Fornaseri C, Carbone V, Giangrandi D, Giordano M, Mortellaro C
Dipartimento di Scienze Cliniche e Biologiche, Università degli Studi, Torino.
Minerva Stomatol. 1997 Dec;46(12):693-9.
Rokitamycin is a semisynthetic macrolide with a lactonic ring with 16 atoms, showing anti-bacterial action at concentrations near to MIC. A controlled clinical study is carried out, in parallel groups, whose aim was to assess the therapeutic action and safety of two dosage schemes of rokitamycin, in the short term treatment (5 days) of acute infective processes of odontostomatological origin.
Twenty patients (14 males, 6 females) were recruited for the trial, suffering from alveolitis, abscess, phlegmon, sialadenitis and suppurating cysts. The patients were divided in a randomized fashion into two groups: 10 patients were treated orally with 800 mg/day and 10 with 1200 mg/day. Rokitamycin was supplied in 400 mg tablets.
The 5 days of treatment with rokitamycin determined the complete resolution of the infective process, with eradication of the germs originally isolated, all belonging to the Streptococcus genus. Clinical efficacy was evident by the third day of treatment, with a prompt improvement of symptoms (functional limitation, pain, tumefaction) and the return of body temperature to within normal limits, in a totally superimposable fashion between the two groups. Safety was excellent with both doses, with no side effects observed.
The results of the study show that treatment with rokitamycin in the short term, at the usual dosage of 800 mg/day, is a valid therapeutic scheme in infective processes in odontostomatology.
罗他霉素是一种具有16元内酯环的半合成大环内酯类抗生素，在接近最低抑菌浓度时显示抗菌作用。本研究采用平行组对照临床研究，旨在评估罗他霉素两种给药方案在治疗口腔颌面部急性感染性疾病（疗程5天）中的疗效和安全性。
招募了20名患者（14名男性，6名女性），患有牙槽炎、脓肿、蜂窝织炎、涎腺炎和化脓性囊肿。患者被随机分为两组：10名患者口服800毫克/天，10名患者口服1200毫克/天。罗他霉素以400毫克片剂形式提供。
罗他霉素治疗5天使感染过程完全消退，最初分离出的所有细菌（均属于链球菌属）被根除。治疗第三天临床疗效明显，症状（功能受限、疼痛、肿胀）迅速改善，体温恢复正常，两组情况完全相同。两种剂量的安全性都很好，未观察到副作用。
研究结果表明，罗他霉素以800毫克/天的常用剂量进行短期治疗，是口腔颌面部感染性疾病的有效治疗方案。
