补气活血化瘀止血方对经皮冠状动脉介入治疗术后主要不良心血管事件及出血的影响

Study of the effect of supplementing Qi and hemostatic formula on MACE and bleeding after PCI

目的探究补气活血化瘀止血配方对经皮冠状动脉介入治疗(PCI)术后主要不良心血管事件(MACE)及出血的影响。方法以2019年1月至2020年1月在成都市第五人民医院行PCI的冠心病病人124例为研究对象,病人的中医症候表现为气虚血瘀证。采用随机数表法将病人随机分为两组,每组62例。观察组给予补气活血化瘀止血配方和泮托拉唑钠肠溶胶囊安慰剂,对照组给予补气活血化瘀止血配方安慰剂和泮托拉唑钠肠溶胶囊。观察两组MACE、术后出血及PCI术后第7天、第30天腺苷二磷酸(ADP)抑制率、花生四烯酸(AA)抑制率、ADP诱导的血凝块强度(MAADP)。结果观察组MACE发生率(3.2%)与对照组(9.7%)比较,差异无统计学意义(P>0.05)。观察组出血事件发生率(29.0%)、出血类型、出血部位与对照组出血事件发生率(24.2%)、出血类型、出血部位比较,差异无统计学意义(P>0.05)。观察组PCI术后30 d MAADP、ADP抑制率、AA抑制率与PCI术后7 d比较,差异无统计学意义(P>0.05)。对照组PCI术后30 d MAADP与PCI术后7 d比较显著升高,PCI术后30 d ADP抑制率与PCI术后7 d比较显著降低(P<0.05)。结论补气活血化瘀止血配方预防PCI术后出血的效果与泮托拉唑钠肠溶胶囊相似。此外,由于潜在的CYP450酶依赖性机制,补气活血化瘀止血配方对氯吡格雷的干扰作用较泮托拉唑钠肠溶胶囊小。

Objective To explore the effect of supplementing Qi and hemostatic formula on major adverse cardiovascular events(MACE)and bleeding after percutaneous coronary intervention(PCI).Methods A total of 124 patients with coronary heart disease who underwent PCI in the Fifth People's Hospital of Chengdu from January 2019 to January 2020 were selected as the research subjects.The TCM syndromes of the patients were qi deficiency and blood stasis syndrome.Random number table method was used to ran‐domly divide the patients into 2 groups,with 62 cases in each group.Patients in the study group were given supplementing Qi and he‐mostatic formula and pantoprazole sodium enteric-coated capsules placebo,and patients in the control group were given supplementing Qi and hemostatic formula placebo and pantoprazole sodium enteric-coated capsules.The MACE,gastrointestinal bleeding,and adenos‐ine diphosphate(ADP)inhibition rate,arachidonic acid(AA)inhibition rate,ADP-induced blood clot intensity(MAADP)on day 7 and day 30 after PCI were observed.Results There was no significant difference between the incidence of MACE(3.2%)in the study group and the incidence of MACE(9.7%)in the control group(P>0.05).There was no significant difference between the incidence of bleeding events(29.0%),bleeding types,bleeding sites in the study group and the incidence of bleeding events(24.2%),bleeding types,bleeding sites in the control group(P>0.05).There was no significant difference in MAADP,ADP inhibition rate and AA inhibi‐tion rate between the 30 days after PCI and 7 days after PCI in the study group(P>0.05).The MAADP at 30 days after PCI was signifi‐cant higher than that at 7 days after PCI,and the ADP inhibition rate at 30 days after PCI was significantly lower than that at 7 days af‐ter PCI in the control group(P<0.05).Conclusions The effect of supplementing Qi and hemostatic formula for preventing gastrointes‐tinal bleeding in PCI is similar to that of pantoprazole sodium enteric-coated capsules.In addition,the supplementing Qi and hemostat‐ic formula has less interference with clopidogrel than pantoprazole sodium enteric-coated capsules due to the potential CYP450-inde‐pendent mechanism.