背景:核磁共振成像的定量测量已被广泛用于评估多发性硬化症的治疗效果.目的:确定是否干扰素β-1b对多发性硬化脑萎缩的影响能通过MRI测量表达出来.设计:随机对照观察.单位:日本京都宇多野病院神经疾病研究中心.对象:选择1998-01/12在在日本京都宇多野病院神经疾病研究中心收治的188例多发性硬化患者,男55例,女133例,年龄16~59岁,平均(36±11)岁.纳入标准:①按poser再发缓解型诊断标准临床确诊为多发性硬化.②扩展残疾状况评分表得分≤7分.③在过去的1年中至少1次复发,或在就诊之前的2年间有至少2次复发,但就诊前30 d无复发,神经系统体征稳定至少1个月,干扰素β-1b皮试阴性.④均对检测项目知情同意.纳入患者中,视神经脊髓型148例,经典型50例.方法:①药物治疗:所有患者给予干扰素β-1b注射剂,根据注射剂量不同将患者分为低剂量组(n=93)和高剂量组(n=95),分别给予160万U和800万U隔日干扰素β-1b注射剂皮下注射,共使用2年.②磁共振扫描检查:对所有患者包括病灶的部位(视神经、大脑、小脑、脑干和脊髓)进行磁共振扫描,T1和T2加权轴面磁共振检查由同一神经病学家评估,T2加权像病灶面积是逐层相加计算出总面积以mm2表示,检查指标为第三脑室、侧脑室宽度、脑宽度进行测量,结果采用萎缩率表示.③神经功能缺损检查:采用Kurtzke扩展残疾状况评分表(从0分到10分,0分为正常,分数越高病情越严重)评估.④相关因素分析:对148例典型多发性硬化患者脑萎缩情况和T2病灶面积和扩展残疾状况评分表得分变化两项因素进行相关性分析,同时对起始时变量(年龄,病程,复发率,T2病灶面积和扩展残疾状况评分表得分)和脑萎缩情况进行相关性分析.主要观察指标:①两组患者脑萎缩情况比较.②脑萎缩测量相关因素分析.结果:纳入198例患者全部进入结果分析.①两组患者脑萎缩情况比较结果:高剂量组经典型多发性硬化患者侧脑室宽度、三脑室宽度、脑宽度萎缩率分别是2.84%,3.15%和1.3%,明显低于低剂量组(4.09%,5.36%,1.97%,P<0.01).高剂量组视神经脊髓型多发性硬化患者侧脑室宽度、三脑室宽度、脑宽度的萎缩率分别是0.9%,1.55%和0.6%,与低剂量组无明显差异(1.65%,1.75%,0.7%,P>0.05).②经典型多发性硬化患者侧脑室宽度与T2病灶面积和EDSS得分均有明显相关性(r=0.33,0.27,P<0.01),三脑室宽度与T2病灶面积和EDSS得分有明显相关性(r=0.31,0.29,P<0.05),脑宽度与T2病灶面积和EDSS得分也有明显相关性(r=0.11,0.14,P<0.05),起始时EDSS得分和T2病灶面积变化与侧脑室宽度明显相关(r=0.23,0.33,P<0.05),其他起始时的参数未能显示出有意义的关系.结论:干扰素β-1b对脑萎缩的影响是有积极意义的,在高和低剂量组之间,有意义的差别被显示出来.脑萎缩测量提供了一个独立的关于干扰素β-1b治疗多发性硬化的肯定作用和剂量的影响.
揹景:覈磁共振成像的定量測量已被廣汎用于評估多髮性硬化癥的治療效果.目的:確定是否榦擾素β-1b對多髮性硬化腦萎縮的影響能通過MRI測量錶達齣來.設計:隨機對照觀察.單位:日本京都宇多野病院神經疾病研究中心.對象:選擇1998-01/12在在日本京都宇多野病院神經疾病研究中心收治的188例多髮性硬化患者,男55例,女133例,年齡16~59歲,平均(36±11)歲.納入標準:①按poser再髮緩解型診斷標準臨床確診為多髮性硬化.②擴展殘疾狀況評分錶得分≤7分.③在過去的1年中至少1次複髮,或在就診之前的2年間有至少2次複髮,但就診前30 d無複髮,神經繫統體徵穩定至少1箇月,榦擾素β-1b皮試陰性.④均對檢測項目知情同意.納入患者中,視神經脊髓型148例,經典型50例.方法:①藥物治療:所有患者給予榦擾素β-1b註射劑,根據註射劑量不同將患者分為低劑量組(n=93)和高劑量組(n=95),分彆給予160萬U和800萬U隔日榦擾素β-1b註射劑皮下註射,共使用2年.②磁共振掃描檢查:對所有患者包括病竈的部位(視神經、大腦、小腦、腦榦和脊髓)進行磁共振掃描,T1和T2加權軸麵磁共振檢查由同一神經病學傢評估,T2加權像病竈麵積是逐層相加計算齣總麵積以mm2錶示,檢查指標為第三腦室、側腦室寬度、腦寬度進行測量,結果採用萎縮率錶示.③神經功能缺損檢查:採用Kurtzke擴展殘疾狀況評分錶(從0分到10分,0分為正常,分數越高病情越嚴重)評估.④相關因素分析:對148例典型多髮性硬化患者腦萎縮情況和T2病竈麵積和擴展殘疾狀況評分錶得分變化兩項因素進行相關性分析,同時對起始時變量(年齡,病程,複髮率,T2病竈麵積和擴展殘疾狀況評分錶得分)和腦萎縮情況進行相關性分析.主要觀察指標:①兩組患者腦萎縮情況比較.②腦萎縮測量相關因素分析.結果:納入198例患者全部進入結果分析.①兩組患者腦萎縮情況比較結果:高劑量組經典型多髮性硬化患者側腦室寬度、三腦室寬度、腦寬度萎縮率分彆是2.84%,3.15%和1.3%,明顯低于低劑量組(4.09%,5.36%,1.97%,P<0.01).高劑量組視神經脊髓型多髮性硬化患者側腦室寬度、三腦室寬度、腦寬度的萎縮率分彆是0.9%,1.55%和0.6%,與低劑量組無明顯差異(1.65%,1.75%,0.7%,P>0.05).②經典型多髮性硬化患者側腦室寬度與T2病竈麵積和EDSS得分均有明顯相關性(r=0.33,0.27,P<0.01),三腦室寬度與T2病竈麵積和EDSS得分有明顯相關性(r=0.31,0.29,P<0.05),腦寬度與T2病竈麵積和EDSS得分也有明顯相關性(r=0.11,0.14,P<0.05),起始時EDSS得分和T2病竈麵積變化與側腦室寬度明顯相關(r=0.23,0.33,P<0.05),其他起始時的參數未能顯示齣有意義的關繫.結論:榦擾素β-1b對腦萎縮的影響是有積極意義的,在高和低劑量組之間,有意義的差彆被顯示齣來.腦萎縮測量提供瞭一箇獨立的關于榦擾素β-1b治療多髮性硬化的肯定作用和劑量的影響.
배경:핵자공진성상적정량측량이피엄범용우평고다발성경화증적치료효과.목적:학정시부간우소β-1b대다발성경화뇌위축적영향능통과MRI측량표체출래.설계:수궤대조관찰.단위:일본경도우다야병원신경질병연구중심.대상:선택1998-01/12재재일본경도우다야병원신경질병연구중심수치적188례다발성경화환자,남55례,녀133례,년령16~59세,평균(36±11)세.납입표준:①안poser재발완해형진단표준림상학진위다발성경화.②확전잔질상황평분표득분≤7분.③재과거적1년중지소1차복발,혹재취진지전적2년간유지소2차복발,단취진전30 d무복발,신경계통체정은정지소1개월,간우소β-1b피시음성.④균대검측항목지정동의.납입환자중,시신경척수형148례,경전형50례.방법:①약물치료:소유환자급여간우소β-1b주사제,근거주사제량불동장환자분위저제량조(n=93)화고제량조(n=95),분별급여160만U화800만U격일간우소β-1b주사제피하주사,공사용2년.②자공진소묘검사:대소유환자포괄병조적부위(시신경、대뇌、소뇌、뇌간화척수)진행자공진소묘,T1화T2가권축면자공진검사유동일신경병학가평고,T2가권상병조면적시축층상가계산출총면적이mm2표시,검사지표위제삼뇌실、측뇌실관도、뇌관도진행측량,결과채용위축솔표시.③신경공능결손검사:채용Kurtzke확전잔질상황평분표(종0분도10분,0분위정상,분수월고병정월엄중)평고.④상관인소분석:대148례전형다발성경화환자뇌위축정황화T2병조면적화확전잔질상황평분표득분변화량항인소진행상관성분석,동시대기시시변량(년령,병정,복발솔,T2병조면적화확전잔질상황평분표득분)화뇌위축정황진행상관성분석.주요관찰지표:①량조환자뇌위축정황비교.②뇌위축측량상관인소분석.결과:납입198례환자전부진입결과분석.①량조환자뇌위축정황비교결과:고제량조경전형다발성경화환자측뇌실관도、삼뇌실관도、뇌관도위축솔분별시2.84%,3.15%화1.3%,명현저우저제량조(4.09%,5.36%,1.97%,P<0.01).고제량조시신경척수형다발성경화환자측뇌실관도、삼뇌실관도、뇌관도적위축솔분별시0.9%,1.55%화0.6%,여저제량조무명현차이(1.65%,1.75%,0.7%,P>0.05).②경전형다발성경화환자측뇌실관도여T2병조면적화EDSS득분균유명현상관성(r=0.33,0.27,P<0.01),삼뇌실관도여T2병조면적화EDSS득분유명현상관성(r=0.31,0.29,P<0.05),뇌관도여T2병조면적화EDSS득분야유명현상관성(r=0.11,0.14,P<0.05),기시시EDSS득분화T2병조면적변화여측뇌실관도명현상관(r=0.23,0.33,P<0.05),기타기시시적삼수미능현시출유의의적관계.결론:간우소β-1b대뇌위축적영향시유적겁의의적,재고화저제량조지간,유의의적차별피현시출래.뇌위축측량제공료일개독립적관우간우소β-1b치료다발성경화적긍정작용화제량적영향.
BACKGROUND: The quantitative measurements based on magnetic resonance imaging (MRI) have been vastly used in evaluating the therapeutic efficacy on multiple sclerosis (MS).OBJ ECTIVE: To determine whether the effect of IFNB-1b on brain atrophy of MS could be shown with analysis of MRI measurement.DESIGN: Randomized controlled observation.SETTING : Center for Neurological Diseases, Utano National Hospital.PARTICIPANTS: Totally 188 patients with MS, including 55 males and 133 females aged from 16-59 years, averagely(36±11) years, from Center for Neurological Diseases, UtanoNational Hospital from January to December 1998 were enrolled. Inclusive criteria: ①according to Poser RR type criteria were considered as having MS for enrollment, ②Expanded Disability Status Scale (EDSS) score of 7.0 or less, ③at least 1 relapse in the past year or at least 2 relapses in the past two years prior to enrollment, but no relapse for 30 days before enrollment, stable neurological state for at least 1 month and negative results of the IFNB-1b needle-prick test, and ④they all knew the detected items and agreed. In the included patients, there were 148 cases of optic nerves and spinal cord type and 40 cases of classical type.METHODS: ①Drug treatment: All the patients were treated with IFNB-1b injectable preparation (provided by Japanese Pharmaceuticals Company). According to the different injected dosage, the patients were divided into low-dosage group (n =93) and high-dosage group (n =95), given with 1.6 million U and 8 million U of IFNB-1b subcutaneously on alternate days for 2 years. ②MRI examination: The patients received MRI in lesion site (optic nerves, cerebrum, cerebellum, brainstem, and spinal cord). T1 and T2-weighted axial MRI scan were performed by a single neurologist. The area of the MS lesions in T2-weighted images was summed slice by slice for a total lesion area and was recorded as mm2. Third ventricle, lateral ventricle width and brain width were measured and expressed by atrophy rate. ③Neurologic impairment examination: Neurologic impairment was evaluated with Kurtzke EDSS (from 0 point to 10 points, 0 point as normal, the higher score represented severe condition). ④Analysis of related factors: Correlation analysis was performed in brain atrophy condition and T2 focus area with EDSS score in 148 MS patients with typical MS. At the same time,correlation analysis was conducted between variance (age, progress, relapse rate, T2 focus area and EDSS score) and brain atrophy.MAIN OUTCOME MEASURES: ①Comparison of brain atrophy in patients of the two groups, and ②analysis of related factors of brain atrophy measurements.RESULTS: Totally 188 patients were involved in the result analysis. ①Outcome of brain atrophy comparison in the two groups: In classical type MS the rates of atrophy measures in high-dosage group were 2.84%, 3.15%, and 1.3% in lateral ventricle width, third ventricle width and brain width, respectively, and significantly lower than those in low-dosage group (4.09%, 5.36% and 1.97%, P < 0.01). In optic nerve and spinal cord type MS patients, the rates of brain atrophy were 0.9%, 1.55% and 0.6% in lateral ventricle width, third ventricle width and brain width, respectively in high-dosage group, and there was no significant difference as compared with the low-dosage group (1.65%, 1.75% and 0.7%, P <0.05). ②There was significant correlation of lateral ventricle width, T2 focus area and EDSS score in classical MS patients (r =0.33,0.27, P < 0.01 ). There was significant correlation of third ventricle width, T2 focus area and EDSS score (r=0.31,0.29, P < 0.05). There was significant correlation of brain width, T2 focus area and EDSS score (r =0.11,0.14, P <0.05). There was significant correlation of baseline EDSS score and T2 focus area with lateral ventricle width (r =0.23,0.33, P < 0.05). The other baseline variables failed to show a significant contribution to the process.CONCLUSION: The effects of IFNB-1b on brain atrophy were positive and significant differences were also found between both high- and low-dosage groups. This brain atrophy measurement provides an independent MRI confirmation of a therapy and dose effect of IFNB-1b for MS.