Topical Antibiotics to Prevent Lyme Disease

描述（由申请人提供）：莱姆病，由螺旋体伯氏疏螺旋体引起，是美国最常见的蜱传感染，自2002年以来每年报告超过20,000例。在预防莱姆病的现有策略中，只有重组外表面蛋白a疫苗接种和单剂量强力西环素肩胛骨伊蚊蜱叮咬的抗生素化学预防已被证明可以减少人类病例的发病率。然而，莱姆病疫苗已不再销售。2003年6月，美国疾病控制和预防中心公共卫生服务部门建议，在被肩周虫蜱叮咬后，考虑使用单剂量多西环素作为预防莱姆病的一种选择（Hayes EB, Piesman J.）。中华医学杂志2003年6月12日：348:2424-30)。使用强力霉素的一个实际限制是，这种药物不是非处方药；需要抗生素处方，并且必须在去除蜱虫后72小时内获得药物，以使治疗有效。此外，多西环素仅推荐用于被肩胛骨蜱叮咬并充血的患者，这是一项需要技巧的评估，只有在蜱被保存并且相对完整的情况下才能进行。此外，强力霉素禁止用于幼儿和孕妇或哺乳期妇女。各种局部抗菌剂广泛用于治疗常见疾病。这些准备是被广泛接受和安全的。一项动物研究表明，某些局部抗菌制剂在预防蜱虫叮咬后传播的伯氏疏螺旋体感染方面非常有效，但不幸的是，这项研究没有测试批准用于人类的抗生素制剂。目前的建议的目的是研究局部抗生素制剂适用于人类在小鼠模型中的功效。如果成功，这些研究将具有高度相关的公共卫生意义，并应导致未来的人体试验，以测试局部抗菌治疗在肩胛骨蜱叮咬后有莱姆病风险的患者的有效性和安全性。

DESCRIPTION (provided by applicant): Lyme disease, caused by the spirochete Borrelia burgdorferi, is the most common tick-borne infection in the United States with more than 20,000 cases reported annually since 2002. Of the available strategies to prevent Lyme disease, only vaccination with a recombinant outer surface protein A and antibiotic chemoprophylaxis of Ixodes scapularis tick bites with single-dose doxycycline have been shown to decrease the incidence of human cases. However, the Lyme vaccine is no longer marketed. In June 2003, authorities from the United States Public Health Services at the Centers for Disease Control and Prevention suggested that single-dose doxycycline be considered as an option for the prevention of Lyme disease after an I. scapularis tick bite (Hayes EB, Piesman J. How can we prevent Lyme disease. N Engl J Med 2003 June 12:348:2424-30). A practical limitation of using doxycycline is that the drug is not available over-the-counter; an antibiotic prescription is required and the medication must be obtained within 72 hours of tick removal for the treatment to be effective. In addition, doxycycline is only recommended for patients bitten by I. scapularis ticks that are engorged with blood, an assessment that requires skill and can only be done if the tick has been saved and is relatively intact. Further, doxycycline is contraindicated in young children and pregnant or lactating women. A variety of topical antimicrobials are in wide general usage for treatment of common conditions. These preparations are well accepted and safe. An animal study demonstrated that application of certain topical antimicrobial preparations was highly efficacious in preventing disseminated Borrelia burgdorferi infection after a tick bite, but unfortunately this study did not test antibiotic formulations approved for use on humans. The purpose of the current proposal is to investigate the efficacy of a topical antibiotic preparation suitable for use in humans in a mouse model. If successful, these studies would have highly relevant public health implications and should result in future human trials to test the efficacy and safety of topical antimicrobial therapy in patients at risk for Lyme disease after an Ixodes scapularis tick bite.