摘要
目的探讨小剂量利妥昔单抗治疗复发难治性原发免疫性血小板减少症（ITP）的疗效及安全性。方法研究纳入20例复发难治性ITP患者，给予利妥昔单抗100mg静脉滴注，每周1次，连用4周，动态观察血常规、肝肾功能及凝血功能。采用流式细胞术检测治疗前后CD3＋、CD4＋、CD8＋、CD19＋淋巴细胞数。免疫比浊法定量检测治疗前后血清免疫球蛋白（IgG、lgM、IgA）水平。用ELISA方法检测血小板膜糖蛋白抗体。治疗前后各项检测指标比较采用配对t检验。结果治疗后中位起效时间为18d，PLT达峰值时间为（24±7）d。治疗后PLT[（124±106）×10^9／L]显著高于治疗前[（13±5）×10^9／L]（P〈0．01）。11例（55％）患者达完全反应（CR），4例（20％）有效（R），5例（25％）无效（NR）。中位疗效持续时间为8（5～23）个月。治疗前后外周血WBC、HGB、血清免疫球蛋白以及CD3＋、CD4＋、CD8＋淋巴细胞数无明显变化，CD19＋淋巴细胞数治疗后[（50．53±29．11）×10^9／L]较治疗前[（125．65±14．12）×10^9／L]明显下降（P〈0．01）。3例患者治疗前血小板自身抗体检测阳性，治疗后均为阴性。1例患者在首次输注利妥昔单抗后发生轻微不良反应。结论小剂量利妥昔单抗是一种治疗复发难治性ITP安全有效的药物，但其最佳用药方案、长期疗效以及不良反应有待临床进一步观察验证。
Objective To investigate the efficacy and safety as well as the effects of lower dose of rituximab on B-lymphocytes, serum immunoglobulin, and platelet glycoprotein-specific antibodies in patients with chronic refractory immune thrombocytopenic purpura （ITP）. Methods Twenty chronic refractory ITP patients, median age 47 （20 to 60） years old, received intravenous rituximab at the dose of 100mg once weekly for 4 consecutive weeks. Laboratory studies included complete blood cell count, regular monitoring of liver and kidney functions, blood coagulation and serum concentrations of IgG, IgM and IgA. CD3＋, CD4＋, CD8 ＋ , CD19＋, CD20 ＋ cell numbers were assayed by flow cytometry prior to and following rituximab. Platelet glycoprotein antibodies were detected by ELISA. The detection of indicators were compared by paired T test, with P 〈 0.05 as statistically significant. Results There was significant difference of the average platelet count between prior- [ （ 13 ± 5） ×10^9/L] and post-treatment [ （ 124 ± 106） ×10^9/L] with lower dose rituximab （P 〈 0.01 ）. Reaching PLT peak period was of （24 ＋ 7） d with median time of 18 d. The responses were of 11 （55%） CR,4 （20%） R and 5 （25%） NR, respectively, with median response duration of 8 months （5 - 23 months）. There were no significant changes of peripheral blood white blood cell count, hemoglobin, serum immunoglobulin, as well as CD3 ＋ , CD4 ＋ , CD8 ＋ lymphocyte counts during prior- and post- treatment. CD19＋/CD20＋ cells were almost depleted in all patients I（125. 65 ± 14. 12） ×10^6/L vs （50.53 ±29.11 ） ×10^6/L,P 〈 0.01 ） J. Expectedly, three cases of positive detection of platelet antibodies were negative after 4 weeks of lower dose of rituximab; one patient experienced infusion-related reaction. Conclusion Treatment with lower close rituximab may be an effective and safe approach in patient with chronic refractory ITP. However, the optimal therapeutic schedule, long-term efficacy and advers
出处
《中华血液学杂志》
CAS
CSCD
北大核心
2012年第3期204-206,共3页
Chinese Journal of Hematology
