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目的 探讨比伐芦定对女性拟行经皮冠状动脉介入(PCI)治疗的冠心病患者的凝血功能及安全性的影响。方法 将71例女性拟行PCI的冠心病患者随机分为普通肝素组(n=39)和比伐芦定组(n=32)。分别于PCI术前、用药后5 min、术后即刻、停药后0.5、1和2 h测定激活凝血时间(ACT)。用药前、用药结束后6、24和72 h分别测定凝血酶时间(TT)、活化部分凝血酶时间(APTT)、凝血酶原时间(PT)、纤维蛋白原(Fib)。分别在用药前、用药后24 h测定血小板计数(PLT)。30 d内主要不良心脑血管事件(MACCE)、术后出血并发症以及支架血栓事件。结果 比伐芦定用药后5 min、术后即刻ACT值显著大于肝素组(P<0.01);停药后30 min和术前,两组患者ACT差异无统计学意义;停药后1 h、2 h ACT比伐芦定组小于普通肝素组(P<0.01)。两组术后凝血4项及PLT,比较均无统计学意义。两组患者随访30 d,MACCE及支架内血栓发生率差异无统计学意义,术后30 d出血总发生率及美国出血学术研究联合会(BARC) Ⅱ-Ⅴ型出血发生率差异有统计学意义(P<0.05)。结论 与普通肝素相比,比伐芦定对女性行PCI的冠心病患者抗凝治疗中起效更快,半衰期短,更安全有效。
Objective To investigate the effect of bivalirudin on the coagulation function and safety of women with coronary artery disease undergoing percutaneous coronary intervention (PCI). Methods Seventy-one patients with coronary artery disease who underwent PCI were randomly divided into unfractionated heparin group (n = 39) and bivalirudin group (n = 32). Activation of clotting time (ACT) was measured before PCI, 5 min after administration, immediately after operation, and at 0.5, 1 and 2 h after drug withdrawal. Thrombolytic time (TT), activated partial thromboplastin time (PTTT), prothrombin time (PT) and fibrinogen (Fib) were measured at 6, 24 and 72 h after treatment. The platelet count (PLT) was measured 24 h after treatment and before treatment. Major adverse cardiovascular and cerebrovascular events (MACCE), postoperative bleeding complications, and stent thrombosis within 30 days. Results After 5 minutes of bivalirudin treatment, the ACT value at postoperative immediately after operation was significantly higher than that in heparin group (P <0.01). There was no significant difference in ACT between the two groups 30 min after operation and before operation 2 h ACT bivalirudin group was less than the unfractionated heparin group (P & lt; 0.01). There were no significant differences between the two groups in 4 postoperative coagulation and PLT. There was no significant difference in the incidence of thrombosis between MACCE and stent after 30 days of follow-up in both groups. The incidence of hemorrhage 30 days after operation and the incidence of BARC Ⅱ-Ⅴ bleeding in the two groups were statistically significant (P & lt; 0.05). Conclusion Compared with unfractionated heparin, bivalirudin has a faster onset, shorter half-life and safer and more effective anticoagulation in women with coronary artery disease undergoing PCI.