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瑞舒伐他汀與阿托伐他汀強化降脂治療急性腦梗死的療效及安全性比較

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  本文關(guān)鍵詞:瑞舒伐他汀與阿托伐他汀強化降脂治療急性腦梗死的療效及安全性比較 出處:《大連醫(yī)科大學》2017年碩士論文 論文類型:學位論文


  更多相關(guān)文章: 瑞舒伐他汀 阿托伐他汀 強化降脂 療效 安全性


【摘要】:目的他汀預防和治療缺血性卒中(ischemic Stroke IS)的確切療效性已被廣泛認可,強化降脂因其優(yōu)越性已應用于臨床,瑞舒伐他汀和阿托伐他汀作為最常見他汀藥物,兩者之間的選擇仍存在爭議,本研究了比較兩者強化降脂對急性腦梗死的效果及安全性。材料與方法選取大連醫(yī)科大學附屬第一醫(yī)院神經(jīng)內(nèi)科2016年1月至2016年12月114例初次急性腦梗死患者,其中男79例,女35例,年齡50-80歲,將所有患者隨機分成兩組,瑞舒伐汀組57例(A組),男41例,女16例,平均年齡(64.89±9.10),阿托伐他汀組57例(B組),男38例,女19例,平均年齡(65.82±7.94)。所有入院患者均經(jīng)頭CT或MRI確診為急性腦梗死;首次發(fā)病;發(fā)病48小時以內(nèi);既往1月內(nèi)未服用他汀類藥物。所有入選對象排除標準:心源性栓塞以及其他外傷、腫瘤等引起的腦栓塞患者;合并嚴重心臟疾病、肝衰竭、腎功不全及消化道疾病的患者;妊娠期、哺乳期女性;有他汀類藥物過敏史;腦梗塞繼發(fā)出血者;合并嚴重營養(yǎng)代謝障礙性疾病。所有入選患者均給予阿司匹林腸溶片100mg+硫酸氫氯吡格雷75mg雙聯(lián)抗血小板聚集、改善循環(huán)、營養(yǎng)神經(jīng)等治療,控制血壓、血糖,合理糾正離子紊亂等癥。再此基礎(chǔ)上A組給予瑞舒伐他汀20mg每晚1次口服,B組給予阿托伐他汀60mg每晚1次口服。療程為5周。并于出院時對患者及家屬詳細交代服藥必要性,交代隨訪時間、復查項目。停藥標準:有出現(xiàn)胃腸道不適癥狀者;天冬氨酸氨基轉(zhuǎn)移酶(aspartate transaminase,AST)或丙氨酸氨基轉(zhuǎn)移酶(alanine aminotransferase,ALT)大于正常值2倍者;嚴重腎功能損害者;肌肉疼痛或肌酸激酶高于正常值3倍者;堅持拒絕服藥者等。所有入選患者用藥前及用藥后第1周(約出院時)、第5周抽空腹血,化驗血脂水平:甘油三脂(triglyceride,TG)、總膽固醇(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);肝腎功能:肌酐、ALT、AST;肌酸激酶;空腹血糖。用藥5周后通過電話、門診隨診等方式詢問患者復發(fā)情況、服藥情況以及不良反應。利用SPSS 19.0統(tǒng)計分析軟件進行數(shù)據(jù)庫并完成相關(guān)統(tǒng)計學處理,計量資料用均數(shù)±標準差表示,組間比較采用t檢驗;計數(shù)資料采用率表示,組間比較采用X~2檢驗,P0.05差異具有統(tǒng)計學意義。結(jié)果(1)所有入選患者基線比較(年齡、性別、吸煙率及高血壓、糖尿病等),經(jīng)統(tǒng)計學分析后無明顯差異(P0.05)。都具有可比性。(2)AB兩組TC、TG、LDL-C、HDL-C治療前經(jīng)統(tǒng)計學分析無差異。(1)治療1周后,AB兩組TC均較治療前下降(P0.01),且A組下降程度較B組明顯(P0.05);治療5周后,AB兩組TC值比1周時TC下降(P0.05),5周時兩組之間TC值差異無統(tǒng)計學意義(P0.05)。(2)治療1周時,AB兩組TG值均較治療前下降(P0.01),AB兩組間下降幅度差異無統(tǒng)計學意義(P0.05);治療5周后,AB兩組TG值比1周時下降(P0.05),5周時兩組之間TG值差異無統(tǒng)計學意義(P0.05)。(3)治療1周時,AB兩組LL-C值均較治療前下降,治療前后具有明顯統(tǒng)計學差異(P0.01),A組LL-C值下降幅度大于B組,有明顯統(tǒng)計學意義(P0.01);治療5周時,A組LDL-C較1周時略上升,無統(tǒng)計學意義(P0.05),較治療前明顯下降(P0.05),B組LDL-L較1周時下降,有統(tǒng)計學意義(P0.05),5周時AB兩組間LDL-C值差異無統(tǒng)計學意義。(4)AB兩組治療前后及兩組間HDL-C值均無統(tǒng)計學差異。(5)A組腦梗死再發(fā)1例,B組未見再發(fā),兩組腦梗死復發(fā)率無明顯差異(P0.05)(2)(1)A組治療后出現(xiàn)肝酶升高(3倍AST或ALT2倍)者4例、肝酶明顯升高(AST或ALT3倍)1例、肌酸肌酶明顯升高1例,共出現(xiàn)不良反應6例(12%)。B組出現(xiàn)肝酶升高(3倍AST或ALT2倍)者1例、肌酸激酶明顯升高者1例、肌肉疼痛者(停藥后,患者癥狀明顯緩解)1例,共出現(xiàn)不良反應3例(7%)。兩組治療前后腎功能檢查均未見肌酐明顯升高情況。A組出現(xiàn)不良反應比值較B組大,但兩者之間差異無統(tǒng)計學意義(P0.05)。(2)部分患者入組時肝酶輕度偏高(AST或ALT2倍),但仍繼續(xù)強化降脂治療,治療1周或5周后,肝酶均恢復正常,未見持續(xù)存或加重肝毒性情況發(fā)生。(3)本研究入組的非糖尿病且完成整個治療和隨訪過程的患者78例,A組40例,B組38例,AB兩組的空腹血糖各治療前后相比及兩組之間個時間段相比均無統(tǒng)計學差異(P0.05),且兩組治療后均未見新發(fā)糖尿病。(3)A組所有入組的57例患者治療隨訪過程中擅自停藥、減量等依從性差而退出治療者6例(10.5%),B組依從性差者14例(24.6%),A組依從性優(yōu)于B組(P0.05)。結(jié)論1.瑞舒伐他汀和阿托伐他汀能有效降低TC、TG、LDL-C濃度,對HDL-C無明顯升高作用。2.瑞舒伐他汀和阿托伐他以1:3的劑量比強化治療時,瑞舒伐他汀短期內(nèi)降脂效果強于阿托伐他汀,長期降脂效果相當。兩者的腦梗死二級預防作用無明顯差異。3.瑞舒伐他汀不良反應比例高于阿托伐他汀,但無統(tǒng)計學差異。4.瑞舒伐他汀服藥依從性優(yōu)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
【學位授予單位】:大連醫(yī)科大學
【學位級別】:碩士
【學位授予年份】:2017
【分類號】:R743.3

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