Crabbé F, Grobbelaar T M, van Dyck E, Dangor Y, Laga M, Ballard R C
Intervention Unit, Institute of Tropical Medicine, Antwerp, Belgium.
Genitourin Med. 1997 Dec;73(6):506-9. doi: 10.1136/sti.73.6.506.
To reassess the in vivo and in vitro efficacy of cefaclor for the treatment of uncomplicated gonococcal infection.
Open clinical trail conducted in South Africa among consecutive male patients with symptoms and signs of uncomplicated urethritis and laboratory evidence of gonorrhoea.
Patients were treated with 3 g of cefaclor plus 1 g probenecid as a single dose. Urethral specimens were cultured for Neisseria gonorrhoeae at the initial visit and at follow up. Patients were considered cured if follow up cultures were negative. Treatment was considered to have failed in the patients infected with identical gonococcal strains at the initial and at the control visit. Those with evidence of infection at the follow up visit were administered 400 mg of ofloxacin and doxycycline 100 mg twice daily for 7 days. Minimal inhibitory concentrations (MICs) of cefaclor were determined by an agar dilution technique on the gonococcal isolates from the study subjects. The results were compared with those of isolates from three other African countries.
Of 155 patients evaluated, 151 were cured (97%). Thirty per cent of the patients complained of adverse effects, mainly gastrointestinal. Even though MICs for the isolates from the three other African countries were significantly higher than those for the isolates from the study, none was considered resistant to cefaclor in vitro. MICs were markedly influenced by the type of test medium used.
The trial demonstrated the efficacy of a single oral dose of cefaclor with probenecid for the treatment of uncomplicated gonococcal urethritis in South Africa. Its potential as an alternative therapy to third generation cephalosporins deserves to be further investigated.
重新评估头孢克洛治疗单纯性淋菌感染的体内和体外疗效。
在南非对连续的有单纯性尿道炎症状和体征且有淋病实验室证据的男性患者进行开放性临床试验。
患者接受3克头孢克洛加1克丙磺舒单剂量治疗。在初诊和随访时采集尿道标本培养淋病奈瑟菌。如果随访培养结果为阴性,则认为患者治愈。在初诊和对照访视时感染相同淋菌菌株的患者,若治疗失败,则对随访时有感染证据的患者给予400毫克氧氟沙星和100毫克强力霉素,每日两次,共7天。采用琼脂稀释技术测定研究对象淋菌分离株对头孢克洛 的最低抑菌浓度(MIC)。将结果与其他三个非洲国家的分离株结果进行比较。
在评估的155例患者中,151例治愈(97%)。30%的患者抱怨有不良反应,主要是胃肠道反应。尽管其他三个非洲国家分离株的MIC显著高于研究中的分离株,但在体外均未发现对头孢克洛耐药。MIC受所用测试培养基类型的显著影响。
该试验证明在南非单剂量口服头孢克洛加丙磺舒治疗单纯性淋菌性尿道炎有效。其作为第三代头孢菌素替代疗法的潜力值得进一步研究。