干扰素β-1b治疗385例多发性硬化患者的回顾性研究

A retrospective study on 385 Chinese patients with multiple sclerosis treated with interferon β-1b

目的 观察干扰素β-1b（IFNβ-1b）治疗中国多发性硬化（MS）患者的疗效、安全性和依从性.方法 收集2011年1月至2014年2月在我国北方地区22家医院神经科就诊并接受IFNβ-1b治疗的MS患者385例,对其疗效、安全性和依从性做一回顾性分析.结果 （1） 27例临床孤立综合征（CIS）患者治疗后,92.6％的患者无临床复发;MRI显示96.3％的患者无新增T2病灶,100.0％的患者无强化病灶;14例患者与治疗前扩展残疾状况量表（EDSS）评分相比,治疗后EDSS评分差异无统计学意义（t=1.344,P=0.202）.（2） 346例复发缓解型MS（RRMS）患者治疗后,164例患者用药时间≥1年,中位年复发率由治疗前的1.0降至治疗后的0（Z=-9.667,P=0.000）;MRI显示,309例（89.3％）患者无新增T2病灶,321例（92.8％）患者无强化病灶;178例患者平均EDSS评分（分）由治疗前的3.3±1.8降至治疗后的2.9±1.9（t=4.603,P=0.000）.（3） 12例继发进展型MS患者治疗后,7例患者用药时间≥1年,中位年复发率由治疗前的0.3降至治疗后的0（Z=-1.690,P=0.091）;MRI显示,11例（91.7％）患者无新增T2病灶,12例（100.0％）患者无强化病灶;7例患者平均EDSS评分（分）由治疗前的5.4±2.2变为治疗后的5.6±2.2（t=-0.795,P=0.457）.（4） 385例患者至随访时,25.4％的患者停药,主要停药原因为经济原因（25.5％）、不良反应（19.4％）和自觉无效（15.3％）;常见不良反应为流感样症状、注射部位反应、肝酶升高和血象异常.结论 IFNβ-1b可减少中国CIS和RRMS患者临床复发和MRI病灶活动,改善RRMS患者残疾程度,安全性好.经济原因是患者停药的最主要原因.

Objective To investigate the efficacy,safety and compliance of interferon β-1b（IFNβ-1b） in Chinese patients with multiple sclerosis （MS）.Methods This multicenter,non-interventional,retrospective study was conducted in 22 hospitals in northern China to analyze data from 385 Chinese patients with MS treated with IFNβ-1b enrolled from January 2011 to February 2014.Annualized relapse rate （ARR）,MRI activity,Expanded Disability Status Scale（EDSS） scores,side effects and discontinuation rates were assessed.Results （1） Among 27 patients with clinically isolated syndrome （CIS）,92.6% patients had no clinical relapse;96.3% patients had no new T2 lesion and 100.0% patients had no enhanced lesion on MRI;no statistically significant difference was found in EDSS scores in 14 patients before and after treatment （t =1.344,P =0.202）.（2） Among 346 patients with relapsing remitting MS （RRMS）,164 patients received treatment more than 1 year,and their median ARR reduced from 1.0 before treatment to 0 after treatment （Z =-9.667,P =0.000）;309 （89.3 %） patients had no new T2 lesion and 321（92.8%） patients had no enhanced lesion on MRI;178 patients＇ EDSS scores reduced from 3.3 ± 1.8 before treatment to 2.9 ± 1.9 after treatment （t =4.603,P =O.000）.（3） Among 12 patients with secondary progressive MS,7 patients received treatment more than 1 year,and their median ARR reduced from 0.3 before treatment to 0 after treatment,though the difference was not statistically significant （Z =-1.690,P =0.091）;11 （91.7%） patients had no new T2 lesion and 12（100.0%） patients had no enhanced lesion on MRI;no statistically significant difference was found in EDSS scores in 7 patients before and after treatment （t =-0.795,P =0.457）.（4） Totally 25.4% patients stopped using drug,mainly due to economical reason（25.5%）,side effects（19.4%） and perception of lack of efficacy（15.3%）.The common side effects included flu-like symptoms,injection site reactions,increased liver transaminases and abnormal count of blood cells.Conclusions IFNβ-1b reduces clinical relapse and MRI lesion activity of Chinese patients with CIS and RRMS,improves EDSS score of patients with RRMS,and has good safety.The economical reason is the most important one for Chinese patients to stop using the drug.