不同剂量利妥昔单抗治疗原发性难治性免疫性血小板减少症的临床观察

Clinical observation of different doses of rituximab treating primary refractory immune thrombocytopenia

目的探讨不同剂量利妥昔单抗治疗原发性难治性免疫性血小板减少症(immune thrombocytopenia,ITP)的临床疗效。方法将46例患者随机分为2组。A组:22例ITP患者,利妥昔单抗剂量为100 mg/周,连用4周;B组:24例ITP患者,利妥昔单抗剂量为375 mg/m2,每周1次,连用4周。比较2组疗效、不良反应、血小板计数、血小板特异性抗体、IFN-γ、IL-12及IL-10的水平。结果 A组、B组总有效率分别为72.73%、70.83%,2组有效率差异无统计学意义。A组、B组药物治疗后不良反应均比较轻微,2组不良反应发生率比较差异无统计学意义。2组治疗后血小板数均较治疗前明显升高(均为P<0.001),但2组间比较差异无统计学意义。2组治疗后血小板特异性抗体均较治疗前明显降低(P<0.001),但2组间比较差异无统计学意义。2组治疗后IL-10水平均较治疗前明显升高(P<0.001),但2组间比较差异无统计学意义。2组治疗后IL-12、IFN-γ水平均较治疗前明显降低(P<0.001),但2组间比较差异无统计学意义。结论小剂量利妥昔单抗治疗难治性原发性ITP疗效确切,可有效改善临床症状,安全性好,成本较低。

Objective To study clinical curative effect of different doses of rituximab treating primary refractory immune thrombocytopenia. Methods 46 patients were randomly divided into two groups. Group A: 22 patients with ITP,treated by rituximab with a dose of 100 mg /week,lasting for 4 weeks; Group B: 24 patients with ITP,treated by rituximab with a dose of 375( mg /m2) /week,lasting for 4 weeks. Curative effect,adverse reactions,platelets count,platelet specific antibody,IFN-γ,IL-12 and IL-10 levels of two groups were compared. Results Total effective rate of group A and group B were 72. 73%,70. 83%,respectively. Efficency of two groups was no statistically significant difference. Drug adverse reactions after treatment in group A and group B were relatively mild,and the incidence rates of adverse reaction were similar between the two groups,with no statistical significance. PLT of the two groups after treatment significantly increased than before treatment( P < 0. 001),but there was no statistically significant difference when compared between two groups. Platelet specific antibody in the two groups after treatment significantly decreased than before treatment( P < 0. 001),but there was no statistically significant difference when compared between two groups. IL-10 level of two groups after treatment significantly increased than before treatment( P < 0. 001),but there was no statistically significant difference when compared between two groups. IL-12 and IFN-γ levels of two groups after treatment were significantly lower than before treatment( P < 0. 001),but there was no statistically significant difference when compared between two groups. Conclusion Curative effect of small dose of rituximab treating refractory primary ITP is good. Small dose of rituximab can effectively improve the clinical symptoms,and it has high safety and low cost.