Li Yan-Chun, Huang Jing, Li Xin, Zhao Su-Mei
Department of Nephrology, Beijing Chao-Yang Hospital, Beijing, China.
Department of Nephrology, Beijing Chao-Yang Hospital, Beijing, China.
Nefrologia (Engl Ed). 2019 May-Jun;39(3):269-276. doi: 10.1016/j.nefro.2018.10.008. Epub 2019 Feb 10.
Idiopathic membranous nephropathy (IMN), which is considered one of the most common causes of nephrotic syndrome in adult patients, is frequently managed with immunosuppressive agents. Both tacrolimus (TAC) and cyclophosphamide (CTX) are recommended as immunosuppressive agents in the management of IMN. However, profound effects and moderate evidence on the two drugs remains poorly defined at this period. The meta-analysis aims to summarize current best evidence on the efficacy as well as safety of TAC and CTX among IMN patients.
We searched the publications on comparison of the safety and efficacy of TAC versus CTX for IMN up to April 2018. After rigorous reviewing on the quality, the data was extracted from eligible trials. All trials analyzed the summary hazard ratios (HRs) of the endpoints of interest.
Moderate-strong evidence indicated that tacrolimus and cyclophosphamide had comparable effects on remission rate (either CR or PR) (p>0.05). No significant differences were found in the following parameters: the rates of diarrhea, glucose intolerance (or diabetes mellitus), gastrointestinal syndrome, as well as hypertension because of adverse effects (p>0.05). However, patients with TAC therapy had a higher chance to develop urinary tract infection (p=0.010) and tremor (p=0.006). Additionally, remarkably higher risk existed in leukopenia among the CTX group as compared with the TAC group (p=0.03).
This meta-analysis presents a comprehensive assessment of current available evidence for the therapy of IMN, indicating a comparable remission rate with both TAC and CTX, while the long-term effects are needed for further verification. Nevertheless, different adverse effect profiles of two groups need careful consideration. Remarkably higher rates of urinary tract infection and tremor were observed among TAC group, while higher risk of leukopenia was found among CTX group. Further research into the treatment efficacy of both drugs is warranted to confirm the present conclusions.
特发性膜性肾病（IMN）被认为是成年患者肾病综合征最常见的病因之一，常采用免疫抑制剂进行治疗。他克莫司（TAC）和环磷酰胺（CTX）均被推荐作为IMN治疗中的免疫抑制剂。然而，在此期间，这两种药物的显著疗效和适度证据仍不明确。本荟萃分析旨在总结目前关于TAC和CTX在IMN患者中的疗效及安全性的最佳证据。
我们检索了截至2018年4月关于TAC与CTX治疗IMN的安全性和疗效比较的出版物。在对质量进行严格审查后，从符合条件的试验中提取数据。所有试验均分析了感兴趣终点的汇总风险比（HRs）。
中到强的证据表明，他克莫司和环磷酰胺在缓解率（完全缓解或部分缓解）方面具有相似的效果（p>0.05）。在以下参数方面未发现显著差异：腹泻率、葡萄糖不耐受（或糖尿病）、胃肠道综合征以及因不良反应导致的高血压（p>0.05）。然而，接受TAC治疗的患者发生尿路感染（p=0.010）和震颤（p=0.006）的几率更高。此外，与TAC组相比，CTX组白细胞减少的风险显著更高（p=0.03）。
本荟萃分析对目前IMN治疗的现有证据进行了全面评估，表明TAC和CTX的缓解率相当，但其长期效果仍需进一步验证。然而，两组不同的不良反应情况需要仔细考虑。TAC组观察到的尿路感染和震颤发生率显著更高，而CTX组白细胞减少的风险更高。有必要对这两种药物的治疗效果进行进一步研究以证实目前的结论。
