Ruggiero G, Utili R, Adinolfi L E, Attanasio V, Scarano M P, Mazzone A, Costa G, Califano L, Costa F
Institute of Medical Therapy, 1st Medical School, University of Naples, Italy.
J Antimicrob Chemother. 1993 Mar;31 Suppl C:103-9. doi: 10.1093/jac/31.suppl_c.103.
A single-blind, randomized, parallel-group study was conducted to compare the efficacy and safety of dirithromycin with miocamycin in the treatment of streptococcal pharyngitis/tonsillitis caused by Group A streptococci. The study population consisted of 60 patients: 30 were randomized to receive 500 mg dirithromycin od and 30 to receive 600 mg miocamycin bd. All 30 dirithromycin-treated patients were eligible for efficacy analysis. A favourable clinical response was observed in 100% of these patients at the post-therapy visit. In the miocamycin-treated group, 28 of 30 (93.3%) patients were eligible for efficacy analysis; a favourable clinical response was observed in 100%. Bacteriological cure of evaluable dirithromycin- and miocamycin-treated patients was 96.7% and 92.9%, respectively. No statistically significant post-therapy differences in clinical or bacteriological response rates were noted between the two groups. Adverse event analysis showed no significant differences between treatment groups. There were no serious adverse events during the study. Two miocamycin-treated patients were prematurely withdrawn from the study due to adverse events (diarrhoea). Analysis of clinical laboratory data revealed no statistically significant differences between the treatment groups that were considered to be drug related. The results of this study suggest that dirithromycin has comparable safety and efficacy to miocamycin in the treatment of streptococcal pharyngitis/tonsillitis infections caused by Group A streptococci.
进行了一项单盲、随机、平行组研究，以比较地红霉素与米卡霉素治疗A组链球菌引起的链球菌性咽炎/扁桃体炎的疗效和安全性。研究人群包括60例患者：30例随机接受每日一次500mg地红霉素治疗，30例接受每日两次600mg米卡霉素治疗。所有30例接受地红霉素治疗的患者均符合疗效分析标准。在治疗后随访时，这些患者中有100%观察到良好的临床反应。在米卡霉素治疗组中，30例患者中有28例（93.3%）符合疗效分析标准；观察到良好临床反应的比例为100%。可评估的接受地红霉素和米卡霉素治疗的患者的细菌学治愈率分别为96.7%和92.9%。两组之间在治疗后临床或细菌学反应率方面未发现统计学上的显著差异。不良事件分析显示治疗组之间无显著差异。研究期间未发生严重不良事件。两名接受米卡霉素治疗的患者因不良事件（腹泻）提前退出研究。临床实验室数据分析显示，治疗组之间在被认为与药物相关的方面没有统计学上的显著差异。这项研究的结果表明，在治疗A组链球菌引起的链球菌性咽炎/扁桃体炎感染方面，地红霉素与米卡霉素具有相当的安全性和疗效。
