早期将抗生素由静脉转为口服治疗严重社区获得性肺炎:多中心随机试验

Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia:multicentre randomised trial

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。

Objectives To compare the effectiveness of an early switch to oral antibiotics with the standard 7 days course of intravenous antibiotics in severe community acquired pneumonia. Design Multicentre randomised controlled trial. Setting Five teaching hospitals and 2 university medical centres in the Netherlands. Participants 302 patients in non-intensive care wards with severe community acquired pneumonia. 265 patients fulfilled the study requirements. Intervention Three days of treatment with intravenous antibiotics followed, when clinically stable, by oral antibiotics or by 7 days of intravenous antibiotics. Main outcome measures Clinical cure and length of hospital stay. Results 302 patients were randomised （mean age 69.5 （ standard deviation 14.0 ） , mean pneumonia severity score 112.7 （ 26.0 ））. 37 patients were excluded from analysis because of early dropout before day 3, leaving 265 patients for intention to treat analysis. Mortality at day 28 was 4% in the intervention group and 6% in the control group （mean difference 2%, 95% confidence interval -3% to 8% ）. Clinical cure was 83% in the intervention group and 85% in the control group （2% , - 7% to 10%）. Duration of intravenous treatment and length of hospital stay were reduced in the intervention group, with mean differences of 3.4 days （3.6 （1.5） v7.0 （2.0） days; 2.8 to 3.9） and 1.9 days （9.6 （5.0） v 11.5 （4.9） days; 0.6 to 3.2）, respectively. Conclusions Early switch from intravenous to oral antibiotics in patients with severe community acquired pneumonia is safe and decreases length of hospital stay by 2 days. Trial registration Clinical Trials NCT00273676.