国产比伐卢定对经桡动脉直接PCI治疗的急性心肌梗死患者治疗效果与安全性研究

发布时间：2018-04-30 02:06

  本文选题：比伐卢定 + 肝素联合替罗非班　； 参考：《河北医科大学》2013年硕士论文

【摘要】：目的：本研究对经桡动脉直接经皮冠状动脉介入治疗(PercutaneousCoronary Intervention; PCI)的急性ST段抬高型心肌梗死（ST-segmentelevation acute myocardial infarction; STEMI）患者应用国产比伐卢定与肝素联合替罗非班的治疗效果与安全性进行比较，探讨国产比伐卢定在急性ST段抬高型心肌梗死患者中的治疗效果与安全性。 方法：入选河北医科大学第二医院心血管内五科于2011年2月到2013年2月期间收治的70例诊断明确为STEMI并于发病12小时内经桡动脉途径行冠脉造影（Coronary angiography; CAG）检查或直接PCI治疗的患者，平均年龄为57.39±8.35（≤75）岁，其中男性48例，女性22例。全部入选患者用药前分为比伐卢定组（35例，A组），和肝素联合替罗非班组（35例，B组）。给药方法：比伐卢定组在PCI前静脉注射负荷剂量的国产比伐卢定0.75mg/kg，，而后立即按照1.75mg/(k g·h)维持静脉泵入至术毕，随后以小剂量0.2mg/(k g·h)维持泵入，共应用24小时后停用。当静脉给予负荷剂量的国产比伐卢定5min后对活化凝血时间（activated clotting time;ACT）进行检测，当ACT小于225s时，则另外追加0.3mg/kg的比伐卢定进行静脉注射。肝素联合替罗非班组在PCI前静脉注射肝素钠100U/kg（最大10000U），根据负荷量静脉注射5min后检测ACT结果，若ACT小于225s，则需再追加肝素20U/kg静脉注射，并予后续维持泵入使ACT在200s-300s之间，共应用24小时后停用。替罗非班：于PCI术前开始负荷量为5μg/kg在3分钟内推注完毕而后以0.075μg/kg/min的速率维持泵入24h。 合并用药:1. A组与B组停用比伐卢定或肝素与替罗非班前2小时给予低分子肝素5000u重叠，之后为5000u2/日，连续7天；2.所有患者均在术前给予氯吡格雷及阿司匹林，各负荷量300mg，PCI术后阿司匹林口服100mg/d联合氯吡格雷口服75mg/d，至少1年。辅助治疗药物有：他汀类、ACEI/ARB类、β受体阻滞剂、硝酸酯类等。入院时及PCI术后30天的各项常规检查指标：血常规、肾功能、肝功能、电解质、血糖、纤维蛋白原、肌酸激酶同工酶（CK-MB）和肌钙蛋白I（cTnI）浓度。两组间治疗效果评价指标：ACT测定，PCI治疗成功率，PCI术后的TIMI3级血流发生率和TMPG分级的结果。安全性评价指标:直接PCI治疗后24小时内、30天内总不良临床事件发生率。总不良临床事件包括：出血事件(根据REPLACE-2出血分级标准)、主要不良心血管事件（Major adverse cardiacevents, MACE）、血小板减少症。其中出血事件根据REPLACE-2出血分级标准、BARC出血分级标准[16]（Bleeding Academic Research ConsortiumConsensus Report）评定出血程度；主要不良心血管事件定义为：恶性心律失常、严重心衰、再梗死、靶血管血运重建及心源性死亡；血小板减少症（定义为药物应用后，血小板计数100×109／L）的发生率。根据STEMI患者的TIMI危险评分分为低危亚组和中高危亚组，比较两组间不同危险程度亚组的患者的总不良临床事件发生率。 所有数据统计学处理均采用SPSS19.0统计软件包进行，其中计数资料用百分比表示，应用χ2进行检验，计量资料以均数±标准差表示，应用两个独立样本均数的t检验，非正态的计量资料和等级相关资料应用秩和检验，以P0.05认为具有统计学差异。 结果： 1两组基础临床资料比较： 两组间年龄、男性患者比例、体重指数、高血压、糖尿病、高脂血症、冠心病（CHD）家族史、吸烟史、既往心肌梗死病史、既往PCI治疗史、发病至入院时间、TIMI危险评分和贫血情况等基线资料水平差异无统计学意义，入院时及PCI术后30天的各项常规检查指标及其它常规检查指标：肌酐清除率、血红蛋白、红细胞计数、血小板计数、肝功能、血糖、纤维蛋白原、肌酸激酶同工酶（CK-MB）和肌钙蛋白I（cTnI）浓度均无统计学差异。 2两组间治疗效果比较： 全部患者的CAG检查结果显示：A组与B组间梗死相关血管的比例无显著统计学差异。 A组与B组之间ACT峰值（330.68±102.08vs.301.57±123.27, P=0.29）、直接PCI成功率（94.3%vs.91.4%, P=1.00）、PCI后TMPG分级≥2的比例（85.7%vs.82.9%, P=0.94）、PCI后TIMI血流3级的分布比例（94.3%vs.91.4%, P=1.00）均无统计学差异。 3两组间治疗的安全性比较： 两组患者CAG检查和直接PCI治疗后24小时内各种不良临床事件发生率比较：总不良临床事件发生率(5.7%vs.11.4%, P=0.67)无显著统计学差异。术后24小时内出血（根据REPLACE-2出血分级标准）事件发生率(5.7%vs.11.4%, P=0.67)两组也无明显统计学差异。其中B组有一例严重消化道出血并经积极治疗后恢复的患者，A组则无。两组均未发生支架置入术后急性血栓形成以及其它主要不良心血管事件。 两组患者CAG检查和直接PCI治疗后30天内各种不良临床事件结局：总不良临床事件发生率(5.7%vs.14.3%, P=0.43)和REPLACE-2出血分级标准（5.7%vs.14.3%, P=0.43）未见显著统计学差异，但BARC出血标准的总出血事件（11.4%vs.34.3%, P=0.04)有统计学差异。主要不良心血管事件发生率(0.0%vs.2.9%, P=1.000)无显著统计学差异。B组有一例再灌注性心律失常并经积极治疗后恢复的患者。两组均无血小板减少症、支架置入术后血栓形成和死亡发生。 4两组间不同危险程度亚组患者的总不良临床事件发生率比较： 与肝素联合替罗非班相比，单独应用比伐卢定在低危亚组患者中未见显著统计学差异(14.3%vs.23.1%, P=0.649)，但在中高危亚组患者中出血事件的发生率(9.5%vs.40.1%, P=0.046)显著减少。 结论： 在行经桡动脉路径直接PCI治疗的急性STEMI患者中，单独应用国产比伐卢定在PCI治疗效果及MACE事件发生率方面与肝素联合替罗非班相似，但可显著减少术后30天内的出血事件，较适用于STEMI-TIMI评分中高危的STEMI患者。
[Abstract]:Objective: To compare the efficacy and safety of homemade duvastudin and heparin in patients with acute ST segment elevation myocardial infarction (ST-segmentelevation acute myocardial infarction; STEMI) by direct percutaneous coronary intervention (PercutaneousCoronary Intervention; PCI) with radial artery percutaneous coronary intervention (PCI). Objective to investigate the efficacy and safety of domestic Bi fudududin in patients with acute ST segment elevation myocardial infarction.
Methods: 70 patients admitted to the second hospital of Hebei Medical University from February 2011 to February 2013 were admitted to 70 patients who were diagnosed as STEMI and were examined by Coronary angiography; CAG or direct PCI within 12 hours of the onset of the radial artery, with an average age of 57.39 + 8.35 (less than 75) years, among which men 48 Patients were divided into 22 cases. The total selected patients were divided into bivfudine group (35 cases, A group), and heparin combined tironon group (35 cases, group B). The method of administration: the domestic bivudine 0.75mg/kg was injected at the pre PCI intravenous injection of the bivudine group at PCI, and then immediately followed the 1.75mg/ (k g h) to the end of the venous pump, followed by a small dose of 0.2mg/. (k g. H) was pumped in and was discontinued after 24 hours of application. The activated coagulation time (activated clotting time; ACT) was detected after the intravenous dose of homemade devastatin 5min. When ACT was less than 225s, the 0.3mg/kg was added to the intravenous injection. Heparin combined with tironon group before PCI, and heparin intravenous heparin was injected. Sodium 100U/kg (maximum 10000U), ACT results were detected after intravenous injection of 5min according to the dose of 5min. If ACT was less than 225s, heparin 20U/kg was required to be injected again, and a follow-up maintenance pump was used to make ACT at 200s-300s between 24 hours later. Tironon class: before PCI, the load was 5 mu g/kg in 3 minutes and then 0.075. Maintenance of the pump into 24h. at the rate of g/kg/min
Combined use of drugs: 1. A and B groups were discontinued with devastatin or heparin to give low molecular weight heparin 5000U 2 hours before tirofiban, followed by 5000u2/ day for 7 days. All patients were given clopidogrel and aspirin before operation, each load was 300mg, and aspirin oral 100mg/d combined with clopidogrel after PCI for oral 75mg/d, at least 1 years. Adjuvant therapies include statins, ACEI/ARB, beta blockers, nitrates, and other routine examination indexes at 30 days after admission and PCI: blood routine, renal function, liver function, electrolytes, blood glucose, fibrinogen, creatine kinase isozyme (CK-MB) and muscle calcin I (cTnI) concentration. The evaluation index of therapeutic effect among the two groups: ACT test The success rate of PCI treatment, the TIMI3 level blood flow rate and TMPG grade after PCI. Safety evaluation index: the incidence of total adverse clinical events within 24 hours after direct PCI treatment. Total adverse clinical events included hemorrhage events (according to REPLACE-2 bleeding classification criteria), and major adverse cardiovascular events (Major adverse cardiac) Events, MACE), thrombocytopenia. Bleeding events were based on REPLACE-2 bleeding classification criteria, BARC bleeding classification standard [16] (Bleeding Academic Research ConsortiumConsensus Report) to assess the degree of bleeding; the major adverse cardiovascular events were defined as malignant arrhythmia, severe heart failure, re infarction, target vessel blood revascularization, and cardiac origin. Sexual death; the incidence of thrombocytopenia (defined as 100 x 109 / L) of the platelet count after drug use. The incidence of total adverse clinical events was compared between the lower and middle risk subgroups based on the TIMI risk score of the STEMI patients and compared with the two groups of different risk subgroups.
All data statistics processing were carried out by SPSS19.0 statistical software package, in which the count data were expressed as a percentage, and x 2 was used to test the data. The measurement data were represented by mean number of standard deviation, and the t test of the average number of two independent samples was applied. The rank sum test was applied to the non normal measurement data and the rank correlation data, and the statistics were considered to be statistically significant by P0.05. Difference.
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