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急性莱姆病神经螺旋体病药物治疗的疗效与安全性——一项系统评价

Efficacy and safety of pharmacological treatments for acute Lyme neuroborreliosis - a systematic review.

作者信息

Dersch R, Freitag M H, Schmidt S, Sommer H, Rauer S, Meerpohl J J

机构信息

German Cochrane Centre, Medical Center - University of Freiburg, Freiburg, Germany.

Department of Neurology, Medical Center - University of Freiburg, Freiburg, Germany.

出版信息

Eur J Neurol. 2015 Sep;22(9):1249-59. doi: 10.1111/ene.12744. Epub 2015 Jun 8.

DOI:10.1111/ene.12744
PMID:26058321
Abstract

BACKGROUND AND PURPOSE

Our aim was to evaluate the available evidence for pharmacological treatment of acute Lyme neuroborreliosis as a basis for evidence-based clinical recommendations in a systematic review.

METHODS

A systematic literature search of Medline, EMBASE, the Cochrane Library and three trial registries was performed. Randomized controlled trials (RCTs) and non-randomized studies (NRS) were evaluated. Risk of bias was assessed using the Cochrane risk of bias tools. The primary outcome was 'residual neurological symptoms' whilst the secondary outcomes were disability, quality of life, pain, fatigue, depression, cognition, sleep, adverse events and cerebrospinal fluid pleocytosis. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

RESULTS

After screening 5779 records, eight RCTs and eight NRS were included. Risk of bias was generally high. No statistically significant difference was found between doxycycline and beta-lactam antibiotics in a meta-analysis regarding residual neurological symptoms at 4-12 months [risk ratio (RR) 1.27, 95% confidence interval (CI) 0.98-1.63, P = 0.07] or adverse events (RR 0.82, 95% CI 0.54-1.25, P = 0.35). Significantly fewer neurological symptoms for cefotaxime compared with penicillin were found (RR 1.81, 95% CI 1.10-2.97, P = 0.02). Adverse events were significantly fewer for penicillin (RR 0.56, 95% CI 0.38-0.84, P = 0.005).

CONCLUSIONS

Evidence regarding pharmacological treatment of acute Lyme neuroborreliosis is scarce and therefore insufficient to recommend preference of beta-lactam antibiotics over doxycycline or vice versa. However, due to considerable imprecision, relevant differences between treatments cannot be excluded. No evidence suggesting benefits of extended antibiotic treatments could be identified. Further well-designed trials are needed. Individual treatment decisions should address patients' preferences and individual conditions like prior allergic reactions.

摘要

背景与目的

我们的目的是评估急性莱姆病神经疏螺旋体病药物治疗的现有证据,作为系统评价中循证临床推荐的基础。

方法

对医学期刊数据库(Medline)、荷兰医学文摘数据库(EMBASE)、考克兰图书馆以及三个试验注册库进行系统文献检索。对随机对照试验(RCT)和非随机研究(NRS)进行评估。使用考克兰偏倚风险工具评估偏倚风险。主要结局为“残留神经症状”,次要结局为残疾、生活质量、疼痛、疲劳、抑郁、认知、睡眠、不良事件和脑脊液细胞增多。使用推荐分级的评估、制定与评价(GRADE)方法评估证据质量。

结果

在筛选5779条记录后,纳入了8项随机对照试验和8项非随机研究。偏倚风险总体较高。在一项荟萃分析中,关于4至12个月时的残留神经症状,多西环素与β-内酰胺类抗生素之间未发现统计学显著差异[风险比(RR)1.27,95%置信区间(CI)0.98 - 1.63,P = 0.07],不良事件方面也无差异(RR 0.82,95% CI 0.54 - 1.25,P = 0.35)。与青霉素相比,头孢噻肟的神经症状明显更少(RR 1.81,95% CI 1.10 - 2.97,P = 0.02)。青霉素的不良事件明显更少(RR 0.56,95% CI 0.38 - 0.84,P = 0.005)。

结论

关于急性莱姆病神经疏螺旋体病药物治疗的证据稀少,因此不足以推荐优先选择β-内酰胺类抗生素而非多西环素,反之亦然。然而,由于存在相当大的不精确性,不能排除治疗之间的相关差异。未发现延长抗生素治疗有益的证据。需要进一步设计良好的试验。个体治疗决策应考虑患者的偏好和个体情况,如既往过敏反应。

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