IFN-β-1a治疗多发性硬化的多中心前瞻开放对照研究

目的 客观观察和评定利比（Rebif,IFN-β-1a）治疗缓解复发型多发性硬化（RRMS）的临床疗效和安全性.方法 60例依据McDonald（2005）标准确诊的RRMS患者纳入利比组（其中疗程6月者38例,疗程12月12例,18月6例,24月4例）,同一时期内性别、年龄、病程和EDSS分值相匹配的60例RRMS患者纳入对照组.利比组RRMS患者接受利比44 μg皮下注射,每周3次,疗程6-24月.对照组患者口服转移因子治疗.每位入选患者在治疗前记录症状、体征、实验室及MRI检查资料,评定EDSS分值.治疗后每3月随访1次,除记录治疗前项目外,增加利比副反应.随访观察期为2年.疗效评估终点选择在（1）治疗后6月;（2）治疗后12月;（3）治疗后18月;（4）治疗后24月.疗效评定考核指标采用（1）MS年平均复发次数;（2）复发间隔时间;（3）EDSS下降值.结果 利比组患者年平均复发次数为（0.57±0.11）次,对照组为（1.23±0.20）次（P〉0.001）.利比组复发间隔时间为（464.7±20.8）d,对照组为（275.4±16.4）d（P〉0.001）.利比组RRMS患者在利比治疗6、12、18、24月后EDSS分别下降（0.48±0.08）、（0.52±0.06）、（0.93±0.08）、（1.05±0.10）分;对照组分别下降（0.23±0.09）、（-0.29±0.08）、（-0.62±0.12）、（-1.12±0.11）分,2组比较有显著差异（P〉0.001）.利比组有4例（6.67%）出现注射部位红肿,4例（6.67%）出现流感样症状,2例（3.33%）转氨酶轻度增高.此三类副反应均较轻微,2周后自行消失,仅个别患者需要对症处理.结论 RRMS患者在缓解期使用利比44 μg,每周3次皮下注射,能够显著减少MS的复发次数、延长复发间歇时间、延缓残疾进展速度;利比注射时间越长效果越好.利比治疗RRMS安全有效.

A prospective multi-central controlled opening trial of therapeutic effect of rebif on multiple sclerosis patients

Objective To evaluate the therapeutic efficacy and the safety of Rebif （recombinant interfer-on-beta-la） in the patients with relapsing remitting multiple sclerosis （RRMS）. Methods 120 RRMS pa- tients, diagnosed according to McDonald criteria （2005）, hospitalized and followed-up in Tongji hospital, Huaxi hospital, and Xiangya hospital, during recently 6 years （from Jan 1, 2005 to Dec 31, 2010）, were en rolled in the trial, and respectively divided into Rebif group（60 cases）and controlled group （60 cases）, based on the similar disease course and similar EDSS （The expanded disability status scale）. The patients in Rebif group were treated with Rebif 44/lg, injected subcutaneously three times weekly. The patients of controlled group were treated with transfer factor capsule. All the patients with RRMS were regularly followed-up 3 month to 2 years. The end-points of the trial were respectively chosen at 6th, 12th, 18th, and 24th month. The medical history collection, physical and laboratory examination, MRI and EDSS were recorded in 120 pa- tients before the medications. Four observation parameters, annual relapsing times, relapsing interval dura- tion, the changes of EDSS and the cerebrospinal MRI were evaluated. All the adverse effects of Rebif were re corded, such as injecting site reactions, flu-like symptoms, depressive symptoms, and so on. Paired t-test and x2test were used to analyses of clinical data. Results At end-points of 6th, 12th, 18th, and 24th moon, theaverage decrease of EDSS in Rebif group was respectively 0. 48 ± 0. 08, 0. 52 ± 0. 06,0.93 ± 0. 06 and 1.25 ± 0. 10, while 0. 23 ± 0. 09, - 0. 29 ± 0. 08, - 0. 62 ± 0. 12, and - 1.12 ± 0. 11 in controlled group （P〈0. 001 ）. The annual relapsing times was 0. 57 ± 0. 11 in Rebif group and 1.23 ± 0. 20 in controlled one （P〈0. 001）. The relapsing interval duration was 464. 7 ± 20. 8 days in Rebif group, and 275. 4 ± 16. 4 days in cntrolled one （P〈0. 001）. There were 4 patients occurring injection site reactions （6. 67%）, 4 cases （6. 67%） with flu-like symptoms, and 2 cases （3. 33%） transient GPT increasing in Rebif group. Conclusions It is suggested that there are more advantages to the RRMS patients injected subcutaneously Rebif44（g three times weekly. Rebif is therapeutically effective in reducing MS relapsing times, lengthening relapsing interval duration, and dela-ying the accumulation of physical disability. Rebif is very safe and effective in treatment of RRMS patients.