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固定剂量低剂量普雷加巴林与杜洛西丁组合,或普雷加巴林单疗法治疗神经性疼痛:双盲,随机,并行组研究
Krishnaprasad K1, Sunil Dutt2, Pankaj Rattan2
1Medical Services, Torrent Pharmaceuticals Limited, Gandhinagar, Gujrat, 382428, India.
F1000Research
|April 15, 2024
概括
低剂量普雷加巴林和杜洛西丁的固定剂量组合表明,与治疗神经病痛时的普雷加巴林单一治疗相比,它没有劣势. 这两种治疗都提供了类似的疼痛缓解,而头和昏昏欲睡是常见的副作用.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
- 疼痛管理 疼痛管理
背景情况:
- 神经性疼痛管理具有挑战性,以普雷加巴林和杜洛西丁作为一线治疗方法.
- 国际指导方针建议结合一线药物来有效控制神经病痛.
- 这项研究研究了用于治疗神经病痛的普雷加巴林和杜洛西丁的固定剂量组合 (FDC).
研究的目的:
- 为了评估低剂量Pregabalin和杜洛西丁FDC的疗效和安全性,与Pregabalin单一治疗相比.
- 在中度至重度神经病痛患者的第七周疼痛强度变化进行比较.
- 评估FDC与单疗法相比的非劣势性.
主要方法:
- 一个第三阶段,随机,双盲,双模拟,并行组非劣势性研究.
- 328名中度至重度神经病痛的成年患者被随机 (1:1) 分配7周.
- 治疗组接受了FDC (普雷加巴林50-75毫克+杜洛西丁20-30毫克两次) 或普雷加巴林单一治疗 (75-150毫克两次).
主要成果:
- 298名患者完成了这项研究;148名患者在FDC组和150名患者在Pregabalin组.
- 7周后每日疼痛的平均变化为FDC的 -4.49和pregabalin的 -4.66 (p<0.0001).
- 低剂量FDC的非劣质性被证明;头和昏昏欲睡是常见的,发病率相似. 周围胀在FDC中较少发生.
结论:
- 低剂量普雷加巴林和杜洛西丁的固定剂量组合提供了与高剂量普雷加巴林单一治疗相似的止痛效果.
- 在两组治疗中,头和昏昏欲睡是最常见的不良事件.
- 低剂量的FDC是管理中度至重度神经病痛的可行选择.
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