替格瑞洛对老年不稳定型心绞痛患者有效性及安全性的研究

发布时间：2018-06-07 07:48

本文选题：替格瑞洛 + 老年　；参考：《天津医科大学》2017年硕士论文

【摘要】：研究目的:以老年不稳定型心绞痛患者为研究对象,通过随访观察口服替格瑞洛与氯吡格雷1月期间主要不良心血管事件、出血、一般不良反应的发生率及肝肾功能、尿酸、BNP、hs-CRP等变化评估替格瑞洛在老年患者中的有效性及安全性。研究方法:选取2015年2月至2016年10月就诊于天津市第一中心医院国际诊疗中心且年龄大于等于60岁的不稳定型心绞痛患者88例。根据随机数字表法随机分为替格瑞洛组和氯吡格雷组。替格瑞洛组44人,氯吡格雷组44人。替格瑞洛组给予替格瑞洛负荷剂量180mg口服,然后给予维持量90mg每天2次,联合口服阿司匹林100mg每天1次。氯吡格雷组给予硫酸氢氯吡格雷负荷剂量300mg口服,然后维持量75mg每天1次,联合口服阿司匹林100mg每天1次。两组均常规应用指南推荐的冠心病二级预防药物如β受体阻滞剂、他汀类药物、血管紧张素转换酶抑制剂(ACEI)/血管紧张素Ⅱ受体拮抗剂(ARB)、硝酸酯类等。记录入选患者用药前基本临床资料;两组分别于服药前及服药1月后抽取静脉血测定肌酐、谷丙转氨酶、尿酸及BNP、hs-CRP水平并进行组内及组间比较;观察随访并比较服药1月期间两组间主要不良心血管事件(心源性死亡、心肌梗死、再发性心绞痛、心力衰竭、脑血栓形成)、出血及一般不良反应(呼吸困难、心动过缓)的发生率。从而观察替格瑞洛在老年不稳定型心绞痛患者中的有效性及安全性。研究结果:1.基线资料比较两组患者一般基本资料(年龄、性别、吸烟史、饮酒史、体重指数、血小板、总胆固醇、甘油三酯、低密度脂蛋白胆固醇、高密度脂蛋白胆固醇)及相关心血管危险因素(高血压、高脂血症、糖尿病)无统计学差异(P0.05)。2.有效性比较2.1血BNP、hs-CRP比较服药前,替格瑞洛组与氯吡格雷组两组间BNP水平无明显差异(P0.05)。服药1月后,替格瑞洛组与氯吡格雷组两组间BNP均较用药前降低,且替格瑞洛组较氯吡格雷组下降更为显著,差异有统计学意义(P0.05)。服药前,替格瑞洛组与氯吡格雷组两组间血hs-CRP水平无明显差异(P0.05)。服药1月后,替格瑞洛组与氯吡格雷组两组血hs-CRP均较用药前下降,且替格瑞洛组较氯吡格雷组下降更为显著,差异有统计学意义(P0.05)。2.2主要不良心血管事件发生率比较主要不良心血管事件中替格瑞洛组与氯吡格雷组两组中均无心源性死亡、心肌梗死、心力衰竭、脑血栓形成等重大不良心血管事件发生。替格瑞洛组出现4例再发性心绞痛,氯吡格雷组出现8例再发性心绞痛,但两组间无统计学差异(P=0.352)。3.安全性比较3.1肝肾功能、尿酸的比较口服双联抗血小板药物治疗1月后,替格瑞洛组的谷丙转氨酶、肌酐较治疗前无明显差异(P0.05);尿酸值较治疗前升高,差异有统计学意义(P=0.004)。氯吡格雷组治疗后与治疗前的谷丙转氨酶、肌酐、尿酸均无明显差异(P0.05)。口服双联抗血小板药物治疗1月后,替格瑞洛组与氯吡格雷组相比较,两组间谷丙转氨酶、肌酐无明显差异(P0.05),替格瑞洛组尿酸值较氯吡格雷组升高,差异有统计学意义(P=0.001)。3.2不良事件发生情况两组均未出现主要致命/危及生命的出血、主要出血、次要出血。轻微出血替格瑞洛组较氯吡格雷组高(13.64%vs.4.55%),但两组间差异无统计学意义(P=0.266)。其中替格瑞洛组发生轻微出血6例,包括4例皮下出血点,2例牙龈出血;氯吡格雷组发生皮下出血及牙龈出血各1例,均观察未停药,后症状体征缓解。替格瑞洛组出现轻度呼吸困难2例,未停药、未经处理后自行缓解,氯吡格雷组未出现呼吸困难。两组患者住院随访期间均未发生缓慢性心律失常。结论:与氯吡格雷相比,替格瑞洛在老年不稳定型心绞痛患者的抗栓治疗中,可降低血BNP、hs-CRP水平,并未使主要不良心血管事件的发生风险升高、未增加严重出血事件的发生率,肝肾功能无明显变化,具有较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.
【学位授予单位】：天津医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R541.4

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