Aliberti Stefano, Ramirez Julio, Giuliani Fabio, Wiemken Timothy, Sotgiu Giovanni, Tedeschi Sara, Carugati Manuela, Valenti Vincenzo, Marchioni Marco, Camera Marco, Piro Roberto, Del Forno Manuela, Milani Giuseppe, Faverio Paola, Richeldi Luca, Deotto Martina, Villani Massimiliano, Voza Antonio, Tobaldini Eleonora, Bernardi Mauro, Bellone Andrea, Bassetti Matteo, Blasi Francesco
Department of Pathophysiology and Transplantation, University of Milan, Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
University of Louisville, School of Medicine, Department of Medicine, Division of Infectious Diseases, Louisville, KY, United States.
Pulm Pharmacol Ther. 2017 Aug;45:191-201. doi: 10.1016/j.pupt.2017.06.008. Epub 2017 Jun 27.
International experts suggest tailoring antibiotic duration in community-acquired pneumonia (CAP) according to patients' characteristics. We aimed to assess the effectiveness of an individualized approach to antibiotic duration based on time in which CAP patients reach clinical stability during hospitalization. In a multicenter, non-inferiority, randomized, controlled trial hospitalized adult patients with CAP reaching clinical stability within 5 days after hospitalization were randomized to a standard vs. individualized antibiotic duration. In the Individualized group, antibiotics were discontinued 48 h after the patient reached clinical stability, with at least five days of total antibiotic treatment. Early failure within 30 days was the primary composite outcome. 135 patients were randomized to the Standard group and 125 to the Individualized group. The trial was interrupted by the safety committee because of an apparent inferiority of the Individualized group over the Standard treatment: 14 (11.2%) patients in the Individualized group experienced early failure vs. 10 (7.4%) patients in the Standard group, p = 0.200, at the intention-to-treat analysis. 30-day mortality rate was four-time higher in the Individualized group than the Standard group. Shortening antibiotic duration according to patients' characteristics still remains an open question.
国际专家建议根据患者特征调整社区获得性肺炎（CAP）的抗生素使用疗程。我们旨在评估基于CAP患者住院期间达到临床稳定时间的个体化抗生素疗程方法的有效性。在一项多中心、非劣效性、随机对照试验中，将住院后5天内达到临床稳定的成年CAP患者随机分为标准抗生素疗程组和个体化抗生素疗程组。在个体化组中，患者达到临床稳定后48小时停用抗生素，总抗生素治疗时间至少为5天。30天内早期治疗失败是主要的复合结局。135例患者被随机分配到标准组，125例被随机分配到个体化组。由于个体化组相对于标准治疗明显较差，该试验被安全委员会中断：在意向性分析中，个体化组有14例（11.2%）患者出现早期治疗失败，而标准组有10例（7.4%）患者，p = 0.200。个体化组的30天死亡率比标准组高四倍。根据患者特征缩短抗生素疗程仍然是一个悬而未决的问题。
