Zhang Haitao, Zhou Minlin, Han Xiaoyan, Yang Yang, Yu Xin
National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing Clinical School of Second Military Medical University, Nanjing University School of Medicine, Nanjing.
Shanghai Roche Pharmaceuticals Ltd., Shanghai, PR China.
Medicine (Baltimore). 2020 Aug 14;99(33):e21121. doi: 10.1097/MD.0000000000021121.
Mycophenolate mofetil (MMF) has been recommended for the treatment of lupus nephritis (LN). Although inter-racial differences exist regarding the appropriate dose and efficacy of MMF in patients with LN, no definitive meta-analysis has yet been conducted in Chinese patients. This analysis investigated the efficacy and safety of MMF in Chinese patients with proliferative LN.
A systematic literature search was conducted to select randomized controlled trials that reported at least one of the following: complete remission (CR), partial remission, total remission (TR; defined as complete remission + partial remission), relapse rate, serum creatinine, creatinine clearance, end-stage renal disease, death, infections, amenorrhea, leukopenia, alopecia, gastrointestinal symptoms, or liver damage.
Eighteen trials (927 patients) were included; 14 (750 patients) reported CR, partial remission, and TR. Two trials (58 patients) reported relapse rates during maintenance treatment. MMF induction significantly improved CR and TR vs cyclophosphamide (relative risk 1.34, 95% confidence interval: 1.13-1.58; P < .001; relative risk 1.16, 95% confidence interval: 1.02-1.33; P = .03), and was associated with significantly lower risks of infection (P < .001), amenorrhea (P < .001), leukopenia, and alopecia. No significant difference in relapse rate was evident between the MMF and azathioprine groups (P = .66).
According to this meta-analysis of 18 trials, MMF is significantly more effective than cyclophosphamide induction, and is associated with reduced incidences of infections, amenorrhea, leukopenia, and alopecia in Chinese patients with proliferative LN.
霉酚酸酯(MMF)已被推荐用于治疗狼疮性肾炎(LN)。尽管在LN患者中,MMF的合适剂量和疗效存在种族差异,但尚未对中国患者进行明确的荟萃分析。本分析研究了MMF在中国增殖性LN患者中的疗效和安全性。
进行系统的文献检索,以选择报告了以下至少一项的随机对照试验:完全缓解(CR)、部分缓解、总缓解(TR;定义为完全缓解+部分缓解)、复发率、血清肌酐、肌酐清除率、终末期肾病、死亡、感染、闭经、白细胞减少、脱发、胃肠道症状或肝损伤。
纳入了18项试验(927例患者);14项试验(750例患者)报告了CR、部分缓解和TR。2项试验(58例患者)报告了维持治疗期间的复发率。与环磷酰胺相比,MMF诱导显著改善了CR和TR(相对风险1.34,95%置信区间:1.13 - 1.58;P <.001;相对风险1.16,95%置信区间:1.02 - 1.33;P =.03),并且感染风险(P <.001)、闭经风险(P <.001)、白细胞减少和脱发的风险显著更低。MMF组和硫唑嘌呤组之间的复发率无显著差异(P =.66)。
根据对18项试验的荟萃分析,MMF诱导治疗比环磷酰胺更有效,并且在中国增殖性LN患者中,其感染、闭经、白细胞减少和脱发的发生率降低。