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目的比较早期由静脉转换成口服抗生素与常规静脉使用7天抗生素治疗严重社区获得性肺炎(CAP)的疗效。设计多中心随机对照试验。地点荷兰5家教学医院和2所大学的医学中心。参加者非 ICU 住院的严重 CAP 患者302例,其中265例满足研究要求。干预静脉抗生素治疗3天,病情稳定后换成口服抗生素,或静脉使用抗生素治疗7天。主要评价结果临床治愈和住院天数。结果 302例患者被随机分组(平均年龄69.5岁,标准差14.0),肺炎严重度评分平均112.7(26.0)。37例患者因为提前3天退出而未纳入分析,对其余265例患者进行分析研究。第28天的死亡率在干预组是4%,对照组是6%(平均差2%,95%可信区间-3%～8%)。临床治愈率在干预组是83%,对照组是85%(2%;-7%～10%)。与对照组相比,干预组患者静脉治疗时间为3.4天[3.6(1.5)比7.0(2.0)天;2.8～3.9],患者住院天数减少1.9天[9.6(5.0)比11.5(4.9)天;0.6～3.2]。结论早期将抗生素由静脉应用转换成口服治疗严重 CAP 是安全的,并且可以减少住院时间2天。试验注册号临床试验 NCT00273676。
Objective To compare the efficacy of 7 days antibiotics used in the early conversion from intravenous to oral antibiotics and conventional intravenous therapy for severe community-acquired pneumonia (CAP). Design a multicenter randomized controlled trial. Location 5 teaching hospitals in the Netherlands and 2 medical centers in universities. 302 non-ICU hospitalized patients with severe CAP were enrolled, of whom 265 met the study requirements. Intervention with intravenous antibiotics for 3 days, after stable change into oral antibiotics, or intravenous antibiotics for 7 days. The main evaluation results of clinical cure and hospitalization days. Results 302 patients were randomized (mean age 69.5 years, standard deviation 14.0), pneumonia severity score average 112.7 (26.0). Thirty-seven patients were excluded from the analysis because they had withdrawn three days earlier, and the remaining 265 patients were analyzed. Mortality at day 28 was 4% in the intervention group and 6% in the control group (mean difference 2%, 95% confidence interval -3% -8%). The clinical cure rate was 83% in the intervention group and 85% in the control group (2%; -7% -10%). Compared with the control group, patients in the intervention group had a median of 3.4 days [3.6 (1.5) vs. 7.0 (2.0) days; 2.8 to 3.9] and a reduction in hospitalization days of 1.9 days [9.6 (5.0) vs. 11.5 0.6 ~ 3.2]. Conclusion Early conversion of antibiotics from intravenous use to oral treatment of severe CAP was safe and could reduce hospitalization for 2 days. Trial Registration Number Clinical Trial NCT00273676.