Takeuchi Tsutomu, Okada Kenya, Yoshida Hisao, Yagi Nobuyuki
a Division of Rheumatology, Department of Internal Medicine , Keio University School of Medicine , Tokyo , Japan.
b Post-Marketing Surveillance Department , Regulatory Affairs and Reliability Assurance Center, Asahi Kasei Pharma Corporation , Tokyo , Japan.
Mod Rheumatol. 2018 Jan;28(1):85-94. doi: 10.1080/14397595.2017.1349573. Epub 2017 Jul 19.
To understand the status of mizoribine use in patients with lupus nephritis (LN) and to collect safety- and efficacy-related data on 2-year treatment with mizoribine.
A continuous survey was conducted between March 2010 and July 2015.
The analysis set included 559 patients (mean age 39.5 years, females 82.6%, mean duration of systemic lupus erythematosus (SLE) 8.4 years, mean duration of LN 5.9 years). Renal function was satisfactory for 6 months, but worsened from 12 months, with significant worsening at 24 months. By the ACR 2006 remission criteria (eGFR >60), at 24 months, 26.5% of patients achieved complete remission, and 63.3% achieved complete or partial remission. The urine protein to creatinine ratio decreased significantly. The SLE Disease Activity Index 2000 score decreased significantly at 12 and 24 months. Overall, 98 (17.5%) patients experienced 124 adverse drug reactions (ADRs); 3.6% experienced serious ADRs. Mizoribine was used with a steroid in 99.3% and an immunosuppressant in 51.2%; tacrolimus was used in 43.8%. The oral steroid dosage decreased from baseline to 24 months. The incidence of ADRs was not significantly different with concomitant tacrolimus use.
The results suggest that long-term mizoribine is safe and effective, even when used with tacrolimus.
了解米唑立宾在狼疮性肾炎（LN）患者中的使用情况，并收集有关米唑立宾2年治疗的安全性和有效性相关数据。
于2010年3月至2015年7月进行了一项连续性调查。
分析集包括559例患者（平均年龄39.5岁，女性占82.6%，系统性红斑狼疮（SLE）平均病程8.4年，LN平均病程5.9年）。肾功能在6个月时良好，但从12个月起恶化，在24个月时显著恶化。根据美国风湿病学会（ACR）2006年缓解标准（估算肾小球滤过率（eGFR）>60），在24个月时，26.5%的患者实现完全缓解，63.3%的患者实现完全或部分缓解。尿蛋白肌酐比值显著下降。SLE疾病活动指数2000评分在12个月和24个月时显著下降。总体而言，98例（17.%)患者发生了124次药物不良反应（ADR）；3.6%的患者发生严重ADR。99.3%的患者米唑立宾与类固醇联用，51.2%的患者与免疫抑制剂联用；43.8%的患者使用他克莫司。口服类固醇剂量从基线至24个月减少。联用他克莫司时ADR发生率无显著差异。
结果表明，长期使用米唑立宾是安全有效的，即使与他克莫司联用也是如此。
