注射用重组人TNK组织型纤溶酶原激活剂对比阿替普酶治疗急性缺血性脑卒中的成本-效果分析

Cost-Effectiveness Analysis of Recombinant Human TNK Tissue-type Plasminogen Activator Injection versus Alteplasefor Treating Acute Ischemic Stroke in China

关键词:  急性缺血性脑卒中  静脉溶栓  成本-效果分析

Key words:  acute ischemic stroke  intravenous thrombolysis  cost-effectiveness analysis

摘要:

目的 从中国医疗卫生体系的角度出发,评估重组人TNK组织型纤溶酶原激活剂(rhTNK-tPA)相比于阿替普酶(rt-PA)治疗发病4.5h内急性缺血性脑卒中(AIS)需要静脉溶栓的患者的成本效果。方法 基于一项中国多中心RCT研究(TRACE-2)构建决策树-马尔可夫模型,模拟周期为3个月,模型结果为AIS患者采用两种溶栓药物的短期和终身的总直接医疗成本和总质量调整生命年(QALYs),据此得到rhTNK-tPA相比于rt-PA的增量成本效果比(ICER)；并通过单因素敏感性和概率敏感性分析检测模型结果的稳健性。结果 成本-效果分析结果显示,rhTNK-tPA和rt-PA组的终身成本分别为136 076元和148 355元,总QALYs分别为6.01和5.95。rhTNK-tPA组的治疗费用较rt-PA组更低且获得的QALYs更高,即rhTNK-tPA相较于rt-PA更具经济性。敏感性分析结果显示基础分析结果具有稳健性。结论 相比rt-PA,对于在发病4.5h内需要静脉溶栓的AIS患者采用rhTNK-tPA进行溶栓更具成本效果优势。

Abstract:

Objectives: To assess the cost-effectiveness of recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA) compared to alteplase (rt-PA) for intravenous thrombolysis in acute ischemic stroke (AIS) patients within 4.5 hours of symptom onset, from the perspective of the healthcare system. Methods: Based on the data from a multi-center randomized controlled trial (TRACE-2) in China, a decision tree-Markov model was developed with a cycle length of three months and time frame of 1 year or lifetime. The model estimated the short-term and lifetime direct medical costs and total quality-adjusted life years (QALYs) for AIS patients receiving thrombolytic agent. The incremental cost-effectiveness ratio (ICER) of rhTNK-tPA relative to rt-PA was calculated. One-way sensitivity analysis and probabilistic sensitivity analysis were conducted to assess the robustness of the model results. Results: The cost-effectiveness analysis demonstrated that the lifetime costs for patients in the rhTNK-tPA and rt-PA groups were CNY 136 076 and CNY 148 355, respectively, with corresponding QALYs of 6.01 and 5.95. The rhTNK-tPA group not only incurred lower treatment costs but also achieved higher QALYs, suggesting that rhTNK-tPA is a dominant therapeutic option compared to rt-PA. The deterministic and probabilistic sensitivity analyses showed the base-case results to be robust. Conclusion: Based on available evidence, rhTNK-tPA is more cost-effective than rt-PA for AIS patients requiring intravenous thrombolysis within 4.5 hours of onset.