腹腔内感染的短程抗菌治疗
Short-Course Antimicrobial Therapy for Intraabdominal Infection.
作者信息
Guidry Christopher A, Sawyer Robert G
出版信息
N Engl J Med. 2015 Oct 15;373(16):1578. doi: 10.1056/NEJMc1508694.
BACKGROUND
The successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics. The appropriate duration of antimicrobial therapy remains unclear.
METHODS
We randomly assigned 518 patients with complicated intraabdominal infection and adequate source control to receive antibiotics until 2 days after the resolution of fever, leukocytosis, and ileus, with a maximum of 10 days of therapy (control group), or to receive a fixed course of antibiotics (experimental group) for 4±1 calendar days. The primary outcome was a composite of surgical-site infection, recurrent intraabdominal infection, or death within 30 days after the index source-control procedure, according to treatment group. Secondary outcomes included the duration of therapy and rates of subsequent infections.
RESULTS
Surgical-site infection, recurrent intraabdominal infection, or death occurred in 56 of 257 patients in the experimental group (21.8%), as compared with 58 of 260 patients in the control group (22.3%) (absolute difference, −0.5 percentage point; 95% confidence interval [CI], −7.0 to 8.0; P = 0.92). The median duration of antibiotic therapy was 4.0 days (interquartile range, 4.0 to 5.0) in the experimental group, as compared with 8.0 days (interquartile range, 5.0 to 10.0) in the control group (absolute difference, −4.0 days; 95% CI, −4.7 to −3.3; P<0.001). No significant between-group differences were found in the individual rates of the components of the primary outcome or in other secondary outcomes.
CONCLUSIONS
In patients with intraabdominal infections who had undergone an adequate source-control procedure, the outcomes after fixed-duration antibiotic therapy (approximately 4 days) were similar to those after a longer course of antibiotics (approximately 8 days) that extended until after the resolution of physiological abnormalities. (Funded by the National Institutes of Health; STOP-IT ClinicalTrials.gov number, NCT00657566.)
背景
腹腔内感染的成功治疗需要解剖学源头控制与抗生素联合使用。抗菌治疗的合适疗程仍不明确。
方法
我们将518例复杂性腹腔内感染且源头控制充分的患者随机分组，一组接受抗生素治疗直至发热、白细胞增多和肠梗阻症状消退后2天，最长治疗10天（对照组），另一组接受固定疗程的抗生素治疗（试验组），为期4±1个日历日。主要结局是根据治疗组情况，在首次源头控制手术后30天内发生手术部位感染、复发性腹腔内感染或死亡的复合情况。次要结局包括治疗疗程及后续感染发生率。
结果
试验组257例患者中有56例（21.8%）发生手术部位感染、复发性腹腔内感染或死亡，对照组260例患者中有58例（22.3%）发生（绝对差异为−0.5个百分点；95%置信区间[CI]为−7.0至8.0；P = 0.92）。试验组抗生素治疗的中位疗程为4.0天（四分位间距为4.0至5.0），对照组为8.0天（四分位间距为5.0至10.0）（绝对差异为−4.0天；95%CI为−4.7至−3.3；P<0.001）。在主要结局各组成部分的个体发生率或其他次要结局方面，未发现组间有显著差异。
结论
在已接受充分源头控制手术的腹腔内感染患者中，固定疗程（约4天）抗生素治疗的结局与延长至生理异常消退后的较长疗程（约8天）抗生素治疗的结局相似。（由美国国立卫生研究院资助；STOP - IT临床试验注册号，NCT00657566）
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