【摘要】：目的觀察利妥昔單抗治療難治性特發(fā)性血小板減少性紫癜(RITP)的臨床療效及安全性。方法將66例RITP患兒隨機分為試驗組33例和對照組33例。對照組予以靜脈滴注地塞米松1 mg·kg~(-1),隔天1次,每周4次,共4周。試驗組在對照組治療的基礎(chǔ)上,予以靜脈滴注利妥昔單抗100 mg,每周1次,共4周。比較2組患兒臨床療效,比較治療前后患兒血清腫瘤壞死因子(TNF-α)、白細胞介素18(IL~(-1)8),人末端補體復(fù)合物9(s C5b-9)、輔助性T細胞1(Th1)、輔助性T細胞2(Th2)及Th1/Th2比值,記錄藥物不良反應(yīng)情況。結(jié)果治療后,試驗組和對照組的總有效率分別為93.94%(31/33例)和75.76%(25/33例)差異有統(tǒng)計學(xué)意義(P0.05)。治療后,試驗組與對照組IL~(-1)8分別為(242.39±63.24),(200.02±71.65)pg·m L~(-1);TNF-α分別為(69.87±18.32),(60.25±12.33)μg·L~(-1),s C5b-9分別為(572.33±124.32),(496.28±99.75)ng·m L~(-1);Th1/Th2分別為2.53±0.57,1.73±0.46,差異均有統(tǒng)計學(xué)意義(均P0.05)。試驗組發(fā)生皮疹2例和肺部感染1例,對照組發(fā)生肺部感染3例,2組藥物不良反應(yīng)發(fā)生率均為9.09%(3/33例),差異無統(tǒng)計學(xué)意義(P0.05)。結(jié)論利妥昔單抗與大劑量糖皮質(zhì)激素聯(lián)合應(yīng)用對RITP患兒療效較好,能降低血清TNF-α、IL~(-1)8、s C5b-9水平,改善Th1、Th2比例失調(diào),具有較好的臨床效果。
[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- 偽, 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 鹵63.24), (鹵71.65) pg m L ~ (-1); TNF- 偽 was (69.87 鹵18.32), (鹵60.25 鹵12.33) 渭 g L ~ (-1), s C5b-9, respectively (572.33 鹵124.32), () 496.28 鹵99.75) ng m L ~ (-1); Th1/Th2 was 2.53 鹵0.57, 1.73 鹵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- 偽, IL~ (-1) 8s C5b-9 levels and improve the imbalance of Th1,Th2 ratio. It has a good clinical effect.
【作者單位】： 湖北醫(yī)藥學(xué)院附屬隨州醫(yī)院兒科;浙江省中醫(yī)院血液科;
【基金】：浙江省醫(yī)藥衛(wèi)生科技計劃基金資助項目(2011ZDA021)
【分類號】：R725.5

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