Health and Social Research Center, Universidad de Castilla-La Mancha, 16071 Cuenca, Spain.
Pharmacy Service, Hospital Virgen de la Luz, 16002 Cuenca, Spain.
Int J Environ Res Public Health. 2022 Feb 3;19(3):1753. doi: 10.3390/ijerph19031753.
Migraine is a common and disabling primary headache disorder, associated with many medical comorbidities, highly prevalent, with complex treatment and management. Currently, monoclonal antibodies targeting the trigeminal sensory neuropeptide, calcitonin gene-related peptide (CGRP), are available. The aim of this protocol is to provide a review comparing the effects and safety profile of different monoclonal antibodies in migraine patients.
The literature search will be performed through the MEDLINE, Embase, CENTRAL, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), Web of Science and Scopus databases, following the PICO strategy. Real World studies and randomized clinical trials assessing the effect of monoclonal antibodies against CGRP interventions (erenumab, eptinezumab, fremanezumab and galcanezumab) on monthly migraine days (MMD), monthly headache days (MHD), headache impact test (HIT-6) and triptan days of use (TriD) will be included. In Real World studies, the DerSimonian and Laird method will be used to calculate pooled estimates of the mean change difference and in randomized clinical trials, a network meta-analysis will be performed to estimate the comparative effects of different monoclonal antibodies against CGRP.
The findings of this study will be reported in a peer-reviewed journal.
This study will provide evidence to health professionals on the efficacy and safety of different monoclonal antibodies against CGRP on the outcomes studied.
偏头痛是一种常见且使人丧失能力的原发性头痛疾病，与许多医学合并症相关，具有高患病率，治疗和管理复杂。目前，有针对降钙素基因相关肽（CGRP）的感觉神经肽的单克隆抗体可用。本方案旨在比较偏头痛患者中不同单克隆抗体的效果和安全性。
将通过 MEDLINE、Embase、CENTRAL、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台（ICTRP）、Web of Science 和 Scopus 数据库，根据 PICO 策略进行文献检索。将纳入评估 CGRP 干预（erenumab、eptinezumab、fremanezumab 和 galcanezumab）对每月偏头痛天数（MMD）、每月头痛天数（MHD）、头痛影响测试（HIT-6）和曲坦日使用天数（TriD）的影响的真实世界研究和随机临床试验。在真实世界研究中，将使用 DerSimonian 和 Laird 方法计算平均变化差异的汇总估计值，在随机临床试验中，将进行网络荟萃分析以估计不同 CGRP 单克隆抗体的相对效果。
本研究的结果将在同行评议的期刊上报告。
本研究将为卫生专业人员提供有关 CGRP 不同单克隆抗体在研究结果方面的疗效和安全性的证据。
