Guidugli F, Castro A A, Atallah A N
Internal Medicine, Federal University of Sao Paulo, Rua Humberto I, 962 apt. 16, Sao Paulo, Sao Paulo, Brazil, 04018-033. cochrane.dmed.epm.br
Cochrane Database Syst Rev. 2000(2):CD001306. doi: 10.1002/14651858.CD001306.
Leptospirosis is a parasitic disease transmitted by animals. Severe leptospirosis may result in hospitalisation and about five per cent of the patients die. In clinical practice, penicillin is widely used for treating leptospirosis.
To evaluate the effectiveness and safety of antibiotics versus placebo or other antibiotic regimens in treating leptospirosis. We addressed the following clinical questions: a) Are treatment regimens with antibiotics more efficient than placebo for leptospirosis? b) Are treatment regimens with antibiotics safe when compared to placebo for leptospirosis? c) Which antibiotic regimen is the most efficient and safest in treating leptospirosis?
Electronic searches and searches of the identified articles were combined.
Randomised clinical trials in which antibiotics were used as treatment for leptospirosis. Language, date, or other restrictions were not applied.
Patients with clinical manifestations of leptospirosis.
Any antibiotic regimen compared with a control group (placebo or another antibiotic regimen).
Data and methodological quality of each trial were independently extracted and assessed by two reviewers. The random effects model was used irrespective of significant statistical heterogeneity.
Three trials met inclusion criteria. Allocation concealment and double blind methods were not clearly described in two. Of the patients enrolled, 75 were treated with placebo and 75 with antibiotics: 61 (81.3%) penicillin and 14 (18.6%) doxycycline. The patients assigned to antibiotics compared to placebo showed: a) Mortality: 1% (1/75) versus 4% (3/75); risk difference -2%, 95% confidence interval -8% to 4%. b) Duration of hospital stay (days): weighted mean difference 0.30, 95% confidence interval -1.26 to 1.86. c) Prolonged hospital stay (> seven days): 30% (7/23) versus 74% (14/19); risk difference -43%, 95% confidence interval -70% to -16%. Number needed-to-treat 3, 95% confidence interval 2 to 7. d) Period of disappearance of fever (days): weighted mean difference -4.04, 95% confidence interval -8.65 to 0.58. e) Leptospiruria: 5% (4/75) versus 40% (30/75); risk difference -46%, 95% confidence interval -88% to -3%. Number needed-to-treat 2, 95% confidence interval 1 to 33.
REVIEWER'S CONCLUSIONS: Antibiotic regimens for treatment of leptospirosis is a form of care for which the evidence is insufficient to provide clear guidelines for practice. The randomised trials suggest that antibiotics could be a useful treatment for leptospirosis. Because of the questionable quality of two of the three trials, the indication for general use of antibiotics is uncertain. However, the evidence suggest that penicillin may cause more good than harm.
钩端螺旋体病是一种由动物传播的寄生虫病。严重的钩端螺旋体病可能导致住院治疗，约5%的患者会死亡。在临床实践中，青霉素被广泛用于治疗钩端螺旋体病。
评估抗生素与安慰剂或其他抗生素治疗方案在治疗钩端螺旋体病方面的有效性和安全性。我们提出了以下临床问题：a) 抗生素治疗方案对钩端螺旋体病的治疗效果是否比安慰剂更有效？b) 与安慰剂相比，抗生素治疗方案治疗钩端螺旋体病是否安全？c) 哪种抗生素治疗方案在治疗钩端螺旋体病方面最有效且最安全？
电子检索与对已识别文章的检索相结合。
将抗生素用作钩端螺旋体病治疗方法的随机临床试验。未施加语言、日期或其他限制。
有钩端螺旋体病临床表现的患者。
任何抗生素治疗方案与对照组（安慰剂或另一种抗生素治疗方案）进行比较。
两名审阅者独立提取并评估每个试验的数据和方法学质量。无论是否存在显著的统计学异质性，均使用随机效应模型。
三项试验符合纳入标准。其中两项试验未明确描述分配隐藏和双盲方法。纳入的患者中，75例接受安慰剂治疗，75例接受抗生素治疗：61例（81.3%）使用青霉素，14例（18.6%）使用多西环素。与安慰剂组相比，接受抗生素治疗的患者表现出：a) 死亡率：1%（1/75）对4%（3/75）；风险差异为-2%，95%置信区间为-8%至4%。b) 住院天数：加权平均差异为0.30，95%置信区间为-1.26至1.86。c) 住院时间延长（>7天）：30%（7/23）对74%（14/19）；风险差异为-43%，95%置信区间为-70%至-16%。需治疗人数为3，95%置信区间为2至7。d) 发热消失时间（天）：加权平均差异为-4.04，95%置信区间为-8.65至0.58。e) 钩端螺旋体尿症：5%（4/75）对40%（30/75）；风险差异为-46%，95%置信区间为-88%至-3%。需治疗人数为2，95%置信区间为1至33。
抗生素治疗钩端螺旋体病的方案是一种证据不足、无法为实践提供明确指导的治疗方式。随机试验表明抗生素可能是治疗钩端螺旋体病的有效方法。由于三项试验中的两项质量存疑，抗生素普遍使用的指征尚不确定。然而，证据表明青霉素可能利大于弊。
