O'Doherty B, Dutchman D A, Pettit R, Maroli A
Charlotte Row, Gorey, Co. Wexford, Eire, UK.
J Antimicrob Chemother. 1997 Dec;40 Suppl A:73-81. doi: 10.1093/jac/40.suppl_1.73.
This randomized, multicentre, double-blind, double-dummy study assessed the efficacy and safety of 7 or 10 day regimens of grepafloxacin, 600 mg od, compared with amoxycillin, 500 mg tds, in the treatment of community-acquired pneumonia (CAP). A total of 264 patients were recruited at 43 centres (127 received grepafloxacin and 137 received amoxycillin), of whom 207 patients (78%) completed the study. Clinical and microbiological efficacy were assessed at the end-of-treatment visit (3-5 days after the last dose) and at the follow-up visit (28-42 days after the last dose). At follow-up, patients in the evaluable population treated with grepafloxacin demonstrated a clinical response rate (76%; 87/114) equivalent to that seen with amoxycillin (74%, 85/111, 95% CI = -12%, 10%) while, in the intent-to-treat population with a documented bacterial pathogen, the clinical success rate in the grepafloxacin group (78%, 29/37) was significantly higher than in the amoxycillin group (58%, 28/48), 95% CI = 2%, 43%). In patients from the evaluable population in whom the pathogens were documented the clinical success rate favoured grepafloxacin, compared with amoxycillin (79%, 26/33 versus 63%, 26/42, respectively; 95% CI = -5.2%, 38.1%). Microbiological eradication with grepafloxacin was statistically superior to amoxycillin in the evaluable population; the success rate was 89% (32/36) in the grepafloxacin group compared with 71% (32/45) for the amoxycillin group (95% CI = 2%, 37%). The pathogens most commonly isolated from patients were Haemophilus influenzae, Moraxella catarrhalis and Streptococcus pneumoniae. The success rates for infections caused by S. pneumoniae and H. influenzae at follow-up were higher with grepafloxacin than with amoxycillin. Grepafloxacin was well tolerated, with a safety profile comparable to that of amoxycillin. The therapeutic judgement of patients and investigators at the patient's last visit, as well as the assessment of individual respiratory signs and symptoms, yielded comparable results with both treatments. The results of this study indicate that grepafloxacin, 600 mg od for 7-10 days, is equivalent to or better than amoxycillin, 500 mg tds for 7-10 days in achieving a successful clinical and microbiological response in the treatment of patients with CAP.
这项随机、多中心、双盲、双模拟研究评估了每日一次口服600毫克格帕沙星7天或10天方案与每日三次口服500毫克阿莫西林相比，在治疗社区获得性肺炎（CAP）方面的疗效和安全性。共有43个中心招募了264例患者（127例接受格帕沙星治疗，137例接受阿莫西林治疗），其中207例患者（78%）完成了研究。在治疗结束访视（最后一剂后3 - 5天）和随访访视（最后一剂后28 - 42天）时评估临床和微生物学疗效。在随访时，接受格帕沙星治疗的可评估人群中的患者临床反应率为76%（87/114），与阿莫西林治疗的反应率（74%，85/111，95%可信区间 = -12%，10%）相当；而在意向性治疗人群中，有记录的细菌病原体患者中，格帕沙星组的临床成功率（78%，29/37）显著高于阿莫西林组（58%，28/48），95%可信区间 = 2%，43%）。在可评估人群中记录了病原体的患者中，与阿莫西林相比，临床成功率更倾向于格帕沙星（分别为79%，26/33和63%，26/42；95%可信区间 = -5.2%，38.1%）。在可评估人群中，格帕沙星的微生物清除率在统计学上优于阿莫西林；格帕沙星组的成功率为89%（32/36），而阿莫西林组为71%（32/45）（95%可信区间 = 2%，37%）。从患者中最常分离出的病原体是流感嗜血杆菌、卡他莫拉菌和肺炎链球菌。随访时，由肺炎链球菌和流感嗜血杆菌引起的感染，格帕沙星的成功率高于阿莫西林。格帕沙星耐受性良好，安全性与阿莫西林相当。患者和研究者在患者最后一次访视时的治疗判断以及对个体呼吸体征和症状的评估，两种治疗方法得出了类似的结果。本研究结果表明，每日一次口服600毫克格帕沙星7 - 10天在治疗CAP患者时，在实现成功的临床和微生物学反应方面等同于或优于每日三次口服500毫克阿莫西林7 - 10天。
