血脂康对不稳定型心绞痛伴肝酶升高患者的疗效与安全性

Curative effect and safety of Xuezhikang Capsule in patients with unstable angina pectoris complicating elevated liver enzymes

目的探讨血脂康对不稳定型心绞痛伴肝酶升高患者的疗效与安全性。方法纳入96例服用阿托伐他汀后引起肝酶升高3倍以上的不稳定型心绞痛患者。随机均分为3组,每组32例患者,A组停阿托伐他汀;B组阿托伐他汀减半;C组更换为血脂康。总疗程为4周,治疗前后测定总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、甘油三脂(TG)、高敏C反应蛋白(hs-CRP)、丙氨酸转氨酶(ALT)。随访主要不良心血管事件(MACEs),包括心源性死亡、致死性心肌梗死(MI)、非致死性MI、猝死发生情况。结果与治疗前比较,治疗4周后三组患者ALT水平均显著下降,治疗前后比较有统计学差异(P<0.05),A、C组患者ALT水平下降较B组患者更显著,与B组患者比较有统计学差异(P<0.05),A、C组之间ALT水平比较,无统计学差异(P>0.05)。B、C组患者治疗4周后TC、LDL-C、TG、hs-CRP水平均下降,治疗前后比较有统计学差异(P<0.05);C组患者HDL-C水平较治疗前升高(P<0.05),治疗前后比较有统计学差异(P<0.05);A组患者TC、LDL-C、TG、hs-CRP水平下降不明显,治疗前后比较无统计学差异(P>0.05)。与A组患者治疗后比较,C组患者TG、hs-CRP水平明显下降,差异有统计学意义(P<0.05)。A组、B组、C组MACEs事件发生率分别为12.5%、9.4%、3.1%,组间比较差异有统计学意义(P<0.05)。结论他汀引起肝酶显著升高的不稳定型心绞痛患者,换用血脂康安全有效。本研究入选患者病例数较少,有待更多的试验证实。

Objective To investigate the curative effect and safety of Xuezhikang Capsule in patients with unstable angina pectoris （UAP） complicating elevated liver enzymes. Methods The patients （n=96） with UAP and liver enzymes elevated by 3 times after taking atorvastatin were randomly divided into group A （stopping taking atorvastatin）, group B （taking half-dose atorvastatin） and group C （taking Xuezhikang Capsule only, each n=32）. The total therapeutic course was 4 w. The levels of total cholesterol （TC）, high-density lipoprotein-cholesterol （HDL-C）, low-density lipoprotein-cholesterol （LDL-C）, triglyceride （TG）, high-sensitivity C-reactive protein （hs-CRP） and alanine aminotransferase （ALT） were detected before and after treatment. The incidence of major adverse cardiac events （MACE） was followed up including cardiac death, fatal myocardial infarction （MI）, non-fatal MI and sudden death. Results After treatment for 4 w, ALT level decreased significantly in 3 groups （P〈0.05）, which was more significant in group A and group C （P〈0.05）, but there was no statistical difference between group A and group C （P〉0.05）. After treatment for 4 w, the levels of TC, LDL-C, TG and hs-CRP decreased in group B and group C （P〈0.05）. The level of HDL-C increased in group C after treatment （P〈0.05）. The decreases of levels of TC, LDL-C, TG and hs-CRP were not significant （P〉0.05） in group A after treatment. Compared with group A after treatment, the levels of TG and hs-CRP decreased significantly in group C （P〈0.05）. The incidence of MACE was 12.5%in group A, 9.4%in group B and 3.1%in group C （P〈0.05）. Conclusion In UAP patients with elevated liver enzymes induced by atorvastatin, Xuezhikang Capsule is safe and effective for them. Because of the study has less cases, further trials are needed to proof the results.