长期应用糖皮质激素治疗对RRMS患者临床复发和神经功能残疾进展的影响  

Effects of long-term maintenance treatment with corticosteriod on relapses and neurological disability progression in patients with relapsing-remitting multiple sclerosis

作　　者：董会卿[1] 刘峥[1] 张普[1] 宋海庆[1] 张津[1] 贾建平[1] 陈彪[1] 

机构地区：[1]首都医科大学宣武医院神经内科,100053

出　　处：《中国神经免疫学和神经病学杂志》2010年第5期323-326,共4页Chinese Journal of Neuroimmunology and Neurology

基　　金：北京市教育委员会科技发展计划面上项目(KM200910025015)

摘　　要：目的探讨长期小剂量糖皮质激素治疗对复发缓解型多发性硬化(relapsing-remitting multiple sclerosis,RRMS)患者临床复发和神经功能残疾进展的影响。方法采用随机单盲对照Ⅱ期临床试验,将120例神经功能残疾评分≤5.5分的RRMS患者随机分为长期治疗组、中期治疗组、短期治疗组及对照组4组,每组各30例,连续随访2～5年,中位随访时间3年,观察总复发次数、年均复发次数、年均EDSS分及年均EDSS进展分的变化,以及不良反应和并发症发生情况。结果 120例患者中112例完成了临床试验。随访2～5年后,长期治疗组、中期治疗组和短期治疗组中有关总复发次数(中位数均为1.0次)、年均复发次数[分别为(1.2±0.6)、(1.2±0.8)、(1.5±0.5)次/年]、年均EDSS评分[分别为(2.4±0.46)、(2.5±0.54)、(2.3±0.32)分]、年均EDSS进展分[分别为(0.62±0.03)、(0.53±0.04)、(0.46±0.06)分]与对照组(分别为1.0次、(1.3±0.7)次/年、(2.5±0.48)分、(0.52±0.07)分]比较差异均无统计学意义(P>0.05)。长期治疗组、中期治疗组高血压(分别为13例、9例)及糖尿病(分别为14例、11例)发生率与对照组(高血压4例、糖尿病3例)比较均明显增高(均P<0.01),短期治疗组高血压(7例)及糖尿病(8例)发生率亦高于对照组(均P<0.05)。结论长期应用糖皮质激素对RRMS患者的复发和神经功能残疾进展无明显治疗作用,且存在较多并发症和不良反应。Objective To assess the effect of long-term maintenance treatment with corticosteriod on relapses and neurological disability progression in patients with relapsing-remitting multiple sclerosis （RRMS） and to obtain its toxicity and salty. Methods A randomized, controlled, single-blind, phase Ⅱ clinical trial of corticosteriod treatment was conducted in patients with RRMS. One hundred and twenty RRMS patients with baseline Expanded Disability Status Scale （EDSS） scores ranging from 0 to 5.5 were randomly divided into four groups： the long-term maintenance treatment group, medium-term maintenance treatment group, short-term maintenance treatment group and the control group （each group has 30 cases）. The follow-up time was between two and five years, and the median follow-up time was 3 years. The total relapse times, the annual average relapse times, the annual average EDSS scores and the annual average EDSS progression scores changes were observed. The status of adverse reactions and complications were detected. Results One hundred and twelve of 120 patients completed the trial as planned. The results showed that there were no significant differences （all P〉 0.05） among the long-term maintenance treatment group and medium-term maintenance treatment group and short-term maintenance treatment group in the total relapse times （median： 1.0, 1.0, 1.0）, the annual relapse times （1.2±0.6, 1.2±0.8, 1.5±0.5）, the mean EDSS scores （2.4±0.46, 2.5±0.54, 2.3±0.32）, the annual EDSS progression scores （0. 62 ± 0. 03, 0.53 ± 0. 04, 0.46 ± 0.06） compared with the control group （1.0, 1.3±0.7, 2.5±0.48, 0. 52±0. 07）. However, there were significantly differences of incidence rate of the side effects such as hypertension （P〈0.01） and diabetes （P〈0.01） in the long-term （13 cases withhypertension, 14 cases with diabetes） and medium-term maintenance treatment groups （9 cases with hypertension, 11 cases with diabetes） compared with the control group （4 cases wit

关 键 词：多发性硬化 复发缓解性 糖皮质激素类 治疗 

分 类 号：R744.51[医药卫生—神经病学与精神病学]