Section of Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Imperial College London and Charing Cross Hospital, Fulham Palace Road, London, W6 8RF, UK.
School of Medicine, Dentistry and Biomedical Sciences, Queen's University of Belfast, Belfast, UK.
Intensive Care Med. 2017 May;43(5):663-671. doi: 10.1007/s00134-016-4649-0. Epub 2016 Dec 21.
We performed an individual patient data meta-analysis to assess the possible benefits and harms of statin therapy in adults with acute respiratory distress syndrome (ARDS) and to investigate effects in specific ARDS subgroups.
We identified randomised clinical trials up to 31 October 2016 that had investigated statin therapy versus placebo in patients with ARDS. Individual patient data from each trial were compiled. Conventional two-stage meta-analyses were performed for primary and secondary outcomes, and one-stage regression models with single treatment-covariate interactions for subgroup analyses. Risk of bias was assessed using the Cochrane Risk of Bias Tool.
Six trials with a total of 1755 patients were included. For the primary outcomes, there was no significant effect of statin therapy on 28-day mortality [relative risk (RR) 1.03, 95% CI 0.86-1.23], ventilator-free days (mean difference 0.34 days, 95% CI -0.68 to 1.36) or serious adverse events (RR 1.14, 95% CI 0.84-1.53). There was a significantly increased incidence of raised serum creatine kinase or transaminase levels with statin therapy (106/879; 12.1%) versus control (78/876; 8.9%) (RR 1.40, 95% CI 1.07-1.83, p = 0.015). There were no significant treatment-covariate interactions in the predefined subgroups investigated.
We found no clinical benefit from initiation of statin therapy in adult patients with ARDS, either overall or in predefined subgroups. While there was an increased incidence of raised serum creatine kinase and transaminase levels, there was no difference in serious adverse events among groups. Therefore, we do not recommend initiation of statin therapy for the treatment of ARDS.
我们进行了一项个体患者数据荟萃分析，以评估他汀类药物治疗成人急性呼吸窘迫综合征（ARDS）的可能益处和危害，并探讨特定 ARDS 亚组的影响。
我们确定了截至 2016 年 10 月 31 日的随机临床试验，这些试验调查了他汀类药物治疗与 ARDS 患者安慰剂治疗的效果。从每个试验中编译了个体患者数据。对主要和次要结局进行了常规两阶段荟萃分析，并对亚组分析进行了具有单一治疗协变量相互作用的单阶段回归模型。使用 Cochrane 风险偏倚工具评估了风险偏倚。
共有 6 项试验，总计 1755 名患者纳入研究。对于主要结局，他汀类药物治疗对 28 天死亡率[相对风险（RR）1.03，95%置信区间（CI）0.86-1.23]、无呼吸机天数（平均差异 0.34 天，95%CI-0.68 至 1.36）或严重不良事件（RR 1.14，95%CI 0.84-1.53）均无显著影响。他汀类药物治疗组（106/879；12.1%）比对照组（78/876；8.9%）的血清肌酸激酶或转氨酶水平升高的发生率显著增加（RR 1.40，95%CI 1.07-1.83，p=0.015）。在研究的预定亚组中，未发现治疗协变量之间存在显著的相互作用。
我们没有发现开始他汀类药物治疗成人 ARDS 患者有临床获益，无论是整体还是在预定亚组中。虽然血清肌酸激酶和转氨酶水平升高的发生率增加，但各组严重不良事件无差异。因此，我们不建议使用他汀类药物治疗 ARDS。
