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银杏制剂治疗注意力缺陷多动障碍的疗效与安全性:一项系统评价方案

Efficacy and safety of ginkgo preparations for attention deficit hyperactivity disorder: a systematic review protocol.

作者信息

He Sufei, Wang Miao, Si Jinhua, Zhang Tianyi, Cui Hong, Gao Xiumei

机构信息

Collaborative Innovation Center of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

College of Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

出版信息

BMJ Open. 2018 Feb 20;8(2):e020434. doi: 10.1136/bmjopen-2017-020434.

Abstract

INTRODUCTION

Attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed and treated childhood psychiatric disorders. The analogous diagnosis adopted in Europe is hyperkinetic disorder, which is defined in the WHO's International Classification of Diseases 10th edition (ICD-10). Hyperkinetic disorder includes more severe conditions. Ginkgo preparations are used in the treatment of ADHD. The present study will assess the efficacy and safety of ginkgo preparations in the treatment of ADHD in the currently published literature.

MATERIALS AND METHODS

All prospective randomised controlled trials (RCTs) will be included in this systematic review. Patients diagnosed with ADHD according to American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders fourth edition (DSM-IV), Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), ICD-10 or Chinese Classification and Diagnosis of Mental Diseases third edition (CMDD) will be included. A comprehensive search for RCTs to evaluate the effectiveness and tolerance of ginkgo preparations will be performed. The primary outcomes are the ADHD Rating Scale-IV and Revised Conners' Parent Rating Scale. The secondary outcomes are quality of life evaluated by the KINDL scale, adverse effects/events, Conners' Teacher Rating Scale, Strengths and Weaknesses of ADHD Symptoms and Normal Behaviour Scale and Fremdbeurteilungsbogen für Hyperkinetische Störungen. Exclusion criteria are the following: (1) case reports, not randomised trial, non-comparative studies and (2) patients who were not diagnosed based on DSM-IV, DSM-5, ICD-10 or CMDD. The following databases will be searched from their inception until January 2018: Medline, Embase, the Cochrane Central Register of Controlled Trials, Web of Science, China Biology Medicine Disc, China National Knowledge Infrastructure Database, Wanfang Database and Chinese Scientific Journals Database. Two authors will independently perform the study selection, extract the data and assess the study quality and risk of bias.

ETHICS AND DISSEMINATION

This systematic review does not require ethics approval. It will be published in a peer-reviewed journal.

PROSPERO REGISTRATION NUMBER

CRD42017077190.

摘要

引言

注意力缺陷多动障碍(ADHD)是儿童期最常被诊断和治疗的精神疾病之一。欧洲采用的类似诊断是多动障碍,这在世界卫生组织《国际疾病分类》第10版(ICD - 10)中有定义。多动障碍包括更严重的情况。银杏制剂用于治疗ADHD。本研究将评估银杏制剂在治疗ADHD方面的疗效和安全性,基于当前已发表的文献。

材料与方法

所有前瞻性随机对照试验(RCT)都将纳入本系统评价。根据美国精神病学协会《精神疾病诊断与统计手册》第四版(DSM - IV)、《精神疾病诊断与统计手册》第五版(DSM - 5)、ICD - 10或《中国精神疾病分类与诊断标准》第三版(CMDD)诊断为ADHD的患者将被纳入。将全面检索RCT以评估银杏制剂的有效性和耐受性。主要结局指标是ADHD评定量表 - IV和修订版康纳斯父母评定量表。次要结局指标是通过儿童生活质量量表(KINDL)评估的生活质量、不良反应/事件、康纳斯教师评定量表、ADHD症状及正常行为的优势与劣势量表以及多动障碍的他人评价问卷。排除标准如下:(1)病例报告、非随机试验、非对照研究;(2)未根据DSM - IV、DSM - 5、ICD - 10或CMDD诊断的患者。将检索以下数据库自创建至2018年1月的数据:医学索引(Medline)、荷兰医学文摘数据库(Embase)、考克兰系统评价数据库(Cochrane Central Register of Controlled Trials)、科学引文索引(Web of Science)、中国生物医学文献数据库(China Biology Medicine Disc)、中国知网数据库(China National Knowledge Infrastructure Database)、万方数据库和中文科技期刊数据库。两名作者将独立进行研究筛选、提取数据并评估研究质量和偏倚风险。

伦理与传播

本系统评价无需伦理批准。它将发表在同行评审期刊上。

国际前瞻性系统评价注册平台(PROSPERO)注册号:CRD42017077190。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0b35/5855296/dfc7213a3de9/bmjopen-2017-020434f01.jpg

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