本文選題：比伐盧定 + 肝素聯(lián)合替羅非班　； 參考：《河北醫(yī)科大學(xué)》2013年碩士論文

【摘要】：目的：本研究對經(jīng)橈動脈直接經(jīng)皮冠狀動脈介入治療(PercutaneousCoronary Intervention; PCI)的急性ST段抬高型心肌梗死（ST-segmentelevation acute myocardial infarction; STEMI）患者應(yīng)用國產(chǎn)比伐盧定與肝素聯(lián)合替羅非班的治療效果與安全性進(jìn)行比較，探討國產(chǎn)比伐盧定在急性ST段抬高型心肌梗死患者中的治療效果與安全性。 方法：入選河北醫(yī)科大學(xué)第二醫(yī)院心血管內(nèi)五科于2011年2月到2013年2月期間收治的70例診斷明確為STEMI并于發(fā)病12小時內(nèi)經(jīng)橈動脈途徑行冠脈造影（Coronary angiography; CAG）檢查或直接PCI治療的患者，平均年齡為57.39±8.35（≤75）歲，其中男性48例，女性22例。全部入選患者用藥前分為比伐盧定組（35例，A組），和肝素聯(lián)合替羅非班組（35例，B組）。給藥方法：比伐盧定組在PCI前靜脈注射負(fù)荷劑量的國產(chǎn)比伐盧定0.75mg/kg，，而后立即按照1.75mg/(k g·h)維持靜脈泵入至術(shù)畢，隨后以小劑量0.2mg/(k g·h)維持泵入，共應(yīng)用24小時后停用。當(dāng)靜脈給予負(fù)荷劑量的國產(chǎn)比伐盧定5min后對活化凝血時間（activated clotting time;ACT）進(jìn)行檢測，當(dāng)ACT小于225s時，則另外追加0.3mg/kg的比伐盧定進(jìn)行靜脈注射。肝素聯(lián)合替羅非班組在PCI前靜脈注射肝素鈉100U/kg（最大10000U），根據(jù)負(fù)荷量靜脈注射5min后檢測ACT結(jié)果，若ACT小于225s，則需再追加肝素20U/kg靜脈注射，并予后續(xù)維持泵入使ACT在200s-300s之間，共應(yīng)用24小時后停用。替羅非班：于PCI術(shù)前開始負(fù)荷量為5μg/kg在3分鐘內(nèi)推注完畢而后以0.075μg/kg/min的速率維持泵入24h。 合并用藥:1. A組與B組停用比伐盧定或肝素與替羅非班前2小時給予低分子肝素5000u重疊，之后為5000u2/日，連續(xù)7天；2.所有患者均在術(shù)前給予氯吡格雷及阿司匹林，各負(fù)荷量300mg，PCI術(shù)后阿司匹林口服100mg/d聯(lián)合氯吡格雷口服75mg/d，至少1年。輔助治療藥物有：他汀類、ACEI/ARB類、β受體阻滯劑、硝酸酯類等。入院時及PCI術(shù)后30天的各項常規(guī)檢查指標(biāo)：血常規(guī)、腎功能、肝功能、電解質(zhì)、血糖、纖維蛋白原、肌酸激酶同工酶（CK-MB）和肌鈣蛋白I（cTnI）濃度。兩組間治療效果評價指標(biāo)：ACT測定，PCI治療成功率，PCI術(shù)后的TIMI3級血流發(fā)生率和TMPG分級的結(jié)果。安全性評價指標(biāo):直接PCI治療后24小時內(nèi)、30天內(nèi)總不良臨床事件發(fā)生率�？偛涣寂R床事件包括：出血事件(根據(jù)REPLACE-2出血分級標(biāo)準(zhǔn))、主要不良心血管事件（Major adverse cardiacevents, MACE）、血小板減少癥。其中出血事件根據(jù)REPLACE-2出血分級標(biāo)準(zhǔn)、BARC出血分級標(biāo)準(zhǔn)[16]（Bleeding Academic Research ConsortiumConsensus Report）評定出血程度；主要不良心血管事件定義為：惡性心律失常、嚴(yán)重心衰、再梗死、靶血管血運(yùn)重建及心源性死亡；血小板減少癥（定義為藥物應(yīng)用后，血小板計數(shù)100×109／L）的發(fā)生率。根據(jù)STEMI患者的TIMI危險評分分為低危亞組和中高危亞組，比較兩組間不同危險程度亞組的患者的總不良臨床事件發(fā)生率。 所有數(shù)據(jù)統(tǒng)計學(xué)處理均采用SPSS19.0統(tǒng)計軟件包進(jìn)行，其中計數(shù)資料用百分比表示，應(yīng)用χ2進(jìn)行檢驗，計量資料以均數(shù)±標(biāo)準(zhǔn)差表示，應(yīng)用兩個獨立樣本均數(shù)的t檢驗，非正態(tài)的計量資料和等級相關(guān)資料應(yīng)用秩和檢驗，以P0.05認(rèn)為具有統(tǒng)計學(xué)差異。 結(jié)果： 1兩組基礎(chǔ)臨床資料比較： 兩組間年齡、男性患者比例、體重指數(shù)、高血壓、糖尿病、高脂血癥、冠心�。–HD）家族史、吸煙史、既往心肌梗死病史、既往PCI治療史、發(fā)病至入院時間、TIMI危險評分和貧血情況等基線資料水平差異無統(tǒng)計學(xué)意義，入院時及PCI術(shù)后30天的各項常規(guī)檢查指標(biāo)及其它常規(guī)檢查指標(biāo)：肌酐清除率、血紅蛋白、紅細(xì)胞計數(shù)、血小板計數(shù)、肝功能、血糖、纖維蛋白原、肌酸激酶同工酶（CK-MB）和肌鈣蛋白I（cTnI）濃度均無統(tǒng)計學(xué)差異。 2兩組間治療效果比較： 全部患者的CAG檢查結(jié)果顯示：A組與B組間梗死相關(guān)血管的比例無顯著統(tǒng)計學(xué)差異。 A組與B組之間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分級≥2的比例（85.7%vs.82.9%, P=0.94）、PCI后TIMI血流3級的分布比例（94.3%vs.91.4%, P=1.00）均無統(tǒng)計學(xué)差異。 3兩組間治療的安全性比較： 兩組患者CAG檢查和直接PCI治療后24小時內(nèi)各種不良臨床事件發(fā)生率比較：總不良臨床事件發(fā)生率(5.7%vs.11.4%, P=0.67)無顯著統(tǒng)計學(xué)差異。術(shù)后24小時內(nèi)出血（根據(jù)REPLACE-2出血分級標(biāo)準(zhǔn)）事件發(fā)生率(5.7%vs.11.4%, P=0.67)兩組也無明顯統(tǒng)計學(xué)差異。其中B組有一例嚴(yán)重消化道出血并經(jīng)積極治療后恢復(fù)的患者，A組則無。兩組均未發(fā)生支架置入術(shù)后急性血栓形成以及其它主要不良心血管事件。 兩組患者CAG檢查和直接PCI治療后30天內(nèi)各種不良臨床事件結(jié)局：總不良臨床事件發(fā)生率(5.7%vs.14.3%, P=0.43)和REPLACE-2出血分級標(biāo)準(zhǔn)（5.7%vs.14.3%, P=0.43）未見顯著統(tǒng)計學(xué)差異，但BARC出血標(biāo)準(zhǔn)的總出血事件（11.4%vs.34.3%, P=0.04)有統(tǒng)計學(xué)差異。主要不良心血管事件發(fā)生率(0.0%vs.2.9%, P=1.000)無顯著統(tǒng)計學(xué)差異。B組有一例再灌注性心律失常并經(jīng)積極治療后恢復(fù)的患者。兩組均無血小板減少癥、支架置入術(shù)后血栓形成和死亡發(fā)生。 4兩組間不同危險程度亞組患者的總不良臨床事件發(fā)生率比較： 與肝素聯(lián)合替羅非班相比，單獨應(yīng)用比伐盧定在低危亞組患者中未見顯著統(tǒng)計學(xué)差異(14.3%vs.23.1%, P=0.649)，但在中高危亞組患者中出血事件的發(fā)生率(9.5%vs.40.1%, P=0.046)顯著減少。 結(jié)論： 在行經(jīng)橈動脈路徑直接PCI治療的急性STEMI患者中，單獨應(yīng)用國產(chǎn)比伐盧定在PCI治療效果及MACE事件發(fā)生率方面與肝素聯(lián)合替羅非班相似，但可顯著減少術(shù)后30天內(nèi)的出血事件，較適用于STEMI-TIMI評分中高危的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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