德克斯基托洛芬 (Dexketoprofen Trometamol) 和特拉马多尔 (Tramadol Hydrochloride) 固定剂量组合治疗中度至严重的急性腰部疼痛:一个第四期,随机,并行组,安慰剂,主动对照研究 (DANTE)
Giustino Varrassi1, Magdi Hanna2, Stefano Coaccioli3
1Paolo Procacci Foundation, Via Tacito 7, 00193, Rome, Italy. giuvarr@gmail.com.
Pain and therapy
|June 26, 2024
概括
德克斯基托/特拉马多尔 (DKP/TRAM) 在急性腰部疼痛缓解方面表现优于单独使用的特拉马多尔. 虽然不符合主要终点,但DPK/TRAM在二次分析中证明了有效性和安全性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 疼痛管理 疼痛管理
- 临床试验 临床试验
背景情况:
- 德克斯基托/特拉马多尔 (DKP/TRAM) 是一种固定剂量组合止痛药.
- 带有或没有根细胞病的急性腰痛 (LBP) 需要有效的治疗选择.
研究的目的:
- 评估DKP/TRAM对中度至重度急性LBP的疗效和安全性.
- 在一个随机对照试验中,将DKP/TRAM与特拉马多尔和安慰剂进行比较.
主要方法:
- 进行了一项国际,多中心,随机,双盲,安慰剂控制的第四阶段研究 (DANTE).
- 538名中度至重度急性LBP患者被随机分配给DKP/TRAM,特拉马多尔或安慰剂.
- 主要终点是达到数值评分尺度疼痛强度 (NRS-PI) 分数<4或≥30%的减少的时间.
主要成果:
- 与安慰剂相比,DKP/TRAM显示了实现主要终点的患者比例较高,但它在统计学上并不显著 (46.1%与42.6%相比).
- DKP/TRAM在4,6和8小时的总疼痛缓解方面表现优于单独使用的特拉马多尔.
- 从1小时开始,DKP/TRAM与安慰剂相比,观察到NRS-PI得分的显著降低,而DKP/TRAM与特拉马多尔相比,显示出较低的总疼痛强度差异.
结论:
- 尽管没有达到主要终点,但二次分析表明,DPK/TRAM在急性LBP的总疼痛缓解方面优于安慰剂和单独的特拉马多尔.
- DKP/TRAM被认为是适度至严重的急性腰部疼痛的有效和安全的治疗选择.
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