Riskalla Mona M, Somers Emily C, Fatica Richard A, McCune W Joseph
Department of Pediatrics and Communicable Diseases, University of Michigan Health System, Ann Arbor, Michigan, USA.
J Rheumatol. 2003 Jul;30(7):1508-12.
To quantify the adverse events (AE) associated with mycophenolate mofetil (MMF) in patients with systemic lupus erythematosus (SLE), to examine the relationship between AE and dosage of MMF, and to assess the overall tolerability of MMF in SLE patients.
A consecutive cohort of adults with SLE who received MMF between October 1996 and June 1999 was identified. Charts were reviewed for baseline data, AE, MMF dosing characteristics, and clinical response at baseline, 3 months, and at final followup or drug discontinuation.
The 54 SLE patients were followed for a mean of 12.4 +/- 7.0 person-months. Baseline characteristics: 92.6% female, 72.2% white, mean age 38.3 years, and a mean of 9.6 years since diagnosis. Twenty-one of 54 patients (38.9%) had a total of 28 gastrointestinal AE. Twenty-four of 54 (44.4%) patients had a total of 37 infections, only one of which required hospitalization. Leukopenia occurred 3 times but never required dose adjustment. AE occurred at a similar rate at all MMF doses. Kaplan-Meier estimates show most drug discontinuation occurred in the first 2.5 months and 73% of patients were still on the drug at 12 months. Sixteen of 54 patients discontinued MMF because of AE (n = 9), lack of efficacy (n = 3), pregnancy (n = 2), and administrative reasons (n = 2). Clinical improvement in patients was noted with significant decreases in disease activity measured by the SLEDAI and prednisone dose at 3 months and at final followup.
The majority of patients tolerated MMF. A range of doses was tolerated and associated with clinical improvement, suggesting that a flexible dosing schedule should be considered when using MMF in patients with SLE.
量化系统性红斑狼疮（SLE）患者中与霉酚酸酯（MMF）相关的不良事件（AE），研究AE与MMF剂量之间的关系，并评估MMF在SLE患者中的总体耐受性。
确定了1996年10月至1999年6月期间接受MMF治疗的连续性SLE成年患者队列。查阅病历以获取基线数据、AE、MMF给药特征以及基线、3个月、最终随访或停药时的临床反应。
54例SLE患者平均随访12.4±7.0人月。基线特征：92.6%为女性，72.2%为白人，平均年龄38.3岁，自诊断以来平均病程9.6年。54例患者中有21例（38.9%）共发生28次胃肠道AE。54例患者中有24例（44.4%）共发生37次感染，其中仅1例需要住院治疗。白细胞减少发生3次，但从未需要调整剂量。所有MMF剂量下AE的发生率相似。Kaplan-Meier估计显示，大多数停药发生在最初的2.5个月内，73%的患者在12个月时仍在使用该药物。54例患者中有16例因AE（n = 9）、缺乏疗效（n = 3）、妊娠（n = 2）和管理原因（n = 2）而停用MMF。在3个月和最终随访时，通过SLEDAI和泼尼松剂量测量的疾病活动度显著降低，患者有临床改善。
大多数患者耐受MMF。一系列剂量均可耐受并与临床改善相关，这表明在SLE患者中使用MMF时应考虑灵活的给药方案。
