Solera J, Espinosa A, Martínez-Alfaro E, Sánchez L, Geijo P, Navarro E, Escribano J, Fernández J A
Department of Medicine, Albacete General Hospital, Spain.
Antimicrob Agents Chemother. 1997 Jan;41(1):80-4. doi: 10.1128/AAC.41.1.80.
The objective of the present prospective, noncomparative, multicenter study was assess the safety and efficacy of gentamicin and doxycycline therapy for human brucellosis. In the first part of the study, a cohort of 17 patients received 100 mg of doxycycline (or 50 mg/kg of body weight per day if the body weight was < 40 kg) orally every 12 h for 45 days (cohort 1). In the second part of the study a subsequent cohort of 35 patients was treated with doxycycline at the same dosage for 30 days (cohort 2). All patients were treated intramuscularly with gentamicin at 240 mg (or 5 mg/kg per day if the body weight was < 50 kg) once daily for the first 7 days. Both cohorts showed a favorable response during therapy, and there were no therapeutic failures. Relapse was noted in 1 (5.9%; 95% confidence interval [95% CI], 0.15 to 28.7%) of the 17 patients in cohort 1 and in 8 (22.9%; 95% CI, 10.4 to 40.1%) of the 35 patients in cohort 2. Nineteen patients (36.5%; 95% CI, 23.6 to 51.0%) had adverse effects, with no differences between cohorts, and no patients had a treatment-limiting adverse effect. The study indicates that the combination of doxycycline for 45 days and gentamicin for 7 days is an effective and well-tolerated therapy for human brucellosis. The relapse rates obtained with doxycycline treatment for 30 days appear to be higher than those obtained with doxycycline treatment for 45 days.
本前瞻性、非对照、多中心研究的目的是评估庆大霉素和多西环素治疗人类布鲁氏菌病的安全性和有效性。在研究的第一部分,一组17例患者每12小时口服100毫克多西环素(若体重<40千克,则每天口服50毫克/千克体重),持续45天(第1组)。在研究的第二部分,随后一组35例患者接受相同剂量的多西环素治疗30天(第2组)。所有患者在治疗的前7天每天一次肌肉注射240毫克庆大霉素(若体重<50千克,则每天注射5毫克/千克)。两组在治疗期间均显示出良好的反应,且无治疗失败病例。第1组17例患者中有1例(5.9%;95%置信区间[95%CI],0.15至28.7%)复发,第2组35例患者中有8例(22.9%;95%CI,10.4至40.1%)复发。19例患者(36.5%;95%CI,23.6至51.0%)出现不良反应,两组之间无差异,且无患者出现限制治疗的不良反应。该研究表明,45天的多西环素与7天的庆大霉素联合使用是治疗人类布鲁氏菌病的一种有效且耐受性良好的疗法。30天多西环素治疗的复发率似乎高于45天多西环素治疗的复发率。