Clinic of Infectious Diseases, University Hospital, SE-58185, Linköping, Sweden.
BMC Infect Dis. 2012 Aug 10;12:186. doi: 10.1186/1471-2334-12-186.
Persistent symptoms after treatment of neuroborreliosis (NB) are well-documented, although the causative mechanisms are mainly unknown. The effect of repeated antibiotic treatment has not been studied in detail. The aim of this study was to determine whether: (1) persistent symptoms improve with doxycycline treatment; (2) doxycycline has an influence on systemic cytokine responses, and; (3) improvement of symptoms could be due to doxycycline-mediated immunomodulation.
METHODS/DESIGN: 15 NB patients with persistent symptoms ≥6 months post-treatment were double-blindly randomized to receive 200 mg of doxycycline or a placebo for three weeks. After a six-week wash-out period, a cross-over with a three-week course of a placebo or doxycycline was conducted. The primary outcome measures were improvement of persistent symptoms assessed by neurological examinations, a symptom severity score and estimation of the quality of life. The secondary outcome measure was changes in systemic cytokine responses.
All 15 patients finished the study. No doxycycline-mediated improvement of post-treatment symptoms or quality of life was observed. Nor could any doxycycline-mediated changes in systemic cytokine responses be detected. The study was completed without any serious adverse events.
No doxycycline-mediated improvement of post-treatment symptoms or quality of life was observed. Nor could any doxycycline-mediated changes in systemic cytokine responses be detected. The study was completed without any serious adverse events. To conclude, in this pilot study, doxycycline-treatment did not lead to any improvement of either the persistent symptoms or quality of life in post-NB patients. Accordingly, doxycycline does not seem to be the optimal treatment of diverse persistent symptoms post-NB. However, the results need to be confirmed in larger studies.
NCT01205464 (clinicaltrials.gov).
神经莱姆病（NB）治疗后持续存在症状已有充分记录，尽管其发病机制主要未知。重复抗生素治疗的效果尚未详细研究。本研究的目的是确定：（1）持续性症状是否会随多西环素治疗而改善；（2）多西环素是否对全身细胞因子反应有影响；（3）症状改善是否归因于多西环素介导的免疫调节。
方法/设计：15 名 NB 患者在治疗后出现持续症状≥6 个月，进行双盲随机分组，接受 200mg 多西环素或安慰剂治疗 3 周。在 6 周洗脱期后，进行交叉试验，接受 3 周安慰剂或多西环素治疗。主要终点为神经系统检查、症状严重程度评分和生活质量评估的持续性症状改善。次要终点为全身细胞因子反应的变化。
所有 15 名患者均完成了研究。未观察到多西环素治疗后症状或生活质量的改善。也未检测到多西环素介导的全身细胞因子反应变化。研究完成过程中无任何严重不良事件。
未观察到多西环素治疗后症状或生活质量的改善。也未检测到多西环素介导的全身细胞因子反应变化。研究完成过程中无任何严重不良事件。综上所述，在这项初步研究中，多西环素治疗并未导致 NB 后患者的持续性症状或生活质量有任何改善。因此，多西环素似乎不是 NB 后多种持续性症状的最佳治疗方法。然而，这些结果需要在更大规模的研究中加以确认。
NCT01205464（clinicaltrials.gov）。
