Naples Anesthesia and Physician Associates, Naples, Florida.
Purdue Pharma L.P., Stamford, Connecticut, USA.
Pain Med. 2018 May 1;19(5):967-977. doi: 10.1093/pm/pnx022.
This study evaluated the safety and effectiveness of a once-daily, single-entity, extended-release hydrocodone bitartrate (HYD) among patients with chronic noncancer and non-neuropathic pain who required opioid rotation from a previous analgesic regimen that primarily consisted of immediate-release (IR) oxycodone.
Post hoc analyses of a primary study that assessed HYD 20 to 120 mg over a 52-week period are presented. The primary study included a dose titration period (up to 45 days), a 52-week maintenance period, and an optional taper period (up to 14 days).
Relative to baseline, mean "average pain over the last 24 hours" declined by 1.9 points at the end of the titration period and by 2.6 points at the end of the maintenance period. Additionally, interference and severity of pain as measured by the Brief Pain Inventory-Short Form decreased by 2.3 and 1.9 points, respectively, during the maintenance period. The use of supplemental opioid analgesics decreased. Most patients remained on a stable HYD dose throughout the maintenance period. Most patients indicated satisfaction with HYD and considered it convenient and easy to use. HYD demonstrated a safety profile typical of µ opioids; nausea, constipation, vomiting, and dizziness were the most frequently reported opioid-related adverse events during the study.
In patients with chronic pain who received HYD over a 52-week period, treatment was generally well tolerated and provided effective analgesia among those who rotated from a pain regimen primarily consisting of IR oxycodone.
本研究评估了每日一次、单一实体、缓释氢可酮酒石酸盐（HYD）在慢性非癌症和非神经病理性疼痛患者中的安全性和有效性，这些患者需要从以前主要由即时释放（IR）羟考酮组成的镇痛方案中转用阿片类药物。
呈现了一项主要研究的事后分析，该研究评估了 HYD 在 52 周内的 20 至 120mg 剂量。主要研究包括剂量滴定期（最多 45 天）、52 周维持期和可选的减量期（最多 14 天）。
与基线相比，在滴定期末，“过去 24 小时平均疼痛”的平均水平下降了 1.9 分，在维持期末下降了 2.6 分。此外，在维持期末，简短疼痛问卷-短表测量的疼痛干扰和严重程度分别下降了 2.3 和 1.9 分。辅助阿片类药物的使用减少了。大多数患者在整个维持期内保持稳定的 HYD 剂量。大多数患者表示对 HYD 满意，并认为它方便易用。HYD 表现出与 µ 阿片类药物典型的安全性特征；恶心、便秘、呕吐和头晕是研究期间最常报告的与阿片类药物相关的不良反应。
在接受 HYD 治疗 52 周的慢性疼痛患者中，治疗通常耐受性良好，为那些从主要由 IR 羟考酮组成的疼痛方案中转用的患者提供了有效的镇痛。
