Di Meiqi, Hu Lingling, Gui Shuhua, Li Chaosheng, Han Likun
Department of Neurology, Affiliated Hospital of Jiangnan University, 214000 Wuxi, Jiangsu, China.
J Oral Facial Pain Headache. 2024 Dec;38(4):24-32. doi: 10.22514/jofph.2024.036. Epub 2024 Dec 12.
Calcitonin gene-related peptide (CGRP) monoclonal antibodies in the treatment of episodic and chronic migraine was invetigated. A comprehensive literature search was conducted in Ovid Medline, Web of Science and Embase databases from their inception until April 2024 for randomized controlled trials comparing CGRP monoclonal antibodies with placebo or other active treatments in adults with episodic or chronic migraine. The primary outcome assessed was the incidence of hypertension, and secondary outcomes were tolerability, acceptability and adverse events. Data analysis was performed using a random-effects model, and the strength of evidence was evaluated using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) approach. A total of eleven studies involving 9729 participants were found eligible and included for data analysis. The results revealed that the pooled odds ratio for the incidence of hypertension in patients receiving CGRP monoclonal antibodies compared to placebo was (95% confidence interval (CI): 0.60, 2.21; = 32%), suggesting no significant increase in hypertension risk. Moreover, no significant differences were observed in tolerability or acceptability between the CGRP monoclonal antibody and placebo groups. However, the overall risk of total adverse events was significantly higher in the CGRP monoclonal antibody group (odds ratio (OR): 1.13; 95% CI: 0.97, 1.33; = 56%; = 0.01). These findings indicate that CGRP monoclonal antibodies are well-tolerated and present a generally safe option for treating episodic and chronic migraine. Although there was no significant increase in the incidence of hypertension, a slight rise in overall adverse events was observed. Consequently, CGRP monoclonal antibodies may be considered a viable treatment option for patients who have not found other treatments effective or tolerable, or who have contraindications to alternative therapies. The study protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO) (http://www.crd.york.ac.uk, registration number: CRD42024554897).
研究了降钙素基因相关肽（CGRP）单克隆抗体治疗发作性和慢性偏头痛的效果。从数据库创建至2024年4月，在Ovid Medline、科学网和Embase数据库中进行了全面的文献检索，以查找比较CGRP单克隆抗体与安慰剂或其他活性治疗药物对发作性或慢性偏头痛成人患者疗效的随机对照试验。评估的主要结局是高血压的发生率，次要结局是耐受性、可接受性和不良事件。采用随机效应模型进行数据分析，并使用推荐分级、评估、制定与评价（GRADE）方法评估证据强度。共纳入11项研究，涉及9729名参与者，符合条件并纳入数据分析。结果显示，与安慰剂相比，接受CGRP单克隆抗体治疗的患者发生高血压的合并优势比为（95%置信区间（CI）：0.60，2.21；P = 32%），表明高血压风险无显著增加。此外，CGRP单克隆抗体组与安慰剂组在耐受性或可接受性方面未观察到显著差异。然而，CGRP单克隆抗体组总不良事件的总体风险显著更高（优势比（OR）：1.13；95% CI：0.97，1.33；P = 56%；I² = 0.01）。这些发现表明，CGRP单克隆抗体耐受性良好，是治疗发作性和慢性偏头痛的总体安全选择。虽然高血压发生率没有显著增加，但观察到总体不良事件略有上升。因此，对于未发现其他治疗有效或耐受，或对替代疗法有禁忌证的患者，CGRP单克隆抗体可被视为一种可行的治疗选择。该研究方案已在国际前瞻性系统评价注册库（PROSPERO）（http://www.crd.york.ac.uk，注册号：CRD42024554897）注册。
