Arcieri G, Griffith E, Gruenwaldt G, Heyd A, O'Brien B, Becker N, August R
Am J Med. 1987 Apr 27;82(4A):381-6.
This report presents the results of 146 clinical trials of the oral form of ciprofloxacin, a new quinolone antimicrobial agent active against a broad spectrum of gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and methicillin-resistant strains of staphylococci. The safety of ciprofloxacin was assessed in 2,829 patients, most of whom were treated in the United States, and the analysis of efficacy was based on data from 3,981 patients evaluated through June 1986. In general, the patients received ciprofloxacin at a dosage of 250 to 750 mg every 12 hours; the median dose was 500 mg twice daily. Dose-ranging studies in male patients with urinary tract infections indicated that a regimen of 500 or 750 mg twice daily was not substantially more effective than a regimen of 250 mg twice daily. Forty-four double-blind, controlled trials were conducted to compare the efficacy and safety of oral ciprofloxacin with those of standard therapeutic agents in the treatment of infections of the urinary tract, skin and skin structure, respiratory tract, and bone. Ciprofloxacin at 250 mg twice daily was as effective as trimethoprim/sulfamethoxazole at 160/800 mg twice daily in the treatment of urinary tract infections. Orally administered ciprofloxacin in a regimen of 750 mg twice daily was shown to be as effective as cefotaxime administered intravenously at 2 g three times daily in the treatment of infections of the skin and skin structure. When compared with ampicillin for the treatment of respiratory tract infections, ciprofloxacin was as effective in resolving or improving markedly the signs and symptoms of infection and eradicated a higher percentage of causative organisms. Adverse reactions considered probably or possibly related to the drug were reported for 16.2 percent of the patients treated; most were of only mild or moderate intensity and resolved after therapy was completed. Emergence of resistant organisms associated with ciprofloxacin therapy has been reported infrequently.
本报告介绍了146项口服环丙沙星的临床试验结果。环丙沙星是一种新型喹诺酮类抗菌药物，对多种革兰氏阴性菌和革兰氏阳性菌均有活性，包括铜绿假单胞菌和耐甲氧西林葡萄球菌菌株。对2829例患者评估了环丙沙星的安全性，其中大多数患者在美国接受治疗，疗效分析基于截至1986年6月评估的3981例患者的数据。一般来说，患者每12小时接受250至750毫克环丙沙星治疗；中位剂量为每日两次，每次500毫克。对男性尿路感染患者进行的剂量范围研究表明，每日两次500或750毫克的治疗方案并不比每日两次250毫克的治疗方案更有效。进行了44项双盲对照试验，以比较口服环丙沙星与标准治疗药物在治疗尿路感染、皮肤及皮肤结构感染、呼吸道感染和骨感染方面的疗效和安全性。每日两次250毫克的环丙沙星在治疗尿路感染方面与每日两次160/800毫克的甲氧苄啶/磺胺甲恶唑疗效相当。每日两次750毫克口服环丙沙星在治疗皮肤及皮肤结构感染方面与每日三次静脉注射2克头孢噻肟疗效相当。与氨苄西林相比，环丙沙星在治疗呼吸道感染时，在缓解或显著改善感染体征和症状方面同样有效，且根除致病微生物的比例更高。接受治疗的患者中有16.2%报告了可能或可能与药物相关的不良反应；大多数不良反应仅为轻度或中度，治疗结束后症状缓解。与环丙沙星治疗相关的耐药菌出现情况鲜有报道。
