口服普萘洛尔治疗特发性震颤亚组：系统评价和荟萃分析方案。
Oral propranolol for treatment of the subgroups of essential tremor: a systematic review and meta-analysis protocol.
机构信息
Department of Neurology, First Affiliated Hospital, Hainan Medical University, Haikou, Hainan, China.
Department of Neurology, First Affiliated Hospital, Hainan Medical University, Haikou, Hainan, China
出版信息
BMJ Open. 2020 Jan 15;10(1):e032096. doi: 10.1136/bmjopen-2019-032096.
INTRODUCTION
Essential tremor (ET), a tremor disorder, is one of the most common movement disorders. Only oral drugs (propranolol, primidone, topiramate, etc）are still the first-line treatment recommended by the Food and Drug Administration. Propranolol is thought to potentially reduce upper limb action tremor. However, it has a poor effect on axial tremor symptoms, such as essential head tremor and voice tremor. Studies have shown that tremor severity develops over time, possibly producing other clinical tremors and neurological soft signs (such as memory loss, gait abnormalities, balance disorders, etc), which further increases the difficulty of treating tremors. However, some recent studies provide emerging evidence for oral propranolol on subgroups of ET, which is based on the anatomical distribution of ET (lower extremities, head, sound, tongue, etc). This systematic review aims to synthesise these new data to improve the efficacy of propranolol in ET subgroups.
METHODS AND ANALYSIS
We will search for randomised controlled trials from the PubMed, MEDLINE, EMBASE, Cochrane Library, UptoDate and PEDro databases from inception to June 2019. All data will be extracted independently by two reviewers and compared at the end of the review. The two reviewers will screen the study quality, and the Cochrane Collaboration's tool in Review Manager (RevMan) V.5.3.3 will be used to evaluate risk of bias. Our primary outcome will be the functional disability component related to tremors, as measured by the Fahn-Tolosa-Marin Tremor Rating Scale subscales B and C. Secondary outcomes will include severity of tremors and quality of life. Narrative and meta-analytical syntheses are planned.
ETHICS AND DISSEMINATION
Published aggregated data will be used in this review analysis and therefore no ethical approval is required. The results will be published in peer-reviewed journals, and proliferation activities will include diverse social stakeholders, non-academic groups and patients.
PROSPERO REGISTRATION NUMBER
CRD42018112580.
简介
特发性震颤（ET）是一种震颤障碍，是最常见的运动障碍之一。目前，仅有口服药物（普萘洛尔、丙戊酸钠、托吡酯等）仍然是食品和药物管理局推荐的一线治疗方法。普萘洛尔被认为可能会减轻上肢动作性震颤。然而，它对轴向震颤症状（如特发性头部震颤和声音震颤）的效果较差。研究表明，震颤严重程度会随时间推移而发展，可能会产生其他临床震颤和神经学软体征（如记忆力减退、步态异常、平衡障碍等），这进一步增加了震颤的治疗难度。然而，一些最近的研究为 ET 的亚组提供了口服普萘洛尔的新证据，这是基于 ET 的解剖分布（下肢、头部、声音、舌头等）。本系统评价旨在综合这些新数据，以提高普萘洛尔在 ET 亚组中的疗效。
方法和分析
我们将从 PubMed、MEDLINE、EMBASE、Cochrane 图书馆、UpToDate 和 PEDro 数据库中搜索从成立到 2019 年 6 月的随机对照试验。所有数据将由两位评审员独立提取，并在审查结束时进行比较。两位评审员将筛选研究质量，并使用 Review Manager（RevMan）V.5.3.3 中的 Cochrane 协作工具评估偏倚风险。我们的主要结局将是震颤相关的功能障碍部分，由 Fahn-Tolosa-Marin 震颤评定量表 B 和 C 子量表测量。次要结局将包括震颤严重程度和生活质量。计划进行叙述性和荟萃分析综合。
伦理和传播
本综述分析将使用已发表的汇总数据，因此不需要伦理批准。研究结果将发表在同行评议的期刊上，并将通过各种社会利益相关者、非学术团体和患者进行传播活动。
PROSPERO 注册号：CRD42018112580。
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