利妥昔单抗治疗难治性特发性血小板减少性紫癜的临床研究  

Clinical trial of rituximab in the treatment of refractory idiopathic thrombocytopenic purpura

作　　者：涂小琼[1] 贾德昭[1,2] 郑智茵[2] 

机构地区：[1]湖北医药学院附属随州医院儿科,湖北随州441300 [2]浙江省中医院血液科,杭州310006

出　　处：《中国临床药理学杂志》2017年第17期1647-1650,共4页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省医药卫生科技计划基金资助项目(2011ZDA021)

摘　　要：目的观察利妥昔单抗治疗难治性特发性血小板减少性紫癜(RITP)的临床疗效及安全性。方法将66例RITP患儿随机分为试验组33例和对照组33例。对照组予以静脉滴注地塞米松1 mg·kg^(-1),隔天1次,每周4次,共4周。试验组在对照组治疗的基础上,予以静脉滴注利妥昔单抗100 mg,每周1次,共4周。比较2组患儿临床疗效,比较治疗前后患儿血清肿瘤坏死因子(TNF-α)、白细胞介素18(IL^(-1)8),人末端补体复合物9(s C5b-9)、辅助性T细胞1(Th1)、辅助性T细胞2(Th2)及Th1/Th2比值,记录药物不良反应情况。结果治疗后,试验组和对照组的总有效率分别为93.94%(31/33例)和75.76%(25/33例)差异有统计学意义(P<0.05)。治疗后,试验组与对照组IL^(-1)8分别为(242.39±63.24),(200.02±71.65)pg·m L^(-1);TNF-α分别为(69.87±18.32),(60.25±12.33)μg·L^(-1),s C5b-9分别为(572.33±124.32),(496.28±99.75)ng·m L^(-1);Th1/Th2分别为2.53±0.57,1.73±0.46,差异均有统计学意义(均P<0.05)。试验组发生皮疹2例和肺部感染1例,对照组发生肺部感染3例,2组药物不良反应发生率均为9.09%(3/33例),差异无统计学意义(P>0.05)。结论利妥昔单抗与大剂量糖皮质激素联合应用对RITP患儿疗效较好,能降低血清TNF-α、IL^(-1)8、s C5b-9水平,改善Th1、Th2比例失调,具有较好的临床效果。Objective To explore the clinical efficacy and safety profile of rituximab on the treatment of refractory idiopathic thrombocytopenic purpura（ RITP ）. Methods A total of 66 children with RITP were randomly divided into treatment group （n = 33 ） and control group （n = 33）. The control group received dexamethasone, 1 mg· kg-1, iv, 4 times a week . On the basis of the control group, the treatment group was treated with rituximab 100 mg, iv, once a week. Both groups were treated for 4 weeks. The clinical efficacy of the two groups were observed and compared. The serum levels of tumor necrosis factor - a （ TNF - a）, interleukin- 18 （ IL - 18 ）, human terminal complement complex 9 （ sCSb - 9 ）, helper T cells 1 （ Thl ）, helper T ceils 2 （Th2） before and after treatment were compared. Results After treatment, the total effective rate of the treatment group was 93.94% （31/33 cases） , while that of the control group was 75.76% （25/33 cases）, with statisticallysignificant difference （P 〈0. 05）. After treatment, the IL- 18 level of the treatment group and the control group were （242. 39±63.24）, （200.02 ±1.65） pg · mL-l. The TNF-a level were （69.87 ±18.32）, （60.25 ±12.33） p,g. L-1. The sC5b - 9 level were （572.33 ± 124. 32）, （496.28 ± 99.75） ng · mL-1;The Thl/Th2 were 2. 53 ±0. 57, 1.73 ± 0. 46. There were significant differences in all the parameters above between the 2 groups （ P 〈 0. 05 ）. The adverse drug reactions of the treatment group were rash （2 cases） and pulmonary infection （ 1 case） , and the control group were pulmonary infection （3 cases）, the incidences of adverse drug reactions in the 2 groups were both 9.09% （3/33 cases）. Conclusion In the treatment of RITP, the combination of rituximab and large dose glucocorticoid exerted considerable efficacy by reducing the concerntration of serum TNF - aa, IL - 18, sC5b - 9, Thl, Th2.

关 键 词：利妥昔单抗 特发性血小板减少性紫癜 安全性 

分 类 号：R973[医药卫生—药品]