重组人白介素-11联合环孢素治疗糖皮质激素无效ITP的临床研究

Clinical study of rh IL-11 and cyclosporin A on ITP unresponsive to corticosteroid

目的探讨重组人白介素-11(rh IL-11)联合环孢素治疗糖皮质激素无效的原发免疫性血小板减少症(ITP)的远期临床疗效及其安全性。方法选取糖皮质激素治疗无效的ITP患者60例,患者随机分为治疗组(40例)和对照组(20例)。治疗组应用rh IL-11和环孢素治疗,对照组长春新碱和静脉注射用免疫球蛋白治疗,分别在治疗前、后检测两组血小板计数,观察两组临床疗效和不良反应。结果治疗组第1个月、3个月、5个月、12个月末的有效率分别为82.5%、80.0%、72.5%和52.5%,对照组的有效率分别为55.0%、50.0%、40.0%和25.0%,治疗组均优于对照组,差异有统计学意义(P<0.05)。治疗组、对照组不良反应轻微,大多数患者耐受良好。结论 rh IL-11联合环孢素治疗糖皮质激素无效的ITP的中远期疗效满意,安全性良好,可作为理想的二线方案。

Objective To evaluate the clinical efficacy and safety of recombinant human interleukin-11( rh IL-11) and cyclosporine A( Cs A) on primary immune thrombocytopenia( ITP) unresponsive to corticosteroid. Methods Sixty ITP patients unresponsive to corticosteroid were selected and divided into control group and treatment group. 40 patients in treatment group were treated with rh IL-11 and Cs A,while 20 patients in control group accepted vincristine and intravenous immunoglobulin. Clinical efficacy and adverse reactions were observed respectively. Results The overall response rates in treatment group were 82. 5%,80. 0%,72. 5% and 52. 5% on 1st month,3rd month,5th month,12 th month after treatment respectively,which were higher than 55. 0%,50. 0%,40. 0% and 25. 0% in control group respectively( P < 0. 05). Side effects in both groups were mild and well tolerated. Conclusion Rh IL-11 and Cs A is effective and safety in the treatment of refractory ITP,and can be considered as an ideal second-line treatment.