羥乙基淀粉對急性缺血性腦卒中患者的療效觀察
本文選題:羥乙基淀粉 + 急性缺血性腦卒中; 參考:《鄭州大學》2017年碩士論文
【摘要】:背景和目的既往有研究發(fā)現(xiàn)羥乙基淀粉(Hydroxyethyl starch,HES)存在嚴重的腎功能及凝血系統(tǒng)的不良反應,且可導致死亡率增加,因此其臨床應用的安全性及有效性一直存在爭論;2010年Boldt教授的90多篇關于HES的論文被質(zhì)疑,HES的安全性及有效性再次引起關注,美國食品和藥品監(jiān)督管理局(Food and Drug Administration,FDA)兩次對該藥發(fā)出警告,歐洲藥品管理局風險評估委員會也對此藥發(fā)出繳市聲明,禁止其在嚴重燒傷、敗血癥等急危重癥患者中進行液體復蘇時使用。雖然有大規(guī)模的臨床薈萃分析發(fā)現(xiàn)HES使用過程中存在腎功能損傷及凝血功能異常,但大多是針對液體丟失過多的急危重癥患者,對于其他相對較輕的疾病使用HES的安全性評價并不多。HES在急性缺血性卒中(acute ischemic infarcton,ACI)患者中的療效也存在爭論,既往有研究發(fā)現(xiàn)HES對于低灌注導致的缺血性腦血管病是有確切療效的,也有研究觀察到其并沒有明顯療效,對其在ACI患者中的不良反應也未進行大規(guī)模的臨床觀察。因此,本課題就HES在ACI患者中的療效如何及其對該類患者的腎臟及凝血系統(tǒng)的影響進行臨床觀察。對象和方法選擇2014.10-2016.10住院患者117例作為研究對象,均在鄭州大學第五附屬醫(yī)院住院治療,并確診為ACI;根據(jù)是否使用HES分為對照組和試驗組(HES組),其中對照組有55例,給予抗動脈粥樣硬化、抗血小板聚集、改善循環(huán)、降血壓等常規(guī)治療;62例作為試驗組,在對照組治療的基礎上給予HES 130/0.4500ml靜點,1次/d,療程14d。收集入院時、治療第7天、治療第14天、治療后第1個月及治療后第3個月不同時間段的神經(jīng)功能缺損程度、日常生活能力指數(shù)、凝血功能及腎功能變化情況。資料收集均由經(jīng)同一正規(guī)培訓的兩名醫(yī)師完成。采用SPSS 17.0軟件包進行統(tǒng)計學處理;資料中年齡及入院時病程采用(sx±)表示,并用獨立樣本t檢驗處理,余指標采用卡方檢驗;腎功能及凝血功能各指標符合正態(tài)分布均以(sx±)表示,采用重復測量方差分析處理數(shù)據(jù)結(jié)果。顯著性水平α=0.05。結(jié)果兩組患者入院時的傳統(tǒng)危險因素的差異無統(tǒng)計學意義,經(jīng)入院治療,患者的神經(jīng)功能缺損癥狀、日常生活能力均較入院時明顯改善(P0.05,0.05),兩組間NIHSS和BI比較除入院時無差異外,余同一測量點兩組間比較差異有統(tǒng)計學意義;試驗組較對照組治療期間肌酐及尿素氮值偏高(P0.05,0.05)、估計腎小球濾過率降低(P0.05),治療后第3個月各指標均有好轉(zhuǎn);對照組腎損傷不明顯;試驗組及對照組凝血功能除試驗組APTT稍延長外,余各指標間無明顯差異。結(jié)論HES對急性缺血性腦卒中患者腎功能及凝血系統(tǒng)可造成不同程度的影響,但經(jīng)治療后患者腎損傷及凝血功能在治療后第3個月均有好轉(zhuǎn),未發(fā)現(xiàn)HES增加出血風險;各組NIHSS及BI治療后較入院時均明顯改善,試驗組神經(jīng)系統(tǒng)癥狀及日常生活能力均較對照組改善明顯。因此在嚴格控制適應癥的情況下,該藥物對急性缺血性卒中患者的治療價值是值得肯定的。
[Abstract]:Background and objective: Previous studies have found that hydroxyethyl starch (Hydroxyethyl, starch, HES) adverse reactions have renal function and blood coagulation system seriously, and can lead to increased mortality, so the safety and efficacy of its clinical application has been controversial; more than 90 2010 professor Boldt paper on HES was questioned, safe and effective HES once again attracted attention, the U.S. Food and Drug Administration (Food and Drug Administration, FDA) two issued a warning to the drug, the European Medicines Agency Risk Assessment Committee issued the drug payment statement to ban it in the city, severe burns, fluid resuscitation with sepsis in critically ill patients. Although there is a large scale clinical meta-analysis found that coagulation dysfunction and abnormal renal function in the process of using HES, but mostly for excessive fluid loss of critically ill patients, For the safety evaluation of other relatively mild disease using HES is not.HES in acute ischemic stroke (acute ischemic, infarcton, ACI) patients in previous debate, studies have found that ischemic cerebrovascular disease caused by HES for low perfusion is a definite curative effect, also has been observed and no the obvious curative effect, clinical observation scale nor the adverse reactions in patients with ACI. Therefore, this topic is how the efficacy of HES in patients with ACI and its effects on the kidney and blood coagulation in the patients of clinical observation. Objects and methods 117 cases of hospitalized patients with 2014.10-2016.10 were as the research object. In the Fifth Affiliated Hospital of Zhengzhou University hospital, and were diagnosed as ACI; according to whether the use of HES divided into control group and experimental group (HES group), the control group had 55 cases, anti atherosclerosis, anti blood Platelet aggregation, improve circulation, lowering blood pressure and other conventional treatment; 62 cases as experimental group, given HES 130/0.4500ml intravenously based on the treatment in control group, 1 /d, 14D. treatment were collected at admission, treatment for seventh days, fourteenth days of treatment, after treatment for first months and third months after treatment and the time the degree of neurologic impairment, daily life ability index, the changes of coagulation function and renal function. Data collection was completed by two physicians through the same formal training. SPSS 17 software package was used for statistical analysis. The baseline data in age and admission duration using (SX +), and independent samples t test, more than index by chi square test; each index of renal function and coagulation function were in accord with normal distribution (SX +) said, using repeated measures analysis of variance data processing results. Significant level was =0.05. the results of two groups of patients in hospital when traditional risk No statistically significant differences in the factors, after hospital treatment, neurological symptoms of patients, daily life ability were significantly improved compared with admission (P0.05,0.05), between the two groups NIHSS and BI compared with no difference on admission, more than the same measuring point difference between the two groups have statistical significance; the experimental group than the control group during the treatment of urea nitrogen and creatinine values (P0.05,0.05), estimated glomerular filtration rate decreased (P0.05), third months after the treatment of each index were improved; renal damage is not obvious in control group; experimental group and control group in blood coagulation function in the experiment group APTT was slightly extended, but no obvious differences among the indicators. Conclusion HES can cause different effects on renal function of patients with acute ischemic stroke and blood coagulation, third months after treatment were improved in patients with renal injury but after coagulation and after treatment, HES did not increase the risk of bleeding were found; NIHSS and BI After treatment, the neurological symptoms and activities of daily living in the experimental group were significantly improved than those in the control group. Therefore, in the strict control of indications, the therapeutic value of the drug for patients with acute ischemic stroke is worth affirming.
【學位授予單位】:鄭州大學
【學位級別】:碩士
【學位授予年份】:2017
【分類號】:R743.3
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