities was then evaluated in terms of clinical symptoms, laboratory findings, and adverse outcomes. Results Compared with the control group, the score of the main symptom score, anxiety and depression of the two groups were significantly lower than those of the control group (P<0.05). In the intervention group, there were 97 patients treated with Xinkeshu Tablets.Compared with the control group, the scores of anxiety and depression decreased significantly (P<0.05) 6 months after treatment. Compared with the control group, serum hs-CRP and ADP, AA-induced platelet aggregation rate were significantly lower in the intervention group (P<0.05). The incidence of major adverse cardiovascular events (MACEs) was significantly lower in the intervention group than in the control group at 2 years of follow-up (P<0.05).Conclusion Chinese and Western medicine in combination can improve Chinese medicine syndrome in CHD patients. This combination treatment method have the effect of anti-inflammatory, reduce platelet aggregation rate,regulate emotion and can improve the prognosis of the patients.