目的:探讨海曲泊帕乙醇胺片联合环孢素(cyclosporine A,CsA)方案治疗难治性原发免疫性血小板减少症(immune throm-bocytopenia,ITP)的临床疗效和安全性。方法:选取2018年12月至2023年09月蚌埠医学院第二附属医院血液内科诊治的52例复发难治的ITP患者。采用随机数表法将52例病例随机纳入实验组(26例)和对照组(26例),实验组接受海曲泊帕联合环孢素的治疗方案,对照组接受地塞米松联合重组人血小板生成素(recombinant human thrombopoietin,rhTPO)的治疗方案。比较两组患者经过不同方案治疗后血小板的恢复情况及治疗过程中不良反应的发生情况。结果:治疗后,实验组总有效率73%,对照组总有效率73%,两组对比差异无统计学意义(P>0。05);观察治疗期间血小板数值变化情况,与治疗前比较,实验组和对照组患者治疗后PLT水平均升高(P<0。05);2组治疗14 d、28 d时PLT水平高于治疗7 d(P<0。05);治疗7 d时,实验组PLT水平略低于对照组(P>0。05),差异无统计学意义;治疗14d、28d时,实验组PLT水平均高于对照组,差异有统计学意义(P<0。05);对照组不良反应率46%,而实验组不良反应发生率35%,显著低于对照组,差异有统计学意义(P<0。05)。结论:海曲泊帕联合环孢素治疗ITP疗效与地塞米松联合重组人血小板生成素的疗法相当,但安全性更高,有望成为难治性ITP患者的二线治疗方案。
Clinical Efficacy and Safety of Haiqubopaethanolamine Tablets Combined with Cyclosporine A in the Treatment of Refractory Immune Thrombocytopenia
Objective:To explore the efficacy and safety of Haiqubopaethanolamine tablets combined with cyclosporine(CsA)in the treatment of refractory immune thrombocytopenia(ITP).Methods:52 patients with relapsed and refractory ITP admitted to our hospi-tal from December 2018 to September 2023 were selected and randomly divided into the control group and experimental group,with 26 cases in each group.The experimental group was treated by Haiqubopaethanolamine tablets and cyclosporine,while the control group was treated by dexamethasone and recombinant human thrombopoietin(rhTPO).The clinical efficacy and incidence of adverse reactions after treatment were compared between two groups.Results:The total effective rates of experimental group and control group were both 73%,with no statistically significant difference was observed between two groups(P>0.05).Observing the changes in platelet count dur-ing treatment,compared with before treatment,both the experimental group and the control group showed an increase in PLT levels after treatment(P<0.05);At 14 and 28 days of treatment,PLT levels in two groups were higher than those at 7 days of treatment(P<0.05);At 7 days of treatment,the PLT level in the experimental group was slightly lower than that in the control group(P>0.05),and the difference was not statistically significant;At 14 and 28 days of treatment,the PLT levels in the experimental group were higher than those in the control group,and the difference was statistically significant(P<0.05);The incidence rates of adverse reactions in the control group and experimental group were 46%and 35%respectively,which was lower in the experimental group than that in the control group(P<0.05).Conclusion:Haiqubopaethanolamine tablets combined with cyclosporine has equal clinical efficacy to dexamethasone and rhTPO in the treatment of refractory ITP,but Haiqubopaethanolamine tablets combined with cyclosporine shows higher safety,which may be used as second-line treatment regimen.