Bennett Michael H, Lehm Jan P, Jepson Nigel
Department of Anaesthesia, Prince of Wales Clinical School, University of NSW, Sydney, NSW, Australia.
Cochrane Database Syst Rev. 2015 Jul 23;2015(7):CD004818. doi: 10.1002/14651858.CD004818.pub4.
Acute coronary syndrome (ACS), includes acute myocardial infarction and unstable angina, is common and may prove fatal. Hyperbaric oxygen therapy (HBOT) will improve oxygen supply to the threatened heart and may reduce the volume of heart muscle that perishes. The addition of HBOT to standard treatment may reduce death rate and other major adverse outcomes.This an update of a review previously published in May 2004 and June 2010.
The aim of this review was to assess the evidence for the effects of adjunctive HBOT in the treatment of ACS. We compared treatment regimens including adjunctive HBOT against similar regimens excluding HBOT. Where regimens differed significantly between studies this is clearly stated and the implications discussed. All comparisons were made using an intention to treat analysis where this was possible. Efficacy was estimated from randomised trial comparisons but no attempt was made to evaluate the likely effectiveness that might be achieved in routine clinical practice. Specifically, we addressed:Does the adjunctive administration of HBOT to people with acute coronary syndrome (unstable angina or infarction) result in a reduction in the risk of death?Does the adjunctive administration of HBOT to people with acute coronary syndrome result in a reduction in the risk of major adverse cardiac events (MACE), that is: cardiac death, myocardial infarction, and target vessel revascularization by operative or percutaneous intervention?Is the administration of HBOT safe in both the short and long term?
We updated the search of the following sources in September 2014, but found no additional relevant citations since the previous search in June 2010 (CENTRAL), MEDLINE, EMBASE, CINAHL and DORCTHIM. Relevant journals were handsearched and researchers in the field contacted. We applied no language restrictions.
Randomised studies comparing the effect on ACS of regimens that include HBOT with those that exclude HBOT.
Three authors independently evaluated the quality of trials using the guidelines of the Cochrane Handbook and extracted data from included trials. Binary outcomes were analysed using risk ratios (RR) and continuous outcomes using the mean difference (MD) and both are presented with 95% confidence intervals. We assessed the quality of the evidence using the GRADE approach.
No new trials were located in our most recent search in September 2014. Six trials with 665 participants contributed to this review. These trials were small and subject to potential bias. Only two reported randomisation procedures in detail and in only one trial was allocation concealed. While only modest numbers of participants were lost to follow-up, in general there is little information on the longer-term outcome for participants. Patients with acute coronary syndrome allocated to HBOT were associated with a reduction in the risk of death by around 42% (RR: 0.58, (95% CI 0.36 to 0.92), 5 trials, 614 participants; low quality evidence).In general, HBOT was well-tolerated. No patients were reported as suffering neurological oxygen toxicity and only a single patient was reported to have significant barotrauma to the tympanic membrane. One trial suggested a significant incidence of claustrophobia in single occupancy chambers of 15% (RR of claustrophobia with HBOT 31.6, 95% CI 1.92 to 521).
AUTHORS' CONCLUSIONS: For people with ACS, there is some evidence from small trials to suggest that HBOT is associated with a reduction in the risk of death, the volume of damaged muscle, the risk of MACE and time to relief from ischaemic pain. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously, and an appropriately powered trial of high methodological rigour is justified to define those patients (if any) who can be expected to derive most benefit from HBOT. The routine application of HBOT to these patients cannot be justified from this review.
急性冠状动脉综合征(ACS),包括急性心肌梗死和不稳定型心绞痛,很常见且可能致命。高压氧治疗(HBOT)将改善对受威胁心脏的氧气供应,并可能减少坏死心肌的体积。在标准治疗中加入HBOT可能降低死亡率和其他主要不良后果。这是对先前于2004年5月和2010年6月发表的一篇综述的更新。
本综述的目的是评估辅助性HBOT治疗ACS效果的证据。我们比较了包括辅助性HBOT的治疗方案与不包括HBOT的类似方案。如果各研究之间的方案差异显著,将明确说明并讨论其影响。所有比较尽可能采用意向性分析。疗效通过随机试验比较进行估计,但未尝试评估在常规临床实践中可能实现的效果。具体而言,我们探讨:
对急性冠状动脉综合征(不稳定型心绞痛或心肌梗死)患者辅助使用HBOT是否会降低死亡风险?
对急性冠状动脉综合征患者辅助使用HBOT是否会降低主要不良心脏事件(MACE)的风险,即:心脏死亡、心肌梗死以及通过手术或经皮介入进行的靶血管血运重建?
HBOT的使用在短期和长期是否安全?
我们于2014年9月更新了对以下来源的检索,但自2010年6月上次检索以来未发现其他相关引文(Cochrane系统评价数据库、医学期刊数据库、荷兰医学文摘数据库、护理学与健康领域数据库和丹麦癌症与健康数据库)。对相关期刊进行了手工检索,并联系了该领域的研究人员。我们未设语言限制。
比较包括HBOT的方案与不包括HBOT的方案对ACS影响的随机研究。
三位作者根据Cochrane手册的指南独立评估试验质量,并从纳入试验中提取数据。二元结局采用风险比(RR)分析,连续结局采用平均差(MD)分析,两者均给出95%置信区间。我们采用GRADE方法评估证据质量。
在2014年9月的最新检索中未找到新的试验。六项试验共665名参与者纳入本综述。这些试验规模较小且存在潜在偏倚。只有两项详细报告了随机化程序,且只有一项试验实施了分配隐藏。虽然失访的参与者数量不多,但总体而言,关于参与者长期结局的信息很少。分配接受HBOT的急性冠状动脉综合征患者死亡风险降低约42%(RR:0.58,95%CI 0.36至0.92,5项试验,614名参与者;低质量证据)。
总体而言,HBOT耐受性良好。未报告有患者发生神经型氧中毒,仅报告有一名患者鼓膜有明显气压伤。一项试验表明,单人舱内幽闭恐惧症的发生率为15%(接受HBOT者幽闭恐惧症的RR为31.6,95%CI 1.92至521)。
对于ACS患者,小型试验有一些证据表明,HBOT与死亡风险降低、受损肌肉体积减少、MACE风险降低以及缺血性疼痛缓解时间缩短有关。鉴于患者数量较少、方法学缺陷和报告不佳,这一结果应谨慎解释,有必要进行一项方法学严谨、样本量充足的试验,以确定(如果有的话)哪些患者可能从HBOT中获益最大。本综述无法证明对这些患者常规应用HBOT是合理的。