Harvard School of Public Health, Boston, Massachusetts, United States of America.
PLoS One. 2007 Jul 25;2(6):e551. doi: 10.1371/journal.pone.0000551.
To examine the efficacy and safety of Prosaptide (PRO) for the treatment of painful HIV-associated sensory neuropathies (HIV-SN).
A randomized, double-blind, placebo-controlled, multicenter study in participants with sensory neuropathy. Pain modulating therapy was discontinued prior to baseline. Participants were stratified by sural sensory nerve action potential (SNAP) amplitude. Participants were trained to use an electronic diary (ED) to record pain.
Peripheral neuropathies are common complications of HIV infection. The pathogenesis is unknown and currently treatments are restricted to symptomatic measures. We examined PRO against placebo (PBO) for treatment of painful HIV-SN and performed a post-hoc evaluation of an electronic diary (ED) to record HIV-associated neuropathic pain.
Eligible participants included adults with neurologist-confirmed painful HIV-SN.
2, 4, 8, or 16 mg/d PRO or PBO administered via subcutaneous (SC) injection for six weeks. Neurotoxic antiretroviral drug usage was held constant.
Changes from baseline in the weekly average of evaluable daily random prompts measuring pain using the Gracely pain scale and adverse events.
237 participants were randomized. The study was stopped after a planned futility analysis. There were no between-group differences in the frequency of adverse events or laboratory toxicities. The 6-week mean (sd) Gracely pain scale changes were -0.12 (0.23), -0.24 (0.35), -0.15 (0.32), -0.18 (0.34), and -0.18 (0.32) for the 2, 4, 8, 16 mg, and PBO arms respectively. A similar variability of pain changes recorded using the ED were noted compared to previous trials that used paper collection methods.
6-week treatment with PRO was safe but not effective at reducing HIV-associated neuropathic pain. Use of an ED to record neuropathic pain is novel in HIV-SN, resulted in reasonable compliance in recording pain data, but did not decrease the variability of pain scores compared to historical paper collection methods.
Current Controlled Trials NCT00286377.
研究 Prosaptide（PRO）治疗与人类免疫缺陷病毒（HIV）相关感觉神经病变（HIV-SN）相关疼痛的疗效和安全性。
这是一项在感觉神经病变患者中进行的随机、双盲、安慰剂对照、多中心研究。在基线前停止使用疼痛调节治疗。根据腓肠神经感觉神经动作电位（SNAP）振幅对参与者进行分层。参与者接受电子日记（ED）记录疼痛的培训。
周围神经病变是 HIV 感染的常见并发症。发病机制尚不清楚，目前的治疗方法仅限于对症治疗。我们研究了 PRO 与安慰剂（PBO）治疗 HIV-SN 疼痛的效果，并对记录 HIV 相关神经病理性疼痛的电子日记（ED）进行了事后评估。
合格的参与者包括神经科医生确诊的 HIV-SN 相关疼痛的成年人。
2、4、8 或 16 mg/d PRO 或 PBO 经皮下（SC）注射给药，持续 6 周。神经毒性抗逆转录病毒药物的使用保持不变。
共有 237 名参与者被随机分组。在计划的无效性分析后，研究停止。各组间不良反应或实验室毒性的发生频率无差异。6 周平均（标准差）Gracely 疼痛量表变化分别为-0.12（0.23）、-0.24（0.35）、-0.15（0.32）、-0.18（0.34）和-0.18（0.32），分别为 2、4、8、16 mg 和 PBO 组。与以前使用纸质收集方法的试验相比，使用 ED 记录疼痛变化的变异性相似。
PRO 治疗 6 周是安全的，但不能有效减轻 HIV 相关神经病理性疼痛。使用 ED 记录神经病理性疼痛是 HIV-SN 中的一种新方法，在记录疼痛数据方面具有合理的依从性，但与历史上的纸质收集方法相比，并未降低疼痛评分的变异性。
当前对照试验 NCT00286377。
