Müller O, Wettich K
Lilly Deutschland GmbH, Bad Homburg, Germany.
J Antimicrob Chemother. 1993 Mar;31 Suppl C:97-102. doi: 10.1093/jac/31.suppl_c.97.
A total of 193 patients with streptococcal pharyngitis/tonsillitis received 500 mg dirithromycin once daily and 196 patients 250 mg erythromycin four times daily for ten days in a double-blind, parallel-group multicentre study. In the dirithromycin treatment group, 97 (50.3%) patients completed the study and were evaluated for efficacy analysis, and 99/196 (50.5%) erythromycin-treated were evaluated for efficacy of treatment. Favourable clinical responses to treatment (cure or improvement of symptoms) at the post-therapy visit (three to five days after therapy completion) occurred in 89 (91.7%) dirithromycin- and 93 (93.9%) erythromycin-treated patients. Bacteriological response was favourable (pathogen eliminated in 81 (83.5%) dirithromycin- and 87 (87.9%) erythromycin-treated patients. At late post-therapy (three to five weeks after treatment) 82/89 (92.1%) dirithromycin- and 90/93 (96.8%) erythromycin-treated patients had a favourable clinical response. Bacteriological response at late post-therapy was favourable in 77 (86.5%) dirithromycin- and 85 (94.4%) erythromycin-treated patients. No deaths occurred during or after treatment, and the serious events experienced by three dirithromycin- and one erythromycin-treated patients were unrelated to treatment. Five patients taking dirithromycin and seven taking erythromycin discontinued treatment prematurely, mainly due to gastrointestinal disturbances. Adverse events that occurred in 2% or more of patients in each treatment group were mainly gastrointestinal (diarrhoea, abdominal pain, nausea and vomiting); headache and rash were also reported. No significant differences in clinical laboratory data were detected that were considered to be drug-related.
在一项双盲、平行组多中心研究中，193例链球菌性咽炎/扁桃体炎患者每日一次接受500毫克地红霉素治疗，196例患者每日四次接受250毫克红霉素治疗，疗程为十天。在地红霉素治疗组中，97例（50.3%）患者完成研究并接受疗效分析，196例接受红霉素治疗的患者中有99例（50.5%）接受了治疗疗效评估。治疗后访视（治疗完成后三至五天）时，89例（91.7%）接受地红霉素治疗和93例（93.9%）接受红霉素治疗的患者对治疗有良好的临床反应（症状治愈或改善）。细菌学反应良好（81例（83.5%）接受地红霉素治疗和87例（87.9%）接受红霉素治疗的患者病原体被清除）。治疗后期（治疗后三至五周），82/89（92.1%）接受地红霉素治疗和90/93（96.8%）接受红霉素治疗的患者有良好的临床反应。治疗后期细菌学反应良好的患者在地红霉素治疗组中有77例（86.5%），在红霉素治疗组中有85例（94.4%）。治疗期间及治疗后均未发生死亡，3例接受地红霉素治疗和1例接受红霉素治疗的患者所经历的严重事件与治疗无关。5例服用地红霉素和7例服用红霉素的患者提前终止治疗，主要原因是胃肠道不适。每个治疗组中2%或更多患者发生的不良事件主要是胃肠道方面的（腹泻、腹痛、恶心和呕吐）；也有头痛和皮疹的报告。未检测到被认为与药物相关的临床实验室数据有显著差异。
