益气化痰通络方联合药物涂层球囊治疗气虚痰瘀阻络型冠心病的临床疗效研究  

Clinical Study on Yiqi Huatan Tongluo Prescription Combined with Drug-Coated Balloon in the Treatment of Coronary Heart Disease of Qi Deficiency and Phlegm Stasis Obstructing Collateral Type

作　　者：黄美春 梁宇鹏[2] 刘培中[2] 章圣云 彭瑟[2] 李创鹏[2] 张和针 赖天伟 艾长江 刘擎[2] 张艾蒙 李少慧 HUANG Mei-Chun;LIANG Yu-Peng;LIU Pei-Zhong;ZHANG Sheng-Yun;PENG Se;LI Chuang-Peng;ZHANG He-Zhen;LAI Tian-Wei;AI Chang-Jiang;LIU Qing;ZHANG Ai-Meng;LI Shao-Hui(The Second Clinical Medical School of Guangzhou University of Chinese Medicine,Guangzhou 510006 Guangdong,China;Zhuhai Hospital of Guangdong Provincial Hosptial of Chinese Medicine,Zhuhai 519000 Guangdong,China)

机构地区：[1]广州中医药大学第二临床医学院,广东广州510006 [2]广东省中医院珠海医院,广东珠海519000

出　　处：《广州中医药大学学报》2024年第10期2656-2662,共7页Journal of Guangzhou University of Traditional Chinese Medicine

基　　金：广东省医学科学技术研究基金项目(编号:B2021044);珠海市社会发展领域科技计划项目(编号:ZH22036201210077PWC)。

摘　　要：【目的】探究益气化痰通络方(由五爪龙、三七、法半夏、茯苓、荷叶、甘草等组成)联合药物涂层球囊(drug coated balloon,DCB)治疗冠心病的安全性、临床疗效及对低剪切力相关血清学指标的影响。【方法】将106例拟行经皮冠状动脉介入治疗的气虚痰瘀阻络型冠心病患者随机分为治疗组和对照组,每组各53例。对照组给予药物洗脱支架植入,治疗组给予药物涂层球囊治疗,并于术后口服益气化痰通络方12周。观察2组患者治疗前后低剪切力相关血清学指标血清单核细胞趋化因子1(MCP-1)、白细胞介素1β(IL-1β)、血管内皮生长因子(VEGF)水平的变化情况,并比较2组患者的中医证候疗效及术后1年不良事件发生率。【结果】(1)中医证候疗效方面:治疗12周后,治疗组的总有效率为88.68%(47/53),对照组为75.47%(40/53),组间比较(χ^(2)检验),治疗组的中医证候疗效明显优于对照组(P<0.05)。(2)血流低剪切力内皮功能障碍相关指标方面:治疗后,对照组的血清MCP-1、IL-1β、VEGF水平均较治疗前无明显下降(P>0.05),而治疗组的血清MCP-1、IL-1β水平均较治疗前明显下降(P<0.05);组间比较,治疗组对血清MCP-1、IL-1β、VEGF水平的下降作用均明显优于对照组(P<0.05)。(3)不良事件总发生率方面:术后随访1年,治疗组的不良事件总发生率为18.87%(10/53),对照组为20.75%(11/53),组间比较,差异无统计学意义(P>0.05)。【结论】对于气虚痰瘀阻络型冠心病患者,益气化痰通络方联合DCB可有效作用于冠脉血流低剪切力内皮功能障碍相关靶点,有利于减轻炎症反应,改善心绞痛症状,提高临床疗效,且术后1年不良事件发生率未见增加,具有良好的安全性和有效性。Objective To investigate the clinical efficacy and safety of Yiqi Huatan Tongluo Prescription(mainly composed of Fici Simplicissimae Radix,Notoginseng Radix et Rhizoma,Pinelliae Rhizoma Praeparatum,Poria,Nelumbinis Folium,and Glycyrrhizae Radix et Rhizoma,etc.)combined with drug-coated balloon(DCB)in the treatment of coronary heart disease(CHD)and to observe its effect on low-shear related serological indicators.Methods A total of 106 patients with CHD of qi deficiency and phlegm stasis obstructing collateral type who were scheduled to undergo percutaneous coronary intervention were randomly divided into a treatment group and a control group,with 53 cases in each group.The control group was treated with drug-eluting stent implantation,and the treatment group was treated with DCB.After the operation,the control group was given conventional antiplatelet aggregation drugs,and the treatment group was given oral administration of Yiqi Huatan Tongluo Prescription.The medication for the two groups lasted for 12 weeks.The changes in the serum levels of monocyte chemoattractant protein 1(MCP-1),interleukin 1β(IL-1β)and vascular endothelial growth factor(VEGF)in the two groups were observed before and after treatment.Moreover,the traditional Chinese medicine(TCM)syndrome efficacy after treatment and the incidence of adverse events one year after operation were compared between the two groups.Results(1)After 12 weeks of treatment,the total effective rate for TCM syndrome efficacy of the treatment group was 88.68%(47/53),and that of the control group was 75.47%(40/53).The intergroup comparison(tested by chi-square test)showed that the TCM syndrome efficacy in the treatment group was significantly superior to that in the control group(P<0.05).(2)The analysis of indicators related to endothelial dysfunction in the blood flow with low shear stress showed that after treatment,the levels of serum MCP-1,IL-1βand VEGF in the control group presented no obvious changes(P>0.05),but the serum levels of MCP-1 and IL-1βin the treatme

关 键 词：冠心病 经皮冠状动脉介入治疗 益气化痰通络方 气虚痰瘀阻络型 药物涂层球囊(DCB) 低剪切力 内皮功能 不良事件 

分 类 号：R259.414[医药卫生—中西医结合]