摘要
目的探讨急性冠脉综合征(acute coronary syndrome,ACS)早期及长期抗炎干预治疗的有效性和安全性,以及探索更小剂量秋水仙碱治疗下的有效性和安全性。方法选取2021年7月—2022年3月在广州市花都区人民医院心血管内科住院,并经冠状动脉造影检查确诊为冠心病急性冠脉综合征,同时超敏C反应蛋白(hypersensitive C-reactive protein,hs-CRP)升高的患者310例,随机分配至秋水仙碱0.5 mg组(治疗1组,107例)、秋水仙碱0.25 mg组(治疗2组,108例)和空白对照组(对照3组,95例),根据各分组的基线数据具有可比性。入组后进行12个月的随访,比较三组受试者之间非计划再次血运重建、再发急性冠脉综合征、已复苏的心脏停搏、因心血管疾病死亡的复合终点事件的发生率,并评估受试者用药的安全性。结果进行中位时间为11.3个月的随访。随访结果显示,治疗1组复合心血管终点事件发生率低于对照3组,差异有统计学意义(P=0.039,风险比0.45;95%CI 0.21~0.96)。而治疗2组与对照3组对比,差异无统计学意义(P=0.102,风险比1.54;95%CI0.26~1.13)。三组受试者的安全事件发生率对比,差异无统计学意义(P>0.05)。结论小剂量秋水仙碱能减少ACS患者复合终点事件发生率,而更小剂量秋水仙碱对ACS患者的获益仍需进一步研究证实。小剂量及更小剂量秋水仙碱相对对照3组,安全性可接受。
Objective To investigate the effectiveness and safety of early and long-term anti-inflammatory intervention in acute coronary syndrome(ACS)and explore the effectiveness and safety of lower-dose colchicine treatment.Methods A total of 310 patients admitted to the department of cardiology,People's Hospital of Huadu District,Guangzhou City from July 2021 to March 2022,diagnosed with acute coronary syndrome of coronary heart disease confirmed by coronary angiography,and presenting elevated high-sensitivity C-reactive protein(hs-CRP)levels were randomly assigned to three groups:colchicine 0.5 mg group(treatment group 1),colchicine 0.25 mg group(treatment group 2),and blank control group(control group 3),the baseline data of each group were comparable.A 12-month follow-up was conducted after enrollment to compare the incidence of unplanned repeat revascularization,recurrent acute coronary syndrome,resuscitated cardiac arrest,and cardiovascular disease-related death as composite endpoints among the three groups,as well as to assess the safety of the participants'medication.Results A median follow-up period of 11.3 months was conducted.The follow-up results showed that the incidence of composite cardiovascular endpoint events in treatment group 1 was significantly lower than that in control group 3(P=0.039,hazard ratio 0.45;95%CI 0.21~0.96).However,there was no statistically significant difference between treatment group 2 and control group 3(P=0.102,hazard ratio 1.54;95%CI 0.26~1.13).There were no statistically significant differences in the occurrence of safety events among the three groups of participants(P>0.05).Conclusion Lower-dose colchicine can reduce the incidence of composite endpoint events in ACS patients,while the benefits of even lower-dose colchicine in ACS patients require further research for confirmation.The safety of lower-dose and even lower-dose colchicine compared to the control group is acceptable.
作者
徐旭鸿
肖俊会
余碧珍
徐志奇
江志羔
李俐
XU Xuhong;XIAO Junhui;YU Bizhen;XU Zhiqi;JIANG Zhigao;LI Li(Department of Cardiovascular Medicine,People's Hospital of Huadu District,Guangzhou City,Guangzhou Guangdong 510800,China;Department of Hematology,People's Hospital of Huadu District,Guangzhou City,Guangzhou Guangdong 510800,China)
出处
《中国卫生标准管理》
2023年第23期139-142,共4页
China Health Standard Management
基金
广州市花都区科技计划项目(21-HDWS-019)。
关键词
急性冠脉综合征
冠心病
秋水仙碱
C反应蛋白
残余炎症风险
炎症因子
acute coronary syndrome
coronary heart disease
colchicine
C-reactive protein
residual inflammation risk
inflammatory factors