Law Constance, Amsden Guy W
Section of Clinical Pharmacology, Department of Adult and Pediatric Medicine, and Clinical Pharmacology Research Center, Bassett Healthcare, Cooperstown, NY 13326, USA.
Ann Pharmacother. 2004 Mar;38(3):433-9. doi: 10.1345/aph.1D001. Epub 2004 Jan 23.
To describe the pharmacology, efficacy, and safety data of the use of single-dose azithromycin for respiratory tract infections in children and adults.
A MEDLINE search (1990-September 2003) was performed to identify all pertinent studies and review articles. When appropriate information was not available in the literature, data were obtained from the product manufacturers or abstracts from international conferences.
All available studies were reviewed to provide pharmacokinetic, pharmacodynamic, efficacy, and safety data on use of single-dose azithromycin for respiratory tract infections.
Several studies have demonstrated that shorter regimens of azithromycin (1500 mg over 3 day vs 5 day or single dose vs 3 day) provide higher serum exposures compared with the longer regimens. This makes it possible to give the same dose over a shorter period of time and achieve the same efficacy with the potential for enhanced adherence. Single-dose azithromycin 30 mg/kg was approved in 2003 for treatment of acute otitis media (AOM) in children. Studies have demonstrated that, when administering azithromycin as a single dose, its efficacy and safety are comparable to that of other standard regimens for AOM. Single-dose regimens for treatment of respiratory tract infections in adults have not been studied widely, with only 2 studies being conducted for treatment of community-acquired pneumonia and one study for treatment of tonsillitis; all demonstrated at least equal efficacy with the single-dose regimen compared with comparators given for longer periods of time.
Available data regarding single-dose azithromycin are promising. Although use of this regimen in children is warranted based on studies to date, additional large-scale trials are needed prior to mainstream use of the regimen in adults.
描述单剂量阿奇霉素用于儿童和成人呼吸道感染的药理学、疗效及安全性数据。
进行了MEDLINE检索（1990年至2003年9月）以识别所有相关研究和综述文章。当文献中没有合适信息时，数据从产品制造商处或国际会议摘要中获取。
对所有可得研究进行综述，以提供关于单剂量阿奇霉素用于呼吸道感染的药代动力学、药效学、疗效及安全性数据。
多项研究表明，与较长疗程相比，阿奇霉素的较短疗程（3天内1500毫克对比5天或单剂量对比3天）可提供更高的血清暴露量。这使得能够在更短时间内给予相同剂量并达到相同疗效，且有可能提高依从性。单剂量30毫克/千克的阿奇霉素于2003年被批准用于治疗儿童急性中耳炎（AOM）。研究表明，当将阿奇霉素作为单剂量给药时，其疗效和安全性与其他治疗AOM的标准疗程相当。用于治疗成人呼吸道感染的单剂量疗程尚未得到广泛研究，仅进行了2项治疗社区获得性肺炎的研究和1项治疗扁桃体炎的研究；所有研究均表明，与较长时间给药的对照方案相比，单剂量方案至少具有同等疗效。
关于单剂量阿奇霉素的现有数据很有前景。尽管根据迄今为止的研究，该疗程在儿童中的使用是合理的，但在该疗程在成人中广泛应用之前，还需要进行更多大规模试验。
