Badaró Roberto, Molinar Fernando, Seas Carlos, Stamboulian Daniel, Mendonça João, Massud João, Nascimento Luiz Olympio
University Hospital Professor Edgard Santos, Salvador, BA, Brazil.
Braz J Infect Dis. 2002 Oct;6(5):206-18. doi: 10.1590/s1413-86702002000500001.
The safety and efficacy of cefepime empiric monotherapy compared with standard broad-spectrum combination therapy for hospitalized adult patients with moderate to severe community-acquired bacterial infections were evaluated. In an open-label, multicenter study, 317 patients with an Acute Physiology and Chronic Health Evaluation (APACHE II) score ranging from >5 to =19 were enrolled with documented pneumonia (n=196), urinary tract infection (n=65), intra-abdominal infection (n=38), or sepsis (n=18). Patients were randomly assigned 1:1 to receive cefepime 1 to 2 g IV twice daily or three times a day or IV ampicillin, cephalothin, or ceftriaxone +/-aminoglycoside therapy for 3 to 21 days. For both treatment groups, metronidazole, vancomycin, or macrolide therapy was added as deemed necessary. The primary efficacy variable was clinical response at the end of therapy. Two hundred ninety-six (93%) patients met evaluation criteria and were included in the efficacy analysis. Diagnoses included the following: 180 pneumonias (90 cefepime, 90 comparator), 62 urinary tract infections (29 cefepime, 33 comparator), 37 intra-abdominal infections (19 cefepime, 18 comparator), and 17 sepses (8 cefepime, 9 comparator). At the end of therapy, overall clinical success rates were 131/146 (90%) for patients treated with cefepime vs 125/150 (83%) for those treated with comparator (95% confidence interval [CI]: -2.6% to 16.3%). The clinical success rate for patients with community-acquired pneumonia, the most frequent infection, was 86% for both treatment groups. Among the patients clinically evaluated, 162 pathogens were isolated and identified before therapy. The most commonly isolated pathogens were Escherichia coli (n=49), Streptococcus pneumoniae (n=29), Haemophilus influenzae (n=14), and Staphylococcus aureus (n=11). Bacteriologic eradication/presumed eradication was 97% for cefepime vs 94% for comparator-treated patients. Drug-related adverse events were reported in 16% of cefepime patients and 19% of comparator patients. In conclusion, cefepime had higher cure rates compared with broad-spectrum combination therapy as an initial empiric treatment for hospitalized patients with moderate to severe community-acquired infections, including urinary tract infections, intra-abdominal infections, and sepsis.
评估了头孢吡肟经验性单药治疗与标准广谱联合治疗对中度至重度社区获得性细菌感染的住院成年患者的安全性和有效性。在一项开放标签、多中心研究中，纳入了317例急性生理与慢性健康状况评分（APACHE II）在>5至=19之间的患者，其中记录有肺炎（n = 196）、尿路感染（n = 65）、腹腔内感染（n = 38）或败血症（n = 18）。患者按1:1随机分配，接受每日两次或三次静脉注射1至2 g头孢吡肟，或静脉注射氨苄西林、头孢噻吩或头孢曲松+/-氨基糖苷类治疗3至21天。对于两个治疗组，必要时添加甲硝唑、万古霉素或大环内酯类治疗。主要疗效变量是治疗结束时的临床反应。296例（93%）患者符合评估标准并纳入疗效分析。诊断包括以下几种：180例肺炎（头孢吡肟组90例，对照组合90例）、62例尿路感染（头孢吡肟组29例，对照组合33例）、37例腹腔内感染（头孢吡肟组19例，对照组合18例）和17例败血症（头孢吡肟组8例，对照组合9例）。治疗结束时，头孢吡肟治疗的患者总体临床成功率为131/146（90%），而对照组为125/150（83%）（95%置信区间[CI]：-2.6%至16.3%）。社区获得性肺炎患者（最常见的感染类型）的临床成功率在两个治疗组中均为86%。在接受临床评估的患者中，治疗前分离并鉴定出162种病原体。最常分离出的病原体是大肠埃希菌（n = 49）、肺炎链球菌（n = 29）、流感嗜血杆菌（n = 14）和金黄色葡萄球菌（n = 11）。头孢吡肟治疗患者的细菌清除/假定清除率为97%，而对照组为94%。头孢吡肟组16%的患者和对照组19%的患者报告了与药物相关的不良事件。总之，作为中度至重度社区获得性感染（包括尿路感染、腹腔内感染和败血症）住院患者的初始经验性治疗，头孢吡肟的治愈率高于广谱联合治疗。
