不同剂量利妥昔单抗注射液治疗难治性免疫性血小板减少症的疗效及对凝血指标的影响

Efficacy of Different Doses of Rituximab Injection in Treatment of Refractory Immune Thrombocytopenia and Its Influence on Coagulation Indexes

目的:探讨不同剂量利妥昔单抗注射液治疗难治性免疫性血小板减少症(rITP)的疗效及对凝血指标的影响。方法:选取2015年1月-2017年5月南方医科大学深圳医院及宜昌市第一人民医院收治的r ITP患者80例。采用随机数字表法将其分为标准剂量组(n=40)和小剂量组(n=40)。两组患者均采用利妥昔单抗注射液治疗,标准剂量组患者用药剂量为375 mg/m^2,小剂量组患者用药剂量为100 mg/m^2。比较两组患者临床疗效、治疗前后的凝血指标及治疗过程中不良反应发生情况。结果:小剂量组患者治疗总有效率为67.5%,高于标准剂量组的55.0%,但比较差异无统计学意义(P>0.05);治疗后,两组患者PLT水平高于治疗前,PT、APTT水平均低于治疗前,比较差异均有统计学意义(P<0.0.5);但治疗前后,两组患者PLT、PT、APTT比较,差异均无统计学意义(P>0.05);小剂量组不良反应发生率为12.5%,低于标准剂量组的32.5%,比较差异有统计学意义(χ~2=4.588,P=0.032)。结论:小剂量利妥昔单抗注射液与标准剂量临床效果相似,对凝血指标具有显著的改善作用,且安全性更好。

Objective：To investigate the efficacy of different doses of Rituximab Injection in treatment of refractory immune thrombocytopenia（rITP） and its influence on coagulation index.Method：A total 80 patients with r ITP were selected from Shenzhen Hospital of Southern Medical University and Yichang First People＇s Hospital from January 2015 to May 2017 were selected.According to the random number table method,they were divided into standard dose group（n=40） and small dose group（n=40）.They were treated with Rituximab Injection,the dosage of standard dose group was 375 mg/m^2,and small dose group was 100 mg/m^2.The clinical effect,blood coagulation index before and after treatment and the adverse reaction during the treatment between two groups were compared.Result：The total effective rate in small dose group was 67.5%,which was higher than 55.0% of standard dose group,but the difference was not statistically significant（P〉0.05）.After treatment,the levels of PLT in two groups were higher than those of before treatment,and the levels of PT and APTT were lower than those of before treatment,the differences were statistically significant（P〈0.0.5）.But before and after treatment,the levels of PLT,PT and APTT in two groups were compared,the differences were not statistically significant（P〈0.05）.The incidence of adverse reactions in small dose group was 12.5%,which was lower than 32.5% of standard dose group,the difference was statistically significant（χ~2=4.588,P=0.032）.Conclusion：The small dose Rituximab Injection is similar to the standard dose,has a significant improvement on the coagulation index,and the safety is better.