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基于网状Meta分析与成本-效用分析的缺血性卒中静脉溶栓方案综合评价
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| 篇名： | 基于网状Meta分析与成本-效用分析的缺血性卒中静脉溶栓方案综合评价 |
| TITLE： | Comprehensive evaluation of intravenous thrombolysis regimens for ischemic stroke based on network meta-analysis and cost-utility analysis |
| 摘要： | 目的 评价4种静脉溶栓药物[阿替普酶（rt-PA）、替奈普酶（TNK）、瑞替普酶（rPA）、重组人尿激酶原（rhPro-UK）]多剂量方案治疗缺血性卒中的有效性、安全性和经济性差异。方法检索上述药物用于缺血性卒中静脉溶栓的随机对照试验（RCT），通过网状Meta分析（NMA）比较不同方案的疗效与安全性，并构建Markov模型、从中国卫生体系角度评价其经济性。结果共纳入20项RCT，涉及10种方案。NMA显示，18mg+18mgrPA方案（18mgrPA静脉推注2次）在优秀功能结局上优于TNK各剂量组（0.1、0.25、0.4mg/kg）、rt-PA各剂量组（0.6、0.9mg/kg）及35mgrhPro-UK方案；0.25mg/kgTNK方案优于0.6、0.9mg/kgrt-PA方案。在良好功能结局方面，18mg+18mgrPA方案优于0.25、0.4mg/kgTNK，0.6、0.9mg/kgrt-PA及35mgrhPro-UK方案；0.25mg/kgTNK方案优于0.4mg/kgTNK方案。18mg+18mgrPA方案的不良功能结局发生率最低。在避免极差功能结局方面，0.6mg/kgrt-PA方案最佳，0.4mg/kgTNK方案最差。在安全性方面，35mgrhPro-UK方案的症状性颅内出血（sICH）发生率显著低于12mg+12mgrPA（12mgrPA静脉推注2次）和0.4mg/kgTNK方案；0.25mg/kgTNK和0.6、0.9mg/kgrt-PA方案的sICH发生率均显著低于0.4mg/kgTNK方案，且0.6mg/kgrt-PA方案优于0.9mg/kgrt-PA方案。成本-效用分析结果显示，以2倍2025年全国人均国内生产总值为意愿支付阈值，18mg+18mgrPA方案最具经济性优势；敏感性分析结果证明基础分析结果稳健；两项情境分析中，该方案具有经济性的概率均为100%。结论10种缺血性卒中静脉溶栓方案中，18mg+18mgrPA是兼备疗效与经济性的最优方案；35mgrhPro-UK方案可能是高出血风险患者的优选。 |
| ABSTRACT： | OBJECTIVE To evaluate the differences in efficacy， safety， and cost-effectiveness among multiple dosing regimens of four intravenous thrombolytic agents [alteplase （rt-PA）， tenecteplase （TNK）， reteplase （rPA）， and recombinant human prourokinase （rhPro-UK）] in the treatment of ischemic stroke.METHODS Randomized controlled trials （RCTs） of the above agents for intravenous thrombolysis in ischemic stroke were searched. Network meta-analysis （NMA） was performed to compare the efficacy and safety of different regimens， and a Markov model was constructed to evaluate cost-effectiveness from the perspective of the Chinese healthcare system.RESULTS Twenty RCTs involving 10 regimens were included. NMA showed that the 18 mg+18 mg rPA regimen （two intravenous boluses of 18 mg rPA） was superior to all TNK regimens （0.1， 0.25， and 0.4 mg/kg）， all rt-PA regimens （0.6 and 0.9 mg/kg）， and the 35 mg rhPro-UK regimen in terms of excellent functional outcome； the 0.25 mg/kg TNK regimen was superior to the 0.6 and 0.9 mg/kg rt-PA regimens. In terms of good functional outcome， the 18 mg+18 mg rPA regimen was superior to the 0.25 and 0.4 mg/kg TNK regimens， the 0.6 and 0.9 mg/kg rt-PA regimens， and the 35 mg rhPro-UK regimen； the 0.25 mg/kg TNK regimen was superior to the 0.4 mg/kg TNK regimen. The 18 mg+18 mg rPA regimen had the lowest incidence of poor functional outcome. In terms of avoiding extremely poor functional outcomes， the 0.6 mg/kg rt-PA regimen was the best， and the 0.4 mg/kg TNK regimen was the worst. In terms of safety， the incidence of symptomatic intracerebral hemorrhage （sICH） with the 35 mg rhPro-UK regimen was significantly lower than that with the 12 mg+12 mg rPA regimen （two intravenous boluses of 12 mg rPA） and the 0.4 mg/kg TNK regimen； the sICH incidences with the 0.25 mg/kg TNK regimen and the 0.6 and 0.9 mg/kg rt-PA regimens were significantly lower than that with the 0.4 mg/kg TNK regimen， and the 0.6 mg/kg rt-PA regimen was superior to the 0.9 mg/kg rt-PA regimen. Cost-utility analysis showed that， at a willingness-to-pay threshold of twice the 2025 national per capita gross domestic product， the 18 mg+18 mg rPA regimen had the greatest cost-effectiveness advantage； sensitivity analysis confirmed that the base-case results were robust； in both scenario analyses， the probability that this regimen was cost-effective was 100%.CONCLUSIONS Among the 10 intravenous thrombolysis regimens for ischemic stroke， the 18 mg+18 mg rPA regimen was the optimal regimen combining efficacy and cost-effectiveness； the 35 mg rhPro-UK regimen may be the preferred option for patients at high bleeding risk. |
| 期刊： | 2026年第37卷第19期 |
| 作者： | 叶国超；刘帅；陈永邦；孙誉；唐柚青 |
| AUTHORS： | YE Guochao，LIU Shuai，CHEN Yongbang，SUN Yu，TANG Youqing |
| 关键字： | 缺血性卒中;静脉溶栓;阿替普酶;替奈普酶;瑞替普酶;重组人尿激酶原;网状Meta分析;药物经济学 |
| KEYWORDS： | Ischemic stroke;Intravenous thrombolysis;Alteplase;tenecteplase;Reteplase;recombinant human prourokinase;Network Meta-analysis;Pharmacoeconomics |
| 阅读数： | 3 次 |
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