替格瑞洛對老年不穩(wěn)定型心絞痛患者有效性及安全性的研究
發(fā)布時間:2018-06-07 07:48
本文選題:替格瑞洛 + 老年; 參考:《天津醫(yī)科大學(xué)》2017年碩士論文
【摘要】:研究目的:以老年不穩(wěn)定型心絞痛患者為研究對象,通過隨訪觀察口服替格瑞洛與氯吡格雷1月期間主要不良心血管事件、出血、一般不良反應(yīng)的發(fā)生率及肝腎功能、尿酸、BNP、hs-CRP等變化評估替格瑞洛在老年患者中的有效性及安全性。研究方法:選取2015年2月至2016年10月就診于天津市第一中心醫(yī)院國際診療中心且年齡大于等于60歲的不穩(wěn)定型心絞痛患者88例。根據(jù)隨機數(shù)字表法隨機分為替格瑞洛組和氯吡格雷組。替格瑞洛組44人,氯吡格雷組44人。替格瑞洛組給予替格瑞洛負荷劑量180mg口服,然后給予維持量90mg每天2次,聯(lián)合口服阿司匹林100mg每天1次。氯吡格雷組給予硫酸氫氯吡格雷負荷劑量300mg口服,然后維持量75mg每天1次,聯(lián)合口服阿司匹林100mg每天1次。兩組均常規(guī)應(yīng)用指南推薦的冠心病二級預(yù)防藥物如β受體阻滯劑、他汀類藥物、血管緊張素轉(zhuǎn)換酶抑制劑(ACEI)/血管緊張素Ⅱ受體拮抗劑(ARB)、硝酸酯類等。記錄入選患者用藥前基本臨床資料;兩組分別于服藥前及服藥1月后抽取靜脈血測定肌酐、谷丙轉(zhuǎn)氨酶、尿酸及BNP、hs-CRP水平并進行組內(nèi)及組間比較;觀察隨訪并比較服藥1月期間兩組間主要不良心血管事件(心源性死亡、心肌梗死、再發(fā)性心絞痛、心力衰竭、腦血栓形成)、出血及一般不良反應(yīng)(呼吸困難、心動過緩)的發(fā)生率。從而觀察替格瑞洛在老年不穩(wěn)定型心絞痛患者中的有效性及安全性。研究結(jié)果:1.基線資料比較兩組患者一般基本資料(年齡、性別、吸煙史、飲酒史、體重指數(shù)、血小板、總膽固醇、甘油三酯、低密度脂蛋白膽固醇、高密度脂蛋白膽固醇)及相關(guān)心血管危險因素(高血壓、高脂血癥、糖尿病)無統(tǒng)計學(xué)差異(P0.05)。2.有效性比較2.1血BNP、hs-CRP比較服藥前,替格瑞洛組與氯吡格雷組兩組間BNP水平無明顯差異(P0.05)。服藥1月后,替格瑞洛組與氯吡格雷組兩組間BNP均較用藥前降低,且替格瑞洛組較氯吡格雷組下降更為顯著,差異有統(tǒng)計學(xué)意義(P0.05)。服藥前,替格瑞洛組與氯吡格雷組兩組間血hs-CRP水平無明顯差異(P0.05)。服藥1月后,替格瑞洛組與氯吡格雷組兩組血hs-CRP均較用藥前下降,且替格瑞洛組較氯吡格雷組下降更為顯著,差異有統(tǒng)計學(xué)意義(P0.05)。2.2主要不良心血管事件發(fā)生率比較主要不良心血管事件中替格瑞洛組與氯吡格雷組兩組中均無心源性死亡、心肌梗死、心力衰竭、腦血栓形成等重大不良心血管事件發(fā)生。替格瑞洛組出現(xiàn)4例再發(fā)性心絞痛,氯吡格雷組出現(xiàn)8例再發(fā)性心絞痛,但兩組間無統(tǒng)計學(xué)差異(P=0.352)。3.安全性比較3.1肝腎功能、尿酸的比較口服雙聯(lián)抗血小板藥物治療1月后,替格瑞洛組的谷丙轉(zhuǎn)氨酶、肌酐較治療前無明顯差異(P0.05);尿酸值較治療前升高,差異有統(tǒng)計學(xué)意義(P=0.004)。氯吡格雷組治療后與治療前的谷丙轉(zhuǎn)氨酶、肌酐、尿酸均無明顯差異(P0.05)?诜p聯(lián)抗血小板藥物治療1月后,替格瑞洛組與氯吡格雷組相比較,兩組間谷丙轉(zhuǎn)氨酶、肌酐無明顯差異(P0.05),替格瑞洛組尿酸值較氯吡格雷組升高,差異有統(tǒng)計學(xué)意義(P=0.001)。3.2不良事件發(fā)生情況兩組均未出現(xiàn)主要致命/危及生命的出血、主要出血、次要出血。輕微出血替格瑞洛組較氯吡格雷組高(13.64%vs.4.55%),但兩組間差異無統(tǒng)計學(xué)意義(P=0.266)。其中替格瑞洛組發(fā)生輕微出血6例,包括4例皮下出血點,2例牙齦出血;氯吡格雷組發(fā)生皮下出血及牙齦出血各1例,均觀察未停藥,后癥狀體征緩解。替格瑞洛組出現(xiàn)輕度呼吸困難2例,未停藥、未經(jīng)處理后自行緩解,氯吡格雷組未出現(xiàn)呼吸困難。兩組患者住院隨訪期間均未發(fā)生緩慢性心律失常。結(jié)論:與氯吡格雷相比,替格瑞洛在老年不穩(wěn)定型心絞痛患者的抗栓治療中,可降低血BNP、hs-CRP水平,并未使主要不良心血管事件的發(fā)生風(fēng)險升高、未增加嚴重出血事件的發(fā)生率,肝腎功能無明顯變化,具有較好的有效性及安全性。
[Abstract]:Objective: Taking the elderly patients with unstable angina as the research object, the effectiveness and safety of Ti Gray Lo in the elderly patients were evaluated by the follow-up observation of the major adverse cardiovascular events, bleeding, the incidence of adverse reactions, the liver and kidney function, uric acid, BNP, hs-CRP and other changes in the main adverse cardiovascular events during the oral administration of vidrol and clopidogrel in January. Methods: from February 2015 to October 2016, 88 patients with unstable angina pectoris who were diagnosed at the Tianjin First Central Hospital and aged 60 years old were randomly divided into the group of tgrelor and the clopidogrel group. 44 people in the group of trellor and 44 in the clopidogrel group. A dose of 180mg was given for oral administration of 90mg 2 times a day and 1 times a day combined with oral aspirin 100mg. The clopidogrel group was given a load dose of Clopidogrel Hydrogen Sulfate (300mg), then 1 times a day, and 1 times a day combined with oral aspirin 100mg. The two groups were recommended for the two grade coronary heart disease. Drugs such as beta blockers, statins, angiotensin converting enzyme inhibitor (ACEI) / angiotensin II receptor antagonist (ARB), nitrates, etc. were recorded before taking the basic clinical data of the selected patients; the two groups were taken intravenously before and after January to determine the levels of creatinine, alanine transaminase, uric acid, BNP, and hs-CRP. The incidence of major adverse cardiovascular events (cardiac death, myocardial infarction, recurrent angina, heart failure, cerebral thrombosis), bleeding and general adverse reactions (dyspnea, bradycardia) were observed and compared between the two groups during the period of January, and the incidence of unstable angina pectoris in geriatric age was observed. Efficacy and safety in patients. 1. baseline data were compared in two groups of general basic data (age, sex, smoking history, drinking history, body mass index, platelets, total cholesterol, triglycerides, LDL, HDL) and related cardiovascular risk factors (hypertension, hyperlipidemia, and diabetes). There was no statistical difference (P0.05).2. effectiveness compared to 2.1 blood BNP, hs-CRP compared with the clopidogrel group before taking medicine, there was no significant difference in BNP level between the two groups (P0.05). After taking the medicine, the BNP between the two groups of the group and the clopidogrel group was lower than before the medication, and the difference was more significant than the clopidogrel group in the group of greillo. Statistical significance (P0.05). Before taking the medicine, there was no significant difference in the blood hs-CRP level between the two groups of the group and the clopidogrel group (P0.05). After taking the medicine in January, the blood hs-CRP of the two groups in the group of the clopidogrel and the clopidogrel group decreased compared with the clopidogrel group, and the difference was statistically significant (P0.05).2.2 major adverse events. The incidence of cardiovascular events was compared to the major adverse cardiovascular events in the two groups of the group of tegrel and clopidogrel, myocardial infarction, heart failure, and cerebral thrombosis. There were 4 recurrent angina pectoris in the tegero group and 8 cases of recurrent angina in the clopidogrel group, but two groups were found in the clopidogrel group. No statistical difference (P=0.352).3. safety comparison of 3.1 liver and kidney function, uric acid compared with oral antiplatelet drug treatment after January, the gluteno group alanine transaminase, creatinine no significant difference before treatment (P0.05); uric acid value increased before treatment (P=0.004). The clopidogrel group after treatment and treatment before and before treatment There was no significant difference between the glutamic pyruvic transaminase, creatinine and uric acid (P0.05). After January, the two groups of transglutaminase and creatinine were not significantly different (P0.05), and the value of uric acid in the group was higher than that of the clopidogrel group. The difference was statistically significant (P=0.001).3.2 adverse events. There were no major fatal / life-threatening bleeding, major bleeding and secondary hemorrhage in the two groups. The slight bleeding was higher in the group of Grillo than in the clopidogrel group (13.64%vs.4.55%), but there was no significant difference between the two groups (P=0.266). Among them, 6 cases of mild hemorrhage in the tgilo group, including 4 cases of subcutaneous bleeding, 2 cases of gingival bleeding, and clopidogrel. There were 1 cases of subcutaneous hemorrhage and gingival bleeding in each group, all of them were observed without stopping medicine and symptomatic signs were relieved. There were 2 cases of mild dyspnea in the group of gerriro, no medicine, no treatment, and no dyspnea in the clopidogrel group. The two groups had no chronic chronic arrhythmia during the follow-up period. Conclusion: compared with clopidogrel, the two groups of patients were compared with clopidogrel. In the antithrombotic therapy of elderly patients with unstable angina, Ti Gray Lo can reduce the level of blood BNP and hs-CRP. It does not increase the risk of major adverse cardiovascular events, does not increase the incidence of serious bleeding events, and has no obvious changes in liver and kidney function. It has good effectiveness and safety.
【學(xué)位授予單位】:天津醫(yī)科大學(xué)
【學(xué)位級別】:碩士
【學(xué)位授予年份】:2017
【分類號】:R541.4
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