瑞舒伐他汀与阿托伐他汀强化降脂治疗急性脑梗死的疗效及安全性比较

发布时间：2017-12-28 16:13

本文关键词：瑞舒伐他汀与阿托伐他汀强化降脂治疗急性脑梗死的疗效及安全性比较　出处：《大连医科大学》2017年硕士论文　论文类型：学位论文

【摘要】：目的他汀预防和治疗缺血性卒中(ischemic Stroke IS)的确切疗效性已被广泛认可,强化降脂因其优越性已应用于临床,瑞舒伐他汀和阿托伐他汀作为最常见他汀药物,两者之间的选择仍存在争议,本研究了比较两者强化降脂对急性脑梗死的效果及安全性。材料与方法选取大连医科大学附属第一医院神经内科2016年1月至2016年12月114例初次急性脑梗死患者,其中男79例,女35例,年龄50-80岁,将所有患者随机分成两组,瑞舒伐汀组57例(A组),男41例,女16例,平均年龄(64.89±9.10),阿托伐他汀组57例(B组),男38例,女19例,平均年龄(65.82±7.94)。所有入院患者均经头CT或MRI确诊为急性脑梗死;首次发病;发病48小时以内;既往1月内未服用他汀类药物。所有入选对象排除标准:心源性栓塞以及其他外伤、肿瘤等引起的脑栓塞患者;合并严重心脏疾病、肝衰竭、肾功不全及消化道疾病的患者;妊娠期、哺乳期女性;有他汀类药物过敏史;脑梗塞继发出血者;合并严重营养代谢障碍性疾病。所有入选患者均给予阿司匹林肠溶片100mg+硫酸氢氯吡格雷75mg双联抗血小板聚集、改善循环、营养神经等治疗,控制血压、血糖,合理纠正离子紊乱等症。再此基础上A组给予瑞舒伐他汀20mg每晚1次口服,B组给予阿托伐他汀60mg每晚1次口服。疗程为5周。并于出院时对患者及家属详细交代服药必要性,交代随访时间、复查项目。停药标准:有出现胃肠道不适症状者;天冬氨酸氨基转移酶(aspartate transaminase,AST)或丙氨酸氨基转移酶(alanine aminotransferase,ALT)大于正常值2倍者;严重肾功能损害者;肌肉疼痛或肌酸激酶高于正常值3倍者;坚持拒绝服药者等。所有入选患者用药前及用药后第1周(约出院时)、第5周抽空腹血,化验血脂水平:甘油三脂(triglyceride,TG)、总胆固醇(total cholesterol,TC)、低密度脂蛋白(low density liporotein cholestero,LDL-C)、高密度脂蛋白(high density liporotein,HDL-C);肝肾功能:肌酐、ALT、AST;肌酸激酶;空腹血糖。用药5周后通过电话、门诊随诊等方式询问患者复发情况、服药情况以及不良反应。利用SPSS 19.0统计分析软件进行数据库并完成相关统计学处理,计量资料用均数±标准差表示,组间比较采用t检验;计数资料采用率表示,组间比较采用X~2检验,P0.05差异具有统计学意义。结果(1)所有入选患者基线比较(年龄、性别、吸烟率及高血压、糖尿病等),经统计学分析后无明显差异(P0.05)。都具有可比性。(2)AB两组TC、TG、LDL-C、HDL-C治疗前经统计学分析无差异。(1)治疗1周后,AB两组TC均较治疗前下降(P0.01),且A组下降程度较B组明显(P0.05);治疗5周后,AB两组TC值比1周时TC下降(P0.05),5周时两组之间TC值差异无统计学意义(P0.05)。(2)治疗1周时,AB两组TG值均较治疗前下降(P0.01),AB两组间下降幅度差异无统计学意义(P0.05);治疗5周后,AB两组TG值比1周时下降(P0.05),5周时两组之间TG值差异无统计学意义(P0.05)。(3)治疗1周时,AB两组LL-C值均较治疗前下降,治疗前后具有明显统计学差异(P0.01),A组LL-C值下降幅度大于B组,有明显统计学意义(P0.01);治疗5周时,A组LDL-C较1周时略上升,无统计学意义(P0.05),较治疗前明显下降(P0.05),B组LDL-L较1周时下降,有统计学意义(P0.05),5周时AB两组间LDL-C值差异无统计学意义。(4)AB两组治疗前后及两组间HDL-C值均无统计学差异。(5)A组脑梗死再发1例,B组未见再发,两组脑梗死复发率无明显差异(P0.05)(2)(1)A组治疗后出现肝酶升高(3倍AST或ALT2倍)者4例、肝酶明显升高(AST或ALT3倍)1例、肌酸肌酶明显升高1例,共出现不良反应6例(12%)。B组出现肝酶升高(3倍AST或ALT2倍)者1例、肌酸激酶明显升高者1例、肌肉疼痛者(停药后,患者症状明显缓解)1例,共出现不良反应3例(7%)。两组治疗前后肾功能检查均未见肌酐明显升高情况。A组出现不良反应比值较B组大,但两者之间差异无统计学意义(P0.05)。(2)部分患者入组时肝酶轻度偏高(AST或ALT2倍),但仍继续强化降脂治疗,治疗1周或5周后,肝酶均恢复正常,未见持续存或加重肝毒性情况发生。(3)本研究入组的非糖尿病且完成整个治疗和随访过程的患者78例,A组40例,B组38例,AB两组的空腹血糖各治疗前后相比及两组之间个时间段相比均无统计学差异(P0.05),且两组治疗后均未见新发糖尿病。(3)A组所有入组的57例患者治疗随访过程中擅自停药、减量等依从性差而退出治疗者6例(10.5%),B组依从性差者14例(24.6%),A组依从性优于B组(P0.05)。结论1.瑞舒伐他汀和阿托伐他汀能有效降低TC、TG、LDL-C浓度,对HDL-C无明显升高作用。2.瑞舒伐他汀和阿托伐他以1:3的剂量比强化治疗时,瑞舒伐他汀短期内降脂效果强于阿托伐他汀,长期降脂效果相当。两者的脑梗死二级预防作用无明显差异。3.瑞舒伐他汀不良反应比例高于阿托伐他汀,但无统计学差异。4.瑞舒伐他汀服药依从性优于阿托伐他汀。
[Abstract]:The purpose of statins in prevention and treatment of ischemic stroke (ischemic Stroke IS) the curative effect of intensive lipid-lowering has been widely recognized because of its superiority has been applied to clinical, rosuvastatin and atorvastatin statins as the most common, the choice between them is still controversial, this study compared the two intensive lipid-lowering effect and safety on acute cerebral infarction. Materials and methods: the First Affiliated Hospital of Dalian Medical University Department of Neurology from January 2016 to December 2016 114 patients with first acute cerebral infarction patients, 79 were male, 35 were female, aged 50-80 years, all patients were randomly divided into two groups, 57 cases of Fating rosuvastatin group (A group), male 41 cases, female 16 cases, average age (64.89 + 9.10), atorvastatin group (B group) 57 cases, male 38 cases, female 19 cases, average age (65.82 + 7.94). All hospitalized patients were diagnosed with acute cerebral infarction by head CT or MRI; the first onset was less than 48 hours, and statins were not taken in the past January. All subjects were excluded patients with cardiogenic embolism and cerebral embolism caused by other trauma, tumor; severe heart disease, liver failure, renal dysfunction and gastrointestinal disease; pregnancy and lactation of female pregnancy; statin drug allergy; cerebral infarction complicated with severe secondary bleeding; nutrition metabolism disorder. All the selected patients were treated with Aspirin Enteric-coated Tablets 100mg+, clopidogrel bisulfite, 75mg, anti platelet aggregation, circulation improvement, nutrition nerve treatment, blood pressure control, blood sugar control, and correct ionic disorder. On this basis, group A was given 1 times a night for rosuvastatin 20mg, and group B was given 1 times a night for atorvastatin. The course of treatment was 5 weeks. At the time of discharge, the necessity of taking the medicine for the patients and their families was explained in detail, and the follow-up time and the review of the project were given. Stopping criteria: gastrointestinal symptoms; aspartate aminotransferase (aspartate, transaminase, AST) or alanine aminotransferase (alanine, aminotransferase, ALT) 2 times more than the normal value; severe renal impairment; muscle pain or creatine kinase is higher than the normal value of 3 times; to refuse to take medicine etc.. All patients first weeks before and after treatment (about fifth weeks to discharge), abdominal blood lipid level testing: glycerin three greases (triglyceride, TG), total cholesterol (total, cholesterol, TC), low density lipoprotein (low density liporotein Cholestero, LDL-C), high density lipoprotein (high density liporotein, HDL-C); the function of liver and kidney: creatinine, ALT, AST; creatine kinase; fasting blood glucose. After 5 weeks of medication, the patient's relapse, medication and adverse reactions were asked by telephone and out-patient follow-up. SPSS 19 statistical analysis software was used to conduct the database and complete the related statistical processing. The measurement data were expressed by mean + standard deviation. The t test was used in comparison between the groups, and the rate data were used for counting data. X~2 test was used for comparison between groups, and P0.05 difference was statistically significant. Results (1) the baseline comparison of all selected patients (age, sex, smoking rate, hypertension, diabetes, etc.) had no significant difference after statistical analysis (P0.05). They all have comparability. (2) there was no difference between AB and two groups before TC, TG, LDL-C and HDL-C. (1) after 1 weeks of treatment, the TC in AB two group decreased (P0.01) compared with that before treatment (P0.01), and the degree of decline in group A was significantly higher than that in group B (P0.05). After 5 weeks treatment, TC value in AB two group decreased (TC) compared with that at 1 weeks (P0.05), and there was no significant difference in TC value between two groups at 5 weeks (P0.05). (2) at 1 weeks of treatment, the TG value of AB two group decreased compared with that before treatment (P0.01), and the difference between AB two groups was not statistically significant (P0.05). After 5 weeks of treatment, the TG value of AB two group decreased (P0.05) than that of 1 week (P0.05), and there was no significant difference in TG value between two groups at 5 weeks (P0.05). (3) after 1 weeks of treatment, two groups of AB LL-C were lower than that before treatment, before and after treatment with significant difference (P0.01), A group, LL-C value decreased more than the B group, there was statistical significance (P0.01); after 5 weeks of treatment, A group LDL-C was 1 weeks rose slightly without statistical significance. (P0.05), decreased significantly compared with before treatment (P0.05), B LDL-L group compared with 1 weeks decreased, with statistical significance (P0.05), AB 5 LDL-C between the two groups was no significant difference. (4) there was no significant difference in HDL-C between the AB two groups before and after treatment and between the two groups. (5) A group of cerebral infarction recurrence in 1 cases, B group had no recurrence of cerebral infarction group, two recurrence rate had no significant difference (P0.05) (2) (1) A group after the treatment of elevated liver enzymes (3 times AST or ALT2 times) in 4 cases, liver enzymes increased significantly (AST or ALT3 times) in 1 cases, creatine kinase was significantly increased in 1 cases, there were 6 cases of adverse reactions (12%). Group B showed increased liver enzymes (3 times AST or ALT2 times), 1 cases, 1 cases of creatine kinase increased significantly, muscle pain patients (after withdrawal, symptoms relieved), 1 cases, there were 3 cases of adverse reactions (7%). There was no significant increase in creatinine in the two groups before and after treatment. The ratio of adverse reaction in group A was larger than that in group B, but there was no significant difference between the two groups (P0.05). (2) in some patients, the hepatic enzymes were slightly higher (AST or ALT2 times) when they entered the group, but they continued to strengthen the lipid-lowering therapy. After 1 or 5 weeks of treatment, the liver enzymes returned to normal, and no persistent or aggravated hepatotoxicity occurred. (3) this study into the group of non diabetes and complete the whole process of treatment and follow-up of 78 patients, 40 cases of A group, B group of 38 cases, two groups of fasting blood glucose before and after AB treatment and compared between the two groups in each period there was no significant difference between the two groups (P0.05), and after the treatment no new onset diabetes. (3) in the A group, 57 cases of all the patients in the treatment group had poor compliance and 6 cases (10.5%) who quit the treatment during the follow-up period. There were 14 cases (24.6%) of poor compliance in group B, and the compliance in group A was better than that in group B (P0.05). Conclusion 1. rosuvastatin and atorvastatin can effectively reduce the concentration of TC, TG and LDL-C, and have no significant effect on HDL-C. 2. rosuvastatin and atorvastatin at the dose of 1:3 for intensive treatment, rosufavari
【学位授予单位】：大连医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R743.3

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