摘要
目的探讨利妥昔单抗(Rituximab RTX,商品名:美罗华)治疗儿童系统性红斑狼疮(SLE)的疗效及安全性,为传统治疗不耐受和疗效不佳者提供新的治疗途径。方法采用罗氏药厂生产的RTXCD20单克隆抗体,静脉注射。初始剂量188mg/m(体表面积),2周后进行以375mg/m2第2次注射。每次注射前30min给地塞米松25mg,异丙嗪10mg各1次,预防药物过敏。结果 12例SLE患儿用药后4周通过外周血细胞流式仪检测10例(85.71%)B淋巴细胞去除为0,并持续6～8个月逐渐回升。IgG、IgM和IgA血浆检测与用药前差异无统计学意义。12例SLE治疗后1年,临床表现及体征通过SLE活动指数评分由治疗前的(16.0±2.95)分下降到治疗后的(8.67±1.83)分。抗核抗体(ANA)、抗双链DNA抗体(ds-DNA)、补体C3、C4均有不同程度改善。6例狼疮性肾炎(LN)患儿用药6个月,尿蛋白明显改善;4例用药6个月后,血浆肌酐和尿素氮恢复正常。1例合并严重肺部感染。结论 RTXCD20单克隆抗体治疗儿童SLE尤其是重症和LN患儿临床效果较为明显。RTX为传统泼尼松和环磷酰胺治疗不耐受和临床效果不佳者提供了新的治疗途经,但其合并严重感染问题不可忽视。RTX单抗能否替代传统的儿童SLE治疗药物,仍需进一步深入研究。
Objective To observe the efficacy and safety of Rituximab （Roche Pharmaceuticals RTX, trade name： rituximab） treatment for children with systemic lupus erythematosus, and try to find a useful alternative therapeutic approach to those with bad response to traditional therapies. Methods Produced by Roche Pharmaceuticals, CD20 monoclonal antibody rituximab was used by intravenous injection. Initial dose was 188 mg/m^2, 2 weeks later the second injection was given at 375 mg/m^2. Thirty minutes before each injection 5mg Dexamethasone and lOmg Promethazine were given to prevent drug allergy. Results Twelve cases of SLE in children were performed flow cytometry detection of CD20＋ 4 weeks after administration, 10 cases were 0 （85.71% ） in B cell depletion, and gradually rose after 6 - 8 months. IgG, IgM and IgA plasma had no significant difference from the baseline. Clinical manifestations and clinical signs in 12 cases of children were evaluated, and the average score dropped from 16.0 ± 2.95 to 8.67 ±1.83. ANA, Anti-ds-DNA, C3 and C4 had different degrees of improvement. In 6 cases of lupus nephritis children with urinary protein was significantly improved after 6 months of Rituximah treatment; 4 cases of elevated serum creatinine and blood urea nitrogen was also returned to normal after 6 months of treatment. One case had severe pulmonary infection. Conclusion Significant effects of CD20 ＋ monoclonal antibody （rituximab） treatment are shown for children with SLE and lupus nephritis, especially in severe children. This provides a new alternative treatment for those with poor tolerance to traditional Prednisone and cyclophosphamide treatment and with poor clinical effect. However, infection problem can not be ignored. The Rituximab replacement treatment for children with SLE still need further study.
出处
《中国实用儿科杂志》
CSCD
北大核心
2010年第8期611-613,617,共4页
Chinese Journal of Practical Pediatrics
关键词
利妥昔单抗
儿童
红斑狼疮
Rituximab
children
systemic lupus erythematosus
