【目的】 评估复方丹参滴丸联合替罗非班对急性 ST段抬高型心肌梗死（STEMI）患者经皮冠状动脉介入（PCI）术后心肌 缺血再灌注损伤（MIRI）的临床疗效及安全性。【方法】 选取2023年3月至2023年10月期间广州中医药大学顺德医院胸痛中心 收治的92例气滞血瘀型STEMI患者，采用随机数字表法将患者随机分成对照组和试验组，每组各46例。对照组接受PCI术 中冠脉内负荷量联合术后静脉微泵静推替罗非班治疗，试验组在此基础上加用复方丹参滴丸治疗，疗程为4周。观察2组患 者治疗前或术后即刻与治疗 4周后中医证候积分、心功能参数[左室射血分数（LVEF）、心排出量（CO）和左室舒张末期内径 （LVEDD）]及炎症标志物 C 反应蛋白（CRP）、脑钠肽（BNP）水平以及肝、肾功能和凝血功能等安全性指标的变化情况，比较 2组患者的心肌坏死标志物肌酸激酶同工酶（CK-MB）和肌钙蛋白（I cTnI）等心肌酶谱的峰值，评估2组患者的中医证候疗效、 心电图 ST段回落值（STR）改善疗效及不良心血管事件发生情况。【结果】（1）脱落情况方面，研究过程中共有 3例患者脱落， 最终共有 89 例纳入疗效分析，其中对照组 44 例，试验组 45 例。（2）中医证候疗效方面，治疗 4 周后，试验组的总有效率为 95.56%（43/45），对照组为 79.55%（35/44），组间比较（χ2检验），试验组的中医证候疗效明显优于对照组（P＜0.05）。（3）心电 图STR改善疗效方面，治疗4周后，试验组的总有效率为93.33%（42/45），对照组为75.00%（33/44），组间比较（χ2 检验），试 验组的心电图 STR 改善疗效明显优于对照组（P＜0.05）。（4）血清 CRP 和 BNP 水平方面，治疗 4 周后，2 组患者的血清 CRP、 BNP水平均较术后即刻明显降低（P＜0.05），且试验组对血清CRP、BNP水平的降低作用均明显优于对照组（P＜0.01）。（5）心 肌坏死标志物方面，试验组的CK-MB、cTnI峰值均明显低于对照组，差异均有统计学意义（P＜0.05）。（6）心功能参数方面， 治疗4周后，试验组的LVEF和CO均较术后即刻明显改善（P＜0.05），LVEDD较术后即刻有改善趋势，但差异无统计学意义 （P＞0.05）；而对照组的 LVEF、CO、LVEDD 较术后即刻均无明显改善（P＞0.05）；组间比较，试验组对 LVEF 和 CO 的改善 作用均明显优于对照组（P＜0.05或P＜0.01）。（7）中医证候积分方面，治疗4周后，2组患者的胸痛、胸闷、心悸、情志抑郁、 胸胁胀满、面色晦暗积分及证候总积分均较治疗前降低（P＜0.05），且试验组的降低作用均明显优于对照组，差异均有统计 学意义（P＜0.05）。（8）安全性指标方面，2组患者治疗前后的肝、肾功能及凝血功能比较，差异均无统计学意义（P＞0.05）。 （9）术后不良心血管事件发生率方面，对照组的不良心血管事件发生率为 13.64%（6/44），试验组为 6.67%（3/45），组间比较 （Fisher精确检验），差异无统计学意义（P＞0.05）。【结论】 复方丹参滴丸联合替罗非班在改善STEMI患者PCI术后中医证候、 ST段抬高情况、心肌坏死标志物、心功能等方面具有显著疗效，且安全性良好。

Objective To evaluate the clinical efficacy and safety of Compound Danshen Dripping Pills combined with Tirofiban in alleviating myocardial ischemia-reperfusion injury（MIRI） in patients with acute ST-segment elevation myocardial infarction （STEMI） after percutaneous coronary intervention（PCI）. Methods Ninety-two patients with acute STEMI of qi stagnation and blood stasis syndrome who were admitted to the Chest Pain Center of Shunde Hospital，Guangzhou University of Chinese Medicine between March 2023 and October 2023 were equally randomized into a control group and a treatment group using a random number table，with 46 cases in each group. The control group received intracoronary loading dose of Tirofiban during PCI combined with postoperative intravenous micro-pump injection of Tirofiban， while the trial group additionally received Compound Danshen Dripping Pills orally，the treatment course lasted for 4 weeks. Before treatment or immediately after surgery and after 4 weeks of treatment，the two groups were observed in the changes in traditional Chinese medicine （TCM） syndrome scores，cardiac function parameters [including left ventricular ejection fraction （LVEF），cardiac output （CO），and left ventricular end-diastolic diameter （LVEDD）]，and levels of inflammatory markers of C-reactive protein （CRP） and brain natriuretic peptide （BNP），as well as safety indicators such as liver and kidney function and coagulation parameters in both groups. The peak values of myocardial necrosis markers of creatine kinase-MB （CK-MB） and troponin I （cTnI） and other myocardial enzyme profiles between the two groups were compared. After treatment， the TCM syndrome efficacy of improvement， the therapeutic effect on improving ST-segment resolution （STR） of electrocardiogram，and the incidence of adverse cardiovascular events in both groups were assessed. Results （1） There were 3 patients dropping out during the trial，with a final total of 89 cases included in the efficacy analysis （44 cases in the control group and 45 cases in the trial group）.（2） After 4 weeks of treatment， the total effective rate in the trial group was 95.56% （43/45） and that in the control group was 79.55% （35/44）. Intergroup comparison by chi-square test showed that TCM syndrome efficacy in the trial group was significantly superior to that in the control group （P＜0.05）.（3） After 4 weeks of treatment， the total effective rate for improving STR in the trial group was 93.33% （42/45） and that in the control group was 75.00% （33/44）. Intergroup comparison （tested by chi-square test） demonstrated that the trial group had significantly stronger STR improvement efficacy than the control group （P＜0.05）.（4） After 4 weeks of treatment，the serum levels of CRP and BNP in both groups were lower than those immediately after surgery （P＜0.05），and the trial group exhibited significantly greater reductions in both CRP and BNP levels than the control group （P＜0.01）.（5） The peak values of myocardial necrosis markers of CK-MB and cTnI in the trial group were significantly lower than those in the control group，with statistically significant differences （P＜0.05）.（6） After 4 weeks of treatment，the trial group showed significant improvements in LVEF and CO compared to immediate postoperative values （P＜0.05），while LVEDD demonstrated an improving trend without statistical significance （P＞0.05）. The control group showed no significant improvements in LVEF，CO，or LVEDD （P＞0.05）. The intergroup comparison revealed that the trial group had significantly better improvements in LVEF and CO than the control group （P＜0.05 or P＜0.01）. （7）After 4 weeks of treatment， both groups showed reductions in the scores of chest pain， chest tightness， palpitations， emotional depression， hypochondriac distension， and dull complexion， as well as the total syndrome scores when compared to pretreatment values （P＜0.05）， and the trial group presented significantly greater reductions than the control group （P＜0.05）.（8） No statistically significant differences were shown in the parameters of liver/kidney function or coagulation between the two groups before and after treatment （P＞0.05）.（9） The incidence of postoperative adverse cardiovascular events in the control group was 13.64% （6/44） and that in the trial group was 6.67% （3/45），and the intergroup comparison （tested by Fisher’s exact test） showed no statistically significant difference （P＞0.05）. Conclusion The combination therapy of Compound Danshen Dripping Pills and Tirofiban demonstrates significant efficacy in improving TCM syndromes， ST-segment elevation， myocardial necrosis markers，and cardiac function in STEMI patients after PCI，with good safety.

R259.422

广东省中医药局科研项目（编号：20231329）；广东省方证重点实验室项目（编号：2022B1212010012-6）；广东省医学会临床科研 专项基金（编号：A202301030）；2022年佛山市自筹经费类科技计划项目（编号：2220001004023）；佛山市“十四五”医学高水平重点专科 建设项目（编号：FSGSP145105）；佛山市中医专科联盟心血管科建设项目；广州中医药大学顺德医院院内专项项目（编号：YNZX20220010）； 广州中医药大学顺德医院重点专科院内科研项目（编号：YNZX2025007）