rhPro-UK及r-SAK治疗急性ST段抬高型心肌梗死的疗效与安全性评估.pdf

内蒙古医学杂志InnerMongoliaMedJ2023年第55卷第7 期DOI:10.16096/J.cnki.nmgyxzz.2023.55.07.003779rhPro-UK 及 r-SAK 治疗急性 ST 段抬高型心肌梗死的疗效与安全性评估杜思雨1一,韩炜2，杨扬”,郑伟,齐文华1（1.包头医学院研究生院，内蒙古包头0 140 0 0；2.包头市中心医院心内科，内蒙古包头0 140 0 0）摘要目的比较rhPro-UK及r-SAK溶栓治疗STEMI的有效性及安全性。方法选取2 0 2 0 年5月至2 0 2 2 年6 月包头市中心医院心内科收治的符合AHA/ACC诊断标准且无溶栓禁忌证的STEMI患者71例,随机分为rhPro-UK组(35例)、r-SAK组（36 例）后行静脉溶栓治疗,溶栓后9 0 min行冠脉造影检查，对比两组患者的血管开通情况，评估疗效，同时观察记录STEMI患者溶栓后急性期并发症及各种不良事件、出血发生率，进行安全性评估。结果两组血管再通率（94.3%比8 8.9%，P=0.696)比较差异无统计学意义。两组急性期并发症、不良事件、出血发生率等方面差异均无统计学意义。rhPro-UK组溶栓后LVEF值高于r-SAK组，P=0.019。两组应用临床间接指标与行冠脉造影评判血管再通情况间比较差异无统计学意义。结论（1)对STEMI患者应用rhPro-UK、r-SA K 均可有效使IRA开通，rhPro-UK血管开通率略优于r-SAK，但差异无统计学意义；(2)rhPro-UK、r-SA K 不增加心律失常、心功能不全、再次梗死、出血等事件的发生风险，用于STEMI皆安全有效；(3)临床间接指标与行冠脉造影具有相似诊断IRA再通的价值。关键词】急性ST段抬高型心肌梗死；葡激酶；尿激酶原；静脉溶栓；冠状动脉造影；血管再通率【中图分类号】R543【文献标识码】A【文章编号】10 0 4-0 951(2 0 2 3)0 7-0 7 7 9-0 6Evaluation of Efficacy and Safety of Recombinant HumanProurokinase(rhPro-UK)、Re c o m b i n a n t St a p h y l o k i n a s e(r -SA K)i n t h eTreatment of Acute ST-segment Elevation Myocardial InfarctionDU Siyu-,HAN Wei?-,YANG Yang,ZHENG Wei?,QI Wenhua(1.Graduate School of Baotou Medical College,Baotou 014000 China;2.Department of Cardiology,Baotou Central Hospital,Baotou 014000 China)Abstract Objective To compare the efficacy and safety of rhPro-UK and r-SAK in the treatment ofacute ST-segment elevation myocardial infarction(STEMI).Methods A total of 71 STEMI patients whomet AHA/ACC diagnostic criteria for acute myocardial infarction and had no thrombolytic contrainminationswere enrolled in the cardiology Department of Baotou Central Hospital from May 2020 to June 2022,and wererandomly divided into rhPro-UK group(n=35)and r-SAK group(n=36)to receive intravenous throm-bolytic therapy.Ninety minutes later,coronary angiography was performed to compare the vascular opening ofthe two groups.Meanwhile,the incidence of acute complications,various adverse events and bleeding in STE-MI patients after thrombolysis with the above drugs was observed and recorded,and the safety was evaluated.Results There was no significant difference in the rate of vascular recirculation between the two groups(94.3%vs.88.9%,P=0.696).There were no significant differences in acute complications,adverse events一在读硕士研究生通信作者 E-mail:780and bleeding rates between the two groups.The LVEF value of rhPro-UK group was higher than that of r-SAK group(P=0.019).There was no significant difference between the two groups in the application of clini-cal indirect indicators and the evaluation of vascular recanalization after coronary angiography.Conclusion(1)recombinant human urokinase and recombinant staphylokinase can effectively open IRA in STEMI patients,andthe vascular opening rate of rhPro-UK is slightly higher than r-SAK,but there is no statistical significance.(2)rhPro-UK and r-SAK do not increase the risk of arrhythmia,cardiac insufficiency,reinfarction,bleedingand other events,and are safe and effective for STEMI.(3)clinical indicators and coronary angiography havesimilar value in diagnosing IRA recanalization.KeywordsJ STEMI;recombinant human prourokinase(rhPro-UK);recombinant staphylokinase(r-SAK);intravenous thrombolysis;CAG;vascular recanalization rate心血管疾病(cardiovascular disease,CVD)严重威胁居民健康和生命安全，是全球范围内致死、致残的主要原因之一1。我国CVD负担持续增加且逐渐趋于年轻化2,3。急性ST段抬高型心肌梗死(ST-segment elevation myocardial infarction,STE-MI)指患者存在冠状动脉粥样硬化不稳定斑块破裂、糜烂、侵蚀及血管内皮损伤，继而引发血栓形成，或冠状动脉严重痉挛，由于冠状动脉管腔闭塞，供血及供氧急剧减少或中断，相应区域的心肌持续缺血缺氧直至急性坏死，其发病迅速、致死率高，严重危害患者的生命安全及生活质量4。STEMI的再灌注治疗手段包括静脉溶栓、经皮冠状动脉介入（per-cutaneous transluminal coronary intervention,PCI)及急诊冠脉搭桥术等5。直接PCI作为各指南推荐的最佳治疗策略，最常被STEMI患者选择，但仍有部分地区特别是众多基层医院开展和普及直接PCI治疗受限。若于 STEMI发病3h内行溶栓再灌注治疗，可显著提高患者的心肌灌注水平，所获得的临床效果与直接PCI相似，此结论已在临床实践中得到充分证实，且溶栓简单经济，尤其适用于我国大部分基层医院6 。因此,选择理想的溶栓药物尤为重要。本研究旨在探讨和评价对STEMI 患者应用重组人尿激酶原(recombinant human prourokinase,rhPro-UK)、重组葡激酶(recombinant staphylokinase,r-SAK)溶栓后的疗效和安全性,为临床用药提供参考依据。1资料与方法1.1一般资料选取2 0 2 0 年5月至2 0 2 2 年6 月包头市中心医院收治的符合AHA/ACC诊断标准、无溶栓禁忌证且愿意选择溶栓作为再灌注治疗策略的STEMI患者7 1例,随机分为rhProU K 组（35例)、r-SAK组(36 例)7 。纳入标准:持续缺血性胸痛30 min,硝酸甘油治疗后症状不缓解；心电图检查至少存在相邻2 个或2 个以上导联ST段上(胸部导联上抬0.2 mV，肢体导联上抬0.1内蒙古医学杂志InnerMongoliaMedJ2023年第55卷第7 期mV);胸痛发作至拟行溶栓时间 6 0 min，或预计就诊至球囊扩张时间90 min;患者和(或)家属有意愿选择溶栓治疗并签署知情同意书；年龄18 7 5岁，体质量45kg,性别不限。排除标准：非ST段抬高型心肌梗死，合并心源性休克的STEMI；活动性出血或出血体质、患出血性疾病或有出血倾向，包括过去1个月内出现消化道或泌尿道出血、过去6 个月内发生过缺血性卒中、过去6 周内发生过TIA、曾发生出血性卒中；中枢神经系统创伤或动脉瘤；近3周内的严重创伤、手术；可疑的主动脉夹层、感染性心内膜炎；近期进行过难以压迫的穿刺；有创伤性心肺复苏史(时间10min)；使用抗凝药物（如华法林）；严重高血压（积极降压治疗后收缩压仍18 0 mmHg和（或)舒张压110 mmHg);既往存在严重肝肾功能受损；备孕或妊娠期女性;肿瘤患者；患者和(或)家属不同意签署知情同意书。1.2给药方案rhProU K 组给药方法（总剂量50 mg):使用10 mL生理盐水稀释rhPro-UK(商品名：普佑克，上海天士力药业有限公司，批准文号：国药准字S2011003,5mg/支)2 0 mg，于3min左右静脉推注完毕，然后再使用9 0 mL的生理盐水稀释rhPro-UK 30 mg,于 30 min 左右静脉滴注完毕8 。r-SAK组给药方法（总剂量10 mg):r-SAK（商品名：施爱克，江苏康缘药业股份有限公司，5mg/支)10 mg和50 mL生理盐水，先用2 mg(10 mL)剂量静脉注射2 min，余下8 mg(40 mL)剂量在30 min内静注完成9。两组患者除常规吸氧、心电监护外，均予以冠心病二级预防用药,即排除各种用药禁忌证后，依据病情个体化使用受体阻滞剂、硝酸酯类药物、血管紧张素转换酶抑制剂及他汀类药物等10 。溶栓开始前两组患者均口服阿司匹林30 0 mg、氯吡格雷300mg，住院观察期间口服阿司匹林10 0 mg、氯吡内蒙古医学杂志InnerMongoliaMedJ2023年第55卷第7 期格雷7