磺达肝癸钠用于急性冠脉综合征PCI术后并发HIT-Ⅱ患者的抗凝疗效及安全性观察

Efficacy and safety of fondaparinux in heparin induced thrombocytopenia-Ⅱpatients with acute coronary syndromes after percutaneous coronary intervention

目的:观察急性冠脉综合征(ACS)患者经皮冠状动脉介入治疗(PCI)术后发生肝素诱导的血小板减少症Ⅱ型(HIT-Ⅱ)时应用磺达肝癸钠抗凝的疗效及安全性。方法:选择ACS经PCI术后并发HIT-Ⅱ患者38例(观察组),立即停用肝素抗凝治疗,改用磺达肝癸钠替代抗凝7d,监测观察组患者14d内各时间点的血小板计数(PLT)、凝血酶原时间(PT)、活化部分凝血酶时间(APTT)变化情况。另选择同期ACS经PCI术后未并发HIT-Ⅱ的40例患者作为对照组,比较两组患者30d内出血事件及6个月内心血管事件发生率。结果:1肝素治疗前,观察组患者的PLT、PT、APTT均在正常范围内;2发生HIT时观察组患者的PLT显著减少(t=20.991,P<0.01),PT、APTT显著延长(t=13.710、12.355,均P<0.01);3停用肝素(磺达肝癸钠替代治疗)24h时,观察组患者的PLT、PT、APTT开始恢复(t=2.542 6、2.543 9、2.588 4,均P<0.05);4停用肝素(磺达肝癸钠替代治疗)3d、7d时,观察组患者的PLT、PT、APTT均较以前显著恢复(3d时:t=11.175 0、18.767 0、6.820 5;7d时:t=18.767 0、9.776 8、8.141 5,均P<0.01);5停用肝素14d时,观察组患者的PLT、PT、APTT基本恢复肝素治疗前水平(t=0.528 8、1.240 0、1.826 5,均P>0.05);6术后30d内两组患者的轻度出血事件发生率比较差异无统计学意义(χ2=0.393 4,P>0.05);7随访6个月中,两组患者的轻度心血管事件发生率比较差异无统计学意义(χ2=0.782 3,P>0.05)。结论:1停用肝素24h后,观察组患者的PLT、PT、APTT开始恢复,停用肝素14d后,观察组患者的PLT、PT、APTT恢复至正常水平,因此,磺达肝癸钠对HIT-Ⅱ患者的PLT、PT、APTT无明显影响;2与未并发HIT-Ⅱ患者应用依诺肝素相比,磺达肝癸钠不增加心血管事件和出血事件,磺达肝癸钠用于ACS经PCI术后并发HIT-Ⅱ患者的抗凝治疗安全、有效。

Objective：To observe the efficacy and safety of fondaparinux in heparin induced thrombocytopenia-Ⅱ（HIT-Ⅱ）patients with acute coronary syndrome（ACS）after primary percutaneous coronary intervention（PCI）.Method：To choose 38 cases with HIT-Ⅱin patients with ACS after PCI（the observation group）,immediate stop taking heparin therapy,had used fondaparinux alternative anticoagulation for 7days.To monitor the changes of platelet count（PLT）,prothrombin time（PT）,activated partial thromboplastin time（APTT）in patients with the observation group at each time point of 14 days.To compare incidence rate of bleeding events within 30 days and cardiovascular events within 6months in two groups.Result：1Before heparin treatment,PLT,PT,APTT in the observation group were within the normal range;2 When the HIT happened,PLT of patients in the observation group was significantly reduced（t=20.991,P〈0.01）,PT,APTT was significantly prolonged（t=13.710,12.355,all P〈0.01）;324hours after discontinuation of heparin（fondaparinux sodium replacement therapy）,PLT,PT,APTT of patients in the observation group began to recover（t=2.542 6,2.543 9,2.588 4,all P〈0.05）;43days,7days after discontinuation of heparin（fondaparinux sodium replacement therapy）,PLT,PT,APTT of patients in the observation group significantly recovered than before（3days：t=11.175 0,18.767 0,6.820 5;7days：t=18.767 0,9.776 8,8.141 5,all P〈0.01）;514days after discontinuation of heparin,PLT,PT,APTT of patients in the observation group had recovered to the level before the heparin treatment（t=0.528 8,1.240 0,1.826 5,all P〉0.05）;6There was no statistical significance in the mild bleeding within 30 days after operation between two groups（χ2=0.393 4,P〉0.05）;7There was no significant difference in the incidence of cardiovascular events within 6months after operation between two groups（χ2=0.782 3,P〉0.05）.Conclusion：1Twenty-four hours after discontinuation of heparin,PLT,PT,APTT of patients in the observation group began to recover,14 days after discontinuation of heparin,PLT,PT,APTT of patients in the observation group had recovered to the normal level,therefore,it is no obvious effect of fondaparinux on patients with HIT-Ⅱin PLT,PT,APTT;2Fondaparinux does not increase cardiovascular events and bleeding events,compared with enoxaparin in the non concurrent HIT-Ⅱenoxaparin,it is a safe,effective method that fondaparinux for anticoagulation in patients with HIT-ⅡACS after PCI.