Outpatient care compared with hospitalization for community-acquired pneumonia -: A randomized trial in low-risk patients

Outpatient care compared with hospitalization for community-acquired pneumonia -: A randomized trial in low-risk patients
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DOI:
10.7326/0003-4819-142-3-200502010-00006
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发表时间:
2005-02-01
影响因子:
39.2
通讯作者:
Gudiol, F
Gudiol, F
中科院分区:
医学1区
文献类型:
--
作者:
Carratalà, J;Fernández-Sabé, N;Gudiol, F

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背景:肺炎严重程度指数(PSI)一直被提倡作为一种客观的风险分层措施,以帮助确定社区获得性肺炎患者的初始治疗地点。目的:确定psi定义的社区获得性肺炎低危患者的门诊治疗是否与住院治疗一样安全有效。设计:非盲法、随机对照试验。环境:2所三级保健医院。患者:224名风险等级为II或III (PSI评分小于或等于90分)的免疫功能正常的成人,在急诊科接受了社区获得性肺炎的诊断,且无情有可原的情况。干预措施:门诊接受口服左氧氟沙星治疗或住院接受序贯静脉和口服左氧氟沙星治疗。测量:主要终点是根据7个预定义标准在治疗结束时获得总体成功结果的患者百分比。次要终点包括患者的生活质量和满意度。结果:83.6%的门诊患者和80.7%的住院患者获得了总体成功结局(绝对差异为2.9个百分点[95% CI, -7.1至12.9个百分点])。门诊患者总体满意度较高(91.2% vs. 79.1%;绝对差异12.1个百分点[CI, 1.8 ~ 22.5个百分点])。门诊组和住院组的生活质量、药物不良反应发生率(9.1%比9.6%)、医疗并发症发生率(0.9%比2.6%)、后续住院率(6.3%比7.0%)和总死亡率(0.9%比0%)相似。局限性:由于样本量相对较小,检测严重并发症(如死亡)的能力受到限制。结论:在选定的社区获得性肺炎、PSI风险等级为II级和III级并接受左氧氟沙星治疗的患者中,在没有呼吸衰竭、不稳定合并症、复杂胸腔积液和社会问题的情况下,门诊治疗与住院治疗一样安全有效,患者满意度更高。
Background: The Pneumonia Severity Index (PSI) has been advocated as an objective measure of risk stratification to help determine the initial site of treatment for patients with community-acquired pneumonia.Objective: To determine whether outpatient care of PSI-defined low-risk patients with community-acquired pneumonia is as safe and effective as hospitalization.Design: Unblinded, randomized, controlled trial.Setting: 2 tertiary care hospitals.Patients: 224 immunocompetent adults in risk class II or III (PSI scores less than or equal to 90 points) who received a diagnosis of community-acquired pneumonia in the emergency department and had no extenuating circumstances.Intervention: outpatient care with oral levofloxacin therapy or hospitalization with sequential intravenous and oral levofloxacin therapy.Measurements: The primary end point was the percentage of patients with an overall successful outcome at the end of treatment, according to 7 predefined criteria. Secondary end points included patients' quality of life and satisfaction.Results: Overall successful outcome was achieved in 83.6% of outpatients and 80.7% of hospitalized patients (absolute difference, 2.9 percentage points [95% CI, -7.1 to 12.9 percentage points]). More outpatients were satisfied with their overall care (91.2% vs. 79.1%; absolute difference, 12.1 percentage points [CI, 1.8 to 22.5 percentage points]). Quality of life and the percentages of patients with adverse drug reactions (9.1% vs. 9.6%), medical complications (0.9% vs. 2.6%), subsequent hospital admissions (6.3% vs. 7.0%), and overall mortality (0.9% vs. 0%) were similar in the outpatient and hospitalization groups.Limitations: The power to detect a serious complication, such as death, was limited given the relatively small sample size.Conclusions: in selected patients who had community-acquired pneumonia, PSI risk class II and III, and were treated with levofloxacin, outpatient care in the absence of respiratory failure, unstable comorbid conditions, complicated pleural effusions, and social problems was as safe and effective as hospitalization and provided greater patient satisfaction.