Article(id=1241522771038106386, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241522764012647140, articleNumber=null, orderNo=null, doi=10.20043/j.cnki.MPM.202308506, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1692979200000, receivedDateStr=2023-08-26, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773931694993, onlineDateStr=2026-03-19, pubDate=1704816000000, pubDateStr=2024-01-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773931694993, onlineIssueDateStr=2026-03-19, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773931694993, creator=13701087609, updateTime=1773931694993, updator=13701087609, issue=Issue{id=1241522764012647140, tenantId=1146029695717560320, journalId=1227665162245664772, year='2024', volume='51', issue='1', pageStart='1', pageEnd='192', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773931693318, creator=13701087609, updateTime=1773931808852, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1241523248643494379, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241522764012647140, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1241523248643494380, tenantId=1146029695717560320, journalId=1227665162245664772, issueId=1241522764012647140, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=180, endPage=185, ext={EN=ArticleExt(id=1241522771814052638, articleId=1241522771038106386, tenantId=1146029695717560320, journalId=1227665162245664772, language=EN, title=Cost-effectiveness analysis of carotid endarterectomy versus medical therapy for asymptomatic stenosis, columnId=1228016569138213037, journalTitle=Modern Preventive Medicine, columnName=Clinical Medicine and Prevention, runingTitle=null, highlight=null, articleAbstract=
Objective

To analyze the cost-effectiveness of carotid endarterectomy carotid endarterectomy (CEA) and medical therapy for asymptomatic carotid stenosis in Chinese patients over 70 years old.

Methods

Based on the data of different outcomes of asymptomatic carotid stenosis patients who were followed up by CEA and drug therapy for 10 years, a Markov model was established to simulate the cost-effectiveness of the two treatments for 10 years. The outcome index was incremental cost-effectiveness ratio (ICER), which was the ratio of increased cost to increased quality-adjusted life years (QALY), and the thresholds of ICER and willingness to pay (WTP) were compared. In this paper, scenario analysis was carried out, and uncertainty test was carried out by single factor sensitivity analysis and probability sensitivity analysis.

Results

In the basic case analysis, the patients who received CEA could get 7.53 QALYs, the corresponding cost was 67 079.61 yuan and 31 982.38 yuan, and the ICER was 129 435.97 yuan / QALY, which was lower than the threshold of WTP. In scenario analysis, the ICER was 127 946.82 yuan / QALY and 240 283.17 yuan / QALY, respectively. The annual mortality of patients after CEA, the operation cost of CEA, and the perioperative mortality after CEA had great influence on the fluctuation of ICER.

Conclusion

According to the economic evaluation recommendation of WHO, the increased cost of CEA compared with drug therapy is acceptable for Chinese patients with asymptomatic carotid artery stenosis over 70 years old.

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目的

分析颈动脉内膜切除术(carotid endarterectomy,CEA)与药物治疗中国70岁以上无症状颈动脉狭窄患者的成本-效果。

方法

本文通过一项无症状颈动脉狭窄人群经CEA与药物治疗随访10年后不同结局的研究数据,建立Markov模型模拟两种治疗方案10年的成本-效果,结局指标为增量成本-效果比(ICER),即增加的成本与增加的质量调整生命年(QALY)的比值,并将获得ICER与支付意愿(willingness-to-pay,WTP)阈值进行比较。本文进行了情景分析,单因素敏感性、概率敏感性分析进行了不确定检验。

结果

在基础病例分析中,接受CEA的患者可获得7.53QALYs,药物治疗为7.26,相应成本为67 079.61和31 982.38元,获得的ICER为129 435.97元/QALY,低于支付意愿阈值。在情景分析中,ICER分别为127 946.82和240 283.17元/QALY。接受CEA后患者的年死亡率,CEA的手术花费和CEA后围手术期的死亡率对ICER波动影响较大。

结论

依据WHO对经济学评价推荐意见,目前中国70岁以上无症状颈动脉狭窄患者,CEA与药物治疗相比增加的成本是可以接受的。

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杨艳芳,E-mail:
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姚瑶(1990—),女,硕士在读,研究方向:流行病学与卫生统计学

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Journal of Vascular Surgery, 2019, 70(1): 123-129., articleTitle=A multi-institutional analysis of transcarotid artery revascularization compared to carotid endarterectomy, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1241677616927789353, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, xref=1., ext=[AuthorCompanyExt(id=1241677616931983660, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, companyId=1241677616927789353, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=West China School of Public Health, Sichuan University/West China Fourth Hospital, Chengdu, Sichuan 610041, China), AuthorCompanyExt(id=1241677616944566572, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, companyId=1241677616927789353, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.四川大学华西公共卫生学院/华西第四医院,四川 成都 610041)]), AuthorCompany(id=1241677617091367226, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, xref=2., ext=[AuthorCompanyExt(id=1241677617099755836, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, companyId=1241677617091367226, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.四川省安岳县人民医院,四川 资阳 642350)])], figs=[ArticleFig(id=1241677621063373312, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=EN, label=Figure 1, caption=Markov model transition diagram, figureFileSmall=WqbxHG+CnVaYY43Sy24RgA==, figureFileBig=f1K2eRotidrbUBOWFVw8DA==, tableContent=null), ArticleFig(id=1241677621310837261, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=CN, label=图1, caption=Markov模型状态转移图, figureFileSmall=WqbxHG+CnVaYY43Sy24RgA==, figureFileBig=f1K2eRotidrbUBOWFVw8DA==, tableContent=null), ArticleFig(id=1241677621457637909, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=EN, label=Figure 2, caption=One-way sensitivity analysis, figureFileSmall=XViky2IzyWO4XtCWC+5N5w==, figureFileBig=y9c/IkJWd7iZFoQY7riVpw==, tableContent=null), ArticleFig(id=1241677621575078434, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=CN, label=图2, caption=单因素敏感性分析, figureFileSmall=XViky2IzyWO4XtCWC+5N5w==, figureFileBig=y9c/IkJWd7iZFoQY7riVpw==, tableContent=null), ArticleFig(id=1241677621667353129, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=EN, label=Figure 3, caption=Cost-effectiveness acceptability curve, figureFileSmall=AiFAqR70ppSWwjogcVMppw==, figureFileBig=DxITUvc84G1stLw8QbP3GQ==, tableContent=null), ArticleFig(id=1241677621780599346, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=CN, label=图3, caption=成本-效果可接受曲线, figureFileSmall=AiFAqR70ppSWwjogcVMppw==, figureFileBig=DxITUvc84G1stLw8QbP3GQ==, tableContent=null), ArticleFig(id=1241677621906428475, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=EN, label=Figure 4, caption=Incremental cost-effectiveness scatter plot, figureFileSmall=9C+zZVtjgSyWhn//Qryvxg==, figureFileBig=/MvMCWL+2tOPvH52xW6vQQ==, tableContent=null), ArticleFig(id=1241677622044840509, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=CN, label=图4, caption=增量成本-效果散点图, figureFileSmall=9C+zZVtjgSyWhn//Qryvxg==, figureFileBig=/MvMCWL+2tOPvH52xW6vQQ==, tableContent=null), ArticleFig(id=1241677622170669637, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=EN, label=Table 1, caption=

Markov model parameters

, figureFileSmall=null, figureFileBig=null, tableContent=
基础病例取值取值范围分布文献来源
初始概率
CEA组稳定状态0.9650.956~0.974β11
CEA组非致残状态0.0120.006~0.017β11
CEA组致残状态0.0060.002~0.010β11
CEA组心肌梗死0.0060.002~0.010β11
CEA组死亡0.0110.006~0.016β11
药物治疗组稳定状态0.9890.984~0.994β11
药物治疗组非致残状态0.0050.002~0.009β11
药物治疗组致残状态0.0030~0.006β11
药物治疗组心肌梗死0.0010~0.002β11
药物治疗组死亡0.0020~0.004β11
转移概率
CEA组0~5年非致残卒中概率0.0040.002~0.005β11
CEA组0~5年致残卒中概率0.0050.003~0.007β11
CEA组5~10年非致残卒中概率0.0060.004~0.008β11
CEA组5~10年致残卒中概率0.0080.006~0.010β11
药物治疗组0~5年非致残卒中概率0.0090.006~0.011β11
药物治疗组0~5年致残卒中概率0.0120.009~0.015β11
药物治疗组5~10年非致残卒中概率0.0070.005~0.009β11
药物治疗组5~10年致残卒中概率0.0090.007~0.012β11
非致残卒中到致残卒中概率
第一年0.0440.042~0.046β16
一年后016
卒中死亡率0.1120.109~0.116β14
心肌梗死死亡率0.28417
贴现率0.050~0.08β26
非卒中相关死亡率
70~75岁0.01515
≥75岁0.02615
效用值
稳定状态10.86~1β19、20
非致残卒中0.760.71~0.87β19、20
致残卒中0.390.31~0.52β19、20
心肌梗死(第一年)0.721
心肌梗死(一年后)0.821
成本
CEA手术花费35 185.14528 988.18~41 382.11γ24
CEA组每年药费3 5332 649.75~4 416.25γ估算
药物治疗组每年药费3 5332 649.75~4 416.25γ估算
非致残卒中花费12 483.5877 210.72~15 718.45γ22
致残卒中花费16 505.4419 070.89~21 644.42γ22
卒中死亡花费14 145.4766 646.53~18 696.76γ22
心肌梗死花费31 783.99723 838.00~39 730.00γ23
非致残卒中每年花费8 875.6732 657.39~11 321.49γ22
致残卒中每年花费13 504.6373 396.35~16 982.75γ22
心肌梗死每年花费(第一年)53 336.49840 002.37~66 670.62γ21
心肌梗死每年花费(一年后)11 664.6988 748.52~14 580.87γ21
超声费用220165~275γ医疗机构数据
CEA手术后一年内随访次数4医疗机构数据
CEA手术后一年后随访次数1医疗机构数据
模型1
CEA组非卒中死亡率0.05811
药物治疗组非卒中死亡率0.05211
模型2转移概率
CEA组非致残卒中概率0.00512
CEA组致残卒中概率0.00712
药物治疗组非致残卒中概率0.00712
药物治疗组致残卒中概率0.0112
), ArticleFig(id=1241677622300693073, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=CN, label=表1, caption=

Markov模型参数

, figureFileSmall=null, figureFileBig=null, tableContent=
基础病例取值取值范围分布文献来源
初始概率
CEA组稳定状态0.9650.956~0.974β11
CEA组非致残状态0.0120.006~0.017β11
CEA组致残状态0.0060.002~0.010β11
CEA组心肌梗死0.0060.002~0.010β11
CEA组死亡0.0110.006~0.016β11
药物治疗组稳定状态0.9890.984~0.994β11
药物治疗组非致残状态0.0050.002~0.009β11
药物治疗组致残状态0.0030~0.006β11
药物治疗组心肌梗死0.0010~0.002β11
药物治疗组死亡0.0020~0.004β11
转移概率
CEA组0~5年非致残卒中概率0.0040.002~0.005β11
CEA组0~5年致残卒中概率0.0050.003~0.007β11
CEA组5~10年非致残卒中概率0.0060.004~0.008β11
CEA组5~10年致残卒中概率0.0080.006~0.010β11
药物治疗组0~5年非致残卒中概率0.0090.006~0.011β11
药物治疗组0~5年致残卒中概率0.0120.009~0.015β11
药物治疗组5~10年非致残卒中概率0.0070.005~0.009β11
药物治疗组5~10年致残卒中概率0.0090.007~0.012β11
非致残卒中到致残卒中概率
第一年0.0440.042~0.046β16
一年后016
卒中死亡率0.1120.109~0.116β14
心肌梗死死亡率0.28417
贴现率0.050~0.08β26
非卒中相关死亡率
70~75岁0.01515
≥75岁0.02615
效用值
稳定状态10.86~1β19、20
非致残卒中0.760.71~0.87β19、20
致残卒中0.390.31~0.52β19、20
心肌梗死(第一年)0.721
心肌梗死(一年后)0.821
成本
CEA手术花费35 185.14528 988.18~41 382.11γ24
CEA组每年药费3 5332 649.75~4 416.25γ估算
药物治疗组每年药费3 5332 649.75~4 416.25γ估算
非致残卒中花费12 483.5877 210.72~15 718.45γ22
致残卒中花费16 505.4419 070.89~21 644.42γ22
卒中死亡花费14 145.4766 646.53~18 696.76γ22
心肌梗死花费31 783.99723 838.00~39 730.00γ23
非致残卒中每年花费8 875.6732 657.39~11 321.49γ22
致残卒中每年花费13 504.6373 396.35~16 982.75γ22
心肌梗死每年花费(第一年)53 336.49840 002.37~66 670.62γ21
心肌梗死每年花费(一年后)11 664.6988 748.52~14 580.87γ21
超声费用220165~275γ医疗机构数据
CEA手术后一年内随访次数4医疗机构数据
CEA手术后一年后随访次数1医疗机构数据
模型1
CEA组非卒中死亡率0.05811
药物治疗组非卒中死亡率0.05211
模型2转移概率
CEA组非致残卒中概率0.00512
CEA组致残卒中概率0.00712
药物治疗组非致残卒中概率0.00712
药物治疗组致残卒中概率0.0112
), ArticleFig(id=1241677622522991192, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=EN, label=Table 2, caption=

Comparison of the effect of the two groups after 10 years simulated by Markov model (%)

, figureFileSmall=null, figureFileBig=null, tableContent=
治疗方案稳定状态非致残卒中致残卒中心肌梗死死亡
CEA组81.02.73.6012.7
药物治疗组70.93.75.0020.4
), ArticleFig(id=1241677622678180449, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=CN, label=表2, caption=

Markov模型模拟十年后两组治疗方案的效果比较(%)

, figureFileSmall=null, figureFileBig=null, tableContent=
治疗方案稳定状态非致残卒中致残卒中心肌梗死死亡
CEA组81.02.73.6012.7
药物治疗组70.93.75.0020.4
), ArticleFig(id=1241677622787232360, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=EN, label=Table 3, caption=

Cost-effectiveness analysis based on different models

, figureFileSmall=null, figureFileBig=null, tableContent=
模型类型治疗方案成本增量成本效果增量效果ICER
基础病例药物治疗31 982.3835 097.237.2580.271129 435.97
CEA67 079.617.529
模型1药物治疗31 521.7435 087.707.2370.274127 946.82
CEA66 609.447.511
模型2药物治疗31 363.9535 891.077.3350.149240 283.17
CEA67 255.027.485
), ArticleFig(id=1241677622992753266, tenantId=1146029695717560320, journalId=1227665162245664772, articleId=1241522771038106386, language=CN, label=表3, caption=

基于不同模型的成本-效果分析

, figureFileSmall=null, figureFileBig=null, tableContent=
模型类型治疗方案成本增量成本效果增量效果ICER
基础病例药物治疗31 982.3835 097.237.2580.271129 435.97
CEA67 079.617.529
模型1药物治疗31 521.7435 087.707.2370.274127 946.82
CEA66 609.447.511
模型2药物治疗31 363.9535 891.077.3350.149240 283.17
CEA67 255.027.485
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颈动脉内膜切除与药物治疗无症状颈动脉狭窄的成本-效果分析
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姚瑶 1, 2 , 杨艳芳 1
现代预防医学 | 临床与预防 2024,51(1): 180-185
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现代预防医学 | 临床与预防 2024, 51(1): 180-185
颈动脉内膜切除与药物治疗无症状颈动脉狭窄的成本-效果分析
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姚瑶1, 2, 杨艳芳1
作者信息
  • 1.四川大学华西公共卫生学院/华西第四医院,四川 成都 610041
  • 2.四川省安岳县人民医院,四川 资阳 642350
  • 姚瑶(1990—),女,硕士在读,研究方向:流行病学与卫生统计学

通讯作者:

杨艳芳,E-mail:
Cost-effectiveness analysis of carotid endarterectomy versus medical therapy for asymptomatic stenosis
Yao YAO1, 2, Yan-fang YANG1
Affiliations
  • West China School of Public Health, Sichuan University/West China Fourth Hospital, Chengdu, Sichuan 610041, China
出版时间: 2024-01-10 doi: 10.20043/j.cnki.MPM.202308506
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目的

分析颈动脉内膜切除术(carotid endarterectomy,CEA)与药物治疗中国70岁以上无症状颈动脉狭窄患者的成本-效果。

方法

本文通过一项无症状颈动脉狭窄人群经CEA与药物治疗随访10年后不同结局的研究数据,建立Markov模型模拟两种治疗方案10年的成本-效果,结局指标为增量成本-效果比(ICER),即增加的成本与增加的质量调整生命年(QALY)的比值,并将获得ICER与支付意愿(willingness-to-pay,WTP)阈值进行比较。本文进行了情景分析,单因素敏感性、概率敏感性分析进行了不确定检验。

结果

在基础病例分析中,接受CEA的患者可获得7.53QALYs,药物治疗为7.26,相应成本为67 079.61和31 982.38元,获得的ICER为129 435.97元/QALY,低于支付意愿阈值。在情景分析中,ICER分别为127 946.82和240 283.17元/QALY。接受CEA后患者的年死亡率,CEA的手术花费和CEA后围手术期的死亡率对ICER波动影响较大。

结论

依据WHO对经济学评价推荐意见,目前中国70岁以上无症状颈动脉狭窄患者,CEA与药物治疗相比增加的成本是可以接受的。

无症状颈动脉狭窄  /  颈动脉内膜切除术  /  药物治疗  /  成本-效果  /  经济学评价
Objective

To analyze the cost-effectiveness of carotid endarterectomy carotid endarterectomy (CEA) and medical therapy for asymptomatic carotid stenosis in Chinese patients over 70 years old.

Methods

Based on the data of different outcomes of asymptomatic carotid stenosis patients who were followed up by CEA and drug therapy for 10 years, a Markov model was established to simulate the cost-effectiveness of the two treatments for 10 years. The outcome index was incremental cost-effectiveness ratio (ICER), which was the ratio of increased cost to increased quality-adjusted life years (QALY), and the thresholds of ICER and willingness to pay (WTP) were compared. In this paper, scenario analysis was carried out, and uncertainty test was carried out by single factor sensitivity analysis and probability sensitivity analysis.

Results

In the basic case analysis, the patients who received CEA could get 7.53 QALYs, the corresponding cost was 67 079.61 yuan and 31 982.38 yuan, and the ICER was 129 435.97 yuan / QALY, which was lower than the threshold of WTP. In scenario analysis, the ICER was 127 946.82 yuan / QALY and 240 283.17 yuan / QALY, respectively. The annual mortality of patients after CEA, the operation cost of CEA, and the perioperative mortality after CEA had great influence on the fluctuation of ICER.

Conclusion

According to the economic evaluation recommendation of WHO, the increased cost of CEA compared with drug therapy is acceptable for Chinese patients with asymptomatic carotid artery stenosis over 70 years old.

Asymptomatic carotid stenosis  /  Carotid endarterectomy  /  Drug therapy  /  Cost-effectiveness  /  Economic evaluation
姚瑶, 杨艳芳. 颈动脉内膜切除与药物治疗无症状颈动脉狭窄的成本-效果分析. 现代预防医学, 2024 , 51 (1) : 180 -185 . DOI: 10.20043/j.cnki.MPM.202308506
Yao YAO, Yan-fang YANG. Cost-effectiveness analysis of carotid endarterectomy versus medical therapy for asymptomatic stenosis[J]. Modern Preventive Medicine, 2024 , 51 (1) : 180 -185 . DOI: 10.20043/j.cnki.MPM.202308506
根据全球疾病、损伤和风险因素负担研究(GBD),卒中是死亡和致残的主要原因,2019年,全球范围内卒中发病病例超过12 200万例,卒中死亡655万例[1]。在中国,卒中已上升为成年人的主要死亡原因[2],颈动脉狭窄是发生卒中的重要原因之一[3]。目前颈动脉内膜切除术(carotid endarterectomy,CEA)、颈动脉支架植入术(carotid artery stenting,CAS)和药物治疗是治疗颈动脉狭窄和降低卒中风险的三种公认的有效方法[4-5]
对于症状性颈动脉狭窄,鉴于一些强有力的临床试验,CEA被推荐为金标准[6-8]。在不同的研究中已证明CEA可降低任何形式卒中的绝对风险[7-8]。几项经济学评价显示CEA在这些患者中具有成本-效果[9-10]。对于无症状颈动脉狭窄,随机对照试验表明CEA可以降低卒中的发生率。在一项随访期延长至10年的研究(ACST-1试验)中,排除围手术期事件和非卒中死亡后,CEA组和药物组的卒中风险分别为10.8%和16.9%,但这也意味着如果考虑围手术期事件后年获益小于0.61%[11]。另一项最新研究发现,在目前最佳药物治疗下,CEA组5年的卒中风险仍比药物治疗低[12],表明CEA可能带来些许获益。在德国进行的一项真实世界研究表明,在无症状颈动脉狭窄人群中,早期的颈动脉切除术可能比药物治疗更具成本效果[13]。因此,本研究拟分析颈动脉切除术在中国治疗无症颈动脉狭窄的实际成本-效果。
本研究的起始年龄为70岁,与ACST-1试验中接受降脂治疗患者的平均年龄相似[11]。纳入分析的患者需要符合以下标准:(1)狭窄程度至少为动脉直径的60%;(2)无卒中、短暂性脑缺血或其他相关症状;(3)他们可以随机接受CEA治疗或初始药物治疗。
构建循环周期为十年的Markov模型,比较CEA与药物治疗无症状颈动脉狭窄患者的成本-效果。考虑到无症状颈动脉狭窄和CEA后状态稳定,故Markov循环周期设定为一年,研究终止条件为十年,所有统计分析均使用TreeagePro 2019处理。模型中使用了五种健康状态,两组患者以五种状态中的一种进入模型。由于在ACST-1试验中药物治疗的患者即使未接受即刻CEA治疗,但后期随访中患者仍可随机接受手术治疗,仍具有结局事件发生。考虑到围手术期并发症,CEA组围手术期并发症发生率显然高于药物治疗组,故两组进入模型的初始概率不同。Markov模型状态转移图,见图1
 
初始概率,卒中相关转移概率均来自ACST-1研究[11]。卒中相关死亡数据来自于在中国进行的一项调查[14],非卒中相关死亡数据来源于《中国卫生健康统计年鉴2021》[15],非致残卒中到致残卒中的转移概率,第一年为4.4%,一年后为0[16],心肌梗死死亡率为28.4%[17]
初始概率,卒中相关转移概率以及非卒中相关死亡率均来自ACST-1研究中。在ACST-1中,CEA组的非卒中死亡人数为554,观察总人年数为9 582,故模型1中CEA组的非卒中死亡率为0.058。同理,药物治疗组非卒中相关死亡率为0.052,其余概率与基础病例中来源一致。
 
此模型中采用的数据来自一项Keyhani[12]的最新的研究,在该项研究中,CEA组与药物治疗组5年卒中风险分别为5.5%与7.6%,在模型2中假设致残性卒中与非致残性卒中的比例与ACST-1研究中相似,分别为57.84%和42.16%。用公式分别计算CEA和药物治疗从稳定状态到致残卒中、非致残卒中的转移概率P,其余概率同基础病例。其中p为Keyhani研究中CEA与药物治疗两种方案卒中发生风险,T为该研究随访时间,t为本研究所需要的从一种状态到达另一状态的转移概率时间,此处为一年。计算公式[18]P=1-exp[ln(1-p)/(T/t)]。
从已发表的meta分析和原始研究中检索到稳定状态、非致残性卒中和致残性卒中的效用值[19-20],心肌梗死后第一年的效用与一年以后的效用是不同的[21]
主要来源于中国真实世界研究或机构公布的数据[22-24],并考虑到居民消费价格指数(CPI)[25]将所有成本都折算成2021年的成本。根据中国药物经济学评价指南,所有成本和效用均以0.05的贴现率贴现[26]
本研究的主要终点是CEA相对于药物治疗的增量成本-效果比(ICER),即每个质量调整生命年(QALY)的增量成本。本文将2021年我国人均GDP的3倍,即242 928.00元作为支付意愿(WTP)阈值。依据世界卫生组织对于经济学评价的推荐意见:如果获得的增量成本-效果比<人均GDP,则CEA增加的成本是完全能接受的,如果人均GDP<增量-成本效果比<3倍人均GDP,那么增加的成本是可以接受的,如果增量成本-效果比>3倍人均GDP,则建议增加的成本是不能接受的。本文还进行了敏感性分析以来证实模型的稳健性,最后基于不同的参数进行了情景分析。
在基础病例分析中,两种治疗方案在Markov模型模拟十年后,CEA组队列中卒中和死亡的发生比例均低于药物治疗组,见表2。在考虑治疗成本的情况下,无论是基础病例分析还是情景分析均建议CEA增加的成本是可以接受的。见表3
对于概率和效用,假设其服从Beta分布,利用95%置信区间的范围用于进行单因素敏感性分析。对于成本,其范围是从已发表的文章中提取,对于文献中没有提供成本范围的采用上下浮动25%来进行分析,单因素敏感性分析结果见图2,术后患者的年死亡率对增量成本效果比的影响最大,其次是手术花费和围手术期的死亡率。
通过对模型进行100 00次Monte Carlo Simulation来执行分析,其中成本服从γ分布,可以得到成本-效果可接受曲线及增量成本-效果散点图,见图34。当支付意愿阈值设置为3倍人均GDP时,即242 928.00,CEA组增加的成本是可以接受的。
本研究结果表明,在十年的Markov模拟期内,CEA与药物治疗的ICER为129 435.97元/QALY,建议CEA增加的成本是可以接受的。此外,本研究还通过最新发表的类临床随机试验研究验证了模型的稳定性。
最近还有几项研究集中于CEA与药物治疗在无症状颈动脉狭窄的经济评价,在Thapar[27]的研究中,他们使用了ACST-1研究的数据,发现早期CEA对于年龄小于75岁且支付意愿高于20 000英镑/QALY的患者是具有成本效果的。但他们也指出,如果每年卒中率低于1%,早期CEA将不具有成本效果。最近,还有一些临床随机对照试验在试图探讨治疗无症状颈动脉狭窄的其他策略,ACST-2(第二次无症状颈动脉手术试验)研究比较了CEA与颈动脉支架(CAS)治疗无症状颈动脉狭窄,发现CEA和CAS均具有相当的低卒中风险[28]。Brott等的研究也发现CAS效果可能并不亚于CEA。已发表的ACST-1研究是一项比较CEA与药物治疗的大型临床随机试验,但其中一些患者在未使用降脂药物的情况下开始纳入研究,这可能会削弱药物治疗的真正疗效。目前正在进行的CREST-2试验旨在研究血运重建与药物治疗的疗效,可能会提供一些新的观点[29]。然而,这些研究并没有解决颈动脉介入手术何时介入合适的问题。
Howard[30]的研究发现CEA相对于药物治疗的受益在很大程度上取决于狭窄的程度,对于中度狭窄的患者,药物治疗的五年卒中风险较低,但对于重度狭窄的患者完全可以从CEA手术中受益,该研究可能提供了一个新的视角。在此项研究中,CEA患者的年死亡率、手术费用、围手术期死亡对ICER有明显影响,表明手术费用和围术期并发症可能影响CEA的实际疗效,减少手术花费、降低围术期并发症可能是一种持续提高成本-效果的途径。此外,无症状颈动脉狭窄治疗的改善不仅在于药物治疗,还在于支架和经颈动脉血运重建术的进展[31-33]
本研究有几个局限性。首先,研究中的数据不是原始数据,而是从已发表文章转换而来的数据,这可能会引入偏倚。其次,虽然使用了不同来源的数据,并证明CEA在当前中国环境下增加的成本是可以接受的,但如果数据来自中国人群,则会更好。最后,由于缺乏高危患者的数据,这限制了分析CEA在此类人群中的成本-效果,基于此类人群的真实世界研究可能会提供更多的医疗决策信息。
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doi: 10.20043/j.cnki.MPM.202308506
  • 接收时间:2023-08-26
  • 首发时间:2026-03-19
  • 出版时间:2024-01-10
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  • 收稿日期:2023-08-26
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    1.四川大学华西公共卫生学院/华西第四医院,四川 成都 610041
    2.四川省安岳县人民医院,四川 资阳 642350

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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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