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中国成年人中启动他汀类药物治疗的软性与硬性心血管疾病结局模型的风险阈值:一项成本效益分析。

Risk thresholds for soft versus hard cardiovascular disease outcome models for initiating statin therapy among Chinese adults: a cost-utility analysis.

作者信息

Sun Zhijia, Zhang Haijun, Ding Yinqi, Yu Canqing, Sun Dianjianyi, Pang Yuanjie, Pei Pei, Yang Ling, Chen Yiping, Du Huaidong, Huang Dan, Yang Xiaoming, Barnard Maxim, Clarke Robert, Chen Junshi, Chen Zhengming, Li Liming, Lv Jun

机构信息

Department of Epidemiology & Biostatistics, School of Public Health, Peking University, Beijing, 100191, China.

Department of Health Policy and Management, School of Public Health, Peking University, Beijing, 100191, China.

出版信息

BMC Med. 2025 Jul 1;23(1):353. doi: 10.1186/s12916-025-04222-8.

Abstract

BACKGROUND

Current guidelines for atherosclerotic cardiovascular disease (ASCVD) primary prevention mostly recommend risk scores that predict risk of non-fatal myocardial infarction, fatal ischemic heart disease (IHD), and fatal or non-fatal ischemic stroke (hard outcomes), ignoring the burden from other non-fatal IHD outcomes. We explored the optimal risk thresholds for statin initiation using non-laboratory-based soft and hard ASCVD outcome models and compared the cost-utility of such models in the Chinese population.

METHODS

We constructed Markov cohort models to estimate the incidence of ASCVD events, costs, and quality-adjusted life years (QALYs) over a lifetime from a social perspective. The simulation cohort was constructed using data from the China Kadoorie Biobank (CKB). Input data included cost, utility, statin efficacy, and other parameters were derived from published literature. We used CKB-ASCVD models to predict 10-year risk and different risk thresholds to guide statin initiation. The incremental cost-effectiveness ratio (ICER) was estimated as cost per QALY gained. Sensitivity analyses were performed to explore the uncertainty in the models.

RESULTS

The optimal risk threshold was 18% for the soft ASCVD model and 10% for the hard ASCVD model, with ICERs of $7013.48/QALY and $6540.71/QALY, respectively. The optimal thresholds were robust in stratified analyses by region and sex, and one-way sensitivity analyses over a wide range of input parameters. Probabilistic sensitivity analyses showed that these optimal thresholds had around 70% chance of being cost-effective. When analyzed by age group, above optimal thresholds were cost-effective in adults aged 30-59 years but not in those aged 60-75 years. The threshold strategies based on soft ASCVD model were mostly cost-saving compared with those based on hard models to treat the same proportions of the population.

CONCLUSIONS

The risk threshold of 18% for soft ASCVD model and 10% for hard ASCVD model have acceptable cost-utility profiles in the Chinese population. The soft ASCVD model is more cost-effective than the hard model and should be used as a screening tool for ASCVD primary prevention.

摘要

背景

目前关于动脉粥样硬化性心血管疾病(ASCVD)一级预防的指南大多推荐使用风险评分来预测非致死性心肌梗死、致死性缺血性心脏病(IHD)以及致死或非致死性缺血性卒中(硬性结局)的风险,而忽略了其他非致死性IHD结局带来的负担。我们使用基于非实验室指标的软性和硬性ASCVD结局模型探索了启动他汀类药物治疗的最佳风险阈值,并比较了这些模型在中国人群中的成本效益。

方法

我们构建了马尔可夫队列模型,从社会角度估计一生中ASCVD事件的发生率、成本和质量调整生命年(QALY)。模拟队列使用中国慢性病前瞻性研究(CKB)的数据构建。输入数据包括成本、效用、他汀类药物疗效等,其他参数来自已发表的文献。我们使用CKB-ASCVD模型预测10年风险,并采用不同的风险阈值来指导他汀类药物的启动。增量成本效益比(ICER)估计为每获得一个QALY的成本。进行敏感性分析以探索模型中的不确定性。

结果

软性ASCVD模型的最佳风险阈值为18%,硬性ASCVD模型为10%,ICER分别为每QALY 7013.48美元和6540.71美元。在按地区和性别进行的分层分析以及对广泛输入参数的单向敏感性分析中,最佳阈值具有稳健性。概率敏感性分析表明,这些最佳阈值具有约70%的成本效益可能性。按年龄组分析时,高于最佳阈值在30至59岁的成年人中具有成本效益,但在60至75岁的成年人中则不然。与基于硬性模型的阈值策略相比,基于软性ASCVD模型的阈值策略在治疗相同比例人群时大多具有成本节约优势。

结论

软性ASCVD模型的风险阈值为18%,硬性ASCVD模型为10%,在中国人群中具有可接受的成本效益特征。软性ASCVD模型比硬性模型更具成本效益,应用作ASCVD一级预防的筛查工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/25e0/12211359/36960c936ffe/12916_2025_4222_Fig1_HTML.jpg

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