Service de Réanimation Médicale, Université Paris 7-Denis-Diderot, Hôpital Bichat-Claude-Bernard, Assistance Publique-Hôpitaux de Paris, Paris, France.
Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25.
Reduced duration of antibiotic treatment might contain the emergence of multidrug-resistant bacteria in intensive care units. We aimed to establish the effectiveness of an algorithm based on the biomarker procalcitonin to reduce antibiotic exposure in this setting.
In this multicentre, prospective, parallel-group, open-label trial, we used an independent, computer-generated randomisation sequence to randomly assign patients in a 1:1 ratio to procalcitonin (n=311 patients) or control (n=319) groups; investigators were masked to assignment before, but not after, randomisation. For the procalcitonin group, antibiotics were started or stopped based on predefined cut-off ranges of procalcitonin concentrations; the control group received antibiotics according to present guidelines. Drug selection and the final decision to start or stop antibiotics were at the discretion of the physician. Patients were expected to stay in the intensive care unit for more than 3 days, had suspected bacterial infections, and were aged 18 years or older. Primary endpoints were mortality at days 28 and 60 (non-inferiority analysis), and number of days without antibiotics by day 28 (superiority analysis). Analyses were by intention to treat. The margin of non-inferiority was 10%. This trial is registered with ClinicalTrials.gov, number NCT00472667.
Nine patients were excluded from the study; 307 patients in the procalcitonin group and 314 in the control group were included in analyses. Mortality of patients in the procalcitonin group seemed to be non-inferior to those in the control group at day 28 (21.2% [65/307] vs 20.4% [64/314]; absolute difference 0.8%, 90% CI -4.6 to 6.2) and day 60 (30.0% [92/307] vs 26.1% [82/314]; 3.8%, -2.1 to 9.7). Patients in the procalcitonin group had significantly more days without antibiotics than did those in the control group (14.3 days [SD 9.1] vs 11.6 days [SD 8.2]; absolute difference 2.7 days, 95% CI 1.4 to 4.1, p<0.0001).
A procalcitonin-guided strategy to treat suspected bacterial infections in non-surgical patients in intensive care units could reduce antibiotic exposure and selective pressure with no apparent adverse outcomes.
Assistance Publique-Hôpitaux de Paris, France, and Brahms, Germany.
缩短抗生素治疗时间可能会抑制重症监护病房中多重耐药菌的出现。我们旨在确定基于生物标志物降钙素原的算法在这种情况下减少抗生素暴露的有效性。
在这项多中心、前瞻性、平行组、开放标签试验中，我们使用独立的、计算机生成的随机序列将患者以 1:1 的比例随机分配到降钙素原组（n=311 例）或对照组（n=319 例）；在随机分组之前，研究人员对分组情况进行了掩盖，但在分组之后则没有。对于降钙素原组，根据降钙素原浓度的预设截断范围开始或停止抗生素；对照组根据现有指南使用抗生素。药物选择和最终开始或停止抗生素的决定由医生决定。预计患者将在重症监护病房停留超过 3 天，患有疑似细菌感染，年龄在 18 岁及以上。主要终点是第 28 天和第 60 天的死亡率（非劣效性分析），以及第 28 天无抗生素天数（优效性分析）。分析均采用意向治疗。非劣效性边界为 10%。该试验在 ClinicalTrials.gov 注册，编号为 NCT00472667。
9 名患者被排除在研究之外；降钙素原组 307 例，对照组 314 例纳入分析。降钙素原组患者的 28 天死亡率（21.2%[65/307] vs 20.4%[64/314]；绝对差异 0.8%，90%CI-4.6 至 6.2）和 60 天死亡率（30.0%[92/307] vs 26.1%[82/314]；3.8%，-2.1 至 9.7）似乎不劣于对照组。与对照组相比，降钙素原组患者无抗生素天数明显更多（14.3 天[SD 9.1] vs 11.6 天[SD 8.2]；绝对差异 2.7 天，95%CI 1.4 至 4.1，p<0.0001）。
降钙素原指导的治疗策略可减少重症监护病房非手术患者疑似细菌感染的抗生素暴露和选择性压力，且无明显不良后果。
巴黎公立医院集团和德国 Brahms 公司。
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