维生素D_3添加治疗复发型多发性硬化的临床随机对照研究

目的采用临床随机对照研究维生素D3添加治疗复发型多发性硬化(MS)患者的临床疗效和安全性。方法缓解复发型MS患者72例,随机分成维生素D3组(甲泼尼龙+维生素D3治疗)和激素组(甲泼尼龙治疗,为对照),每组36例,维生素D3组在激素治疗基础上添加骨化三醇胶丸口服。治疗前后记录症状、体征,评定扩展残疾状态评分(EDSS)分值,治疗后随访2年。疗效评定考核指标采用MS年复发次数,复发间隔时间,EDSS评分下降值。结果治疗前维生素D3组年龄、病程、复发次数、EDSS数值与激素组比较,差异无统计学意义(P0.05);治疗后第6、12个月EDSS数值与激素组比较,差异也无统计学意义(P0.05)。治疗后第24个月,维生素D3组与激素组比较EDSS数值(P0.05)、年复发次数(P0.05)、复发间隔时间(P0.01),差异有统计学意义。结论维生素D3添加治疗能减少MS的复发次数、延长复发间歇时间、延缓残疾进展速度。

A Randomized Controlled Clinical Study Vitamin D_3 Treatment Forrelapsing Multiple Sclerosis

Aim To evaluate the therapeutic efficacy and the safety of vitamin D3 in the patients with relapsing remitting multiple sclerosis（RRMS）. Methods Seventy two patients with RRMS were randomly assigned into two groups： vitamin D3 treatment group and corticosteroid hormone therapy group. The patients in Vitamin D3 treatment group based on the corticosteroid hormone therapy were treated with Calcitriol Soft Capsules p.o. The medical history collection, physical and laboratory examination, and Expanded Disability Status Scale（EDSS） were recorded in 72 MS patients before and after the medications. All the patients were regularly followed-up（visit） for two years. Three observation parameters, as annual relapsing times, relapsing interval duration, and the changes of EDSS were evaluated. Results Before the treatment, there was no statistically significant difference（P〉0.05） on age, course, relapsing times and EDSS between the two groups. At endpoints of the 6th and 12 nd month, the statistics difference of EDSS was not significant（P〉0.05） in the two groups. At end-points of the 24 th month, there was a statistical difference in EDSS（P〈0.05）, annual relapsingtime（P〈0.05） and relapsing interval duration（P〈0.01） between these two groups at the end of the 24 th month. Conclusion Vitamin D3 is therapeutically effective in reducing MS relapsing times, lengthening relapsing interval duration, and delaying the progress of physical disability.