霉酚酸酯治疗IgA肾病疗效及安全性的Meta分析

目的系统评价霉酚酸酯(MMF)治疗IgA肾病的疗效和安全性。方法计算机检索CNKI、CBM、MEDLINE、PubMed、The Cochrane Library和SCI,检索时限为1997年1月至2012年1月,同时手检国内相关期刊及会议资料,查找MMF治疗IgA肾病的随机对照试验(RCT)。由两名评价者根据纳入与排除标准独立选择文献、提取资料、评价纳入研究质量并交叉核对后,采用RevMan 5.0软件进行Meta分析。结果共纳入8个RCT,合计272例IgA肾病患者。Meta分析结果显示:①MMF组与安慰剂组比较总有效率差异无统计学意义RR=0.72,95%CI(0.21,2.52),P=0.61],MMF+激素组总有效率高于环磷酰胺(CTX)+激素组RR=4.21,95%CI(1.86,9.53),P<0.000 6]以及其他免疫抑制剂+激素组RR=3.03,95%CI(1.47,6.25),P=0.003]。②不良反应:MMF+激素组总不良反应发生率低于CTX+激素组RR=0.16,95%CI(0.07,0.37),P<0.000 1];MMF组与对照组的血肌酐升高率差异无统计学意义RR=2.28,95%CI(0.65,7.94),P=0.20],与对照组发展为终末期肾病的例数差异也无统计学意义RR=2.37,95%CI(0.44,12.83),P=0.32]。结论 MMF联合激素可提高治疗IgA肾病的总有效率,降低总不良反应发生率,但其对IgA肾病远期肾生存率的疗效有赖于高质量、多中心、大样本的临床试验进一步论证。单独使用与安慰剂的疗效相当,与常规治疗的治疗后血肌酐升高率无差异。

Effectiveness and Safety of Mycophenolate Mofetil for IgA Nephropathy： A Meta-Analysis

Objective To systematically evaluate the effectiveness and safety of mycophenolate mofetil （MMF） for IgA Nephropathy （IgAN）. Methods Databases including CNKI, CBM, MEDLINE, PubMed, The Cochrane Library and SCI were searched from January 1997 to January 2012, and the domestic conference data and relevant published articles were also searched manually. All randomized controlled trials （RCTs） on MMF in treating IgAN were independently collected and screened according to the inclusion and exclusion criteria by two reviewers. The data were extracted, the quality of the included studies was assessed and cross-checked, and then meta-analysis was conducted using RevMan 5.0 software. Results A total of 8 RCTs involving 272 patients with IgAN were included. The results of meta-analyses showed that： a） There were no significant differences in the overall effective rate （RR=0.72, 95%CI 0.21 to 2.52, P=0.61） be- tween the MMF group and the placebo group, but the overall effective rate was higher in the MMF＋hormone group than the CTX＋hormone group （RR=4.21, 95%CI 1.86 to 9.53, P〈0.000 1） and other immunosuppressants ＋hormone groups （RR=3.03, 95%CI 1.47 to 6.25, P=0.003）; and b） Adverse reaction： The overall incidence rate of adverse reaction in the MMF＋hormone group was lower than the CTX＋hormone group （RR=0.16, 95%CI 0.07 to 0.37, P〈0.000 1）. There were no significant differences in the elevated serum creatinine rate （RR=2.28, 95%CI 0.65 to 7.94, P=0.20） and the case num- ber of developing end-stage renal disease （ESRD） （RR=2.37, 95%CI 0.44 to 12.83, P=0.32） between the MMF group and the control group. Conclusion MMF combined with hormone in treating IgAN can increase the overall effective rate and decrease the overall incidence rate of adverse reaction, but its effectiveness of improving long-term survival rate has to he further proved by conducting more high-quality, multi-center and large-scale clinical trials. MMF alone has the same effect as the placebo dose, and it shows no differences in elevated serum creatinine after the treatment compared with con- ventional therapies.