Using linked electronic health records data, a cohort of 475 442 UK individuals with at least one prescription of paracetamol, aged between 60 and 90 years, was identified. Outcomes in patients taking sodium-based paracetamol were compared with those taking non-sodium-based formulations of the same. Using a deep learning approach, associations with systolic blood pressure (SBP), major cardiovascular events (myocardial infarction, heart failure, and stroke), and all-cause mortality within 1 year after baseline were investigated.
A total of 460 980 and 14 462 patients were identified for the non-sodium-based and sodium-based paracetamol exposure groups, respectively (mean age: 74 years; 64% women). Analysis revealed no difference in SBP [mean difference -0.04 mmHg (95% confidence interval -0.51, 0.43)] and no association with major cardiovascular events [relative risk (RR) 1.03 (0.91, 1.16)]. Sodium-based paracetamol showed a positive association with all-cause mortality [RR 1.46 (1.40, 1.52)]. However, after further accounting of other sources of residual confounding, the observed association attenuated towards the null [RR 1.08 (1.01, 1.16)]. Exploratory analyses revealed dysphagia and related conditions as major sources of uncontrolled confounding by indication for this association.
This study does not support previous suggestions of increased SBP and an elevated risk of cardiovascular events from short-term use of sodium bicarbonate paracetamol in routine clinical practice.
方法:使用链接的电子健康记录数据,一个由475442名英国人组成的队列,至少有一个扑热息痛处方,年龄在60至90岁之间,已确定。将服用钠基扑热息痛的患者的结果与服用非钠基制剂的患者进行比较。使用深度学习方法,与收缩压(SBP)的关系,主要心血管事件(心肌梗塞,心力衰竭,和中风),对基线后1年内的全因死亡率进行了调查.
结果:共确定了460980例患者和14462例患者为非钠基和钠基扑热息痛暴露组,分别(平均年龄:74岁;64%的女性)。分析显示SBP没有差异[平均差-0.04mmHg(95%置信区间-0.51,0.43)],并且与主要心血管事件没有关联[相对风险(RR)1.03(0.91,1.16)]。扑热息痛钠与全因死亡率呈正相关[RR1.46(1.40,1.52)]。然而,在进一步核算剩余混杂的其他来源后,观察到的关联向零[RR1.08(1.01,1.16)]减弱。探索性分析显示,吞咽困难和相关疾病是不受控制的混杂因素的主要来源,并有这种关联的迹象。
结论:本研究不支持先前关于常规临床实践中短期使用碳酸氢钠对乙酰氨基酚会增加SBP和心血管事件风险升高的建议。