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双靶点抗组胺药与 gepants:疗效和安全性比较分析的系统评价与间接网络荟萃分析

Ditans vs Gepants: A Systematic Review and Indirect Network Meta-Analysis for Comparative Analysis of Efficacy and Safety.

作者信息

Singh Alok, Gupta Dhyuti, Singh Abhishek

机构信息

Department of Pharmacology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India.

Department of Pediatrics, Paramitha Children Hospital, Hyderabad, Telangana, India.

出版信息

Neurol India. 2021 Mar-Apr;69(Supplement):S43-S50. doi: 10.4103/0028-3886.315991.

DOI:10.4103/0028-3886.315991
PMID:34003147
Abstract

BACKGROUND

An acute attack of migraine, incapacitates the migraineurs, and is widely prevalent. And to warden off its symptoms, recently two groups of drugs have been approved and launched.

OBJECTIVE

The aim of this systematic review and indirect meta-analysis is to evaluate and summarize the effectiveness of these pharmacological interventions in managing the aforesaid disease.

MATERIAL AND METHODS

An extensive literature search was done through Cochrane library, Pub Med, clincialtrials.gov, for a period of 5 years (2015-2020), using key words: lasmiditan; ubrogepant; rimegepant; and acute migraine. Randomized double-blind phase III clinical trials, published in English language, were included which explored the efficacy and safety of these drugs. The outcomes of this meta-analysis included proportion of patients' headache, most bothersome symptoms free, and no disability at all at 2 h post-dose, with sustained pain freedom 2-24 h, and experiencing any adverse event. An indirect network meta-analysis was also conducted to determine the comparative effectiveness of these drugs.

RESULTS

A total of seven RCTs involving 7266 patients were included. In general, the new drugs demonstrated better result in all the efficacy parameters. The adverse events were observed in treatment group compared to placebo. While in the indirect comparison, lasmiditan emerged to be superior in all the outcomes, except for sustained pain freedom 2-24 h (rimegepant was better). The adverse events were more with lasmiditan.

CONCLUSION

All the newer drugs have shown significant improvement in the outcomes analyzed. Lasmiditan appears to be superior among the newer drugs in efficacy; however it has more adverse effects.

摘要

背景

偏头痛急性发作会使患者丧失能力,且广泛流行。为预防其症状,最近有两类药物已获批并上市。

目的

本系统评价和间接荟萃分析的目的是评估和总结这些药物干预措施对上述疾病的治疗效果。

材料与方法

通过Cochrane图书馆、PubMed、clinicaltrials.gov进行了为期5年(2015 - 2020年)的广泛文献检索,使用关键词:拉米地坦;乌布罗格潘;利美尼定;以及急性偏头痛。纳入以英文发表的随机双盲III期临床试验,这些试验探讨了这些药物的疗效和安全性。该荟萃分析的结果包括给药后2小时头痛患者的比例、最困扰症状消失且无残疾的患者比例、2 - 24小时持续无疼痛的患者比例以及发生任何不良事件的患者比例。还进行了间接网络荟萃分析以确定这些药物的相对疗效。

结果

共纳入7项涉及7266例患者的随机对照试验。总体而言,新药在所有疗效参数方面均显示出更好的结果。与安慰剂相比,治疗组观察到了不良事件。在间接比较中,除2 - 24小时持续无疼痛(利美尼定更好)外,拉米地坦在所有结局方面均表现更优。拉米地坦的不良事件更多。

结论

所有新药在分析的结局方面均显示出显著改善。拉米地坦在新药中似乎疗效更优;然而其不良反应更多。

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引用本文的文献

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BMJ. 2024 Sep 18;386:e080107. doi: 10.1136/bmj-2024-080107.
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Rimegepant: A Review in the Acute Treatment and Preventive Treatment of Migraine.利马曲班:偏头痛急性治疗和预防治疗的研究进展。
CNS Drugs. 2023 Mar;37(3):255-265. doi: 10.1007/s40263-023-00988-8. Epub 2023 Feb 4.
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New Approaches to Shifting the Migraine Treatment Paradigm.
转变偏头痛治疗模式的新方法。
Front Pain Res (Lausanne). 2022 Sep 6;3:873179. doi: 10.3389/fpain.2022.873179. eCollection 2022.
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Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale.降钙素基因相关肽(CGRP)靶向单克隆抗体和拮抗剂在偏头痛中的应用:当前证据和原理。
BioDrugs. 2022 May;36(3):341-358. doi: 10.1007/s40259-022-00530-0. Epub 2022 Apr 27.