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化瘀祛痰法治疗伴有认知障碍的癫痫的临床疗效及安全性评价:系统评价和 Meta 分析方案。

Clinical efficacy and safety of removing blood stasis and removing phlegm in the treatment of epilepsy with cognitive impairment: A protocol for systematic review and meta-analysis.

机构信息

Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, China.

出版信息

Medicine (Baltimore). 2021 Nov 24;100(47):e27929. doi: 10.1097/MD.0000000000027929.

DOI:10.1097/MD.0000000000027929
PMID:34964768
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8615331/
Abstract

BACKGROUND

Epilepsy is a chronic encephalopathy caused by abnormal discharge of neurons in the brain, resulting in brain dysfunction. Cognitive impairment is one of the most common complications of epilepsy. The current treatment of epilepsy in the control of symptoms at the same time cause a lot of side effects, especially the aggravation of cognitive impairment. Many literatures have stated that the efficacy and safety of integrated traditional Chinese and western medicine in the treatment of epilepsy with cognitive impairment is superior to that of western medicine alone. In this systematic review, we intend to evaluate the clinical efficacy and safety of removing stasis and resolving phlegm in the treatment of epilepsy with cognitive impairment.

METHODS

We will search The Cochrane Library, EMbase, Pubmed, Web of Science, Chinese Journal Full-Text Database (CNKI), Wanfang Database, and VIP database. Simultaneously we will retrieval relevant meeting minutes, eligible research reference lists, symposium abstracts, and gray literatures. We will not apply any restrictions to the language and publication date. All randomized controlled trials about the efficacy and safety of removing blood stasis and phlegm in the treatment of epilepsy with cognitive impairment will be included. Two authors will independently carry out. Any objections will be worked out by a third author through consultation. We will use the Revman 5.3 and Stata 13.0 software for data synthesis, sensitivity analysis, meta regression, subgroup analysis, and risk of bias assessment. The grading of recommendations assessment, development, and evaluation standard will be used to evaluate the quality of evidence.

RESULTS

This systematic review will synthesize the data from the present eligible high quality randomized controlled trials to assess whether the treatment of removing blood stasis and phlegm is effective and safety for epilepsy with cognitive impairment from various evaluation aspects including clinical efficacy of epilepsy, EEG improvement rate, MOCA score, QOLIE-31 cognitive function score, traditional Chinese medicine symptom score, incidence of adverse reactions, frequency of seizures of epilepsy, and duration of seizure of epilepsy.

CONCLUSION

The systematic review will provide evidence to assess the efficacy and safety of removing blood stasis and phlegm in the treatment of patients with epilepsy with cognitive impairment.

PROSPERO REGISTRATION NUMBER

CRD42021224893.

摘要

背景

癫痫是一种由大脑神经元异常放电引起的慢性脑病,导致大脑功能障碍。认知障碍是癫痫最常见的并发症之一。目前癫痫的治疗在控制症状的同时会引起很多副作用,尤其是认知障碍的加重。许多文献表明,中西医结合治疗癫痫合并认知障碍的疗效和安全性优于单纯西药。在本系统评价中,我们旨在评估化瘀祛痰法治疗癫痫合并认知障碍的临床疗效和安全性。

方法

我们将检索 Cochrane 图书馆、EMbase、PubMed、Web of Science、中国全文数据库(CNKI)、万方数据库和 VIP 数据库。同时,我们将检索相关会议记录、合格研究参考文献列表、研讨会摘要和灰色文献。我们将不限制语言和出版日期。所有关于化瘀祛痰法治疗癫痫合并认知障碍的疗效和安全性的随机对照试验都将被纳入。两名作者将独立进行。任何异议将通过第三方作者协商解决。我们将使用 Revman 5.3 和 Stata 13.0 软件进行数据合成、敏感性分析、meta 回归、亚组分析和偏倚风险评估。推荐评估、制定和评估标准将用于评估证据质量。

结果

本系统评价将综合目前高质量随机对照试验的数据,从癫痫临床疗效、脑电图改善率、MOCA 评分、QOLIE-31 认知功能评分、中医症状评分、不良反应发生率、癫痫发作频率、癫痫发作持续时间等方面评估化瘀祛痰法治疗癫痫合并认知障碍的疗效和安全性。

结论

本系统评价将为评估化瘀祛痰法治疗癫痫合并认知障碍患者的疗效和安全性提供证据。

PROSPERO 注册号:CRD42021224893。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b76a/8615331/05e09290c6d3/medi-100-e27929-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b76a/8615331/05e09290c6d3/medi-100-e27929-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b76a/8615331/05e09290c6d3/medi-100-e27929-g001.jpg

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