伏邪理论指导治疗血管重建术后冠状动脉粥样硬化性心脏病临床疗效研究

Clinical study on treatment of coronary heart disease after revascularization accordance with FuXie theory of Chinese medicine

目的观察参红化浊通络颗粒配合西药基础疗法治疗血管重建术后冠状动脉粥样硬化性心脏病(冠心病)气虚痰瘀互阻型的临床疗效。方法采用多中心随机对照研究方法 ,选取经皮冠状动脉介入疗法(percutaneous coronary intervention,PCI)术后6个月之内、中医辨证为气虚痰瘀互阻型的冠心病患者100例,根据随机数字表法分为治疗组和对照组各50例。对照组采用西药抗凝、降血脂基础治疗,降压、降糖对症治疗;治疗组除西药基础治疗外加用参红化浊通络颗粒口服6个月,服药结束后随访6个月。治疗前后对比观察患者再狭窄发生率及狭窄程度、心绞痛复发率、心肌梗死再发率、心衰患病率、中医症状等,综合评定患者疗效。结果随访治疗组有41例患者复查了冠状动脉造影和CTA,对照组20例,治疗组再狭窄发生率约35.7%,对照组约76.9%,有统计学差异(P=0.017),治疗组疗效优于对照组;轻度和中度狭窄程度比较有显著性差异(P=0.038;P=0.04),治疗组狭窄程度优于对照组;2组患者心绞痛复发率比较,有统计学差异(P=0.015)、中医症状改善方面比较有显著性差异(P<0.05)治疗组疗效明显优于对照组。结论依痰瘀伏邪理论自拟方参红化浊通络颗粒配合西药基础治疗能够明显降低PCI术后冠心病再狭窄发生率及狭窄程度、减少心绞痛发作以及心梗再发率和心衰患病率,明显改善胸闷痛、心悸、乏力等中医症状,提高患者生存质量。

Objective To observe the effect of Shenhong Huazhuo Tongluo Granulae and western medicine basic therapy on coronary heart disease after revascularization belongs to blood stasis and sputum block due to deficiency of qi. Methods An open multicentric study including 100 cases PCI patients （ Percutaneous Coronary Intervention） within 6 months after surgery, which the patients was diagnosed with qi deficiency and phlegm retention syndrome in TCM syndrome, divided into study group and control group according to the random number table, 50 cases in each group. The patients in control group were treated with western medicine basic treatment; and the patients in study group in addition to using the basic treatment of western medicine ingredients plus with the Shenhong Huazhuo Tongluo Granulae, followed by 6 months of follow-up. All patients with restenosis rate and the degree of stenosis, rate of angina recurrence and extent of grading, myocardial infarction, recurrence rate, heart failure prevalence of TCM symptoms were compared in the before and after treatment, and integrated assess patient outcomes. Results Restenosis incidence have a significant difference in the treatment group than the control group （P = 0. 017 ） ; the mild and moderate degree of stenosis was significant different, respectively （P= 0. 038; P=0.04）, the degree of stenosis in treatment group was lower than the control group ; two groups of patients with angina recurrence rate, there is significant difference （P= 0. 015 ）, Chinese medicine symptom im- provement is more significant difference （P 〈 0. 05 ） in treatment group than in the control group. Conclusion Shenhong Huazhuo Tongluo Granulae with western medicine basic treatment can significantly reduce angina pectoris after PCI in patients with coronary heart disease, reduce recurrence rate of myocardial infarction, and significant improvement in chest tightness, heart palpitations and other chinese medicine symptoms, improve patients＇ quality of life.