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目的 :综合评价尼洛替尼与达沙替尼治疗慢性髓性白血病(chronic myeloid leukemia,CML)的安全性、有效性及经济性,为医保谈判和临床药物遴选提供决策依据。方法 :选择对伊马替尼耐药的CML患者,通过文献检索获得尼洛替尼与达沙替尼的治疗受益与风险之比。依据各项治疗费用搭建Markov模型,以12个月为周期,推算4年生存期所需的治疗成本,再结合治疗有效率,不良反应率等计算出成本及增量成本,获得增量成本效果值,得到优势治疗方案。以龙卷风图敏感性分析获得影响较大的单因素,并进行单因素分析和双因素分析,检验模型的结果稳定性。结果 :Tree Age中搭建CML疾病治疗过程的Markov模型将治疗成本导入计算,以12个月获得主要分子生物学缓解率(major molecular response,MMR)为指标,得到成本效果比(cost-eff ect ratio,CER)分别为尼洛替尼164 618.5元以及达沙替尼219 129.2元。敏感性分析龙卷风图显示尼洛替尼药价为重要影响因素,在单因素分析及与达沙替尼药价和疗效的双因素分析中均显示出稳定性的优势。结论 :对于伊马替尼耐药或不耐受的CML患者接受二线酪氨酸激酶抑制剂(tyrosine kinase inhibitor,TKI)药物治疗,尼洛替尼更具经济性,且尼洛替尼经济性的结果稳定。因此,在现有药品费用浮动25%、有效率浮动10%、不良反应率浮动10%的条件下,推荐使用尼洛替尼。
OBJECTIVE: To evaluate the safety, efficacy and economy of nilotinib and dasatinib in the treatment of chronic myeloid leukemia (CML), and provide decision-making basis for medical insurance negotiation and clinical drug selection. METHODS: The ratio of benefit to risk of treatment with nilotinib versus dasatinib was determined by literature search in CML patients resistant to imatinib. Markov model was built according to each treatment cost, and the treatment cost required for 4-year survival period was calculated on the 12-month cycle. Then the cost and increment cost were calculated with the treatment efficiency and adverse reaction rate to obtain incremental cost effect Value, get the advantage of treatment programs. The single factor influential in the tornado pattern sensitivity analysis was obtained, and the stability of the model was tested by univariate analysis and two-factor analysis. Results: The Markov model of CML disease treatment in Tree Age was introduced into the calculation of cost of treatment. The major molecular response rate (MMR) obtained at 12 months was used as the index to obtain the cost-eff ect ratio , CERs) were 164 618.5 yuan for nilotinib and 219 129.2 yuan for dasatinib respectively. Sensitivity analysis Tornotre charts show that nilotinib is an important influencing factor and shows the advantage of stability both in the univariate analysis and in the two-factor analysis of dosing and efficacy of dasatinib. CONCLUSIONS: Nilotinib is more economical for patients receiving second-line tyrosine kinase inhibitor (TKI) therapy in CML patients resistant or not tolerant of imatinib, and nilotinib is more economical The result is stable. As a result, nilotinib is recommended for 25% of existing drug costs, 10% of effective rates, and 10% of adverse effects.