Katz Nathaniel P, Mou Joy, Paillard Florence C, Turnbull Barry, Trudeau Jeremiah, Stoker Malcolm
*Analgesic Solutions, Natick †LLX Solutions, Watertown ‡Biobridges, Wellesley, MA §Astellas Pharma Global Development, Leiderdorp, The Netherlands.
Clin J Pain. 2015 Oct;31(10):859-66. doi: 10.1097/AJP.0000000000000186.
Qutenza is a high-dose capsaicin patch used to relieve neuropathic pain from postherpetic neuralgia (PHN) and HIV-associated neuropathy (HIV-AN). In clinical studies, some patients had a dramatic response to the capsaicin patch. Our objective was to determine the baseline characteristics of patients who best benefit from capsaicin patch treatment.
We conducted a meta-analysis of 6 completed randomized and controlled Qutenza studies by pooling individual patient data. Sustained response was defined as>50% decrease in the mean pain intensity from baseline to weeks 2 to 12, and Complete Response as an average pain intensity score≤1 during weeks 2 to 12. Logistic regression was used to identify predictors of response and Complete Response, and subgroups of patients who respond best to the capsaicin patch.
Baseline pain intensity score (BPIS)≤4 was a predictor of Sustained and Complete Response in PHN and HIV-AN patients; absence of allodynia and presence of hypoesthesia, and a McGill Pain Questionnaire (MPQ) sensory score <22 were predictors of Sustained Response in PHN patients; female sex was a predictor of Sustained and Complete Response in HIV-AN patients. Thus, characteristics associated with the highest chance of responding to the capsaicin patch were, for PHN, BPIS≤4, MPQ sensory score≤22, absence of allodynia, and presence of hypoesthesia; for HIV-AN, they were female sex and BPIS≤4. Patients with these characteristics had a statistically significantly greater chance of responding to the capsaicin patch than other patients.
We identified subpopulations of PHN and HIV-AN patients likely to benefit from the capsaicin patch.
Qutenza是一种高剂量辣椒素贴剂,用于缓解带状疱疹后神经痛(PHN)和HIV相关性神经病变(HIV-AN)引起的神经性疼痛。在临床研究中,一些患者对辣椒素贴剂有显著反应。我们的目的是确定最能从辣椒素贴剂治疗中获益的患者的基线特征。
我们通过汇总个体患者数据,对6项已完成的Qutenza随机对照研究进行了荟萃分析。持续缓解定义为从基线到第2至12周平均疼痛强度降低>50%,完全缓解定义为第2至12周平均疼痛强度评分≤1。采用逻辑回归确定缓解和完全缓解的预测因素,以及对辣椒素贴剂反应最佳的患者亚组。
基线疼痛强度评分(BPIS)≤4是PHN和HIV-AN患者持续缓解和完全缓解的预测因素;无异常性疼痛和存在感觉减退,以及麦吉尔疼痛问卷(MPQ)感觉评分<22是PHN患者持续缓解的预测因素;女性是HIV-AN患者持续缓解和完全缓解的预测因素。因此,与对辣椒素贴剂反应可能性最高相关的特征,对于PHN来说,是BPIS≤4、MPQ感觉评分≤22、无异常性疼痛和存在感觉减退;对于HIV-AN来说,是女性和BPIS≤4。具有这些特征的患者对辣椒素贴剂反应的可能性在统计学上显著高于其他患者。
我们确定了可能从辣椒素贴剂中获益的PHN和HIV-AN患者亚群。