Kumamoto Y, Sakai S, Hirose T, Tsunekawa T, Machida T, Kiyota H, Okazaki T, Kishi H, Higashihara E, Aso Y
Department of Urology, Sapporo Medical College.
Jpn J Antibiot. 1988 Oct;41(10):1445-79.
Efficacy and safety of ofloxacin (OFLX), a new quinolone antibacterial agent, were investigated in cases of sexually transmitted male urethritis and cervicitis. Chlamydial infections occupied a large part of the patients enrolled. This study was conducted in 29 institutions. A total of 1,126 patients with gonococcal, chlamydial or non-gonococcal non-chlamydial infections were enrolled in the study. The general dosing regimen of oral OFLX was 100 mg t.i.d. or 200 mg t.i.d. for 14 consecutive days. Along with the clinical efficacy evaluated by doctors in charge, therapeutic and clinical efficacies were determined according to standardized evaluation criteria. The evaluation of therapeutic efficacy was based on bacterial eradication. On the other hand, clinical efficacy was determined upon the improvement in causative bacteria, WBC counts in smear (or initial urine) specimens and urethra/cervical discharges. Clinical efficacy was determined on 7 and 14 days after starting the medication, except for gonococcal infections for which the efficacy was determined on Day 3 and Day 7. The results obtained are summarized as follows. 1. Efficacy evaluation by standardized criteria Therapeutic efficacy rates in gonococcal infections were 97.9% (93/95) on Day 3 and 100% (119/119) on Day 7. In chlamydial infections, the rates were 77.7% (363/467) on Day 7 and 93.6% (392/419) on Day 14. Chlamydial urethritis rated 94.8% (239/252) and cervicitis 91.6% (153/167) on Day 14. Clinical efficacy rates in gonococcal infections were 63.2% (60/95) on Day 3 and 95.8% (114/119) on Day 7. In chlamydial infections, they were 70.0% (327/467) on Day 7 and 89.7% (376/419) on Day 14. Chlamydial urethritis rated 88.5% (223/252) and cervicitis 91.6% (153/167) on Day 14. Clinical efficacy rates in non-gonococcal non-chlamydial infections were 93.3% (97/104) for male urethritis and 65.9% (27/41) for cervicitis on Day 14. 2. Clinical efficacy determined by doctors in charge A total of 1,028 cases, 752 urethritis and 276 cervicitis cases, was evaluated by doctors in charge. Clinical efficacy rates were 90.3% for urethritis and 92.4% for cervicitis. 3. Safety Safety evaluations was conducted in 1,087 patients. Side effects were observed in 23 patients among them (2.12%). None of them were deemed serious. General laboratory examinations were conducted for 169 patients. Abnormal findings were seen in 11 patients (6.51%) or 13 cases, all of which were minor. The results of this multi-center clinical trial demonstrated that OFLX is effective and well tolerated in the treatment of sexually transmitted disease (STD), both gonococcal and chlamydial infections.
对新型喹诺酮类抗菌剂氧氟沙星（OFLX）治疗男性性传播尿道炎和宫颈炎的疗效及安全性进行了研究。衣原体感染在入组患者中占很大比例。本研究在29个机构进行。共有1126例淋病奈瑟菌、衣原体或非淋病奈瑟菌非衣原体感染患者入组。口服OFLX的一般给药方案为100mg每日3次或200mg每日3次，连续14天。除主管医生评估临床疗效外，还根据标准化评估标准确定治疗和临床疗效。治疗效果评估基于细菌清除情况。另一方面，临床疗效根据病原菌、涂片（或初始尿液）标本中的白细胞计数以及尿道/宫颈分泌物的改善情况来确定。在开始用药后7天和14天确定临床疗效，但淋病奈瑟菌感染在第3天和第7天确定疗效。获得的结果总结如下。1. 标准化标准的疗效评估淋病奈瑟菌感染的治疗有效率在第3天为97.9%（93/95），第7天为100%（119/119）。衣原体感染的有效率在第7天为77.7%（363/467），第14天为93.6%（392/419）。衣原体尿道炎在第14天的有效率为94.8%（239/252），宫颈炎为91.6%（（153/167）。淋病奈瑟菌感染的临床有效率在第3天为63.2%（60/95），第7天为95.8%（114/119）。衣原体感染在第7天为70.0%（327/467），第14天为89.7%（376/419）。衣原体尿道炎在第14天的有效率为88.5%（223/252），宫颈炎为91.6%（153/167）。非淋病奈瑟菌非衣原体感染的临床有效率在第14天男性尿道炎为93.3%（97/104），宫颈炎为65.9%（27/41）。2. 主管医生确定的临床疗效主管医生对总共1028例病例进行了评估，其中752例尿道炎病例和276例宫颈炎病例。尿道炎的临床有效率为90.3%，宫颈炎为92.4%。3. 安全性对1087例患者进行了安全性评估。其中23例患者（2.12%）出现副作用。均不被认为严重。对169例患者进行了一般实验室检查。11例患者（6.51%）或13例出现异常结果，均为轻微异常。这项多中心临床试验的结果表明，OFLX在治疗性传播疾病（STD），包括淋病奈瑟菌和衣原体感染方面有效且耐受性良好。
