Saha Debasish, Karim Mohammad M, Khan Wasif A, Ahmed Sabeena, Salam Mohammed A, Bennish Michael L
International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.
N Engl J Med. 2006 Jun 8;354(23):2452-62. doi: 10.1056/NEJMoa054493.
Single-dose azithromycin is effective in the treatment of severe cholera in children, but its effectiveness in adults has not been evaluated.
We conducted a double-blind, randomized trial comparing the equivalence of azithromycin and ciprofloxacin (each given in a single 1-g dose of two 500-mg tablets) among 195 men with severe cholera caused by Vibrio cholerae O1 or O139. Patients were hospitalized for five days. A stool culture was performed daily. Primary outcome measures were clinical success (the cessation of watery stools within 48 hours after drug administration) and bacteriologic success (the inability to isolate V. cholerae after 48 hours).
Therapy was clinically successful in 71 of 97 patients receiving azithromycin (73 percent) and in 26 of 98 patients receiving ciprofloxacin (27 percent) (P<0.001) and bacteriologically successful in 76 of 97 patients receiving azithromycin (78 percent) and in 10 of 98 patients receiving ciprofloxacin (10 percent) (P<0.001). Patients who were treated with azithromycin had a shorter duration of diarrhea than did patients treated with ciprofloxacin (median, 30 vs. 78 hours); a lower frequency of vomiting (43 percent vs. 67 percent); fewer stools (median, 36 vs. 52); and a lower stool volume (median, 114 vs. 322 ml per kilogram of body weight). The median minimal inhibitory concentration of ciprofloxacin for the 177 isolates of V. cholerae O1 was 0.25 mug per milliliter, which was 11 to 83 times as high as that in previous studies at this site.
Single-dose azithromycin was effective in the treatment of severe cholera in adults. The lack of efficacy of ciprofloxacin may result from its diminished activity against V. cholerae O1 strains currently circulating in Bangladesh. (ClinicalTrials.gov number, NCT00229944.).
单剂量阿奇霉素对治疗儿童重症霍乱有效，但在成人中的有效性尚未得到评估。
我们进行了一项双盲随机试验，比较阿奇霉素和环丙沙星（均单次给予1g剂量，即两片500mg片剂）对195例由霍乱弧菌O1或O139引起的重症霍乱男性患者的等效性。患者住院5天。每天进行粪便培养。主要结局指标为临床成功（给药后48小时内水样便停止）和细菌学成功（48小时后无法分离出霍乱弧菌）。
97例接受阿奇霉素治疗的患者中有71例临床治疗成功（73%），98例接受环丙沙星治疗的患者中有26例临床治疗成功（27%）（P<0.001）；97例接受阿奇霉素治疗的患者中有76例细菌学治疗成功（78%），98例接受环丙沙星治疗的患者中有10例细菌学治疗成功（10%）（P<0.001）。接受阿奇霉素治疗的患者腹泻持续时间短于接受环丙沙星治疗的患者（中位数分别为30小时和78小时）；呕吐频率较低（43%对67%）；粪便次数较少（中位数分别为36次和52次）；粪便量较低（中位数分别为每千克体重114ml和322ml）。177株霍乱弧菌O1对环丙沙星的最低抑菌浓度中位数为每毫升0.25μg，比该地点此前研究中的浓度高11至83倍。
单剂量阿奇霉素对治疗成人重症霍乱有效。环丙沙星疗效不佳可能是因为其对目前在孟加拉国传播的霍乱弧菌O1菌株的活性降低。（ClinicalTrials.gov编号，NCT00229944。）
