Handsfield H H, Judson F N, Holmes K K
Antimicrob Agents Chemother. 1981 Nov;20(5):625-9. doi: 10.1128/AAC.20.5.625.
In a randomized, double-blind, dose-ranging study, single oral doses of rosoxacin were used to treat 126 patients with uncomplicated genital or anorectal gonorrhea. Neisseria gonorrhoeae was eradicated from 5 (28%) of 18 men treated with 100 mg, compared with 101 (94%) of 108 men and women treated with 200 mg, 300 mg, or 400 mg (P less than 0.001). Susceptibility to rosoxacin was determined for 6 pretreatment gonococcal isolates from these patients and for 194 stored clinical isolates; 296 (98.7%) of these 300 isolates, including 10 strains of penicillinase-producing N. gonorrhaeae, required a minimal inhibitory concentration of less than or equal to 0.062 microgram/ml. Urethral or cervical infection with Chlamydia trachomatis coexisted with gonococcal infection in 14 (22%) of 63 patients and persisted in 7 of 10 patients treated with rosoxacin. Postgonococcal urethritis developed in 11 (34%) of 32 men who were monitored for 12 to 30 days. Sixty-four subjects (51%) developed transient dizziness, drowsiness, altered visual perceptions, or other symptoms suggestive of central nervous system dysfunction after treatment with rosoxacin, but these symptoms were not clearly dose related. Rosoxacin in doses of greater than or equal to 200 mg appears to be effective for single-dose treatment of uncomplicated gonorrhea, but further studies of its possible central nervous system toxicity are indicated.
在一项随机、双盲、剂量范围研究中,单次口服罗索沙星用于治疗126例无并发症的生殖器或肛门直肠淋病患者。18例接受100mg治疗的男性中,5例(28%)的淋病奈瑟菌被清除,相比之下,108例接受200mg、300mg或400mg治疗的男性和女性中,101例(94%)的淋病奈瑟菌被清除(P小于0.001)。对这些患者的6株治疗前淋病奈瑟菌分离株和194株储存的临床分离株进行了罗索沙星敏感性测定;这300株分离株中的296株(98.7%),包括10株产青霉素酶的淋病奈瑟菌,所需最低抑菌浓度小于或等于0.062微克/毫升。63例患者中有14例(22%)沙眼衣原体尿道或宫颈感染与淋球菌感染并存,在接受罗索沙星治疗的10例患者中,7例感染持续存在。32例接受12至30天监测的男性中有11例(34%)发生了淋菌后尿道炎。64名受试者(51%)在接受罗索沙星治疗后出现短暂头晕、嗜睡、视觉感知改变或其他提示中枢神经系统功能障碍的症状,但这些症状与剂量无明显相关性。剂量大于或等于200mg的罗索沙星似乎对无并发症淋病的单剂量治疗有效,但有必要对其可能的中枢神经系统毒性进行进一步研究。