目的 评价芪参益气滴丸联合最佳药物治疗（OMT）对非阻塞性冠状动脉疾病（NOCAD）患者冠状动脉斑块进展的影响及安全性。方法 采用前瞻性随机对照研究设计，连续筛选2022年10月—2023年3月于天津市胸科医院就诊并经冠状动脉CT血管成像（CCTA）提示NOCAD的患者，最终纳入完成基线及治疗18个月结束时CCTA检查且影像资料符合分析要求的患者400例。患者按1∶ 1随机分为对照组和治疗组，各200例。对照组给予OMT，治疗组在OMT基础上加用芪参益气滴丸，疗程18个月。采用AutoPlaque软件进行斑块层面定量及定性分析，比较两组斑块体积（总斑块体积、非钙化斑块体积、低密度斑块体积、钙化斑块体积）、斑块负荷（总斑块负荷、非钙化斑块负荷、低密度斑块负荷、钙化斑块负荷）、高危斑块特征（低密度斑块、正性重构、餐巾环征、点状钙化）及血管重构参数［重构指数（RI）、最小管腔面积（MLA）］。观察两组治疗期间患者的主要不良心血管事件（MACE）发生率：包括心源性死亡、非致死性心肌梗死、心绞痛入院。结果 治疗前，两组各项斑块体积、各项高危斑块特征发生率、各项斑块负荷、RI、MLA比较，差异均无统计学意义（P＞0.05）；治疗18个月后，治疗组总斑块体积、非钙化斑块体积及低密度斑块体积均低于对照组（P＜0.01）；治疗组低密度斑块、正性重构及餐巾环征发生率亦低于对照组（P＜0.05）。两组钙化斑块相关指标、点状钙化发生率及最小管腔面积（MLA）比较差异无统计学意义（P＞0.05）。治疗期间，两组MACE发生率比较差异无统计学意义，且未观察到严重药物不良反应。结论 在NOCAD患者中，芪参益气滴丸联合OMT可显著减少斑块体积、降低高危斑块特征发生率、改善血管正性重构指标，实现斑块影像学稳定化，且安全性良好，可为NOCAD临床管理提供新的干预依据。

Objective To evaluate the effect and safety of Qishen Yiqi Dropping Pills combined with optimal medical therapy (OMT) on coronary plaque progression in patients with non-obstructive coronary artery disease (NOCAD). Methods A prospective randomized controlled study design was adopted. Patients with NOCAD indicated by coronary computed tomography angiography (CCTA) who visited Tianjin Chest Hospital from October 2022 to March 2023 were consecutively screened. Finally, 400 patients who completed baseline and at the end of the 18-month treatment period and whose imaging data met the analysis requirements were included. Patients were randomly divided into a control group and a treatment group in a 1∶ 1 ratio, with 200 cases in each group. The control group received OMT, while the treatment group was given Qishen Yiqi Dropping Pills in addition to OMT for a course of 18 months. AutoPlaque software was used for quantitative and qualitative analysis at the plaque level. Plaque volume (total plaque volume, non-calcified plaque volume, low-density plaque volume, calcified plaque volume), plaque burden (total plaque burden, non-calcified plaque burden, low-density plaque burden, calcified plaque burden), high-risk plaque features (low-density plaque, positive remodeling, napkin-ring sign, spotty calcification), and vascular remodeling parameters [remodeling index (RI), minimum lumen area (MLA)] were compared between the two groups. The incidence of major adverse cardiovascular events (MACE) during the treatment period was observed in both groups, including cardiac death, non-fatal myocardial infarction, and hospitalization for angina pectoris. Results Before treatment, there were no statistically significant differences between the two groups in terms of plaque volumes, incidence of high-risk plaque features, plaque burdens, RI, or MLA (P > 0.05). After 18 months of treatment, the total plaque volume, non-calcified plaque volume, and low-density plaque volume in the treatment group were lower than those in the control group (P < 0.01). The incidence rates of low-density plaque, positive remodeling, and napkin-ring sign in the treatment group were also lower than those in the control group (P < 0.05). There were no statistically significant differences between the two groups in calcified plaquerelated indicators, incidence of spotty calcification, or MLA (P > 0.05). During the treatment period, there was no statistically significant difference in the incidence of MACE between the two groups, and no serious adverse drug reactions were observed. Conclusion In patients with NOCAD, Qishen Yiqi Dropping Pills combined with OMT can significantly reduce plaque volume, decrease the incidence of high-risk plaque features, improve vascular positive remodeling indicators, achieve imaging stabilization of plaques, and demonstrate good safety. This may provide new intervention evidence for the clinical management of NOCAD.

R972

天津市自然科学基金重点项目（23JCZDJC00930）；现代中医药海河实验室2023年度第二批“揭榜挂帅”科技项目（24HHZYSS00016）；国家中西医协同旗舰科室建设项目；天津市生物医药科技重大专项项目（25ZXSWSY00190）；天津市卫生健康委员会中医药重点领域科研项目（A0104）