左西孟旦在急性失代償期心力衰竭患者中應(yīng)用的有效性及安全性研究
發(fā)布時間:2018-06-05 05:01
本文選題:左西孟旦 + 急性失代償心力衰竭。 參考:《河北醫(yī)科大學(xué)》2013年碩士論文
【摘要】:目的:對慢性收縮性心力衰竭急性失代償期心力衰竭患者在常規(guī)藥物治療基礎(chǔ)上加用左西孟旦,觀察左西孟旦的治療效果以及應(yīng)用的安全性。 方法:入選2011年9月至2012年12月在河北醫(yī)科大學(xué)第二醫(yī)院心內(nèi)五科住院的慢性收縮性心力衰竭急性失代償期患者共74例,隨機分為左西孟旦組37例(排除3例于藥物干預(yù)前發(fā)生心源性休克或室速患者后剩34例),平均年齡61.61±7.37歲,對照組37例(排除1例甲亢復(fù)發(fā)患者后剩36例),平均年齡60.36±7.35歲。入選標(biāo)準(zhǔn):1、慢性收縮性心衰患者,且既往接受標(biāo)準(zhǔn)心衰治療即使用血管緊張素轉(zhuǎn)化酶抑制劑(ACEI)或血管緊張素Ⅱ受體拮抗劑(ARB),醛固酮受體拮抗劑(MRA),β受體阻滯劑聯(lián)合治療;2、因慢性收縮性心衰急性失代償入院;3、入院心功能NYHA Ⅲ-Ⅳ級,超聲心動圖示左室射血分?jǐn)?shù)(LVEF)≤40%。排除標(biāo)準(zhǔn):(1)入院后藥物干預(yù)前發(fā)生心房纖顫、惡性心律失常;(2)入院后藥物干預(yù)前發(fā)生心源性休克、低血壓(收縮壓<90mmHg,平均壓<65mmHg),血容量不足;(3)易過敏體質(zhì),伴其他抗心衰藥物過敏者;(4)嚴(yán)重電解質(zhì)紊亂,嚴(yán)重肝、腎功能不全,血紅蛋白低于90g/L者;(5)近一個月急性心肌梗死,存在心臟瓣膜病變、心包疾病、肥厚性及限制性心肌病,以及自身免疫性疾病,未控制的甲狀腺疾病,有癥狀的肺部疾病且需使用激素、茶堿類藥物治療,合并腫瘤者;(6)年齡>80歲者;(7)患者或患者家屬拒絕參加本項研究者。對照組給予標(biāo)準(zhǔn)心衰藥物治療(ACEI或ARB,MRA,β受體阻滯劑),以及利尿藥物、洋地黃類藥物、硝酸鹽類藥物等;左西孟旦組除與對照組相同的治療外,給予左西孟旦注射液(左西孟旦注射液,悅文,齊魯制藥),首先靜脈給予12μg/kg負(fù)荷量,以0.05μg/kg/min為初始劑量靜脈泵點,維持劑量調(diào)整范圍為0.05μg/kg/min-0.2μg/kg/min,保證收縮壓≥90mmHg,平均壓≥65mmHg,心率≤150次/分,在醫(yī)師密切監(jiān)測下調(diào)整劑量,持續(xù)24小時。觀察以下指標(biāo):(1)用藥前、用藥后6小時、12小時、24小時、48小時患者的心率(次/分)、呼吸頻率(次/分)、收縮壓(mmHg)、舒張壓(mmHg);(2)用藥前、用藥后7天患者的B型鈉尿肽(BNP)值;(3)用藥前、用藥后7天兩組患者的超聲心動圖中左室射血分?jǐn)?shù)(LVEF%)、左室舒張末容積(LVEDV)、左室收縮末容積(LVESV)、每搏量(SV);(4)用藥前、用藥后24小時、用藥后7天兩組患者的腎功能、肝功能、電解質(zhì)、紅細胞壓積、血紅蛋白;(5)患者用藥前、用藥后7天心功能紐約心臟協(xié)會(NYHA)分級。觀察兩組患者主要心臟不良事件事件(MACE)發(fā)生率,MACE包括低血壓、惡性心律失常、猝死、心衰加重。應(yīng)用SPSS13.0統(tǒng)計軟件對觀察數(shù)據(jù)進行統(tǒng)計學(xué)分析,以P<0.05為統(tǒng)計學(xué)顯著差異,有統(tǒng)計學(xué)意義。 結(jié)果: 1左西孟旦組和對照組的基線資料:年齡、性別、體重、吸煙、飲酒均無顯著性差異;心臟基礎(chǔ)疾。簲U張型心肌病、缺血性心肌病患病率無顯著性差異;既往史:糖尿病、高血壓的患病率無顯著性差異;兩組患者入院基線生命體征:心率、呼吸頻率、收縮壓、舒張壓無顯著性差異;兩組患者入院超聲心動圖基線LVEF、LVEDV、LVESV、SV無顯著性差異;入院血液檢查:BNP、肌酐(Scr)、胱抑素C(CysC)、β2微球蛋白(β2-MG)、尿素氮(BUN)、血紅蛋白(HGB)、紅細胞壓積(HCT)、谷草轉(zhuǎn)氨酶(AST)、谷丙轉(zhuǎn)氨酶(ALT)、鉀(K)、鈉(Na)均無顯著性差異;兩組患者心功能NYHA分級、藥物使用方面均無顯著性差異,均P>0.05。 2兩組治療效果比較: 左西孟旦組與對照組患者BNP基線值分別為:1236.24±255.26pg/ml,1297.63±298.60pg/ml,兩者比較無統(tǒng)計學(xué)差異(t=-0.926P=0.358)。用藥后7天,左西孟旦組患者BNP值為668.35±239.69pg/ml,與基線值比較有顯著性差異(t=76.356P=0.000),較基線值顯著降低;對照組患者BNP值為1198.00±232.98pg/ml,與基線值比較有顯著性差異(t=6.350P=0.000),較基線值有所降低。用藥后左西孟旦組與對照組BNP比較有統(tǒng)計學(xué)差異(t=9.373P=0.000),左西孟旦組比對照組下降更明顯。 用藥前測量患者超聲心動圖,LVEF、SV、LVEDV、LVESV左西孟旦組分別為33.52±2.35%、63.75±4.76ml、191.10±19.36ml、127.35±16.40ml,對照組分別為33.09±2.49%、62.83±5.25ml、190.75±19.89ml、127.92±16.64ml。兩組各項分別比較未見統(tǒng)計學(xué)差異(P0.05)。用藥后7天再次行超聲心動圖檢查,LVEF、SV、LVEDV、LVESV左西孟旦組分別為38.04±2.10%、66.04±5.06ml、174.13±16.40ml、108.08±12.63ml,分別與用藥前相比較均可見顯著性差異(t=8.483P=0.000,t=2.121P=0.041,t=3.881P=0.000, t=5.379P=0.000);用藥后7天對照組分別為36.14±2.27%、62.26±5.60ml、173.09±20.23ml、110.83±15.89ml,分別與用藥前相比較,LVEF、LVEDV、LVESV可見顯著性差異(t=4.674P=0.000,t=3.484P=0.000, t=4.023P=0.000), SV未見統(tǒng)計學(xué)差異(t=0.407P=0.687)。用藥后7天兩組LVEF、SV分別比較有統(tǒng)計學(xué)意義(t=3.591P=0.001,,t=2.986P=0.004),左西孟旦組明顯高于對照組;LVEDV、LVESV兩組分別比較未見統(tǒng)計學(xué)差異(t=0.246P=0.806,t=0.797P=0.428)。 用藥前患者心功能NYHA分級左西孟旦組Ⅲ級患者17名(50.00%),Ⅳ級患者17名(50.00%),對照組分別為19名(52.78%)、17名(47.22%),兩組比較無統(tǒng)計學(xué)差異(χ~2=0.054,P=0.816)。用藥后7天心功能Ⅱ級、Ⅲ級、Ⅳ級患者人數(shù)左西孟旦組分別為:12(35.29%)、18(52.94%)、3(8.82%),對照組分別為5(13.89%)、20(55.56%)、10(27.78%),兩組比較有統(tǒng)計學(xué)差異(χ~2=6.704,P=0.035)。 3兩組安全性比較: 左西孟旦組收縮壓、舒張壓用藥后6小時、12小時、24小時、48小時分別與用藥前相比無變化,且與對照組相比也未見顯著性差異。 兩組心率用藥后48小時比用藥前下降,且左西孟旦組下降更明顯;兩組呼吸頻率用藥后24小時、48小時比用藥前下降,且48小時左西孟旦組下降更顯著。 左西孟旦組與對照組腎功能(肌酐、胱抑素C、β2微球蛋白、尿素氮)、肝功能(谷丙轉(zhuǎn)氨酶、谷草轉(zhuǎn)氨酶)、血鈉、血紅蛋白、紅細胞壓積用藥后24小時、7天分別與用藥前比較,均無顯著性差異。對照組血鉀亦無變化,但左西孟旦組用藥后24小時血鉀較用藥前相比輕微下降,且有統(tǒng)計學(xué)差異。 MACE事件發(fā)生率及其他不良反應(yīng)比較:截止試驗進行至用藥后7天時,左西孟旦組發(fā)生MACE事件1例為猝死,對照組發(fā)生MACE事件3例,其中1例短陣室速、1例心衰加重、1例猝死。兩組無低血壓病例發(fā)生。兩組MACE事件比較無統(tǒng)計學(xué)差異(P=0.615)。左西孟旦組還發(fā)生竇性心動過速、嚴(yán)重低血鉀(K~+2.8mmol/L)各1例。 結(jié)論: 在常規(guī)藥物治療基礎(chǔ)上加用左西孟旦可有效提高急性失代償期心力衰竭患者的心功能,且安全可行。
[Abstract]:Objective: To observe the efficacy and safety of levosimendan on the treatment of chronic systolic heart failure in patients with acute decompensated heart failure plus left Xi Mengdan on the basis of conventional medication.
Methods: a total of 74 patients with chronic systolic heart failure in five families of the second hospital of Hebei Medical University from September 2011 to December 2012 were randomly divided into 37 cases of levosimendan group (excluding 3 cases with cardiogenic shock or 34 ventricular tachycardia before drug intervention), the average age was 61.61 + 7.37 years old. Group 37 (36 cases of 1 patients with recurrent hyperthyroidism), the average age of 60.36 + 7.35 years. The standard of admission: 1, chronic systolic heart failure, and previously accepted standard heart failure treatment using angiotensin converting enzyme inhibitor (ACEI) or angiotensin II receptor antagonist (ARB), aldosterone receptor antagonist (MRA), beta blocker combination Treatment; 2, hospitalized for acute decompensation of chronic systolic heart failure; 3, cardiac function NYHA III - IV, echocardiography showed left ventricular ejection fraction (LVEF) < 40%. exclusion criteria: (1) atrial fibrillation, malignant arrhythmia before admission, and (2) cardiac shock and hypotension (90mmH) before admission. G, average pressure < 65mmHg), insufficient blood volume; (3) allergic constitution, with other anti heart failure drug allergy; (4) serious electrolyte disorder, severe liver, renal insufficiency, hemoglobin below 90g/L; (5) acute myocardial infarction in the last month, heart valve disease, pericardial disease, hypertrophic and restrictive cardiomyopathy, and autoimmune Disease, uncontrolled thyroid disease, symptomatic lung disease and use of hormone, theophylline treatment, combined with tumor; (6) the age of 80 years old; (7) patients or patients' families refused to participate in this study. The control group was given standard heart failure medication (ACEI or ARB, MRA, beta blocker), and diuretic drugs, digitalis In addition to the same treatment of the control group, the left Simendan group was given Levosimendan Injection (Levosimendan Injection, Yue Wen, Qilu pharmaceutical). First, the intravenous dose of 12 u g/kg was given to 0.05 mu g/kg/min as the initial dose of intravenous pump, and the dimension of the dose adjustment range was 0.05 u g/kg/min-0.2 mu g/kg/min. The contraction pressure was more than 90mmHg, the mean pressure was more than 65mmHg, the heart rate was less than 150 / sub, and the dosage was adjusted for 24 hours. The following indexes were observed: (1) the heart rate (secondary / score), respiratory frequency (mmHg), diastolic pressure (mmHg), 6 hours after medication, 12 hours, 24 hours, 48 hours, 48 hours, and systolic pressure (mmHg); (2) patients before medication, 7 days after medication. The value of B type natriuretic peptide (BNP); (3) left ventricular ejection fraction (LVEF%), left ventricular end diastolic volume (LVEDV), left ventricular end systolic volume (LVEDV), left ventricular end systolic volume (LVESV), per stroke volume (SV); (4) kidney function, liver function, electrolyte, hematocrit, red blood cell pressure, erythrocyte pressure, hematocrit and red blood of 7 days after drug use. (5) (5) before taking drugs, the heart function New York Heart Association (NYHA) was graded at 7 days after medication. The incidence of major adverse events (MACE) in two groups of patients was observed. MACE included hypotension, malignant arrhythmia, sudden death, and worsened heart failure. The statistical analysis of the observation data was carried out with SPSS13.0 software, and P < 0.05 was statistically significant difference. The difference is statistically significant.
Result錛
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