Mertens J C, van Barneveld P W, Asin H R, Ligtvoet E, Visser M R, Branger T, Hoepelman A I
Elisabeth's Gasthuis, Haarlem, The Netherlands.
Antimicrob Agents Chemother. 1992 Jul;36(7):1456-9. doi: 10.1128/AAC.36.7.1456.
The efficacies and safeties of a three-dose regimen of azithromycin (500 mg once daily for 3 days) and a 15-dose regimen of amoxicillin (500 mg three times daily for 5 days) were compared in a double-blind manner in patients with an acute exacerbation of chronic bronchitis. A total of 92% of patients suffered a type 1 exacerbation. Treatment success, defined as cure or major improvement, was achieved in all patients in the azithromycin group by day 5, compared with 23 (92%) of 25 patients in the amoxicillin group. On day 12, these data were 24 of 25 (96%) in the azithromycin group and 20 of 25 (80%) in the amoxicillin group (results were not significantly different). Several pathogens were isolated (MIC ranges [micrograms per milliliter] in parentheses): Haemophilus influenzae or Haemophilus parainfluenzae was isolated 23 times (azithromycin, less than or equal to 0.06 to 32; amoxicillin, 0.12 to 2); Streptococcus pneumoniae was isolated from 11 patients (azithromcyin, less than or equal to 0.06 greater than 256; amoxicillin, less than or equal to 0.06 to 0.25); Moraxella (Branhamella) catarrhalis was isolated from eight patients (azithromycin, less than or equal to 0.06; amoxicillin, less than or equal to 0.06 to 16); and other members of the family Enterobacteriaceae were isolated from eight patients. One patient treated with azithromycin had Legionella pneumophila pneumonia, and another in that group had a significant rise in titer of antibody against influenza A virus. One patient treated with amoxicillin also had a significant rise in titer of antibody against influenza A virus. Microbiological response rates were comparable. One patient who received azithromycin developed abnormal liver function. Two patients treated with amoxicillin developed abnormal liver functions, one developed exanthema, and one treatment was stopped because of nausea. It is concluded that a three-dose (3-day) regimen of azithromycin is as effective clinically and microbiologically as a 15-dose (5-day) regimen of amoxicillin in the treatment of acute exacerbations of chronic bronchitis.
在慢性支气管炎急性加重期患者中，以双盲方式比较了阿奇霉素三剂量方案（500毫克，每日1次，共3天）和阿莫西林15剂量方案（500毫克，每日3次，共5天）的疗效和安全性。共有92%的患者发生1型加重。阿奇霉素组所有患者在第5天均实现了定义为治愈或显著改善的治疗成功，而阿莫西林组25例患者中有23例（92%）实现了治疗成功。在第12天，阿奇霉素组25例中有24例（96%），阿莫西林组25例中有20例（80%）（结果无显著差异）。分离出几种病原体（括号内为最低抑菌浓度范围[微克/毫升]）：流感嗜血杆菌或副流感嗜血杆菌分离出23次（阿奇霉素，≤0.06至32；阿莫西林，0.12至2）；11例患者分离出肺炎链球菌（阿奇霉素，≤0.06至＞256；阿莫西林，≤0.06至0.25）；8例患者分离出卡他莫拉菌（莫拉菌属[布兰汉菌属]）（阿奇霉素，≤0.06；阿莫西林，≤0.06至16）；8例患者分离出肠杆菌科其他成员。1例接受阿奇霉素治疗的患者发生嗜肺军团菌肺炎，该组另1例患者甲型流感病毒抗体滴度显著升高。1例接受阿莫西林治疗的患者甲型流感病毒抗体滴度也显著升高。微生物学反应率相当。1例接受阿奇霉素治疗的患者出现肝功能异常。2例接受阿莫西林治疗的患者出现肝功能异常，1例出现皮疹，1例因恶心而停药。结论是，在治疗慢性支气管炎急性加重期时，阿奇霉素三剂量（3天）方案在临床和微生物学上与阿莫西林15剂量（5天）方案同样有效。
