Maihöfner C G, Heskamp M-L S
Fürth Hospital, Department of Neurology, University of Erlangen-Nuremberg, Germany.
Eur J Pain. 2014 May;18(5):671-9. doi: 10.1002/j.1532-2149.2013.00415.x. Epub 2013 Oct 29.
This study evaluates the impact of the duration of pre-existing peripheral neuropathic pain on the therapeutic response to the capsaicin 8% cutaneous patch.
The non-interventional QUEPP (QUTENZA - safety and effectiveness in peripheral neuropathic pain) study evaluated the effectiveness of Qutenza(TM) in 1044 non-diabetic patients with peripheral neuropathic pain, who received a single application. Follow-up visits were scheduled at weeks 1-2, 4, 8 and 12. A pre-defined co-analysis of changes in average pain intensity was performed based on the duration of pre-existing pain.
In patients with pre-existing pain for <6 months, the mean relative change of the numeric pain rating scale score on days 7-14 to week 12 versus baseline was -36.6% [4.6 standard error of the mean (SEM); n = 105], -25.1% (1.9 SEM; n = 311) in patients with pain duration of 6 months to 2 years, -22.3% (1.6 SEM; n = 391) in patients with pain for >2-10 years, and -19.2% (2.6 SEM; n = 99) in patients with pain for >10 years. Thirty percent and 50% responder rates were 61.7% and 39.3% in patients with pre-existing pain for <6 months, 42.3% and 23.3% in patients with pain for 6 months to 2 years, 40.9% and 21.6% in patients with pain for >2-10 years, and 32.3% and 14.1% in patients with pain for >10 years.
The highest treatment response to the capsaicin 8% cutaneous patch was observed in patients with a history of pre-existing peripheral neuropathic pain of less than 6 months, suggesting that early initiation of topical treatment might be indicated.
本研究评估既往存在的周围神经性疼痛的持续时间对8%辣椒素皮肤贴片治疗反应的影响。
非干预性QUEPP(QUTENZA - 周围神经性疼痛的安全性和有效性)研究评估了Qutenza™在1044例接受单次给药的非糖尿病周围神经性疼痛患者中的有效性。随访安排在第1 - 2周、4周、8周和12周。根据既往疼痛的持续时间对平均疼痛强度变化进行了预定义的联合分析。
既往疼痛<6个月的患者,第7 - 14天至第12周数字疼痛评分量表评分相对于基线的平均相对变化为-36.6%[平均标准误(SEM)为4.6;n = 105];疼痛持续时间为6个月至2年的患者为-25.1%(1.9 SEM;n = 311);疼痛>2 - 10年的患者为-22.3%(1.6 SEM;n = 391);疼痛>10年的患者为-19.2%(2.6 SEM;n = 99)。既往疼痛<6个月的患者30%和50%反应率分别为61.7%和39.3%;疼痛6个月至2年的患者为42.3%和23.3%;疼痛>2 - 10年的患者为40.9%和21.6%;疼痛>10年的患者为32.3%和14.1%。
在既往存在周围神经性疼痛病史少于6个月的患者中观察到对8%辣椒素皮肤贴片的最高治疗反应,提示可能需要尽早开始局部治疗。