Echols R M, Heyd A, O'Keeffe B J, Schacht P
Miles Inc., Pharmaceutical Division, West Haven, Connecticut 06516.
Sex Transm Dis. 1994 Nov-Dec;21(6):345-52. doi: 10.1097/00007435-199411000-00009.
Antibiotic therapy for Neisseria gonorrhoeae infections has evolved owing to the development of resistance to penicillin and tetracycline therapy. A variety of antimicrobials, including the fluoroquinolones, have been proposed as useful alternatives.
To evaluate the efficacy and safety of oral ciprofloxacin as single-dose treatment for urogenital and extragenital gonococcal infections.
1180 patients with uncomplicated gonococcal infection received single-dose ciprofloxacin regimens ranging from 100 mg to 2000 mg to demonstrate microbiologic efficacy and to determine the minimum effective dose. Eight of 18 studies were randomized, controlled trials with ampicillin/probenecid, amoxicillin/probenecid, ceftriaxone, or spectinomycin as control drugs.
Although a ciprofloxacin dose-response was not detected, 250 mg was used in most of the studies. Among 815 patients with 910 infected sites receiving 250 mg of ciprofloxacin, bacteriologic eradication was achieved in 563 (100%) male urethral, 199 (100%) female cervical, 101 (99%) male and female rectal, and 47 (96%) male and female pharyngeal sites.
Although the World Health Organization and the Centers for Disease Control and Prevention have identified 500 mg of ciprofloxacin as a single-dose treatment regimen for uncomplicated gonorrhea, the clinical data from the multinational studies indicate that a 250-mg single-dose of ciprofloxacin is equally effective in the management of uncomplicated gonorrhea, including extragenital sites of infection.
由于淋病奈瑟菌对青霉素和四环素治疗产生耐药性,淋病感染的抗生素治疗方法不断演变。包括氟喹诺酮类在内的多种抗菌药物已被提议作为有效的替代药物。
评估口服环丙沙星单剂量治疗泌尿生殖系统和生殖系统外淋病感染的疗效和安全性。
1180例无并发症淋病感染患者接受了100毫克至2000毫克不等的单剂量环丙沙星治疗方案,以证明微生物学疗效并确定最低有效剂量。18项研究中有8项为随机对照试验,以氨苄西林/丙磺舒、阿莫西林/丙磺舒、头孢曲松或大观霉素作为对照药物。
虽然未检测到环丙沙星的剂量反应,但大多数研究使用的剂量为250毫克。在815例有910个感染部位的患者中,接受250毫克环丙沙星治疗,男性尿道感染的细菌清除率为563例(100%),女性宫颈感染为199例(100%),男性和女性直肠感染为101例(99%),男性和女性咽部感染为47例(96%)。
虽然世界卫生组织和疾病控制与预防中心已确定500毫克环丙沙星为无并发症淋病的单剂量治疗方案,但多国研究的临床数据表明,250毫克单剂量环丙沙星在治疗无并发症淋病(包括生殖系统外感染部位)方面同样有效。