【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（χ2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-1β and VEGF in the control group presented no obvious changes（P＞0.05），but the serum levels of MCP-1 and IL-1β in the treatment group were significantly lowered compared with those before treatment（P＜0.05）. The intergroup comparison showed that the decrease of serum MCP-1，IL-1β and VEGF levels in the treatment group was significantly superior to that in the control group（P＜0.05）. （3）The one-year follow-up after the operation showed that the total incidence of adverse events in the treatment group was 18.87%（10/53），and that in the control group was 20.75%（11/53）. There was no significant difference between the two groups（P＞0.05）. Conclusion Yiqi Huatan Tongluo Prescription combined with DCB has definite action on the targets related to endothelial dysfunction in coronary blood flow with low shear stress，which is conducive to reducing inflammatory response，improving the symptoms of angina pectoris and enhancing clinical efficacy. The incidence of adverse events did not increase one year after operation，indicating good safety and effectiveness.

R259.414

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）