Subjective Symptoms after Treatment of Lyme Disease

描述（由申请人提供）：症状莱姆病是北美最常见的蜱传感染。虽然治疗后的结果通常很好，但有些患者抱怨持续的主观症状，如疲劳，肌肉骨骼疼痛，或注意力和记忆力问题，尽管疾病的客观体征得到了解决。然而，这些症状在一般人群中也很常见，莱姆病和持续症状之间的因果关系尚未建立。一个尚未回答的关键问题是，在治疗莱姆病后，患者是否比没有莱姆病的人更容易出现慢性（>6个月）主观症状。为了回答这个基本问题，我们建议在美国进行第一项前瞻性、对照性纵向队列研究，以类似的方式对患有和不患有莱姆病的受试者进行为期一年的仔细评估。这项研究也将是第一个能够确定莱姆病后综合征（PLDS）的发病率以及相关的医疗并发症和经济成本的研究。我们还将从这些患者中获得血液样本，与其他研究人员共享，用于未来与PLDS相关的可能生物标志物的研究。最后，在不同的患者队列中，我们将首次描述诊断和治疗后10年以上培养确诊的早期莱姆病患者的结局。 公共卫生相关性：我们研究的目的是确定莱姆病治疗的患者是否比没有莱姆病的人更有可能出现持续症状。为了回答这个基本的和以前没有回答的问题，我们建议在美国进行第一项前瞻性研究，在这项研究中，以类似的方式对患有和不患有莱姆病的受试者进行为期一年的仔细评估。在另一组患者中，我们将首次描述早期莱姆病患者在诊断和治疗后10年以上的结局。

DESCRIPTION (provided by applicant): Symptoms Lyme disease is the most common tick-borne infection in North America. Although the outcome after treatment is generally excellent, some patients complain of persistent subjective symptoms such as fatigue, musculoskeletal pains, or problems with concentration and memory despite resolution of the objective signs of the disease. However, these symptoms are also common in the general population and a causal association between Lyme disease and persistent symptoms has not been established. An unanswered and critically important question is whether, after treatment for Lyme disease, patients are more likely to have chronic (>6 months) subjective symptoms than are individuals who did not have Lyme disease. To answer this fundamental question, we propose to conduct the first prospective, controlled longitudinal cohort study in the United States in which subjects with and without Lyme disease are carefully evaluated in a similar manner for a full year. This study will also be the first to be able to determine the incidence of post-Lyme disease syndrome (PLDS) and the associated medical complications and economic costs. We will also obtain a blood sample from such patients to be shared with other investigators for future research on possible biomarkers associated with PLDS. Finally, in a different cohort of patients, we will describe for the first time the outcome of culture-confirmed patients with early Lyme disease more than 10 years after diagnosis and treatment. PUBLIC HEALTH RELEVANCE: The purpose of our study is to determine whether patients treated for Lyme disease are more likely to have persistent symptoms than individuals who did not have Lyme disease. To answer this fundamental and previously unanswered question, we propose to conduct the first prospective study in the United States in which subjects with and without Lyme disease are carefully evaluated in a similar manner for a full year. In a different group of patients, we will describe for the first time the outcome of patients with early Lyme disease more than 10 years after diagnosis and treatment.