Penicillin at the late stage of leptospirosis: a randomized controlled trial
Penicillin at the late stage of leptospirosis: a randomized controlled trial
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DOI：
10.1590/s0036-46652003000300005
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发表时间：
2003-06-01
期刊：
影响因子：
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通讯作者：
Bina, José Carlos
中科院分区：
文献类型：
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作者：
Costa, Everaldo;Lopes, Antonio Alberto;Bina, José Carlos
有证据表明，及早开始使用青霉素可降低钩端螺旋体病的病死率，并且化学预防对接触钩端螺旋体来源的人是有效的。然而，现有的数据对于在钩端螺旋体病晚期引入青霉素的益处是不一致的。本研究旨在评估症状超过四天后使用青霉素是否能降低钩端螺旋体病的住院病死率。共有253名年龄在15岁至76岁之间的晚期钩端螺旋体病患者，即症状超过四天的患者被选入位于巴西萨尔瓦多的一家传染病医院进行研究。将患者随机分为两组：静脉注射青霉素600万单位(每4小时100万单位)，疗程7d(n=125)，对照组(n=128)。主要结局是住院期间死亡。青霉素治疗组的病死率(12%；15/125)大约是对照组(6.3%；8/128)的两倍。这一差异指向了研究假设的相反方向，但没有统计学意义(p=0.112)。治疗组之间的住院时间相似。根据目前随机临床试验的结果，在出现症状的钩端螺旋体病至少四天后开始使用青霉素对严重形式的钩端螺旋体病患者是没有好处的。因此，应更多地关注钩端螺旋体病的预防和早期治疗。
There is evidence that an early start of penicillin reduces the case-fatality rate of leptospirosis and that chemoprophylaxis is efficacious in persons exposed to the sources of leptospira. The existent data, however, are inconsistent regarding the benefit of introducing penicillin at a late stage of leptospirosis. The present study was developed to assess whether the introduction of penicillin after more than four days of symptoms reduces the in-hospital case-fatality rate of leptospirosis. A total of 253 patients aged 15 to 76 years with advanced leptospirosis, i.e., more than four days of symptoms, admitted to an infectious disease hospital located in Salvador, Brazil, were selected for the study. The patients were randomized to one of two treatment groups: with intravenous penicillin, 6 million units day (one million unit every four hours) for seven days (n=125) and without (n=128) penicillin. The main outcome was death during hospitalization. The case-fatality rate was approximately twice as high in the group treated with penicillin (12%; 15/125) than in the comparison group (6.3%; 8/128). This difference pointed in the opposite direction of the study hypothesis, but was not statistically significant (p=0.112). Length of hospital stay was similar between the treatment groups. According to the results of the present randomized clinical trial initiation of penicillin in patients with severe forms of leptospirosis after at least four days of symptomatic leptospirosis is not beneficial. Therefore, more attention should be directed to prevention and earlier initiation of the treatment of leptospirosis.