Warwick Research in Nursing, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
Warwick Clinical Trials Unit, University of Warwick, Coventry CV4 7AL, UK.
Resuscitation. 2021 Mar;160:84-93. doi: 10.1016/j.resuscitation.2021.01.019. Epub 2021 Jan 30.
We recently reported early outcomes in patients enrolled in a randomised trial of adrenaline in out-of-hospital cardiac arrest: the PARAMEDIC2 (Prehospital Assessment of the Role of Adrenaline: Measuring the Effectiveness of Drug Administration in Cardiac Arrest) trial. The purpose of the present paper is to report long-term survival, quality of life, functional and cognitive outcomes at 3, 6 and 12-months.
PARAMEDIC2 was a pragmatic, individually randomised, double blind, controlled trial with an economic evaluation. Patients were randomised to either adrenaline or placebo. This paper reports results on the modified Rankin Scale scores at 6-months, survival at 6 and 12-months, as well as other cognitive, functional and quality of life outcomes collected at 3 and 6 months (Two Simple Questions, the Mini Mental State Examination, the Informant Questionnaire on Cognitive Decline Evaluation for Cardiac Arrest, Hospital Anxiety and Depression Scale, the Post Traumatic Stress Disorder Checklist - Civilian Version, Short-Form 12-item Health Survey and the EuroQoL EQ-5D-5L).
8014 patients were randomised with confirmed trial drug administration. At 6-months, 78 (2.0%) of the patients in the adrenaline group and 58 (1.5%) of patients in the placebo group had a favourable neurological outcome (adjusted odds ratio 1.35 [95% confidence interval: 0.93, 1.97]). 117 (2.9%) patients were alive at 6-months in the adrenaline group compared with 86 (2.2%) in the placebo group (1.43 [1.05, 1.96], reducing to 107 (2.7%) and 80 (2.0%) respectively at 12-months (1.38 [1.00, 1.92]). Measures of 3 and 6-month cognitive, functional and quality of life outcomes were reduced, but there was no strong evidence of differences between groups.
Adrenaline improved survival through to 12-months follow-up. The study did not find evidence of improvements in favourable neurological outcomes. (ISCRTN 73485024).
我们最近报道了一项肾上腺素用于院外心脏骤停患者的随机试验中的早期结果:PARAMEDIC2 试验(院前评估肾上腺素的作用:评估心脏骤停时药物给药的效果)。本文的目的是报告 3、6 和 12 个月时的长期存活率、生活质量、功能和认知结果。
PARAMEDIC2 是一项实用的、个体随机、双盲、对照试验,同时进行经济评估。患者被随机分配接受肾上腺素或安慰剂。本文报告了 6 个月时改良 Rankin 量表评分、6 个月和 12 个月时的存活率,以及 3 个月和 6 个月时收集的其他认知、功能和生活质量结果(两个简单问题、简易精神状态检查、认知下降评估器用于心脏骤停的询问者问卷、医院焦虑和抑郁量表、创伤后应激障碍检查表 - 平民版、短式 12 项健康调查和 EuroQoL EQ-5D-5L)。
8014 名患者被随机分配并确认接受了试验药物治疗。在 6 个月时,肾上腺素组有 78 名(2.0%)患者和安慰剂组有 58 名(1.5%)患者出现有利的神经结局(调整后的优势比 1.35 [95%置信区间:0.93,1.97])。在肾上腺素组,有 117 名(2.9%)患者在 6 个月时存活,而安慰剂组有 86 名(2.2%)(1.43 [1.05,1.96]),到 12 个月时分别减少到 107 名(2.7%)和 80 名(2.0%)(1.38 [1.00,1.92])。3 个月和 6 个月的认知、功能和生活质量结果测量值降低,但组间差异没有确凿证据。
肾上腺素通过 12 个月的随访提高了生存率。该研究没有发现有利神经结局改善的证据。(ISCRTN 73485024)。