基于疾病风险的地中海膳食对临床心血管事件预防效果的异质性-东南大学学报医学版

基于疾病风险的地中海膳食对临床心血管事件预防效果的异质性

单位：1. 南京中医药大学附属医院 GCP中心, 江苏南京 210029;
2. 四川大学华西医院中国循证医学中心, 四川成都 640041;
3. 陆军军医大学军事预防医学系, 重庆 400038;
4. 南京中医大学附属医院心内科, 江苏南京 210029

关键词：地中海膳食心血管疾病疾病风险模型亚组分析异质性

分类号：R181

出版年·卷·期（页码）：2025·44·第五期（717-724）

摘要：

目的:基于疾病风险评分(DRS)评估地中海膳食模式预防心血管疾病(CVD)高危人群发生临床心血管事件(CVE)效果的异质性。方法:从西班牙PREDIMED试验数据中随机抽取约85%的受试者作为研究对象,并保持原随机化分组(低脂膳食组、地中海膳食+橄榄油组和地中海膳食+坚果组)。基于对照组(低脂膳食组)建立和验证疾病风险模型,计算全部研究对象的DRS,并基于DRS的分位数进行分层和亚组分析。在亚组分析中,采用Cox比例风险回归模型估计两个地中海膳食组的风险比(HR)及95%置信区间(CI)。结果:本研究共纳入研究对象6 324例,包括低脂膳食组2 042例(32.29%)、地中海膳食+橄榄油组2 182例(34.50%)和地中海膳食+坚果组2 100例(33.21%),3组特征的构成基本相似(标准化差异均<0.10)。在全部研究对象中,以低脂膳食组为对照,地中海膳食+橄榄油组发生CVE的风险下降27%(HR=0.73, 95%CI 0.55~0.98,P=0.036),地中海膳食+坚果组的CVE风险下降31%(HR=0.69, 95%CI 0.51~0.94,P=0.017)。在亚组分析中,地中海膳食+橄榄油模式仅在DRS≥1.52的亚组中对CVE有预防效果,而地中海膳食+坚果模式在多个DRS较高的亚组(DRS≥1.00、1.33、1.52及1.64)中均对CVE有预防作用。结论:以低脂膳食为对照,地中海膳食预防CVE的效果在人群中具有异质性,且基线DRS较高者是地中海膳食预防CVE的优势人群。

Objective: To evaluate the heterogeneity of the effect of Mediterranean dietary pattern on the prevention of clinical cardiovascular events(CVE) in people at high risk of cardiovascular disease(CVD) based on the disease risk score(DRS). Methods:Subjects of this study were randomly selected from the subjects of Spanish PREDIMED trail about 85%, and maintaining the original randomization group(low-fat diet group, the Mediterranean diet plus olive oil group and the Mediterranean diet plus nuts group). A disease risk model was established and validated based on the control group(low-fat diet group), and the DRS of all subjects was calculated. Stratified and subgroup analyses were conducted based on the quantile of DRS. In subgroup analyses, compared with control group, Cox proportional hazards regression models were used to estimate the hazard ratio(HR) and 95% confidence interval(CI) of the two Mediterranean diet groups. Results: A total of 6 324 subjects were enrolled in this study, including 2 042(32.29%) in the low-fat diet group, 2 182(34.50%) in the Mediterranean diet plus olive oil group, and 2 100(33.21%) in the Mediterranean diet plus nuts group. The demographic characteristics and risk factors among three groups were basically similar(standardized difference<0.10). Compared with the low-fat diet group, the risk of CVE decreased by 27% in the Mediterranean diet plus olive oil group(HR=0.73, 95% CI 0.55-0.98, P=0.036) and 31% in the Mediterranean diet plus nuts group(HR=0.69, 95% CI 0.51-0.94, P =0.017). In subgroup analyses, the Mediterranean diet plus olive oil prevented CVE in the subgroup with DRS ≥1.52 only, and the Mediterranean diet plus nuts prevented CVE in the subgroups with the higher DRS(DRS≥1.00, 1.33, 1.52, 1.64). Conclusion: Compared with low-fat diet, the effect of Mediterranean diet on prevention of CVE was heterogeneous in the population, and those with higher baseline DRS were the dominant population for prevention of CVE by Mediterranean diet.

参考文献：

[1] World Health Organization.Cardiovascular diseases [OB/OL].World Health Organization.Available at: https: //www.who.int/health-topics/cardiovascular-diseases #tab=tab_1.Accessed July 8, 2024.
[2] 中国心血管病风险评估和管理指南编写联合委员会.中国心血管病风险评估和管理指南[J].中国循环杂志, 2019, 34(1): 4-28.
[3] KAMINSKY L A, GERMAN C, IMBODEN M, et al.The importance of healthy lifestyle behaviors in the prevention of cardiovascular disease[J].Prog Cardiovasc Dis, 2022, 70: 8-15.
[4] MARTÍNEZ-GONZÁLEZ M A, SALAS-SALVADÓ J, ESTRUCH R, et al.Benefits of the Mediterranean diet: insights from the PREDIMED study[J].Prog Cardiovasc Dis, 2015, 58(1): 50-60.
[5] KENT D M, HAYWARD R A.Limitations of applying summary results of clinical trials to individual patients: the need for risk stratification[J].JAMA, 2007, 298(10): 1209-1212.
[6] ROTHWELL P M.Treating individuals 2.Subgroup analysis in randomised controlled trials: importance, indications, and interpretation[J].Lancet, 2005, 365(9454): 176-186.
[7] HARRER M, EBERT D D, KUPER P, et al.Predicting heterogeneous treatment effects of an Internet-based depression intervention for patients with chronic back pain: Secondary analysis of two randomized controlled trials[J].Internet Interv, 2023, 33: 100634.
[8] 卢珍珍, 赵恩慧, 黄丽红.倾向性评分与疾病风险评分匹配对已测量混杂因素的控制效果评价[J].中华疾病控制杂志, 2024, 28(2): 241-248.
[9] GOLIGHER E C, LAWLER P R, JENSEN T P, et al.Heterogeneous treatment effects of therapeutic-dose heparin in patients hospitalized for COVID-19[J].JAMA, 2023, 329(13): 1066-1077.
[10] SUBIRANA I, SANZ H, VILA J.Building Bivariate Tables: The CompareGroups Package for R[J].Stat Soft, 2014, 57: 1-16.
[11] MARTÍNEZ-GONZÁLEZ M Á, CORELLA D, SALAS-SALVADÓ J, et al.Cohort profile: design and methods of the PREDIMED study[J].Int J Epidemiol, 2012, 41(2): 377-385.
[12] 王威, 梁君雅, 于茜, 等.基于STEPP的健康膳食模式与心血管事件风险关联的异质性分析[J].现代医学, 2024, 52(8): 1233-1241.
[13] BECERRA-TOMÁS N, BLANCO MEJÍA S, VIGUILIOUK E, et al.Mediterranean diet, cardiovascular disease and mortality in diabetes: a systematic review and meta-analysis of prospective cohort studies and randomized clinical trials[J].Crit Rev Food Sci Nutr, 2020, 60(7): 1207-1227.
[14] SIERVO M, SHANNON O M, LLEWELLYN D J, et al.Mediterranean diet and cognitive function: from methodology to mechanisms of action[J].Free Radic Biol Med, 2021, 176: 105-117.
[15] WANG Y, HAO Q, SU L, et al.Adherence to the Mediterranean diet and the risk of frailty in old people: a systematic review and meta-analysis[J].J Nutr Health Aging, 2018, 22(5): 613-618.
[16] CRITSELIS E, PANAGIOTAKOS D.Adherence to the Mediterranean diet and healthy ageing: current evidence, biological pathways, and future directions[J].Crit Rev Food Sci Nutr, 2020, 60(13): 2148-2157.
[17] ESTRUCH R, ROS E, SALAS-SALVADÓ J, et al.Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts[J].N Engl J Med, 2018, 378(25): e34.
[18] 邓彦, 荣爽, 程光文, 等.三种健康膳食模式与认知障碍类疾病发生风险关联的Meta分析[J].卫生研究, 2022, 51(5): 725-732.
[19] BROOKES S T, WHITELY E, EGGER M, et al.Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test[J].J Clin Epidemiol, 2004, 57(3): 229-236.
[20] DENNIS J M, SHIELDS B M, HENLEY W E, et al.Disease progression and treatment response in data-driven subgroups of type 2 diabetes compared with models based on simple clinical features: an analysis using clinical trial data[J].Lancet Diabetes Endocrinol, 2019, 7(6): 442-451.
[21] SINHA P, CALFEE C S, DELUCCHI K L.Practitioner's guide to latent class analysis: methodological considerations and common pitfalls[J].Crit Care Med, 2021, 49(1): e63-e79.
[22] 王威, 于茜, 胡馨茹, 等.基于倾向性评分匹配和亚群治疗效果模式图队列研究暴露与结局关联的异质性分析[J].中华流行病学杂志, 2024, 45(5): 748-754.
[23] 李宇飞, 刘建平, 梁士兵, 等.亚群疗效模式图(STEPP)法在临床试验中的应用[J].中国循证医学杂志, 2024, 24(8): 980-985.
[24] 王喆, 毛倩, 管佩霞, 等.基于因果森林的三阴性乳腺癌术后放疗的个性化疗效评价[J].中国卫生统计, 2023, 40(1): 32-35, 40.

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