Trial of short-course antimicrobial therapy for intraabdominal infection.
Trial of short-course antimicrobial therapy for intraabdominal infection.
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DOI：
10.1056/nejmoa1411162
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发表时间：
2015-05-21
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影响因子：
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通讯作者：
STOP-IT Trial Investigators
中科院分区：
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作者：
Sawyer RG;Claridge JA;Nathens AB;Rotstein OD;Duane TM;Evans HL;Cook CH;O'Neill PJ;Mazuski JE;Askari R;Wilson MA;Napolitano LM;Namias N;Miller PR;Dellinger EP;Watson CM;Coimbra R;Dent DL;Lowry SF;Cocanour CS;West MA;Banton KL;Cheadle WG;Lipsett PA;Guidry CA;Popovsky K;STOP-IT Trial Investigators
腹腔感染的成功治疗需要解剖学源头控制和抗生素的结合。抗菌治疗的适当持续时间仍不清楚。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为两组，一组接受抗生素治疗，直至发热、白细胞增多和肠梗阻消退后2天，最多治疗10天（对照组），另一组接受固定疗程的抗生素治疗（实验组），持续4±1个日历天。根据治疗组，主要结局是指源控制手术后30天内的患者部位感染、复发性腹腔内感染或死亡的复合终点。次要结果包括治疗持续时间和后续感染率。实验组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，而对照组260例患者中有58例（22.3%）（绝对差异，-0.5个百分点; 95%置信区间[CI]，-7.0至8.0; P = 0.92）。实验组抗生素治疗的中位持续时间为4.0天（四分位距，4.0 ~ 5.0），对照组为8.0天（四分位距，5.0 ~ 10.0）（绝对差异，-4.0天; 95%CI，-4.7 ~-3.3; P<0.001）。在主要结局或其他次要结局的个体发生率方面，未发现组间差异。在接受了适当的源控制程序的腹腔内感染患者中，固定持续时间抗生素治疗（约4天）后的结局与延长至生理异常消退后的更长抗生素疗程（约8天）后的结局相似。（由美国国立卫生研究院资助; STOP-IT ClinicalTrials.gov编号，NCT 00657566。
The successful treatment of intraabdominal infection requires a combination of anatomical source control and antibiotics. The appropriate duration of antimicrobial therapy remains unclear. 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. 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. 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.)