中国循证儿科杂志2011,Vol.6Issue(2):104-109,6.DOI:10.3969/j.issn.1673-5501.2011.02.006
来氟米特治疗狼疮性肾炎疗效和安全性的Meta分析
Efficacy and safety of leflunomide therapy in lupus nephritis:a meta-analysis
摘要
Abstract
Objective To evaluate the efficacy and safe.ty of leflunomide in treating lupus nephritis( LN ).Methods According to the requirements of meta-analysis, a literature search about efficacy and safety of leflunomide therapy in LN was performed among Cochrane clinical controlled trials database, PubMed.BMJ-Clinical Evidence, CNKI.VIP and Wanfang data from the establishment of the database till December 2010.All included RCTs were graded in term of randomization, allocation concealment and blinding and non-RCTs were graded in term of grouping method, blinding, withdrawal and loss of follow-up,baseline comparability, diagnostic criteria and bias control.RevMan 5.0 software was used for meta-analysis.Results A total of 828 literatures were included.Five RCTs and 2 non-RCTs were enrolled for meta-analysis.Four RCTs described the method of random allocation,1 literature used double blind method.Five RCTs were all lack of information about allocation concealment.selectively reporting and other bias, but reported withdrawal and loss of subjects.Two non-RCTs were lack of grouping method and blinding, but reported withdrawal and loss of subjects , also used established diagnostic criteria.Leflunomide group was treated with leflunomide and glucocorticoid.while control group was given cyclophosphamide and glucocorticoid or placeho.①There was no significant difference in complete remission rate( OR = 1.51, 95% CI:0.90 -2.54 ) , partial remission rate( OR = 1.06.95% CI:0.70 - 1.61 ) or overall remission( OR = 1.63.95 %CI : 0.98 - 2.71 ) between leflunomide group and cyclophosphamide group.② The 24 h urine protein , SCr and SLEDAI scores of leflunomide group were significantly lower than that of cyclophosphamide group.There was no significant difference in C3 , positive rate of anti-ds DNA between leflunomide group and cyclophosphamide group.③There was no significant difference in infection, herpes zoster, hypertension, palpitations, leukopenia, alopecial, elevation in ALT, memoxenia.rashes, or the incidenc:e of gastrointestinal reactions between the two groups.Conclusions Based on the current evidence.the efficacy and safety of leflunomide for treatment of LN are close to cyclophosphamide.Further evidence from RCT studies is needed to elucidate the efficacy and safety of leflunomide for LN.关键词
来氟米特/狼疮性肾炎/Meta分析/疗效/安全性引用本文复制引用
任琪,曾华松..来氟米特治疗狼疮性肾炎疗效和安全性的Meta分析[J].中国循证儿科杂志,2011,6(2):104-109,6.基金项目
广东省自然科学基金:9151026003000004 ()
国家人事部留学归国人员启动基金:200499 ()
广东省科技厅科技攻关重点项目:2003B30503 ()
广州市科技局科技攻关重大项目:2003Z2-E0181 ()
广州市科技局科技攻关一般引导项目:2005Z1-E0104 ()
广州市卫生局重点项目:2005-Zdi-08 ()