痰瘀同治方稳定和消退动脉粥样硬化斑块有效性和安全性的临床研究

Efficacy and Safety of Tanyu Tongzhi Prescription in Stabilizing and Subsiding Atherosclerotic Plaque

目的:评价痰瘀同治方稳定和消退动脉粥样硬化斑块的有效性和安全性,为中医药治疗动脉粥样硬化提供理论依据。方法:选取2021年6月—2022年12月上海中医药大学附属岳阳中西医结合医院心内科收治的动脉粥样硬化病人120例。采用分层区组随机化方法,使用封闭信封法分为对照组、试验组,各60例。对照组给予阿托伐他汀20 mg/d,安慰剂每次4粒,每日3次,口服;试验组给予阿托伐他汀20 mg/d,痰瘀同治方每次4粒,每日3次,口服。两组疗程均为12个月。比较两组临床疗效、中医证候评分、冠状动脉血管内超声、颈动脉及股动脉超声等指标。结果:治疗后9、12个月,试验组治疗有效率高于对照组,差异均有统计学意义(P<0.05)。与对照组比较,试验组治疗后12个月股动脉斑块长径、厚径出现明显下降,治疗后9、12个月颈动脉斑块长径、厚径出现明显下降,治疗后3个月开始三酰甘油、总胆固醇水平出现明显下降,治疗后9个月低密度脂蛋白胆固醇(LDL-C)水平出现明显下降,治疗后6个月开始高密度脂蛋白胆固醇(HDL-C)水平出现明显升高,差异均有统计学意义(P<0.05或P<0.01);两组治疗前后心肌损伤标志物、肝功能、肾功能比较差异无统计学意义(P>0.05)。结论:痰瘀同治方联合西药稳定和消退动脉粥样硬化斑块的疗效优于单纯西药治疗,能明显改善痰瘀互结症状,缩小颈动脉、股动脉斑块的长径和厚径,且安全性较好。

Objective:To evaluate the efficacy and safety of Tanyu Tongzhi prescription in stabilizing and subsiding atherosclerotic plaque.Methods:A total of 120 patients with atherosclerosis were selected.Stratified block randomization method and closed envelope method were used to divide the patients into control group and experimental group,with 60 cases in each group.The control group was given atorvastatin 20 mg/d,placebo 4 capsules,3 times a day,orally.The experimental group was given atorvastatin 20 mg/d,Tanyu Tongzhi prescription 4 capsules,3 times a day,orally.The treatment course of both groups was 12 months.The clinical efficacy,traditional Chinese medicine syndrome score,coronary ultrasound,carotid and femoral ultrasound were compared between the two groups.Results:At 9 and 12 months after treatment,the effective rate of experimental groups was higher than that of control group,and the differences were statistically significant(P<0.05).Compared with the control group,the length and thickness of femoral artery plaque in the experimental group decreased significantly at 12 months after treatment,the length and thickness of carotid artery plaque decreased significantly at 9 and 12 months after treatment,the levels of triglyceride and total cholesterol decreased significantly at 3 months after treatment,and the levels of low-density lipoprotein cholesterol(LDL-C)decreased significantly at 9 months after treatment,the level of high density lipoprotein cholesterol(HDL-C)increased significantly at 6 months after treatment,with statistical significance(P<0.05 or P<0.01).There were no significant difference in myocardial injury markers,liver function and renal function between the two groups before and after treatment(P>0.05).Conclusion:Tanyu Tongzhi prescription combined with western medicine show better effect on stabilizing and and subsiding atherosclerotic plaque than western medicine alone,they can significantly improve the symptoms of phlegm-stasis interjunction,reduce the length and thickness of carotid artery and femoral artery plaque,with better safety.