生物活性 | |||
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描述 | Renal disease in systemic lupus erythematosus carries significant morbidity and mortality. Intensive immunosuppression to dampen kidney inflammation timely and maintenance therapy to prevent renal flares is necessary to reduce the long-term risk of renal failure. Mycophenolate mofetil (MMF) has emerged to be the first-line treatment of lupus nephritis for its better safety profile compared with cyclophosphamide. Low-dose combination of MMF and tacrolimus has been shown to be more efficacious than intravenous pulse cyclophosphamide in inducing remission of lupus nephritis in Chinese patients[1]. Systemic plasma clearance of intravenous MMF was around 10 L/min in healthy individuals, and plasma MMF concentrations fell below the quantitation limit (0.4 mg/L) within 10 minutes of the cessation of infusion. The pharmacokinetics of patients with renal transplants (after 3 months or more) compared with those of healthy individuals were similar after oral MMF[2]. Uncontrolled studies in patients with FRNS (frequently relapsing nephrotic syndrome) and SDSN (steroid-dependent nephrotic syndrome) have shown that many patients can achieve sustained remission of proteinuria with MMF monotherapy[3]. |
临床研究 | |||||
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NCT号 | 适应症或疾病 | 临床期 | 招募状态 | 预计完成时间 | 地点 |
NCT00433186 | Diffuse Cutaneous Systemic Scl... 展开 >>erosis 收起 << | Phase 1 | Completed | - | United States, Massachusetts ... 展开 >> Boston University School of Medicine Boston, Massachusetts, United States, 02118 收起 << |
NCT00548717 | Graft-vs-Host Disease | Phase 2 | Terminated(First two patients ... 展开 >>enrolled after trial reopened, developed grade III-IV acute GVHD and subsequently passed away.) 收起 << | - | United States, Massachusetts ... 展开 >> Dana-Farber Cancer Institute Boston, Massachusetts, United States, 02115 收起 << |
NCT00171379 | Prevention of Acute Rejection ... 展开 >>After Kidney Transplantation 收起 << | Phase 3 | Completed | - | - |
实验方案 | |||
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1mg | 5mg | 10mg | |
1 mM 5 mM 10 mM |
7.69mL 1.54mL 0.77mL |
38.43mL 7.69mL 3.84mL |
76.86mL 15.37mL 7.69mL |
参考文献 |
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[1]Mycophenolate mofetil for lupus nephritis: an update [2]Clinical pharmacokinetics of mycophenolate mofetil [3]Mycophenolate mofetil for sustained remission in nephrotic syndrome |