Adam D
Dr. von Haunersches Kinderspital, Universität München, Germany.
Infection. 1993 Jul-Aug;21(4):265-71. doi: 10.1007/BF01728910.
This Phase III, double-blind, randomized, multicenter study compared the safety and efficacy of clarithromycin, 250 mg b.i.d. administered for either 5 or 10 days, in the treatment of 221 adult patients with purulent bronchitis. Clinical evaluations were performed pre-treatment, during treatment, post-treatment, and at a follow-up visit. Both regimens were well tolerated and effective. No significant differences were observed between patients treated for 5 days and those treated for 10 days in post-treatment, clinical success (98%, 83/85; 99%, 73/74, respectively), or bacterial eradication (100%, 37/37; 94%, 33/35) rates, or in the number of patients reporting drug-related adverse events (16%, 18/112; 24%, 26/109, respectively). Clarithromycin administered for 5 days was at least as safe and as effective as a 10-day regimen in the treatment of purulent bronchitis.
这项III期、双盲、随机、多中心研究比较了250毫克每日两次、给药5天或10天的克拉霉素治疗221例成年化脓性支气管炎患者的安全性和疗效。在治疗前、治疗期间、治疗后以及随访时进行了临床评估。两种治疗方案耐受性良好且有效。治疗5天的患者和治疗10天的患者在治疗后临床成功率（分别为98%，83/85；99%，73/74）、细菌清除率（分别为100%，37/37；94%，33/35）或报告药物相关不良事件的患者数量（分别为16%，18/112；24%，26/109）方面均未观察到显著差异。在治疗化脓性支气管炎方面，5天给药的克拉霉素至少与10天治疗方案一样安全有效。
