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Capsaicin 8 % Patch: A Review in Peripheral Neuropathic Pain

机译:辣椒素8%贴剂:周围神经性疼痛的综述

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摘要

The capsaicin 8 % patch (QUTENZA (R)) is an adhesive patch containing a high concentration (8 % w/w) of synthetic capsaicin, a selective agonist of transient receptor potential vanilloid 1 channel. It is approved for treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain in the EU; it is only approved to treat postherpetic neuralgia (PHN) in the USA. In patients with painful diabetic peripheral neuropathy (PDPN), a single 30-min application of the capsaicin 8 % patch significantly improved pain relief and sleep quality compared with placebo in a 12-week double-blind trial. In a 52-week, randomized trial, up to seven consecutive 30-min treatments with the capsaicin 8 % patch (<= 7 treatments each at least 8 weeks apart) plus standard of care therapy was associated with sustained pain relief and no negative neurological safety consequences compared with standard of care. In two randomized trials, a single 60-min application of the capsaicin 8 % patch reduced pain scores significantly more than a low-concentration (0.04 %) capsaicin control patch in patients with PHN. Capsaicin 8 % patch treatment was noninferior to pregabalin (optimized dosage) in a randomized trial in patients with nondiabetic peripheral neuropathic pain. Results in two trials in patients with HIV-AN were equivocal, with a significant improvement in pain intensity observed in one trial, but not in the other. The capsaicin 8 % patch was associated with expected, transient, capsaicin-related application-site adverse events such as erythema and pain.
机译:辣椒素8%贴剂(QUTENZA(R))是一种粘性贴剂,其中包含高浓度(8%w / w)的合成辣椒素,这是瞬时受体电位香草酸1通道的选择性激动剂。在欧盟,该药被批准用于成人的周围神经性疼痛的单独治疗或与其他药物组合治疗疼痛;它仅在美国被批准用于治疗带状疱疹后遗神经痛(PHN)。在一项为期12周的双盲试验中,与安慰剂相比,在患有糖尿病性周围神经病(PDPN)的患者中,与安慰剂相比,单次30分钟应用辣椒素8%贴剂可显着改善疼痛缓解和睡眠质量。在一项为期52周的随机试验中,使用辣椒素8%贴剂(间隔至少8周,分别= <= 7种治疗方法)加上护理标准治疗,最多可进行7次连续30分钟的治疗,可持续缓解疼痛且无神经学上的不良反应安全后果与照护标准相比。在两项随机试验中,对60%的PHN患者,单次60分钟应用辣椒素8%贴剂可减少疼痛评分,明显优于低浓度(0.04%)的辣椒素对照贴剂。在一项非糖尿病性周围神经性疼痛患者的随机试验中,辣椒素8%贴剂治疗不低于普瑞巴林(最佳剂量)。两项HIV-AN患者试验的结果是模棱两可的,在一项试验中观察到疼痛强度有明显改善,而在另一项试验中则没有。辣椒素8%的贴剂与预期的,短暂的辣椒素相关的应用部位不良事件(如红斑和疼痛)相关。

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