皮下注射小剂量地西他滨治疗骨髓增生异常综合征的疗效与经济学分析

Analysis of Efficacy and Cost of Subcutaneous Injection of Low-dose Decitabine for Patients with Myelodysplastic Syndromes

目的:了解皮下注射小剂量地西他滨治疗骨髓增生异常综合征(MDS)的疗效,并进行药物经济学分析。方法:采用临床研究NCT02779569的病例资料,收集59例MDS患者,根据地西他滨给药方案不同分为皮下注射组和静脉注射组。比较两组疗效、不良反应发生情况,并进行药物经济学分析。结果:两组有效率差异无统计学意义(47.5%vs.36.8%,P>0.05),但皮下注射组感染发生率显著低于静脉注射组(P<0.05),且床位费用、地西他滨药费、输注红细胞和血小板的费用,以及总药费、不良反应处理费用、总住院费等各项指标均显著低于静脉注射组(P<0.001)。采用最小成本分析,提示皮下注射经济学效果较优。结论:地西他滨小剂量皮下注射与传统静脉注射相比,疗效相当,但感染发生率低,各项成本明显降低,药物经济学效果较优,值得临床推广。

Objective:To evaluate the efficacy of low-dose decitabine in the treatment of myelodysplastic syndromes(MDS)patients,and to conduct pharmacoeconomic analysis.Methods:Cases from clinical trial NCT02779569,59 patients with MDS were included and divided to subcutaneous injection group and intravenous injection group depending on the dosing regimen of decitabine.The efficacy,adverse reaction were compared and costs were collected by cost-effectiveness analysis.Results:There was no significant difference in the effective rates between subcutaneous injection group and intravenous injection group(47.5%vs.36.8%,P>0.05).But incidence of infection was significantly lower than that in intravenous injection group(P<0.05).The cost of hospital stay,the cost of decitabine,the cost of red blood cells and platelets,the total cost of drugs,the cost of adverse reactions,and the total expenses were all significantly lower than those of the intravenous injection group(P<0.001).Cost minimization analysis found subcutaneous injection group had better pharmacoeconomic effect.Conclusion:Compared to intravenous injection group,the subcutaneous group got similar effect,lower infection rate,less cost,better pharmacoeconomic effect,it was worthy of clinical promotion.