中国神经再生研究(英文版)

中国神经再生研究(英文版) ›› 2013, Vol. 8 ›› Issue (10): 938-947.doi: 10.3969/j.issn.1673-5374.2013.10.009

• 原著:脑损伤修复保护与再生 • 上一篇    下一篇

降钙素基因相关肽受体拮抗剂olcegepant和telcagepant治疗偏头痛的疗效及安全性：一项meta分析

  

  • 收稿日期:2012-10-24 修回日期:2013-01-27 出版日期:2013-04-05 发布日期:2013-04-05

Therapeutic effects and safety of olcegepant and telcagepant for migraine A meta-analysis

Gang Yao1, 2, Tingmin Yu1, Ximei Han1, 3, Xijing Mao1, Bo Li4   

  1. 1 Department of Neurology, Second Hospital, Jilin University, Changchun 130041, Jilin Province, China
    2 Department of Neurology, First Hospital, Jilin University, Changchun 130021, Jilin Province, China
    3 Department of Neurology, Chifeng Municipal Hospital, Chifeng 024000, Inner Mongolia Autonomous Region, China
    4 Research Room of Epidemiology and Health Statistics, School of Public Health, Jilin University, Changchun 130021, Jilin Province, China
  • Received:2012-10-24 Revised:2013-01-27 Online:2013-04-05 Published:2013-04-05
  • Contact: Tingmin Yu, M.D., Professor, Master’s supervisor, Department of Neurology, Second Hospital, Jilin University, Changchun 130041, Jilin Province, China, ytm_396@163.com.
  • About author:Gang Yao☆, Studying for doctorate.

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摘要：

目的：评估olcegepant和telcagepant两种药物在治疗偏头痛中的疗效和不良反应。
资料来源：检索Medline(1966-01/2012-06)、Pubmed(1966-01/2012-06)、Scopus (1980-01/2012-06)、Cochane对照试验中心（2000/2012-06）以及中国知网(1980-01/2012-06) 数据库。
资料选择：纳入研究均为双盲、随机、安慰剂对照试验，olcegepant和telcagepant治疗先兆或无先兆偏头痛患者的单次急性偏头痛发作。资料还包括与试验药物有关的不良反应，由2名研究者通过Jadad量表评分法独立进行质量评价及数据提取，而后采用RavMan5.0软件对纳入研究进行Meta分析。
结局评价指标：口服olcegepant和telcagepant两种药物后2 h和24 h患者头痛缓解率、疼痛消失率及不良反应发生率。
结果：共纳入6个RCT， Meta分析结果显示：与安慰剂对比，2.5mg/d olcegepant在治疗偏头痛的2 h疼痛缓解率 (OR=5.21，95%CI: 1.91-14.2, P < 0.01)和头痛消失率(OR=31.11, 95% CI: 3.80-254.98, P < 0.01)均显著增加。Telcagepant 150 mg/d和300 mg/d两个剂量治疗偏头痛的2 h和24 h头痛缓解率、疼痛消失率疗效均优于安慰剂(P < 0.01)。而且，300 mg/d剂量的Telcagepant在治疗偏头痛的24h持续头痛缓解率优于150 mg/d (OR=0.78，95% CI: 0.62-0.97, P < 0.05)。研究显示，olcegepant的不良反应发生率与安慰剂比较无显著增加(P=0.28)。给药48 h后telcagepant 300 mg/d不良反应发生率高于安慰剂组(OR=1.21, 95% CI: 1.04-1.42，P < 0.01)。目前尚缺少文献对两种药物疗效进行对比的研究。
结论：两种降钙素基因相关肽受体拮抗剂olcegepant和telcagepant在治疗偏头痛中具有良好的疗效，且不良反应发生率与安慰剂相当，但个别报道服用试验药物患者存在转氨酶增高，可能使其临床应用受到限制。

关键词: 神经再生, 脑损伤, 偏头痛, telcagepant, MK-0974, olcegepant, BIBN4096, 治疗, meta-分析

Abstract:

OBJECTIVE: To evaluate the therapeutic effects and adverse reactions of olcegepant and telcagepant for the treatment of migraine.
DATA RETRIEVAL: We identified studies using Medline (1966-01/2012-06), PubMed (1966-01/2012-06), Scopus (1980-01/2012-06), Cochrane Central Register of Controlled Trials (1980-01/2012-06) and China National Knowledge Infrastructure (1980-01/2012-06).
SELECTION CRITERIA: The included studies were double-blind, randomized and placebo-controlled trials of olcegepant or telcagepant for the treatment of single acute migraine in patients with or without aura. Adverse reaction data were also included. Two independent investigators performed quality evaluation and data extraction using Jadad scoring. Meta-analyses were undertaken using RevMan 5.0.25 software.
MAIN OUTCOME MEASURES: Pain relief rate, pain-free rate, and incidence of adverse reactions were measured in patients 2 and 24 hours after injection of olcegepant and oral telcagepant.
RESULTS: Six randomized, controlled trials were included. Meta-analysis demonstrated that compared with placebo, the pain relief rate (odds ratio, OR = 5.21, 95% confidence interval, CI: 1.91–14.2, P < 0.01) and pain-free rate (OR = 31.11, 95% CI: 3.80–254.98, P < 0.01) significantly increased 2 hours after 2.5 mg/d olcegepant treatment. Pain relief rate and pain-free rate 2 and 24 hours after treatment with telcagepant 150 mg/d and 300 mg/d were superior to placebo (P < 0.01). Moreover, the remission rate of unrelenting headache was higher after 24 hours of 300 mg/d telcagepant treatment compared with 150 mg/d (OR = 0.78, 95% CI: 0.62–0.97, P < 0.05). The incidence of adverse reactions with olcegepant was not significantly greater than placebo (P = 0.28), but within 48 hours of administration of telcagepant 300 mg/d, the incidence of adverse reactions was higher than placebo (OR = 1.21, 95% CI: 1.04–1.42, P < 0.01). Few studies have compared the therapeutic effects of olcegepant and telcagepant.
CONCLUSION: The calcitonin-gene-related peptide receptor antagonists olcegepant and telcagepant have shown good therapeutic effects in the treatment of migraine. Moreover, the incidence of adverse reactions compares favorably with placebo, although liver transaminases may become elevated after long-term use.

Key words: neural regeneration, evidence-based medicine, migraine, telcagepant, MK-0974, olcegepant, BIBN4096, treatment, meta-analysis, neuroregeneration