Efficacy And Safety Of Different Doses Of IFN-β Treat Multiple Sclerosis: A Systematic Review

【Objective】 To evaluate the efficacy and safety of different doses of IFN-beta treatingmultiple sclerosis (RRMS, SPMS, PPMS).【Methods】We searched Medline (1950----2011.12), Embase (1980----2011.12), the CochraneLibrary (2011-4), the Chinese Biomedical Literature Database (1978----2011.12), ChineseAcademic Journal Full-text Database (1979----2011.12), Wanfang Database (1978----2011.12)and other related databases,in the world about RCTs of different doses of IFN-beta (includinghigh-dose group≥28MIU/W, low-dose group≤18MIU/W, the placebo group) treatingMS.iterature screening, in the world about randomized controlled trials (RCTs)of different dosesof IFN-beta (including high-dose group≥28MIU/W, low-dose group≤18MIU/W, the placebogroup), data extracted and quality assessment based on inclusion and exclusion criteria, theresults were analized by the Revman5.15in Cochrane systematic review.【Results】Totally64articles were collected and finally16were included.(1) Meta-analysisresults in efficacy and safety of different doses of IFN-beta treat RRMS showed that:①Meta-analysis results in efficacy and safety of high-dose group of IFN-beta and low-dose grouptreating RRMS showed that: The recurrence rate of high-dose IFN-beta group is lower than thelow dose group [RR=0.79,95%CI (0.69,0.91), P <0.01];The sustained progress rate of thehigh-dose group is lower than the low one.[RR=0.76,95%CI (0.61,0.95), P=0.02];Theincidence of new activity lesions on MRI of the high-dose group is lower than the low dosegroup (P <0.05); The high-dose group has higher incidence of local adverse reactions at theinjection site than the low-dose group (P=0.02);There is no statistical difference in the incidenceof total adverse reactions beteen the two groups.(P=0.09).②Meta-analysis results in efficacy andsafety of low-dose group of IFN-beta and placebo group treating RRMS showed that:The relapserate of the high-dose group is lower than the placebo group [RR=0.87,95%CI (0.76,0.92), P=0.04]; The sustained progress rate of the high-dose group is lower than placebo group [RR=0.84,95%CI (0.62,1.13), P=0.25];The high-dose group has higher incidence of influenza-likesymptoms than the placebo group (P=0.02);There is no statistical difference in the incidence oftotal adverse reactions beteen the two groups.(P=0.85).(2) Meta-analysis results in efficacy andsafety of different doses of IFN-beta treat SPMS showed that:①Meta-analysis results in efficacy and safety of high-dose group of IFN-beta and placebo group treating SPMS showedthat: The recurrence rate of high-dose IFN-beta group is lower than the placebo group [RR=0.73,95%CI (0.66,0.81), P <0.05];The sustained progress rate of the high-dose group is lowerthan the placebo.[RR=0.73,95%CI (0.66,0.81), P <0.05];The incidence of new activity lesionson MRI of the high-dose group is lower than the placebo group [RR=0.77,95%CI (0.71,0.83),P <0.05]; The high-dose group has higher incidence of the total adverse reactions than theplacebo group (P=0.02);There is no statistical difference in the incidence of influenza-likesymptoms beteen the two groups (P=0.09).②Meta-analysis results in efficacy and safety oflow-dose group of IFN-beta and placebo group treating SPMS showed that: The recurrence rateof low-dose IFN-beta group is lower than the placebo group [RR=0.74,95%CI (0.63,0.86), P<0.05];There is no statistical difference in the incidence of the sustained progress beteen the twogroups [RR=0.89,95%CI,(0.78,1.02), P=0.10];The incidence of new activity lesions on MRIof low-dose IFN-beta group is lower than the placebo group [RR=0.75,95%CI (0.67,0.85), P<0.05];The low-dose group has higher incidence of the total adverse reactions than the placebogroup (P <0.05).(3)Systematic Review results in efficacy and safety of different doses ofIFN-beta treat PPMS showed that:There is no statistical difference in the incidence of thesustained progress beteen the Different doses groups.The incidence of new activity lesions onMRI of IFN-beta group is lower than the placebo group.【Conclusions】(1)High dose of IFN-β treat RRMS, SPMS all can reduce relapse frequency,delay sustained progress, reduce MRI of new lesions, especially in IFN-β1a curative effect ofoutstanding.(2)Low dose IFN-β can reduce relapse RRMS frequency, but there is no evidence tosupport the enough SPMS clinical efficacy.(3)IFN-β treat PPMS can reduce reduce MRI of newlesions, but there is no evidence to support the enough SPMS clinical efficacy.(4) High-doseIFN-beta, the highest incidence of adverse reactions in MS, but mostly tolerable, a good safetyprofile.(5) the system evaluation in the literature are high quality of randomized controlled trials,the results highly credible, able to narrow the range of clinical medication, but you can not use afunnel plot to evaluate publication bias (referred to different doses of IFN-β treatment of MSclinical trials less) may overstate intervention effect, still need more high quality research toprovide reliable evidence for its efficacy and safety to be confirmed.