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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 observe the clinical efficacy and safety of rituximab in the treatment of refractory idiopathic thrombocytopenic purpura (RITP). Methods Sixty-six patients with RITP were randomly divided into experimental group (33 cases) and control group (33 cases). The control group was given intravenous dexamethasone 1 mg · kg -1 every other day for 4 times a week for 4 weeks. The experimental group in the control group based on the treatment, to be given intravenous rituximab 100 mg once a week for 4 weeks. The clinical efficacy of two groups of children was compared. The levels of serum tumor necrosis factor (TNF-α), interleukin 18 (IL-8), human complement 9 (s C5b-9) T helper 1 (T helper 1), helper T cell 2 (Th2), and Th1 / Th2 ratios were recorded. Adverse drug reactions 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, with statistical significance (P <0.05). After treatment, the levels of IL-8 in the experimental and control groups were (242.39 ± 63.24) and (200.02 ± 71.65) pg · m L -1, respectively, and the levels of TNF-α were 69.87 ± 18.32 and 60.25 ± 12.33 μg · L -1, and s C5b-9 were (572.33 ± 124.32) and (496.28 ± 99.75) ng · m L -1, respectively. Th1 / Th2 were 2.53 ± 0.57 and 1.73 respectively ± 0.46, the difference was statistically significant (all P <0.05). There were 2 cases of rash and 1 case of pulmonary infection in the experimental group, 3 cases of pulmonary infection in the control group, and 9.09% (3/33 cases) of adverse drug reactions in the two groups. There was no significant difference (P> 0.05) . Conclusion The combination of rituximab and high-dose glucocorticoid has a good effect on children with RITP, and can reduce the level of serum TNF-α, IL-8, s C5b-9 and improve the imbalance of Th1 and Th2, Has a good clinical effect.