FTY720治疗多发性硬化的疗效与安全性系统评价

Efficacy and Safety of FTY720 in the Treatment of Relapsing-Remitting Multiple Sclerosis: A Systematic Review

目的系统评价FTY720治疗复发缓解型多发性硬化(RRMS)的疗效与安全性,为临床应用提供参考。方法计算机检索MEDLINE、EMbase、Cochrane Liabrary、CBM、CNKI,查找有关FTY720治疗复发缓解型多发性硬化的随机对照试验(RCT),检索时限均为从2001年1月1日至2010年12月31日。按纳入排除标准选择文献、提取资料,并以改良Jadad量表评价纳入研究的质量后,采用RevMan 5.1软件进行Meta分析。结果共纳入3个高质量RCT。Meta分析结果显示:①与对照组相比,口服FTY720可显著降低和减少年化复发率[OR=–6.67,95%CI(–10.75,–2.60),P=0.001]、残疾恶化进展患者比例[OR=0.64,95%CI(0.47,0.87),P=0.004]和核磁共振脑部钆强化病变的患者比例[OR=0.28,95%CI(0.21,0.37),P<0.000 01]。②0.5 mg/d和1.25 mg/d FTY720组间疗效差异无统计学意义(P=0.55)。③3种不同剂量(5 mg/d、1.25 mg/d、0.5 mg/d)的FTY720的安全性比较,FTY720 0.5mg/d组安全性最好。结论 FTY720治疗RRMS的安全性好,可显著降低RRMS患者的年化复发率,减少残疾恶化进展和核磁共振脑部钆强化病变。不同剂量的FTY720治疗RRMS无剂量-效应关系,其中以口服0.5 mg/dFTY720安全性最好。

Objective To evaluate the efficacy and safety of FTY720（fligolimod） in different dosages in the treatment of Relapsing-Remitting Multiple Sclerosis（RRMS）,so as to provide references for clinical practice.Methods Such databases as MEDLINE,EMbase,The Cochrane Liabrary,CBM and CNKI were searched for collecting randomized controlled trials（RCTs） of FTY720 in the treatment of RRMS,which were published from January 1,2001 to December 31,2010.The studies were retrieved and the data were extracted according to the predefined inclusion and exclusion criteria,the quality of included studies was evaluated with improved Jadad scale,and the Meta-analyses were performed with RevMan5.1 software.Results Three high quality RCTs were included.The Meta-analyses showed that： a） compared with the control group,orally taking FTY720 could obviously decreased the annualized relapse rate（OR=-6.67,95%CI-10.75 to-2.60,P=0.001）,the confirmed disability progression rate（OR=0.64,95%CI 0.47 to 0.87,P=0.004）,and the incidence rate of intensified lesion on T2-weighted magnetic resonance imaging scans（OR=0.28,95%CI 0.21 to 0.37,P0.00001）;b） There was no significant difference（P=0.55） between the small dosage（0.5mg/d） group and the big dosage（1.25mg/d） group of FTY720;and c） The incidence of adverse events was significantly different among the 3 dosage groups（5mg/d,1.25mg/d and 0.5mg/d）,and the minimum dosage group（0.5mg/d） was safer than the other groups.Conclusion FTY720 is safe to treat RRMS,and it can obviously decrease the annualized relapse rate,confirmed disability progression rate and incidence rate of intense lesion on T2-weighted magnetic resonance imaging scans.There is no dosage-effect relationship found in treating RRMS with FTY720 in different dosages,but the 0.5mg/d FTY720 as the minimum dosage is the safest.