Oosterheert Jan Jelrik, Bonten Marc J M, Schneider Margriet M E, Buskens Erik, Lammers Jan-Willem J, Hustinx Willem M N, Kramer Mark H H, Prins Jan M, Slee Peter H Th J, Kaasjager Karin, Hoepelman Andy I M
Department of Internal Medicine and Infectious Diseases, University Medical Centre, PO Box 85500, 3508 GA Utrecht, Netherlands.
BMJ. 2006 Dec 9;333(7580):1193. doi: 10.1136/bmj.38993.560984.BE. Epub 2006 Nov 7.
To compare the effectiveness of an early switch to oral antibiotics with the standard 7 day course of intravenous antibiotics in severe community acquired pneumonia.
Multicentre randomised controlled trial.
Five teaching hospitals and 2 university medical centres in the Netherlands.
302 patients in non-intensive care wards with severe community acquired pneumonia. 265 patients fulfilled the study requirements.
Three days of treatment with intravenous antibiotics followed, when clinically stable, by oral antibiotics or by 7 days of intravenous antibiotics.
Clinical cure and length of hospital stay.
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) v 7.0 (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.
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.
Clinical Trials NCT00273676 [ClinicalTrials.gov].
比较在重症社区获得性肺炎中早期换用口服抗生素与标准7天静脉抗生素疗程的疗效。
多中心随机对照试验。
荷兰的五家教学医院和两家大学医学中心。
非重症监护病房的302例重症社区获得性肺炎患者。265例患者符合研究要求。
静脉使用抗生素治疗3天,临床情况稳定后换用口服抗生素或继续静脉使用抗生素7天。
临床治愈情况和住院时间。
302例患者被随机分组(平均年龄69.5岁(标准差14.0),平均肺炎严重程度评分为112.7(26.0))。37例患者因在第3天前提前退出而被排除在分析之外,剩余265例患者进行意向性分析。干预组第28天的死亡率为4%,对照组为6%(平均差异2%,95%置信区间为-3%至8%)。干预组的临床治愈率为83%,对照组为85%(2%,-7%至10%)。干预组的静脉治疗时间和住院时间均缩短,平均差异分别为3.4天(3.6(1.5)天对7.0(2.0)天;2.8至3.9)和1.9天(9.6(5.0)天对11.5(4.9)天;0.6至3.2)。
重症社区获得性肺炎患者早期从静脉抗生素转换为口服抗生素是安全的,并可使住院时间缩短2天。
临床试验NCT00273676 [ClinicalTrials.gov] 。