Service of Pneumology, Hospital Universitario Virgen del Rocío, Avda Manuel Siurot s/n, 41013 Seville, Spain.
Thromb Res. 2010 Jul;126(1):e1-5. doi: 10.1016/j.thromres.2009.09.026. Epub 2009 Oct 24.
Limited data exist on the feasibility of providing outpatient care to patients with acute pulmonary embolism (PE).
We conducted a multicenter randomized clinical trial in acute symptomatic PE to compare the efficacy and safety of early discharge versus standard hospitalization. A clinical prediction rule was used to identify low-risk patients. All patients were followed for three months. The primary outcomes were venous thromboembolic recurrences, major and minor bleeding, and overall mortality.
One hundred and thirty two low-risk patients with acute symptomatic PE were randomized to early discharge (n=72) or standard hospitalization (n=60). Overall mortality was 4.2% (95% CI, 0.5-8.9) in the early discharge group and 8.3% (95% CI, 1.1-15) in the standard hospitalization group (Relative Risk (RR) 0.5; 95% confidence interval [CI], 0.12-2.01). Non-fatal recurrences were 2.8% (95% CI, 1.1-6.6) in the early discharge group and 3.3% (95% CI, 1.3-8%) in the standard hospitalization group (RR 0.8; 95% CI, 0.12-5.74). The rates of clinically relevant bleeding were 5.5% in the early discharge group and 5% in the standard hospitalization group (P=0.60). Short-term mortality was 2.8% (95% CI, 0.8-9.6%) in the early discharge group as compared with 0% in the standard hospitalization group. Based on the rate of short-term death in a carefully selected population, the study was suspended.
In spite of the number of complications in patients with acute symptomatic PE randomized to standard hospitalization or early discharge did not differ significantly. The rate of short-term mortality was unexpectedly high in a (a priori) low-risk group of patients with acute PE. The accuracy of clinical prediction scores needs to be validated in well designed clinical trials. (ClinicalTrials.gov number, NCT00214929.).
关于为急性肺栓塞（PE）患者提供门诊治疗的可行性，目前仅有有限的数据。
我们在急性有症状的 PE 患者中进行了一项多中心随机临床试验，比较了早期出院与标准住院治疗的疗效和安全性。采用临床预测规则来识别低危患者。所有患者均随访 3 个月。主要结局为静脉血栓栓塞复发、大出血和小出血、总死亡率。
132 例急性有症状的低危 PE 患者被随机分为早期出院（n=72）或标准住院（n=60）组。早期出院组的总死亡率为 4.2%（95%CI，0.5-8.9），标准住院组为 8.3%（95%CI，1.1-15）（相对危险度（RR）0.5；95%可信区间[CI]，0.12-2.01）。早期出院组非致死性复发率为 2.8%（95%CI，1.1-6.6），标准住院组为 3.3%（95%CI，1.3-8%）（RR 0.8；95%CI，0.12-5.74）。早期出院组有症状出血发生率为 5.5%，标准住院组为 5%（P=0.60）。早期出院组短期死亡率为 2.8%（95%CI，0.8-9.6%），标准住院组为 0%。基于精心选择人群的短期死亡率，该研究被中止。
尽管标准住院或早期出院的急性有症状 PE 患者的并发症发生率没有显著差异，但急性 PE 低危患者的短期死亡率出乎意料地高。临床预测评分的准确性需要在精心设计的临床试验中验证。（临床试验.gov 编号，NCT00214929）。
