Yoo Hugo Hb, Nunes-Nogueira Vania Santos, Fortes Villas Boas Paulo J, Broderick Cathryn
Department of Internal Medicine, Botucatu Medical School, São Paulo State University-UNESP, Botucatu, São Paulo, Brazil, 18618-687.
Cochrane Database Syst Rev. 2019 Mar 6;3(3):CD010019. doi: 10.1002/14651858.CD010019.pub3.
Pulmonary embolism (PE) is a common life-threatening cardiovascular condition, with an incidence of 23 to 69 new cases per 100,000 people each year. For selected low-risk patients with acute PE, outpatient treatment might provide several advantages over traditional inpatient treatment, such as reduction of hospitalisations, substantial cost savings, and improvements in health-related quality of life. This is an update of the review first published in 2014.
To compare the efficacy and safety of outpatient versus inpatient treatment in low-risk patients with acute PE for the outcomes of all-cause and PE-related mortality; bleeding; adverse events such as haemodynamic instability; recurrence of PE; and patients' satisfaction.
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers, to 26 March 2018. We also undertook reference checking to identify additional studies.
We included randomised controlled trials of outpatient versus inpatient treatment of adults (aged 18 years and over) diagnosed with low-risk acute PE.
Two review authors selected relevant trials, assessed methodological quality, and extracted and analysed data. We calculated effect estimates using risk ratio (RR) with 95% confidence intervals (CIs), or mean differences (MDs) with 95% CIs. We used standardised mean differences (SMDs) to combine trials that measured the same outcome but used different methods. We assessed the quality of the evidence using GRADE criteria.
One new study was identified for this 2018 update, bringing the total number of included studies to two and the total number of participants to 451. Both trials discharged patients randomised to the outpatient group within 36 hours of initial triage and both followed participants for 90 days. One study compared the same treatment regimens in both outpatient and inpatient groups, and the other study used different treatment regimes. There was no clear difference in treatment effect for the outcomes of short-term mortality (30 days) (RR 0.33, 95% CI 0.01 to 7.98, P = 0.49; low-quality evidence), long-term mortality (90 days) (RR 0.98, 95% CI 0.06 to 15.58, P = 0.99, low-quality evidence), major bleeding at 14 days (RR 4.91, 95% CI 0.24 to 101.57, P = 0.30; low-quality evidence) and at 90 days (RR 6.88, 95% CI 0.36 to 132.14, P = 0.20; low-quality evidence), minor bleeding (RR 1.08, 95% CI 0.07 to 16.79; P = 0.96, low-quality evidence), recurrent PE within 90 days (RR 2.95, 95% CI 0.12 to 71.85, P = 0.51, low-quality evidence), and participant satisfaction (RR 0.97, 95% CI 0.90 to 1.04, P = 0.39; moderate-quality evidence). We downgraded the quality of the evidence because the CIs were wide and included treatment effects in both directions, the sample sizes and numbers of events were small, and because the effect of missing data and the absence of publication bias could not be verified. PE-related mortality, and adverse effects such as haemodynamic instability and compliance, were not assessed by the included studies.
AUTHORS' CONCLUSIONS: Currently, only low-quality evidence is available from two published randomised controlled trials on outpatient versus inpatient treatment in low-risk patients with acute PE. The studies did not provide evidence of any clear difference between the interventions in overall mortality, bleeding and recurrence of PE.
肺栓塞(PE)是一种常见的危及生命的心血管疾病,每年每10万人中有23至69例新发病例。对于部分选定的低风险急性PE患者,门诊治疗可能比传统住院治疗具有若干优势,如减少住院次数、大幅节省成本以及改善与健康相关的生活质量。这是对2014年首次发表的综述的更新。
比较门诊治疗与住院治疗对低风险急性PE患者全因死亡率和PE相关死亡率、出血、血流动力学不稳定等不良事件、PE复发以及患者满意度等结局的疗效和安全性。
Cochrane血管信息专家检索了Cochrane血管专业注册库、CENTRAL、MEDLINE、Embase、CINAHL和AMED数据库,以及世界卫生组织国际临床试验注册平台和ClinicalTrials.gov试验注册库,检索截至2018年3月26日。我们还进行了参考文献核对以识别其他研究。
我们纳入了对诊断为低风险急性PE的成年人(18岁及以上)进行门诊治疗与住院治疗的随机对照试验。
两位综述作者选择相关试验,评估方法学质量,并提取和分析数据。我们使用风险比(RR)及95%置信区间(CI)或均值差(MD)及95%CI计算效应估计值。我们使用标准化均值差(SMD)合并测量相同结局但使用不同方法的试验。我们使用GRADE标准评估证据质量。
本次2018年更新识别出一项新研究,使纳入研究总数达到两项,参与者总数达到451名。两项试验均在初次分诊后36小时内将随机分配至门诊组的患者出院,且均对参与者随访90天。一项研究在门诊组和住院组中比较了相同的治疗方案,另一项研究使用了不同的治疗方案。在短期死亡率(30天)(RR 0.33,95%CI 0.01至7.98,P = 0.49;低质量证据)、长期死亡率(90天)(RR 0.98,95%CI 0.06至15.58,P = 0.99;低质量证据)、14天时的大出血(RR 4.91,95%CI 0.24至101.57,P = 0.30;低质量证据)和90天时的大出血(RR 6.88,95%CI 0.36至132.14,P = 0.20;低质量证据)、小出血(RR 1.08,95%CI 0.07至16.79;P = 0.96,低质量证据)、90天内PE复发(RR 2.95,95%CI 0.12至71.85,P = 0.51,低质量证据)以及参与者满意度(RR 0.97,95%CI 0.90至1.04,P = 0.39;中等质量证据)等结局方面,治疗效果无明显差异。我们降低了证据质量等级,因为置信区间较宽且包含了两个方向的治疗效果,样本量和事件数较少,并且无法核实缺失数据的影响以及是否存在发表偏倚。纳入研究未评估PE相关死亡率以及血流动力学不稳定和依从性等不良反应。
目前,仅有两项已发表的随机对照试验提供了关于低风险急性PE患者门诊治疗与住院治疗的低质量证据。这些研究未提供证据表明两种干预措施在总体死亡率、出血和PE复发方面存在任何明显差异。