CAJ | 학술논문

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100mg,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.
목적 관찰대제량지새미송연합소제량리타석단항작위이선방안치료원발면역성혈소판감소증(ITP)적료효화안전성.방법 65례ITP환자납입연구,기중당피질격소의뢰52례、당피질격소무효13례;남35례,녀30례,중위년령34(18～70)세.치료방안:지새미송40 mg/d,제1～4천정맥적주,리타석단항100mg,제7、14、21、28천정맥적주.치료전급치료후12개월응용류식세포술검측외주혈조절성T세포(Treg)、B림파세포활화인자(BAFF)、IL-2、IL-10、가용성백세포분화항원40배체(sCD40L).결과 전부65례환자치료1개월시총유효솔위81.5％(53/65),제3、6、12개월시완전반응솔분별위72.3％(47/65)、66.2％ (43/65)、63.1％(41/65).당피질격소의뢰적52례환자치료1개월시총유효솔위90.3％ (47/52),제3、6、12개월시완전반응솔위80.8％(42/52)、76.9％ (40/52)、73.1％(38/52).치료12개월41례완전반응환자적외주혈Treg세포수평고우치료전[(3.01±0.95)％대(1.69±0.35)％,P=0.032],BAFF、IL-2、sCD40L균저우치료전[(648.03±79.63)ng/L대(972.35±93.64)ng/L,P=0.001;(2.84±0.32)ng/L대(4.18±0.46)ng/L,P=0.012;(4.55±0.66)ng/L대(7.73±1.04)ng/L,P=0.006],IL-10여치료전비교차이무통계학의의(P=0.136).소유환자균완성료치료,불량사건발생솔위52.3％(39/65).결론 대제량지새미송연합소제량리타석단항대상규제량당피질격소치료무효혹의뢰적환자잉유교고적반응솔,불량반응발생솔가접수.
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 100mg,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.