艾曲波帕乙醇胺片治疗特发性血小板减少性紫癜患儿的临床研究

Clinical trial of eltrombopag olamine tablets in the treatment of children with idiopathic thrombocytopenic purpura

目的观察艾曲波帕乙醇胺片治疗特发性血小板减少性紫癜患儿的临床疗效及安全性。方法将特发性血小板减少性紫癜患儿随机分为对照组和试验组。对照组给予4 mg·kg^(-1)·d^(-1)环孢素,每日分2~3次,口服;试验组给予艾曲泊帕乙醇胺片每次25 mg,每天1次,口服。2组均治疗3个月。比较2组的临床疗效、血清白细胞介素-2(IL-2)、可溶性白细胞介素-2受体(sIL-2R)的水平,以及药物不良反应的发生情况。结果对照组和试验组各52例。治疗后,试验组和对照组的总有效率分别为92.31%(48例/52例)和78.85%(41例/52例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的血清IL-2分别为(4.35±1.81)和(5.96±2.39)μg·L^(-1);sIL-2R分别为(246.59±130.56)和(419.37±142.13)U·mL^(-1),差异均有统计学意义(均P<0.05)。试验组和对照组的总药物不良反应发生率分别为25.00%和25.00%,差异无统计学意义(P>0.05)。结论艾曲波帕乙醇胺片治疗特发性血小板减少性紫癜儿童患者的临床疗效显著,可以降低IL-2和sIL-2R水平,且药物不良反应较为轻微。

Objective To observe the clinical efficacy and safety of eltrombopag olamine tablets in the treatment of children with idiopathic thrombocytopenic purpura.Methods Children with idiopathic thrombocytopenic purpura were randomly divided into control group and treatment group.The control group was treated with cyclosporine 4 mg·kg^(-1)·d^(-1),2-3 times a day,orally;the treatment group was treated with eltrombopag olamine tablets 25 mg per time,once a day,orally.Two groups were both treated for 3 months.The clinical efficacy,the levels of serum interleukin-2(IL-2)and soluble interleukin-2 receptor(sIL-2R),and the incidence of adverse drug reactions were compared between two groups.Results There were 52 cases in control group and 52 cases in treatment group.After treatment,the total effective rates of treatment group and control group were 92.31%(48 cases/52 cases)and 78.85%(41 cases/52 cases),with significant difference(P<0.05).After treatment,the levels of serum IL-2 were(4.35±1.81)and(5.96±2.39)μg·L^(-1);sIL-2R were(246.59±130.56)and(419.37±142.13)U·mL^(-1);the differences were statistically significant(all P<0.05).The total incidences of adverse drug reactions in treatment group and control group were 25.00%and 25.00%without significant difference(P>0.05).Conclusion Eltrombopag olamine tablets has a definitive clinical efficacy in the treatment of children with idiopathic thrombocytopenic purpura,which can reduce the levels of IL-2 and sIL-2R,and the adverse drug reactions are relatively mild.