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伊氏革蜱叮咬后单次服用多西环素预防莱姆病:一项开放标签随机对照试验。

A single dose of doxycycline after an ixodes ricinus tick bite to prevent Lyme borreliosis: An open-label randomized controlled trial.

机构信息

National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, Bilthoven 3720 BA, the Netherlands.

National Institute for Public Health and the Environment, Centre for Infectious Disease Control, PO box 1, Bilthoven 3720 BA, the Netherlands.

出版信息

J Infect. 2021 Jan;82(1):98-104. doi: 10.1016/j.jinf.2020.06.032. Epub 2020 Jun 18.

DOI:10.1016/j.jinf.2020.06.032
PMID:32565073
Abstract

OBJECTIVES

A single dose of doxycycline after a tick bite can prevent the development of Lyme borreliosis in North America, but extrapolation to Europe is hampered by differences in Borrelia burgdorferi sensu lato genospecies and tick species. We assessed the efficacy of prophylaxis after a tick bite in Europe.

METHODS

We conducted an open-label randomized controlled trial, administering a single dose of 200 mg doxycycline within 72 h after removing an attached tick from the skin, compared to no treatment. Potential participants ≥ 8 years of age who reported a recent tick bite online were invited for the study. After informed consent, they were randomly assigned to either the prophylaxis or the no-treatment group. Participants in the prophylaxis group were asked to visit their general practitioner to administer the antibiotics. All participants were followed up by online questionnaires. Our primary outcome was the development of physician-confirmed Lyme borreliosis in a modified-intention-to-treat analysis. This study is registered in the Netherlands Trial Register (NTR3953) and is closed.

RESULTS

Between April 11, 2013, and June 10, 2015, 3538 potential participants were randomized, of whom 1689 were included in the modified-intention-to-treat analysis. 10 cases of Lyme borreliosis were reported out of 1041 participants (0.96%) in the prophylaxis group, and 19 cases out of 648 no-treatment participants (2.9%), resulting in a relative risk reduction of 67% (95% CI 31 - 84%), and a number-needed-to-treat of 51 (95% CI 29 - 180). No serious adverse events were reported.

CONCLUSIONS

This primary care-based trial provides evidence that a single dose of doxycycline can prevent the development of Lyme borreliosis after an Ixodes ricinus tick bite.

摘要

目的

在被蜱叮咬后单次服用多西环素可预防北美的莱姆病,但是由于伯氏疏螺旋体亚种和蜱种的差异,这种方法在欧洲的推广受到限制。我们评估了在欧洲蜱叮咬后进行预防的效果。

方法

我们进行了一项开放性随机对照试验,在从皮肤上移除附着的蜱后 72 小时内给予 200mg 多西环素单次剂量,与未治疗组进行比较。通过在线邀请报告近期蜱叮咬的≥ 8 岁的潜在参与者参加该研究。在获得知情同意后,他们被随机分配到预防组或未治疗组。预防组的参与者被要求去看他们的全科医生来使用抗生素。所有参与者都通过在线问卷进行随访。我们的主要结局是在改良意向治疗分析中发生经医生确诊的莱姆病。该研究在荷兰临床试验注册中心(NTR3953)注册,现已关闭。

结果

在 2013 年 4 月 11 日至 2015 年 6 月 10 日期间,共随机分配了 3538 名潜在参与者,其中 1689 名被纳入改良意向治疗分析。在预防组的 1041 名参与者中有 10 例(0.96%)报告发生莱姆病,而在未治疗组的 648 名参与者中有 19 例(2.9%),相对风险降低 67%(95%CI 31 - 84%),需要治疗的人数为 51 人(95%CI 29 - 180)。未报告严重不良事件。

结论

这项基于初级保健的试验提供了证据,表明单次服用多西环素可以预防伊氏莱姆疏螺旋体叮咬后的莱姆病发展。

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A single dose of doxycycline after an ixodes ricinus tick bite to prevent Lyme borreliosis: An open-label randomized controlled trial.伊氏革蜱叮咬后单次服用多西环素预防莱姆病:一项开放标签随机对照试验。
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