Phillips H, Van Hook C J, Butler T, Todd W M
Columbiana Clinic of Family Medicine, Ala.
Chest. 1993 Nov;104(5):1387-92. doi: 10.1378/chest.104.5.1387.
In this multicenter, observer-blinded study, 301 patients with signs and symptoms of acute bacterial exacerbation of COPD were randomized (2:1) to receive either cefpodoxime proxetil (200 mg, bid) or cefaclor (250 mg, tid) for 10 days. Clinical and microbiologic evaluations were performed before treatment, during therapy (study days 3 to 5), at the end of therapy (3 to 7 days posttreatment), and at long-term follow-up (4 weeks posttreatment). The most common pretreatment isolates were Haemophilus influenzae, Haemophilus parainfluenzae, and Streptococcus pneumoniae. Significantly (p < 0.001) more bacterial isolates were susceptible in vitro to cefpodoxime (233 of 256, 91 percent) than to cefaclor (215 of 255, 84 percent). There were no statistically significant differences between the two drug regimens in eradication of the initial pathogen (cefpodoxime, 116 of 128, 91 percent; cefaclor, 59 of 64, 92 percent) or end-of-therapy clinical response (cure + proved; cefpodoxime, 99 of 100, 99 percent; cefaclor, 45 of 49, 92 percent) rates for evaluable patients. Both drug treatments were well-tolerated, with a similar incidence of drug-related adverse events (cefpodoxime 11 percent, cefaclor 12 percent). Cefpodoxime (bid) was as safe and effective as cefaclor (tid) in the treatment of acute exacerbation of COPD. The less frequent dosing regimen of cefpodoxime may improve patient compliance compared to those antibiotics that require three or four daily doses.
在这项多中心、观察者盲法研究中,301例有慢性阻塞性肺疾病急性细菌性加重体征和症状的患者被随机分组(2:1),接受头孢泊肟酯(200毫克,每日两次)或头孢克洛(250毫克,每日三次)治疗10天。在治疗前、治疗期间(研究第3至5天)、治疗结束时(治疗后3至7天)以及长期随访(治疗后4周)进行临床和微生物学评估。治疗前最常见的分离菌株是流感嗜血杆菌、副流感嗜血杆菌和肺炎链球菌。体外对头孢泊肟敏感的细菌分离株(256株中的233株,91%)显著多于对头孢克洛敏感的(255株中的215株,84%)(p<0.001)。在可评估患者中,两种药物方案在根除初始病原体(头孢泊肟,128例中的116例,91%;头孢克洛,64例中的59例,92%)或治疗结束时的临床反应(治愈+证实;头孢泊肟,100例中的99例,99%;头孢克洛,49例中的45例,92%)率方面无统计学显著差异。两种药物治疗耐受性良好,药物相关不良事件发生率相似(头孢泊肟11%,头孢克洛12%)。头孢泊肟(每日两次)在治疗慢性阻塞性肺疾病急性加重方面与头孢克洛(每日三次)一样安全有效。与那些需要每日三次或四次给药的抗生素相比,头孢泊肟给药频率较低的方案可能会提高患者的依从性。