长春西汀治疗缺血性脑白质病变的临床研究

发布时间：2018-03-22 08:04

本文选题：长春西汀　切入点：缺血性脑白质病变　出处：《延安大学》2015年硕士论文　论文类型：学位论文

【摘要】：【目的】观察长春西汀对缺血性脑白质病变的有效性及安全性【方法】选取2013年1月至2014年10月在延安大学附属医院神经内科就诊,通过头颅核磁共振检查显示为缺血性脑白质病变,同时根据Fzakas视觉量表[1]分级为3级的患者共62例,随机分为长春西汀药物组和对照组(药物组33例,对照组29例);药物组使用长春西汀注射液(开文通生产批号:A33116A)30mg,配入250ml生理盐水,静滴,用药14天,之后继续口服长春西汀片(开文通生产批号:T1B190B)10mg,3次/日,共3个月;对照组使用空生理盐水250ml,静滴;两组在治疗14天内均使用胞磷胆碱钠注射液0.5g稀释于5%葡萄糖250ml中静滴,每日1次,以及奥扎格雷钠80mg静滴2次/日;试验期间药物组与对照组均持续口服阿司匹林肠溶片100mg,1次/日,阿托伐他汀钙片20mg,1次/日。在试验期间禁止使用其他改善认知、扩张血管及血液稀释剂等药物。入组时对所有患者进行相关生化检查以及蒙特利尔认知评分(MontrealCognitiveAssessment,MoCA),根据患者的评分情况并对其受教育程度偏倚进行校正(受教育程度在12年以下,基础得分+1分),同时对进行ADL指数评估,检测头颅TCD中的PI值,计算1HMRS中的NAA/Cr及Cho/Cr值;在治疗第14天时由同一评分员再次对患者进行MoCA评分、ADL指数及头颅TCD、1HMRS检查并记录数值;在治疗第3个月时分别进行MoCA评分、ADL指数评估。通过两组患者在治疗前后相关指标的变化情况,以及药物组与对照组的认知功能、日常生活能力、影像学变化和血管功能的比较;观察长春西汀的临床治疗效果及不良反应。【结果】1.入选两组患者的一般情况、年龄、性别、受教育程度等无明显统计学差异(P0.05),具有可比性。2.药物组在治疗第14天时MoCA评分及ADL指数与治疗前相比有所升高,差异具有统计学意义(P0.05);PI值较治疗前明显下降,差异具有统计学意义(P0.05);NAA/Cr较治疗前有所升高,差异具有统计学意义(P0.05);而Cho/Cr在治疗前后差异无统计学意义(P0.05);在持续治疗3个月时MoCA评分及ADL指数与治疗前及治疗第14天时比较明显升高,差异均具有统计学意义(P0.05)。3.对照组在第14天时的MoCA评分、ADL指数、PI值、NAA/Cr、Cho/Cr较入组前差异均无统计学意义(P0.05);在第3个月时MoCA评分与ADL指数较入组前及第14天相比差异均无统计学意义(P0.05)。4.药物组与对照组在治疗前的MoCA评分、ADL指数、PI值、NAA/Cr、Cho/Cr值均无统计学意义(P0.05);治疗14天后药物组的PI值较对照组明显降低,差异具有统计学意义(P0.05);NAA/Cr则明显升高,差异具有统计学意义(P0.05);而两组的MoCA评分、ADL指数、Cho/Cr值比较,差异均无统计学意义(P0.05);3个月后的MoCA评分、ADL指数显示药物组较对照组均明显升高,差异具有统计学意义(P0.05)。5.安全性分析。药物组与对照组患者在治疗前均进行血、尿常规、凝血、肝功、肾功、血糖、心电图检查,均未见明显异常。在观察期内62例患者中有5例出现了不良反应。其中对照组2例,表现为转氨酶升高,考虑可能与口服他汀类药物有关,停药后好转。药物组出现3例,1例为上呼吸道感染症状,经对症治疗后好转,1例出现转氨酶轻度升高,后经随访自行好转。1例出现体位性低血压,考虑可能与长春西汀药物有关,后随访恢复正常,完成试验研究。两组间总不良事件发生率的比较无统计学差异(P0.05)。推测缺血性脑白质病变患者使用3个月的长春西汀无明显不良反应。【结论】1.长春西汀可能会改善缺血性脑白质病变患者的微循环及颅内生化代谢。2.长春西汀可改善缺血性脑白质病变患者的认知功能状态及日常生活能力。3.使用长春西汀3个月安全性高,未发现严重不良反应。
[Abstract]:[Objective] to observe Changchun vinpocetine on ischemic brain the efficacy and safety of white matter lesions [method] from January 2013 to October 2014 in Affiliated Hospital of Yan'an University neurology clinic, through cranial MRI showed ischemic cerebral white matter lesions at the same time, according to the Fzakas visual analog scale [1] classification of 3 patients with a total of 62 cases were randomly divided into for the Changchun inpocetine drug group and control group (33 cases, 29 cases in the control group drug group); drug group using Vinpocetine Injection (open the production batch number: A33116A 30mg), with 250ml saline infusion, medication for 14 days, after continuous oral administration of Vinpocetine Tablets (open the production batch number: T1B190B 10mg). 3 times / day, a total of 3 months; the control group using empty saline 250ml, intravenous drip; the treatment in the two groups within 14 days all use Citicoline Sodium Injection 0.5g diluted in 5% glucose 250ml intravenous drip, 1 times a day, and ozagrel Sodium 80mg intravenous drip 2 times / day; during the test of drug group and control group were continuous oral administration of Aspirin Enteric-coated Tablets 100mg, 1 times / day, Atorvastatin Calcium Tablets 20mg, 1 times / day. Prohibit the use of other cognitive improvement during the test, dilation of blood vessels and blood thinners and other drugs. Related biochemical tests and cognitive scores for all patients in Montreal group (MontrealCognitiveAssessment, MoCA), according to the scores of the patients and the level of education bias correction (level of education in the 12 years following the basic score +1), and the ADL index, the PI value in the detection of brain TCD, NAA/Cr and Cho/Cr to calculate the value of the 1HMRS in the treatment of fourteenth; day by the same rater again the MoCA score of patients, ADL index and head TCD, 1HMRS numerical check and record respectively; MoCA score in third months after treatment, the ADL index assessment. Through the two groups of patients Changes in indicators before and after treatment, and the drug group and control group, cognitive function, daily life ability, comparative imaging changes and vascular function; clinical therapeutic effect and adverse reactions were observed Changchun vinpocetine. [results] 1. selected two groups of patients with general condition, age, gender, no obvious statistical education level difference (P0.05), comparable.2. drug group MoCA in the fourteenth day of treatment score and ADL index increased compared with before treatment, the difference was statistically significant (P0.05); PI decreased significantly, the difference was statistically significant (P0.05); NAA/Cr than before treatment increased, the difference was statistically significant (P0.05); and Cho/Cr before and after the treatment, the difference was not statistically significant (P0.05); in the last 3 months treatment with MoCA score and ADL index before treatment and fourteenth days were significantly higher, the difference There was statistical significance (P0.05).3. control group on the fourteenth day of the MoCA score, ADL index, PI value, NAA/Cr, Cho/Cr before entering the group showed no significant difference (P0.05); in third months, MoCA score and ADL index in the group before and 14 days there was no statistically significant difference compared (P0.05.4.) drug group and control group before treatment MoCA score, ADL index, PI, NAA/Cr, Cho/Cr values were not statistically significant (P0.05); after 14 days of treatment, drug group PI was significantly lower than the control group, the difference was statistically significant (P0.05); NAA/Cr was significantly increased, the difference was statistically significant (P0.05); and the two group in the MoCA score, ADL index, Cho/Cr value, there were no significant differences (P0.05); 3 months after the MoCA score, ADL index shows that the drug group were significantly higher than the control group, the difference was statistically significant (P0.05). The drug safety analysis of.5. group and control group patients in the treatment Before treatment were blood, urine routine, blood coagulation, liver function, renal function, blood glucose, ECG examination showed no obvious abnormalities. During the observation period in 62 cases, 5 cases of adverse reactions occurred in 2 cases. Control group showed increased transaminases, consideration may be associated with oral statins, stop after the drug improved. Drug group had 3 cases, 1 cases of upper respiratory tract infection symptoms improved after the symptomatic treatment, 1 cases had slightly elevated transaminase, after follow-up of spontaneously.1 patients had orthostatic hypotension, consideration may be related to Changchun inpocetine drug, after follow-up returned to normal, the incidence rate of completed test. The total adverse events between the two groups had no significant difference (P0.05). No obvious adverse reactions that patients with ischemic cerebral white matter lesions 3 months Changchun vinpocetine. [Conclusion] 1. Changchun fluoxetine may improve microcirculation and cerebral ischemic cerebral white matter lesions in patients Biochemical metabolism.2. Changchun xting can improve the cognitive function and daily living ability of patients with ischemic white matter lesions..3. used 3 months in Changchun xetin, and the safety was high, and no serious adverse reactions were found.

【学位授予单位】：延安大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R741

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