Mou Joy, Paillard Florence, Turnbull Barry, Trudeau Jeremiah, Stoker Malcolm, Katz Nathaniel P
*Analgesic Solutions, Natick ‡LLX Solutions, Watertown §Biobridges, Wellesley, MA †FocusBiocom, Durango, CO ∥Astellas Pharma Global Development, Leiderdorp, The Netherlands.
Clin J Pain. 2014 Apr;30(4):286-94. doi: 10.1097/AJP.0b013e31829a4ced.
Qutenza (capsaicin) 8% patch is used to treat various neuropathic indications, including postherpetic neuralgia (PHN) and human immunodeficiency virus-associated neuropathy (HIV-AN).
We conducted a meta-analysis of Qutenza studies to describe clinical phenomena of effects of Qutenza treatment better, such as onset and duration of pain relief, and the need for retreatments.
The meta-analyses combined individual patient data (1313 participants with PHN and 801 with HIV-AN) from 7 completed randomized, double-blind, controlled studies. Studies had similar designs, and all used the Qutenza patch (8% capsaicin) and a low-dose control patch (0.04% capsaicin). A 30% response was defined as a ≥30% decrease in mean pain intensity score during week 2 to end of follow-up; complete pain relief was defined as an average pain intensity ≤1 during week 2 to end of follow-up. Duration of response was calculated using the data from long-term studies as the time from onset of response to offset of response, retreatment, or end of follow-up (whichever occurred first).
Overall 44% of PHN and 41% of HIV-AN patients had a 30% response, and 11% and 7%, respectively, had complete pain relief 2 to 12 weeks after treatment with Qutenza. The mean (median) onset of response to Qutenza was 3.4 (1) days for PHN and 6.5 (4) days for HIV-AN (delayed due to an initial increase in discomfort). The mean (median) duration of response after 1 Qutenza treatment was 5 (3) months. Of the patients followed-up for 12 months, 40% PHN and 36% HIV-AN patients had a 30% response, and 9% and 10%, respectively, had complete pain relief from week 2 to end of follow-up.
Qutenza is effective in a high proportion of patients. In patients who respond to Qutenza, analgesia starts within a few days of treatment and lasts on average 5 months.
Qutenza(辣椒素)8%贴剂用于治疗多种神经性适应症,包括带状疱疹后神经痛(PHN)和人类免疫缺陷病毒相关神经病变(HIV-AN)。
我们对Qutenza研究进行了荟萃分析,以更好地描述Qutenza治疗效果的临床现象,如疼痛缓解的起效时间和持续时间,以及再次治疗的必要性。
荟萃分析合并了来自7项已完成的随机、双盲、对照研究的个体患者数据(1313例PHN患者和801例HIV-AN患者)。这些研究设计相似,均使用Qutenza贴剂(8%辣椒素)和低剂量对照贴剂(0.04%辣椒素)。30%反应定义为从第2周直至随访结束时平均疼痛强度评分降低≥30%;完全疼痛缓解定义为从第2周直至随访结束时平均疼痛强度≤1。反应持续时间使用长期研究数据计算,即从反应开始至反应消失、再次治疗或随访结束(以先发生者为准)的时间。
总体而言,44%的PHN患者和41%的HIV-AN患者有30%的反应,分别有11%和7%的患者在使用Qutenza治疗2至12周后完全缓解疼痛。PHN患者对Qutenza反应的平均(中位数)起效时间为3.4(1)天,HIV-AN患者为6.5(4)天(因最初不适增加而延迟)。单次Qutenza治疗后的平均(中位数)反应持续时间为5(3)个月。在随访12个月的患者中,40%的PHN患者和36%的HIV-AN患者有30%的反应,分别有9%和10%的患者从第2周直至随访结束时完全缓解疼痛。
Qutenza对很大比例的患者有效。在对Qutenza有反应的患者中,镇痛在治疗后几天内开始,平均持续5个月。