缓释双丙戊酸钠与普通迟释双丙戊酸钠的疗效、安全性和保留率：系统评价和荟萃分析方案。
Efficacy, safety, and retention rate of extended-release divalproex versus conventional delayed-release divalproex: A protocol for systematic review and meta-analysis.
机构信息
Department of Special Medical, Chengdu BOE Hospital, Chengdu, Sichuan Province, China.
Department of Neurology, The Air Force Hospital of Western Theater Command, Chengdu, Sichuan Province, China.
出版信息
Medicine (Baltimore). 2021 Dec 17;100(50):e28290. doi: 10.1097/MD.0000000000028290.
BACKGROUND
A novel once-daily divalproex-extended release (VPA-ER) dose formulation has been developed, which prolongs therapeutic serum levels compared with that of twice-daily conventional divalproex-delayed release (VPA-DR). Currently, there is lack of meta-analysis focusing on drug retention rate between VPA-ER and VPA-DR. Thus, our study is the first one that aims to systematically examine and compare the efficacy, safety, and retention rate of VPA-ER and VPA-DR.
METHODS
Online databases including MEDLINE via PubMed, Cochrane Library, Embase (up to October 30, 2021) will be applied for literature screen. We will conduct meta-analysis by using Stata16.0 software.
RESULTS
This study aims to evaluate the efficacy, safety, and drug retention rate of VPA-ER versus conventional VPA-DR.
CONCLUSION
Once-daily VPA-ER may present a positive efficacy and not increase the incidence of AEs and has a higher retention rate for patients, which can be used as a substitute for conventional VPA-DR.INPLASY registration number: INPLASY2021110090(DOI: 10.37766/inplasy2021.11.0090).
背景
一种新型的每日一次丙戊酸钠延长释放（VPA-ER）剂量制剂已经被开发出来，与每日两次的传统丙戊酸钠延迟释放（VPA-DR）相比，它延长了治疗性血清水平。目前，缺乏专门针对 VPA-ER 和 VPA-DR 药物保留率的荟萃分析。因此，我们的研究旨在首次系统地检查和比较 VPA-ER 和 VPA-DR 的疗效、安全性和保留率。
方法
将使用在线数据库包括 MEDLINE 通过 PubMed、Cochrane 图书馆、Embase（截至 2021 年 10 月 30 日）进行文献筛选。我们将使用 Stata16.0 软件进行荟萃分析。
结果
本研究旨在评估 VPA-ER 与传统 VPA-DR 的疗效、安全性和药物保留率。
结论
每日一次的 VPA-ER 可能具有积极的疗效，不会增加不良反应的发生率，并且对患者的保留率更高，可作为传统 VPA-DR 的替代药物。INPLASY 注册编号：INPLASY2021110090（DOI：10.37766/inplasy2021.11.0090）。
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