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阿奇霉素与多西环素预防钩端螺旋体病的比较:一项随机双盲安慰剂对照试验

Comparison of azithromycin vs doxycycline prophylaxis in leptospirosis, A randomized double blind placebo-controlled trial.

作者信息

Alikhani Ahmad, Salehifar Ebrahim, Zameni Fatemeh, Rafiei Alireza, Yazdani-Charati Jamshid, Delavaryan Leila, Akbari Azita, Babamahmoudi Farhang

机构信息

Mazandaran University of Medical Sciences, Sari, Iran.

出版信息

J Infect Dev Ctries. 2018 Nov 30;12(11):991-995. doi: 10.3855/jidc.10126.

DOI:10.3855/jidc.10126
PMID:32012129
Abstract

INTRODUCTION

Leptospirosis is an important zoonotic disease in paddy field with 29.5% prevalence rate in Mazandaran province and 4% to 52% mortality rate among hospitalized patients. Prevention is an important strategy for the control of this disease. This study aimed to compare the prophylactic effect of azithromycin versus doxycycline against leptospirosis in an endemic area in north of Iran.

METHODOLOGY

In this randomized double-blind placebo-controlled trial, paddy field workers (n = 187) were randomized to receive azithromycin (500mg weekly), doxycycline (200 mg weekly) or placebo starting one week before exposure to paddy field, during and to four weeks after. Paddy field workers aged 18- 65 years who signed the informed consent form were assessed for signs and symptoms of leptospirosis in addition to serologic evidence of the disease 6th and 12th week. Data were analyzed with SPSS version 13 using Chi-square and Fisher exact test and ANOVA.

RESULTS

From June to September 2016, 187 participants were entered the study to receive azithromycin (n = 66), doxycycline (n = 71) or placebo (n = 50). In terms of preventing against clinical leptospirosis, there was not any significant difference between three arms, though there was statistically significant difference of seropositivity after 6 and 12 weeks in comparison to baseline among all three groups (P = 0.029) and between active treatment (eg. azithromycin and doxycycline) groups and placebo group (P = 0.01).

CONCLUSION

Azithromycin like doxycycline decreased seropositivity without significant effect on clinical leptospirosis.

摘要

引言

钩端螺旋体病是稻田地区一种重要的人畜共患病,在马赞德兰省的患病率为29.5%,住院患者的死亡率为4%至52%。预防是控制该病的重要策略。本研究旨在比较阿奇霉素与强力霉素在伊朗北部一个流行地区预防钩端螺旋体病的效果。

方法

在这项随机双盲安慰剂对照试验中,稻田工人(n = 187)被随机分为三组,在接触稻田前一周、接触期间及接触后四周,分别接受阿奇霉素(每周500毫克)、强力霉素(每周200毫克)或安慰剂。年龄在18至65岁且签署知情同意书的稻田工人,在第6周和第12周除了接受疾病的血清学证据评估外,还接受钩端螺旋体病的体征和症状评估。使用SPSS 13版软件,通过卡方检验、Fisher精确检验和方差分析对数据进行分析。

结果

2016年6月至9月,187名参与者进入研究,分别接受阿奇霉素(n = 66)、强力霉素(n = 71)或安慰剂(n = 50)治疗。在预防临床钩端螺旋体病方面,三组之间没有显著差异,尽管与基线相比,所有三组在第6周和第12周时血清阳性率有统计学显著差异(P = 0.029),且活性治疗组(如阿奇霉素和强力霉素)与安慰剂组之间也有显著差异(P = 0.01)。

结论

与强力霉素一样,阿奇霉素可降低血清阳性率,但对临床钩端螺旋体病无显著影响。

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