Siquier B, Sánchez-Alvarez J, García-Mendez E, Sabriá M, Santos J, Pallarés R, Twynholm M, Dal-Ré R
Emergency Room, Hospital Son Dureta, Palma de Mallorca, Spain.
J Antimicrob Chemother. 2006 Mar;57(3):536-45. doi: 10.1093/jac/dki480. Epub 2006 Jan 30.
This randomized, double-blind, non-inferiority trial evaluated the efficacy and safety of pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg twice daily versus amoxicillin/clavulanate 875/125 mg three times daily, both given orally for 7 or 10 days, in the treatment of adults with community-acquired pneumonia in Spain, a country with a high prevalence of penicillin-resistant Streptococcus pneumoniae.
Following 2:1 randomization, 566 patients (intent-to-treat population) received either amoxicillin/clavulanate 2000/125 mg (n = 374) or amoxicillin/clavulanate 875/125 mg (n = 192).
Among the patients who did not deviate from the protocol (clinical per-protocol population), clinical success at day 21-28 post-therapy (test of cure; primary efficacy endpoint) was 92.4% (266/288) for amoxicillin/clavulanate 2000/125 mg and 91.2% (135/148) for amoxicillin/clavulanate 875/125 mg (treatment difference, 1.1; 95% confidence interval, -4.4, 6.6). Bacteriological success at test of cure in the bacteriology per-protocol population was 90.8% (79/87) with amoxicillin/clavulanate 2000/125 mg and 86.0% (43/50) with amoxicillin/clavulanate 875/125 mg (treatment difference 4.8; 95% confidence interval, -6.6, 16.2). At test of cure, amoxicillin/clavulanate 2000/125 mg was clinically and bacteriologically effective against 7/7 penicillin-resistant Streptococcus pneumoniae (MIC > or = 2 mg/L) isolates (including three amoxicillin non-susceptible strains) and amoxicillin/clavulanate 875/125 mg against 5/5 isolates (including one amoxicillin non-susceptible strain).
Both treatment regimens were well tolerated. Amoxicillin/clavulanate 2000/125 mg was at least as effective clinically and as safe as amoxicillin/clavulanate 875/125 mg in the treatment of community-acquired pneumonia in adults in a country with a high prevalence of penicillin-resistant S. pneumoniae and has a more convenient twice daily posology.
本随机、双盲、非劣效性试验评估了每日两次口服给予药代动力学增强型阿莫西林/克拉维酸2000/125毫克与每日三次口服给予阿莫西林/克拉维酸875/125毫克，两种给药方式均持续7或10天，在西班牙治疗社区获得性肺炎成人患者的疗效和安全性。西班牙是肺炎链球菌青霉素耐药率较高的国家。
按照2:1随机分组，566例患者（意向性治疗人群）接受了阿莫西林/克拉维酸2000/125毫克（n = 374）或阿莫西林/克拉维酸875/125毫克（n = 192）治疗。
在未偏离方案的患者（临床符合方案人群）中，治疗后第21 - 28天的临床成功率（治愈试验；主要疗效终点），阿莫西林/克拉维酸2000/125毫克组为92.4%（266/288），阿莫西林/克拉维酸875/125毫克组为91.2%（135/148）（治疗差异为1.1；95%置信区间为 - 4.4, 6.6）。在细菌学符合方案人群的治愈试验中，阿莫西林/克拉维酸2000/125毫克的细菌学成功率为90.8%（79/87），阿莫西林/克拉维酸875/125毫克为86.0%（43/50）（治疗差异为4.8；95%置信区间为 - 6.6, 16.2）。在治愈试验中，阿莫西林/克拉维酸2000/125毫克对7/7株青霉素耐药肺炎链球菌（MIC≥2毫克/升）分离株（包括3株阿莫西林不敏感菌株）具有临床和细菌学疗效，阿莫西林/克拉维酸875/125毫克对5/5株分离株（包括1株阿莫西林不敏感菌株）具有疗效。
两种治疗方案耐受性均良好。在肺炎链球菌青霉素耐药率较高的国家，治疗成人社区获得性肺炎时，阿莫西林/克拉维酸2000/125毫克在临床疗效上至少与阿莫西林/克拉维酸875/125毫克相当，且安全性良好，并且每日两次给药方案更方便。
