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Title: [Efficacy and safety of low-dose rituximab combined with different dosage of glucocorticoids for immune thrombocytopenia].
Author: Xing WW, Li ZY, Yan ZL, Liu KG, Li N, Cao J, Pan XY, He XP, Xu KL.
Journal: Zhonghua Xue Ye Xue Za Zhi; 2013 May; 34(5):409-12. PubMed ID: 23688751.
Abstract:
OBJECTIVE: To compare the efficacy and safety of low-dose rituximab combined with different dosage of glucocorticoids for immune thrombocytopenia (ITP). METHODS: Seventy-four patients (35 male, median age 34 years, range 18-70 years) including 60 newly-diagnosed, 6 persistent, 5 chronic and 3 refractory patients were enrolled in this study, and separated into control (36 cases) and experimental (38 cases) groups according to the dosage of glucocorticoids. Patients in both groups received dexamethasone 40 mg/day on days 1-4, followed by rituximab 100 mg on days 7, 14, 21, 28. The patients in experimental group also received decrements of prednisone 60, 30, 20, 10 mg/day on days 5-7, 8-14, 15-21, 22-28. The initial, long-term efficacy and safety were evaluated. RESULTS: Platelet counts of all patients at day 4 remarkably increased, with the median platelet count from 11(1-26) × 10⁹/L to 84(23-132) × 10⁹/L in control group, and 10(2-20) × 10⁹/L to 80(22-115) × 10⁹/L in experimental group; the platelet counts of patients at day 14 in experimental group [163(19-262) × 10⁹/L] was higher than that of control group [98(18-238) × 10⁹/L] (P<0.05). The overall response (OR) rates at day 28 in experimental group (84.21%) was significantly higher than that of control group (66.67%, P = 0.03). There was no significant difference of sustained response (SR) rates in two groups (63.89%vs 65.79%, 58.33%vs 60.53%, P > 0.05) at six and twelve months follow-up points. Both groups showed similar incidence of adverse events, and no patients discontinued the treatment due to side effects. CONCLUSION: Low-dose rituximab and glucocorticoids was an effective method for ITP patients, and maintenance treatment with decrements of prednisone contributed to improving earlier CR rate. 目的比较两种糖皮质激素联合小剂量利妥昔单方案治疗成人原发免疫性血小板减少症（ITP）的疗效。方法 74例ITP患者，男35例、女39例，中位年龄34（18～70）岁，新诊断的ITP 60例、持续性ITP 6例、慢性ITP 5例、难治性ITP 3例。按糖皮质激素治疗方案随机分为①对照组（36例）：地塞米松40 mg/d 第1~4天口服；利妥昔单抗100 mg 第7、14、21、28天静脉滴注。②试验组（38例）：地塞米松40 mg/d 第1~4天口服；泼尼松60 mg/d 第5~7天、30 mg/d 第8~14天、20 mg/d 第15~21天、10 mg/d 第22~28天口服；利妥昔单抗100 mg第7、14、21、28天静脉滴注。观察比较两组患者的近、远期疗效和不良反应情况。结果治疗第4天，对照组、试验组患者PLT分别由治疗前的11（1～26）×10⁹/L、10（2～20）×10⁹/L升高至84（23～132）×10⁹/L、80（22～115）×10⁹/L；治疗第14天，试验组患者PLT明显高于对照组［163（19～262）×10⁹/L对98（18～238）×10⁹/L，P=0.045］；治疗第28天，试验组患者总有效率高于对照组（84.21%对66.67%，P=0.03）；随访至6、12个月，对照组和试验组患者持续有效率比较，差异无统计学意义（63.89%对65.79%, 58.33%对60.53%, P>0.05）。两组患者不良反应均能耐受。结论大剂量地塞米松后泼尼松维持联合小剂量利妥昔单抗方案治疗ITP早期缓解率优于地塞米松联合小剂量利妥昔单抗方案。

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