長春西汀治療缺血性腦白質(zhì)病變的臨床研究
發(fā)布時間:2018-03-22 08:04
本文選題:長春西汀 切入點(diǎn):缺血性腦白質(zhì)病變 出處:《延安大學(xué)》2015年碩士論文 論文類型:學(xué)位論文
【摘要】:【目的】觀察長春西汀對缺血性腦白質(zhì)病變的有效性及安全性【方法】選取2013年1月至2014年10月在延安大學(xué)附屬醫(yī)院神經(jīng)內(nèi)科就診,通過頭顱核磁共振檢查顯示為缺血性腦白質(zhì)病變,同時根據(jù)Fzakas視覺量表[1]分級為3級的患者共62例,隨機(jī)分為長春西汀藥物組和對照組(藥物組33例,對照組29例);藥物組使用長春西汀注射液(開文通生產(chǎn)批號:A33116A)30mg,配入250ml生理鹽水,靜滴,用藥14天,之后繼續(xù)口服長春西汀片(開文通生產(chǎn)批號:T1B190B)10mg,3次/日,共3個月;對照組使用空生理鹽水250ml,靜滴;兩組在治療14天內(nèi)均使用胞磷膽堿鈉注射液0.5g稀釋于5%葡萄糖250ml中靜滴,每日1次,以及奧扎格雷鈉80mg靜滴2次/日;試驗(yàn)期間藥物組與對照組均持續(xù)口服阿司匹林腸溶片100mg,1次/日,阿托伐他汀鈣片20mg,1次/日。在試驗(yàn)期間禁止使用其他改善認(rèn)知、擴(kuò)張血管及血液稀釋劑等藥物。入組時對所有患者進(jìn)行相關(guān)生化檢查以及蒙特利爾認(rèn)知評分(MontrealCognitiveAssessment,MoCA),根據(jù)患者的評分情況并對其受教育程度偏倚進(jìn)行校正(受教育程度在12年以下,基礎(chǔ)得分+1分),同時對進(jìn)行ADL指數(shù)評估,檢測頭顱TCD中的PI值,計算1HMRS中的NAA/Cr及Cho/Cr值;在治療第14天時由同一評分員再次對患者進(jìn)行MoCA評分、ADL指數(shù)及頭顱TCD、1HMRS檢查并記錄數(shù)值;在治療第3個月時分別進(jìn)行MoCA評分、ADL指數(shù)評估。通過兩組患者在治療前后相關(guān)指標(biāo)的變化情況,以及藥物組與對照組的認(rèn)知功能、日常生活能力、影像學(xué)變化和血管功能的比較;觀察長春西汀的臨床治療效果及不良反應(yīng)!窘Y(jié)果】1.入選兩組患者的一般情況、年齡、性別、受教育程度等無明顯統(tǒng)計學(xué)差異(P0.05),具有可比性。2.藥物組在治療第14天時MoCA評分及ADL指數(shù)與治療前相比有所升高,差異具有統(tǒng)計學(xué)意義(P0.05);PI值較治療前明顯下降,差異具有統(tǒng)計學(xué)意義(P0.05);NAA/Cr較治療前有所升高,差異具有統(tǒng)計學(xué)意義(P0.05);而Cho/Cr在治療前后差異無統(tǒng)計學(xué)意義(P0.05);在持續(xù)治療3個月時MoCA評分及ADL指數(shù)與治療前及治療第14天時比較明顯升高,差異均具有統(tǒng)計學(xué)意義(P0.05)。3.對照組在第14天時的MoCA評分、ADL指數(shù)、PI值、NAA/Cr、Cho/Cr較入組前差異均無統(tǒng)計學(xué)意義(P0.05);在第3個月時MoCA評分與ADL指數(shù)較入組前及第14天相比差異均無統(tǒng)計學(xué)意義(P0.05)。4.藥物組與對照組在治療前的MoCA評分、ADL指數(shù)、PI值、NAA/Cr、Cho/Cr值均無統(tǒng)計學(xué)意義(P0.05);治療14天后藥物組的PI值較對照組明顯降低,差異具有統(tǒng)計學(xué)意義(P0.05);NAA/Cr則明顯升高,差異具有統(tǒng)計學(xué)意義(P0.05);而兩組的MoCA評分、ADL指數(shù)、Cho/Cr值比較,差異均無統(tǒng)計學(xué)意義(P0.05);3個月后的MoCA評分、ADL指數(shù)顯示藥物組較對照組均明顯升高,差異具有統(tǒng)計學(xué)意義(P0.05)。5.安全性分析。藥物組與對照組患者在治療前均進(jìn)行血、尿常規(guī)、凝血、肝功、腎功、血糖、心電圖檢查,均未見明顯異常。在觀察期內(nèi)62例患者中有5例出現(xiàn)了不良反應(yīng)。其中對照組2例,表現(xiàn)為轉(zhuǎn)氨酶升高,考慮可能與口服他汀類藥物有關(guān),停藥后好轉(zhuǎn)。藥物組出現(xiàn)3例,1例為上呼吸道感染癥狀,經(jīng)對癥治療后好轉(zhuǎn),1例出現(xiàn)轉(zhuǎn)氨酶輕度升高,后經(jīng)隨訪自行好轉(zhuǎn)。1例出現(xiàn)體位性低血壓,考慮可能與長春西汀藥物有關(guān),后隨訪恢復(fù)正常,完成試驗(yàn)研究。兩組間總不良事件發(fā)生率的比較無統(tǒng)計學(xué)差異(P0.05)。推測缺血性腦白質(zhì)病變患者使用3個月的長春西汀無明顯不良反應(yīng)!窘Y(jié)論】1.長春西汀可能會改善缺血性腦白質(zhì)病變患者的微循環(huán)及顱內(nèi)生化代謝。2.長春西汀可改善缺血性腦白質(zhì)病變患者的認(rèn)知功能狀態(tài)及日常生活能力。3.使用長春西汀3個月安全性高,未發(fā)現(xiàn)嚴(yán)重不良反應(yīng)。
[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.
【學(xué)位授予單位】:延安大學(xué)
【學(xué)位級別】:碩士
【學(xué)位授予年份】:2015
【分類號】:R741
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