Objective: To observe the efficacy of high-dose dexamethasone in combination with low-dose rituximab as a second-line treatment for patients with immune thrombocytopenia (ITP).
Methods: 65 patients with ITP, previously by conventional dose of glucocorticoids, received high-dose dexamethasone in combination with low-dose rituximab (dexamethasone 40 mg/d for 4 days, rituximab 100 mg, d 7, 14, 21, 28 intravenous infusion). Treatment response, regulatory T cells (Treg), cytokines levels and treatment-related adverse effects were observed.
Results: Total response rate 1 month after treatment was achieved in 81.5% (53/65) of patients, and complete response at 3,6 and 12 months was 72.3% (47/65), 66.2%(43/65), 63.1%(41/65). The higher efficiency and complete response rate was achieved in preexisting glucocorticoid-dependent patients. For patients with complete response, Treg cells continued to show a high level state [(3.01 ± 0.95)% vs (1.69 ± 0.35)%, P=0.032], cytokines of BAFF [(648.03 ± 79.63) ng/L vs (972.35 ± 93.64) ng/L, P=0.001], IL-2 [(2.84 ± 0.32) ng/L vs (4.18 ± 0.46) ng/L, P=0.012], sCD40L[(4.55 ± 0.66) ng/L vs (7.73 ± 1.04) ng/L, P=0.006] significantly lower than that before treatment. The level of IL-10 was increased, but without significance compared with that before treatment (P=0.136). All patients completed the protocol with no serious adverse reactions.
Conclusion: The data show high-dose dexamethasone in combination with low-dose rituximab still has a satisfactory outcomes for patients previously with conventional dose of glucocorticoid.
目的: 观察大剂量地塞米松联合小剂量利妥昔单抗作为二线方案治疗原发免疫性血小板减少症(ITP)的疗效和安全性。
方法: 65例ITP患者纳入研究，其中糖皮质激素依赖52例、糖皮质激素无效13例；男35例，女30例，中位年龄34(18~70)岁。治疗方案：地塞米松40 mg/d，第1~4天静脉滴注，利妥昔单抗100 mg，第7、14、21、28天静脉滴注。治疗前及治疗后12个月应用流式细胞术检测外周血调节性T细胞(Treg)、B淋巴细胞活化因子(BAFF)、IL-2、IL-10、可溶性白细胞分化抗原40配体(sCD40L)。
结果: 全部65例患者治疗1个月时总有效率为81.5%(53/65)，第3、6、12个月时完全反应率分别为72.3%(47/65)、66.2%(43/65)、63.1%(41/65)。糖皮质激素依赖的52例患者治疗1个月时总有效率为90.3%(47/52)，第3、6、12个月时完全反应率为80.8%(42/52)、76.9%(40/52)、73.1%(38/52)。治疗12个月41例完全反应患者的外周血Treg细胞水平高于治疗前[(3.01±0.95)%对(1.69±0.35)%，P=0.032]，BAFF、IL-2、sCD40L均低于治疗前[（648.03±79.63）ng/L对（972.35±93.64）ng/L，P=0.001；（2.84±0.32）ng/L对（4.18±0.46）ng/L，P=0.012；（4.55±0.66）ng/L对（7.73±1.04）ng/L，P=0.006]，IL-10与治疗前比较差异无统计学意义（P=0.136）。所有患者均完成了治疗，不良事件发生率为52.3%(39/65)。
结论: 大剂量地塞米松联合小剂量利妥昔单抗对常规剂量糖皮质激素治疗无效或依赖的患者仍有较高的反应率，不良反应发生率可接受。