激素联合吗替麦考酚酯与环磷酰胺对成人难治性肾病综合征疗效的 Meta 分析

摘要： 目的 系统评价激素联合吗替麦考酚酯与环磷酰胺对成人难治性肾病综合征的有效性及不良反应。方法 电子检索 Embase、 Pubmed、 Cochrane library、 中国知网、 万方和维普中文科技期刊数据库， 检索时间范围为建库至 2014 年 3 月， 纳入涉及激素联合吗替麦考酚酯与环磷酰胺对比治疗成人难治性肾病综合征的随机对照试验 (RCT)， 根据纳入标准和排除标准筛选文献， 经质量评价及提取数据后， 使用 RevMan5.2 软件对经治疗后的成人难治性肾病综合征的完全缓解率、 有效率、 血清白蛋白、 相关不良反应等指标进行数据统计分析。结果 共纳入 RCT 9 篇， 467 例患者， 其中吗替麦考酚酯组 235 例， 环磷酰胺组 232 例。Meta 分析结果显示吗替麦考酚酯组完全缓解率（RR=1.45， 95%CI 为 1.17~1.81， P=0.000 7）、 有效率（RR=1.23， 95%CI 为 1.11~1.36， P < 0.000 1）、 血清白蛋白（WMD= 2.73， 95%CI 为 1.42~4.04， P < 0.000 1）高于环磷酰胺组， 24 h 尿蛋白定量（SMD=-0.63， 95%CI 为-1.16~-0.10， P= 0.02）低于环磷酰胺组， 血清胆固醇水平（SMD=0.31， 95%CI 为-0.23~0.84）， P=0.26）与环磷酰胺组差异无统计学意义。吗替麦考酚酯组肝功能损害（RR=0.13， 95%CI 为 0.06~0.28）、 白细胞下降（RR=0.10， 95%CI 为 0.04~0.23）、 胃肠道反应（RR=0.21， 95%CI 为 0.11~0.39）和脱发（RR=0.08， 95%CI 为 0.02~0.29）的发生率均低于环磷酰胺组（均 P＜ 0.05）； 2 组上呼吸道感染 （RR=0.68， 95%CI 为 0.41~1.14） 和肺部感染 （RR=0.58， 95%CI 为 0.31~1.08） 的发生率差异无统计学意义。结论 吗替麦考酚酯治疗成人难治性肾病综合征的有效性和安全性优于环磷酰胺。

Glucocorticoid combined with mycophenolate mofetil versus cyclophosphamide in the treatment for adult refractory nephrotic syndrome:a Meta-analysis

Abstract：Objective To systematically review the efficacy and safety of mycophenolate mofetil versus cyclophospha⁃ mide in adults with refractory nephrotic syndrome. Methods The randomized controlled trials of mycophenolate mofetil and cyclophosphamide treatment for refractory nephrotic syndrome were searched from Cochrane library, PubMed, EMbase, Wanfang, VIP and CNKI till March 2014. The relevant studies were screened according to inclusion criteria and exclusion criteria. The quality of the included studies was evaluated. Meta-analyses were performed by using RevMan 5.2 software. The indexes were analyzed including the complete remission rate, efficiency, serum albumin, and adverse reaction after com⁃ pleting the treatment for adults with refractory nephrotic syndrome. Results There were 9 RCTs, a total of 467 patients were enrolled. The result of the meta-analysis showed that mycophenolate mofetil could significantly increase complete re⁃ mission rate (RR=1.45, 95% CI=1.17~1.81, P=0.000 7) and efficiency rate (RR=1.23, 95 % CI=1.11~1.36, P < 0.000 1). It can also enhance the level of serum albumin (WMD=2.73, 95% CI=1.42~4.04, P < 0.000 1) and decrease 24-hour urinary protein (SMD=-0.63, 95%CI=-1.16~-0.10, P=0.02) compared with cyclophosphamide in the treatment of refractory nephrot⁃ ic syndrome. There was no significant difference in the serum level of cholesterol between mycophenolate mofetil group and cyclophosphamide group (SMD=0.31, 95%CI=-0.23~0.84, P=0.26 ). The incidence rates of liver dysfunction (RR=0.13,95% CI=0.06~0.28, P < 0.000 01), leukopenia (RR=0.10, 95% CI=0.04~0.23, P < 0.000 01), gastrointestinal reaction (RR=0.21, 95% CI=0.11~0.39, P < 0.000 01) and alopecia (RR=0.08, 95% CI= 0.02~0.29, P < 0.000 01) were significantly lower in my⁃ cophenolate mofetil group than those of cyclophosphamide group. There were no significant differences in respiratory tract in⁃ fection rate (RR=0.68, 95%CI=0.41~1.14, P=0.14) and lung infection rate (RR=0.58, 95%CI =0.31~1.08, P=0.09) between the two groups. Conclusion The safety and efficacy are better in the treatment of refractory nephrotic syndrome using myco⁃ phenolate mofetil than that of cyclophosphamide.