摘要
目的系统评价来氟米特治疗类风湿性关节炎的临床疗效和安全性,为来氟米特在我国的应用提供科学依据。方法在MEDLINE、EMbase、CNKI、万方数据库和CBM检索1989.1~2011.1有关来氟米特治疗类风湿关节炎的随机对照试验(RCT)。由两位研究者按照纳入与排除标准进行文献筛选、资料提取和质量评价后,采用RevMan 5.0软件进行Meta分析。结果共纳入16个RCT,合计3247例患者,其中来氟米特组1711例,甲氨喋呤组1536例。Meta分析结果显示:来氟米特与甲氨蝶呤疗效差异无统计学意义[RR=1.03,95%CI(0.94,1.11),P>0.05],而副反应差异有统计学意义[RR=0.67,95%CI(0.49,0.94),P<0.05]。结论来氟米特治疗类风湿性关节炎疗效与甲氨喋呤相近且其安全性优于甲氨蝶呤,是一种比较安全、有效的改变病程的慢作用药。由于受纳入研究质量限制和可能存在的发表偏倚影响,其疗效和安全性尚需更多高质量的随机双盲试验加以验证。
Objective To evaluate the efficacy and safety of Le unomide(LEF) in the treatment of Rheumatoid Ar-thritis(RA),so as to provide scientific proof for applying LEF in China.Methods Randomized controlled trials(RCTs) about the e ect of LEF on patients with RA from January 1989 to January 2011 were searched from the following databas-es,CNKI,WanFang Data,MEDLINE,EMbase and CBM.A er two reviewers independently screened the studies accord-ing to the inclusion and exclusion criteria,Thextracted the data and assessed the quality,the data were analyzed by RevMan 5.0 so ware.Results Among 3247 patients in 16 included RCTs,1711 patients were in the LEF group,while the other 1536 patients were in the Methotrexate(MXT) group.The results of meta-analyses showed there was no signi cant di er-ence in the efficacy between LEF and MXT(RR=1.03,95%CI 0.94 to 1.11,P0.05),but a signi cant difference was found in the side reaction(RR=0.67,95%CI 0.49 to 0.94,P0.05).Conclusion Based on the current studies,Le unomide is as effective as the commonly-used Methotrexate in the treatment of rheumatiod arthritis at present,much safer than Metho-trexate,and thought as a safe and effective SAARD.For the quality restrictions of the included studies,more double blind RCTs with high quality are required to further assess the effects.
出处
《中国循证医学杂志》
CSCD
2011年第9期1062-1069,共8页
Chinese Journal of Evidence-based Medicine