摘要
目的以霉酚酸酯(MMF)及环磷酰胺(CYC)为对照,评价咪唑立宾(MZR)治疗活动性系统性红斑狼疮(SLE)的疗效和安全性。方法以中国江苏6家研究中心2012年4月至2013年3月收治的90例活动性SLE患者为研究对象。将其随机分为MZR组、MMF组和CYC组。其中MZR组30例,口服MZR 300 mg,隔日1次;MMF组30例,口服MMF 1 g,每日2次;CYC组30例,静脉用CYC 0.5 g,每2周1次。治疗24周后评估疗效和不良反应事件。结果 MZR组、MMF组、CYC组的总有效率分别为75.86%、78.58%和79.31%,完全缓解率分别为34.48%、39.29%和37.93%,3组总有效率和完全缓解率比较差异无统计学意义。治疗后3组患者SLEDAI积分、24 h尿蛋白定量、抗dsDNA抗体滴度均显著下降;3组患者的外周血白细胞计数、血红蛋白含量、血小板计数均明显上升;3种治疗均可明显提高患者血清C3、C4水平;以上各观察指标组间比较差异均无统计学意义。MZR组、MMF组不良事件发生率明显低于CYC组。结论 MZR治疗活动性SLE的疗效与MMF、CYC相当且耐受性较好,可以作为治疗SLE患者的全新治疗药物。
Objective To evaluate the efficacy and safety of mizoribine （MZR） for active systemic lupus erythematosus （SLE） in comparison with mycophenolate mofetil （MMF） and eyclophosphamide （CYC）. Methods Ninety patients with active SLE were enrolled between April 2012 and March 2013. Thirty patients were given MZR orally at a dose of 300 mg every other day. Thirty patients were taken MMF at 2 g per day in two divided doses. Thirty patients received 0. 5 g CYC in- travenously every two weeks. Therapeutic effects and adverse events （AEs） were evaluated at the end of 24-week treatment. Results The overall response rates of MZR, MMF and CYC group were 75.86% ,78.58% , and 79.31% at week 24 respectively. In MZR,MMF and CYC group,34.48% ,39. 29%, and 37.93% patients achieved complete remission respectively. There was no significant difference in the overall response rates or complete remission rates among the three groups. SLEDAI scores,24-hour proteinuria and anti-dsDNA titer significantly decreased in all the three groups. All of the three treatments significantly increased leukocyte counts, hemoglobin levels, platelet counts, and serum complement C3 and C4 levels. No significant difference was observed in the parameters above among the three groups. The incidences of AEs in pa- tients treated with MZR or MMF were significantly lower than those in patients treated with CYC. Conclusion MZR is well tolerated and has an effect similar to MMF or CYC in the treatment of active SLE, which may serve as a novel and alternative approach for SLE patients.
出处
《中国实用内科杂志》
CAS
CSCD
北大核心
2014年第6期584-588,共5页
Chinese Journal of Practical Internal Medicine
基金
国家自然科学基金青年科学基金项目(81302557)
中华医学会临床医学科研专项基金(12040720372)
南京市青年科技人才启动项目(QYK09173)
关键词
咪唑立宾
霉酚酸酯
环磷酰胺
红斑狼疮
系统性
mizoribine
mycophenolate mofetil, cyclophosphamide
lupus erythematosus, systemic
