阳和汤加减治疗冠心病阳虚寒凝证的随机对照研究

Modified Yanghe Decoction in the treatment of coronary heart disease with yang deficiency and cold coagulation： a randomized controlled trial

关键词:  阳和汤  冠心病  稳定型心绞痛  阳虚寒凝证

Key words:  Yanghe Decoction  coronary heart disease  stable angina pectoris  yang deficiency cold condensation evidence

摘要:

[目的] 分析阳和汤加减治疗阳虚寒凝证冠心病的临床疗效及安全性。[方法] 采用随机对照研究，将符合纳入标准的阳虚寒凝证冠心病患者84例随机分为治疗组与对照组各42例。对照组予常规西药治疗，治疗组给予阳和汤加减联合常规西药治疗，连续治疗4周。通过观察治疗前后两组中医证候积分、心绞痛症状积分、西雅图心绞痛量表评分改善情况及心电图变化，并检测超敏C反应蛋白（Hs-CRP）、血脂、血管内皮因子等相关指标，判断疗效。[结果] 中医证候疗效有效率治疗组（87.2%）优于对照组（65.9%），差异具有统计学意义（P＜0.05）；心绞痛改善有效率治疗组（87.2%）优于对照组（68.3%），差异具有统计学意义（P＜0.05）；西雅图心绞痛量表中心绞痛发作频率及提高患者治疗满意程度维度方面治疗组优于对照组，差异具有统计学意义（P＜0.05）。两组心电图总疗效、Hs-CRP及血脂水平改善程度差异无统计学意义（P＞0.05）。血管内皮因子NO、ET-1改善方面治疗组优于对照组，差异具有统计学意义（P＜0.05）。两组治疗前后肝肾功能等安全指标未见明显异常。[结论] 阳和汤可显著缓解冠心病稳定型心绞痛患者心绞痛症状，减少心绞痛发作频次，提高患者生活质量，并有效调节血管内皮舒缩因子水平。

Abstract:

[Objective] To analyze the clinical curative effect and safety of modified Yanghe Decoction in the treatment of coronary heart disease with yang deficiency and cold syndrome. [Method] A randomized controlled study was applied and during the study，84 patients with coronary heart disease with yang deficiency and cold syndrome who met the inclusion criteria were randomly divided into a treatment group and a control group with 42 cases in each group. The control group was treated with conventional Western medicine，and the treatment group was treated with modified Yanghe Decoction combined with conventional Western medicine for 4 consecutive weeks. The curative effect was judged by observing the improvement of traditional Chinese medicine syndrome scores，angina pectoris symptom scores，Seattle Angina Pectoris Scale scores and ECG changes in the two groups before and after treatment，and detecting High-sensitivity C-reactive protein（Hs-CRP），blood lipids，vascular endothelial factor and other related indicators. [Result] The effective rate of traditional Chinese medicine syndrome curative effect in the treatment group（87.2%） was better than that in the control group（65.9%，P＜0.05）. The effective rate of improving angina pectoris in the treatment group（87.2%） was better than that in the control group（68.3%，P＜0.05）. The frequency of angina pectoris attacks in the Seattle Angina Pectoris Scale and the dimensions of improving patient satisfaction with treatment in the treatment group were better than those in the control group（P＜0.05）. There was no significant difference in the total efficacy of ECG，Hs-CRP and blood lipid levels between the two groups（P＞0.05）. The improvement of vascular endothelial factor NO and ET-1 in the treatment group was better than that in the control group（P＜0.05）. There were no obvious abnormalities in safety indicators such as liver and kidney function before and after treatment in the two groups. [Conclusion] Yanghe Decoction can significantly relieve the symptoms of angina pectoris in patients with stable angina pectoris，reduce the frequency of angina pectoris，improve the life quality of patients，and effectively regulate the level of vascular endothelial relaxation and contraction factors.