芬戈莫德治疗复发缓解型多发性硬化的系统评价  

Fingolimod for the treatment of relapsing-remitting multiple sclerosis: a systematic review

作　　者：姜明静[1,2] 曹立颖[1] 刘宁[1,2] 

机构地区：[1]兰州大学,第一临床医学院,730000 [2]兰州大学,第一医院神经内科

出　　处：《中国神经免疫学和神经病学杂志》2013年第2期92-96,100,共6页Chinese Journal of Neuroimmunology and Neurology

摘　　要：目的系统评价芬戈莫德治疗复发缓解型多发性硬化(RRMS)的疗效和安全性。方法应用Co-chrane系统评价方法通过计算机检索Cochrane Library、PubMed、EMBASE、中国生物医学文献数据库、中国期刊全文数据库和维普数据库,并手工检索相关领域杂志。检索不受语种限制,时间均从数据库建库至2012年7月,收集芬戈莫德治疗RRMS的所有随机对照试验相关文献。根据Cochrane协作网推荐的"风险评估工具"进行偏倚风险评估,用RevMan 5.1软件进行统计学分析。结果最终共3个随机对照试验的2749例患者纳入研究。在有效性方面,芬戈莫德0.5mg/d与1.25mg/d组年复发率均低于β1a-干扰素、安慰剂等对照组;芬戈莫德组治疗期间未复发的MS患者人数高于对照组〔其中,1.25mg组OR=2.88,95%CI(1.59～5.22);0.5mg组OR=2.45,95%CI(1.82～3.29)〕;芬戈莫德0.5mg/d组与1.25mg/d组比较EDSS评分降低更明显〔MD=-0.11,95%CI(-0.19～-0.03)〕、治疗期间未复发的MS患者人数更多〔OR=2.45,95%CI(1.82～3.29)〕。在安全性方面,总的不良反应事件〔分别为1.25mg组OR=1.04,95%CI(0.74～1.47);0.5mg组OR=0.85,95%CI(0.36～2.00)〕、总的严重不良反应事件〔分别为1.25mg组OR=1.29,95%CI(0.71～2.34);0.5mg组OR=0.91,95%CI(0.55～1.51)〕、因不良反应而中止治疗的患者数〔其中,1.25mg组OR=2.21,95%CI(1.57～3.12);0.5mg组OR=1.17,95%CI(0.78～1.74)〕等指标,芬戈莫德1.25mg组和0.5mg组与对照组比较均无统计学差异,但芬戈莫德95mg组因不良反应而中止治疗的患者人数与较1.25mg组少。结论芬戈莫德1.25mg和0.5mg治疗RRMS的疗效均优于β1a-干扰素、安慰剂治疗等对照,安全性方面两者无统计学差异。芬戈莫德0.5mg/d治疗RRMS具有一定优势。Objective To systematically assess the clinical efficacy and safety of fingolimod for relapsing-remitting multiple sclerosis （RRMS）. Methods Based on the principles and methods of Cochrane systematic reviews, the Cochrane Library, PubMed, EMBASE, Chinese Bio-medicine Database, China Journal Full-text Database, VIP database were searched from their establishment to July 2012. No language restrictions were applied to the search. Related journals were handsearched as well. Randomized controlled trials （RCTs） of fingolimod treatment for RRMS were included. The authors assessed the quality of the included trials according to the Cochrane Handbook for Systematic Reviews of Interventions Version. The Cochrane Collaboration＇ s software RevMan 5. 1 was used for recta-analysis. Results Three RCTs totaling 2749 patients were included. The results showed that compared with interferon l]-la or placebo, the annualized relapse rate was significantly lower in the two groups receiving fingolimod 1.25 mg daily and 0.5 mg daily, and the number of patients with no confirmed relapse were significantly higher in the two groups [OR--2.88, 95~CI （1.59-5.22）; OR=2.45, 95%CI （1.82-3.29）, respectively]. Meanwhile, the two doses of fingolimod had significant differences in the change of the Expanded Disability Status Scale （EDSS） [MD= --0. 11, 95%CI （--0.19---0.03）] and patients with no confirmed relapse OR = 2.45, 95 % CI （1.82-3.29）]. There were no significant differences between both doses （1.25mg/d or 0.5mg/d） of fingolimod and interferon 13-1a or placebo in the incidence of any adverse event （AE）I-ORal. 04, 95%CI （0.74-1.47）; OR=0.85, 95CI （0.36-2.00）, respectively], any serious AE [-OR=1.29, 95%CI （0.71-2.34）; OR=0.91, 95%CI （0.55-1.51）, respectivelyl~ and any AE led to treatment discontinuation EOR=2. 21, 95~./ooCI （1.57-3. 12） ; OR=I. 17, 95~CI （0.78-1.74）, respectively~. However, the fingolimod 0.5 mg group had less AE led to treatment discontinuation than the fingolimod

关 键 词：复发缓解型多发性硬化 芬戈莫德 1-磷酸鞘氨醇受体调节剂 META分析 系统评价 

分 类 号：R744.51[医药卫生—神经病学与精神病学]