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

发布时间：2018-11-06 07:25

【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(P0.05)。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P0.05)。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(P0.05)。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。
[Abstract]:Objective to observe the efficacy and safety of rituximab in the treatment of refractory idiopathic thrombocytopenic purpura (RITP). Methods 66 children with RITP were randomly divided into trial group (n = 33) and control group (n = 33). In the control group, dexamethasone 1 mg kg~ (-1) was given intravenously, once every other day, 4 times a week for 4 weeks. The experimental group was treated with rituximab once a week for 4 weeks on the basis of control group. Serum TNF- 伪, IL~ (-1) 8, human terminal complement complex 9 (s C5b-9) and helper T cell 1 (Th1) were compared before and after treatment. Adjuvant T cell 2 (Th2) and Th1/Th2 ratio were recorded. Results after treatment, the total effective rates of the experimental group and the control group were 93.94% (31 / 33 cases) and 75.76% (25 / 33 cases) respectively (P0.05). After treatment, IL~ (-1) 8 in the experimental group and the control group was (242.39 卤63.24), (卤71.65) pg m L ~ (-1); TNF- 伪 was (69.87 卤18.32), (卤60.25 卤12.33) 渭 g L ~ (-1), s C5b-9, respectively (572.33 卤124.32), () 496.28 卤99.75) ng m L ~ (-1); Th1/Th2 was 2.53 卤0.57, 1.73 卤0.46, respectively, and the difference was statistically significant (P0.05). There were 2 cases of rash and 1 case of pulmonary infection in the trial group and 3 cases in the control group. The incidence of adverse drug reactions in both groups was 9.09% (3 / 33 cases) with no significant difference (P0.05). Conclusion Rituximab combined with high dose glucocorticoid is effective in the treatment of children with RITP. It can reduce the serum TNF- 伪, IL~ (-1) 8s C5b-9 levels and improve the imbalance of Th1,Th2 ratio. It has a good clinical effect.
【作者单位】：湖北医药学院附属随州医院儿科;浙江省中医院血液科;
【基金】：浙江省医药卫生科技计划基金资助项目(2011ZDA021)
【分类号】：R725.5

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