CAJ | 학술논문

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.
목적 비교량충당피질격소연합소제량리타석단방안치료성인원발면역성혈소판감소증(ITP)적료효.방법 74례ITP환자,남35례、녀39례,중위년령34(18 ～70)세,신진단적ITP 60례、지속성ITP 6례、만성ITP 5례、난치성ITP 3례.안당피질격소치료방안수궤분위①대조조(36례):지새미송40 mg/d제1～4천구복；리타석단항100 mg제7、14、21、28천정맥적주.②시험조(38례):지새미송40 mg/d제1～4천구복；발니송60 mg/d제5～7천、30 mg/d제8～14천、20 mg/d제15～ 21천、10 mg/d제22～28천구복；리타석단항100 mg제7、14、21、28천정맥적주.관찰비교량조환자적근、원기료효화불량반응정황.결과 치료제4천,대조조、시험조환자PLT분별유치료전적11(1～26) ×109/L、10(2 ～20)×109/L승고지84(23 ～ 132)×109/L、80(22～115)×109/L;치료제14천,시험조환자PLT명현고우대조조[163(19 ～ 262)×109/L대98(18 ～238)×109/L,P=0.045]；치료제28천,시험조환자총유효솔고우대조조(84.21％대66.67％,P=0.03)；수방지6、12개월,대조조화시험조환자지속유효솔비교,차이무통계학의의(63.89％대65.79％,58.33％대60.53％,P＞0.05).량조환자불량반응균능내수.결론 대제량지새미송후발니송유지연합소제량리타석단항방안치료ITP조기완해솔우우지새미송연합소제량리타석단항방안.
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 (38cases) groups according to the dosage of glucocorticoids.Patients in both groups received dexamethasone 40mg/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.