Derriennic M, Escande J P
Eli Lilly France, Saint Cloud.
J Antimicrob Chemother. 1993 Mar;31 Suppl C:159-68. doi: 10.1093/jac/31.suppl_c.159.
The efficacy and safety of dirithromycin were compared with those of erythromycin or miocamycin for the treatment of skin and/or skin structure infections in two double-blind, double-dummy, randomized, parallel group, multicentre studies conducted in North America and in Europe, and one single-blind, randomized, parallel group study conducted in Italy. The US and European study patients, in which bacterial infection was confirmed by culture, received either dirithromycin 500 mg once daily or erythromycin base 250 mg four times daily for seven days. Patients in the Italian trial were treated with either 500 mg dirithromycin once daily or with 600 mg miocamycin twice daily for seven days. A total of 156 of the 304 US patients treated with dirithromycin and 127 of the 274 patients treated with erythromycin qualified for efficacy analysis post-therapy. At the post-therapy evaluation, 112 (71.8%) dirithromycin-treated patients were cured and 34 (21.8%) improved compared with 94 (74.0%) and 25 (19.7%) patients treated with erythromycin. The pathogen was eliminated or presumably eliminated in 136 (87.2%) and 110 (86.6%) dirithromycin- and erythromycin-treated patients, respectively. A total of 100 of the 193 dirithromycin-treated patients qualified for efficacy analysis, as did 99 of the 198 erythromycin-treated patients in the European study at post-therapy. Favourable clinical responses (cure or improvement) at the post-therapy visit were recorded in 96 (96.0%) dirithromycin- and 98 (99%) erythromycin-treated patients, and pathogens were eliminated or presumed to have been eliminated in 87 (87.0%) and 88 (88.9%) patients respectively, in the dirithromycin and erythromycin treatment groups. Efficacy analysis was performed in 56 of the 70 Italian patients treated with dirithromycin and in 62 of the 71 patients treated with miocamycin. At post-therapy evaluation, a favourable clinical response was observed in 98.2% of the dirithromycin-treated patients compared with 95.1% of miocamycin-treated patients, whereas a favourable bacteriological response was observed in 52 (92.9%) dirithromycin- and 52 (83.9%) miocamycin-treated patients respectively. In all studies no serious treatment-related events were noted. Events most frequently reported were gastrointestinal in nature. Overall in the three studies, no statistically significant differences were observed between two treatment groups in the clinical and bacteriological outcomes.
在北美和欧洲进行的两项双盲、双模拟、随机、平行组、多中心研究以及在意大利进行的一项单盲、随机、平行组研究中，比较了地红霉素与红霉素或米卡霉素治疗皮肤和/或皮肤结构感染的疗效和安全性。在美国和欧洲的研究中，细菌感染经培养确诊，患者分别接受每日一次500毫克地红霉素或每日四次250毫克红霉素碱治疗，疗程7天。意大利试验中的患者接受每日一次500毫克地红霉素或每日两次600毫克米卡霉素治疗，疗程7天。接受地红霉素治疗的304名美国患者中有156名、接受红霉素治疗的274名患者中有127名符合治疗后疗效分析标准。在治疗后评估中，接受地红霉素治疗的患者有112名（71.8%）治愈，34名（21.8%）病情改善，而接受红霉素治疗的患者分别为94名（74.0%）和25名（19.7%）。地红霉素和红霉素治疗的患者中，病原体分别在136名（87.2%）和110名（86.6%）患者中被清除或推测被清除。在欧洲研究中，接受地红霉素治疗的193名患者中有100名、接受红霉素治疗的198名患者中有99名符合治疗后疗效分析标准。治疗后访视时，接受地红霉素治疗的患者中有96名（96.0%）、接受红霉素治疗的患者中有98名（99%）记录到良好的临床反应（治愈或改善），地红霉素和红霉素治疗组中分别有87名（87.0%）和88名（88.9%）患者的病原体被清除或推测已被清除。接受地红霉素治疗的70名意大利患者中有56名、接受米卡霉素治疗的71名患者中有62名进行了疗效分析。在治疗后评估中，接受地红霉素治疗的患者中有98.2%观察到良好的临床反应，接受米卡霉素治疗的患者中有95.1%观察到良好的临床反应，而接受地红霉素治疗的患者中有52名（92.9%）、接受米卡霉素治疗的患者中有52名（83.9%）观察到良好的细菌学反应。在所有研究中，均未发现严重的治疗相关事件。最常报告的事件为胃肠道性质。总体而言，在三项研究中，两个治疗组在临床和细菌学结果方面未观察到统计学上的显著差异。
