羟乙基淀粉对急性缺血性脑卒中患者的疗效观察

发布时间：2018-04-18 23:20

  本文选题：羟乙基淀粉 + 急性缺血性脑卒中　； 参考：《郑州大学》2017年硕士论文

【摘要】：背景和目的既往有研究发现羟乙基淀粉(Hydroxyethyl starch,HES)存在严重的肾功能及凝血系统的不良反应,且可导致死亡率增加,因此其临床应用的安全性及有效性一直存在争论;2010年Boldt教授的90多篇关于HES的论文被质疑,HES的安全性及有效性再次引起关注,美国食品和药品监督管理局(Food and Drug Administration,FDA)两次对该药发出警告,欧洲药品管理局风险评估委员会也对此药发出缴市声明,禁止其在严重烧伤、败血症等急危重症患者中进行液体复苏时使用。虽然有大规模的临床荟萃分析发现HES使用过程中存在肾功能损伤及凝血功能异常,但大多是针对液体丢失过多的急危重症患者,对于其他相对较轻的疾病使用HES的安全性评价并不多。HES在急性缺血性卒中(acute ischemic infarcton,ACI)患者中的疗效也存在争论,既往有研究发现HES对于低灌注导致的缺血性脑血管病是有确切疗效的,也有研究观察到其并没有明显疗效,对其在ACI患者中的不良反应也未进行大规模的临床观察。因此,本课题就HES在ACI患者中的疗效如何及其对该类患者的肾脏及凝血系统的影响进行临床观察。对象和方法选择2014.10-2016.10住院患者117例作为研究对象,均在郑州大学第五附属医院住院治疗,并确诊为ACI;根据是否使用HES分为对照组和试验组(HES组),其中对照组有55例,给予抗动脉粥样硬化、抗血小板聚集、改善循环、降血压等常规治疗;62例作为试验组,在对照组治疗的基础上给予HES 130/0.4500ml静点,1次/d,疗程14d。收集入院时、治疗第7天、治疗第14天、治疗后第1个月及治疗后第3个月不同时间段的神经功能缺损程度、日常生活能力指数、凝血功能及肾功能变化情况。资料收集均由经同一正规培训的两名医师完成。采用SPSS 17.0软件包进行统计学处理。基线资料中年龄及入院时病程采用(sx±)表示,并用独立样本t检验处理,余指标采用卡方检验;肾功能及凝血功能各指标符合正态分布均以(sx±)表示,采用重复测量方差分析处理数据结果。显著性水平α=0.05。结果两组患者入院时的传统危险因素的差异无统计学意义,经入院治疗,患者的神经功能缺损症状、日常生活能力均较入院时明显改善(P0.05,0.05),两组间NIHSS和BI比较除入院时无差异外,余同一测量点两组间比较差异有统计学意义;试验组较对照组治疗期间肌酐及尿素氮值偏高(P0.05,0.05)、估计肾小球滤过率降低(P0.05),治疗后第3个月各指标均有好转;对照组肾损伤不明显;试验组及对照组凝血功能除试验组APTT稍延长外,余各指标间无明显差异。结论HES对急性缺血性脑卒中患者肾功能及凝血系统可造成不同程度的影响,但经治疗后患者肾损伤及凝血功能在治疗后第3个月均有好转,未发现HES增加出血风险;各组NIHSS及BI治疗后较入院时均明显改善,试验组神经系统症状及日常生活能力均较对照组改善明显。因此在严格控制适应症的情况下,该药物对急性缺血性卒中患者的治疗价值是值得肯定的。
[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.

【学位授予单位】：郑州大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R743.3

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