利妥昔单抗注射液与脾切除术治疗成年人慢性原发免疫性血小板减少症疗效比较

Comparison of the efficacy of rituximab injection and splenectomy for the treatment of chronic primary immune thrombocytopenia

目的比较利妥昔单抗注射液(美罗华)与脾切除术治疗成年人慢性原发免疫性血小板减少症(ITP)的疗效及不良反应.方法回顾性分析大同市第五人民医院2013年3月至2015年6月治疗的慢性ITP患者105例的临床资料,依据治疗方法分为美罗华组(n=43)和脾切除术组(n=62).比较两组患者的临床疗效、不良反应和随访期生存时间.结果治疗3个月后,脾切除术组、美罗华组反应率分别为91.9%(57/62)、69.8%(30/43)(χ2=5.04,P=0.005);治疗12个月后,脾切除术组、美罗华组反应率分别为88.7%(55/62)、58.1%(25/43)(χ2=6.83,P=0.001);脾切除术组治疗3个月后、治疗12个月后完全反应率分别为82.2%(51/62)、80.6%(50/62),均高于美罗华组的39.5%(17/43)、34.9%(15/43),差异均有统计学意义(χ2=7.25、7.63,均P<0.001).两组治疗12个月后不良反应发生率差异无统计学意义(P>0.05).脾切除术组、美罗华组患者生存时间分别为25.58个月、24.69个月,两组差异无统计学意义(t=4.85,P=0.18).结论脾切除术治疗成年人ITP的疗效优于美罗华,不良反应无明显差异.

Objective To compare the efficacy and adverse reaction of rituximab injection( Rituximab) and splenectomy in the treatment of adult chronic idiopathic thrombocytopenic purpura ( ITP). Methods From March 2013 to June 2015,105 chronic ITP patients who were treated in the Fifth People's Hospital of Datong were divided into rituximab group(n=43) and splenectomy group( n =62).The clinical efficacy,adverse reaction and survival time of the two groups were compared.Results There was no statistically significant difference in baseline character-istics between the two groups. After treatment for 3 months, the response rates of the splenectomy group and the rituximab group were 91. 9%( 57/62 ), 69. 8%( 30/43 ), respectively, the difference was statistically significant between the two groups(χ2 =5.04,P=0.005).After treatment for 12 months,the response rates of the splenectomy group and the rituximab group were 88.7%(55/62),58.1%(25/43),respectively,the difference was statistically significant between the two groups ( χ2 =6. 83, P =0. 001 ), respectively. After treatment for 3,12 months, the complete response rates of the splenectomy group were 82.2%(51/62),80.6%(50/62),respectively,which were higher than those of the rituximab group [39.5%(17/43),34.9%(15/43)] (χ2 =7.25,P<0.001).There was no statistically significant difference in adverse reactions after treatment for 1 year between the two groups(P>0.05). The survival time of the splenectomy group was longer,but there was no statistically significant difference( t=4.85, P=0.18).Conclusion The curative effect of splenectomy in the treatment of adult ITP is better than rituximab,and the adverse reaction is not obvious between two methods.