Bartoli Adrian, Michna Edward, He Ellie, Wen Warren
San Francisco Pain Management Center, San Francisco, California.
Brigham and Women's Hospital, Boston, Massachusetts.
J Opioid Manag. 2015 Nov-Dec;11(6):519-33. doi: 10.5055/jom.2015.0305.
A previous 52-week trial of patients with chronic noncancer, non-neuropathic pain (CNNP) showed clinically meaningful improvement in pain intensity, pain interference, and physical health-related quality of life (HRQL) following daily treatment with an extended-release, once-daily hydrocodone (Hysingla(®) ER; HYD) bitartrate tablet.
To examine treatment response within patient subgroups and to assess between-subgroup differences in effectiveness and side effect profile.
Data were from an open-label 52-week trial of treatment with HYD tablets (20-120 mg, once-daily) for patients with moderate-to-severe CNNP. Binary subgroups were defined for the following six factors: age, gender, opioid experience, baseline pain severity, history of depression, and stable HYD dose at completion of a 45-day dose-titration period. Univariable and multivariable models examined changes in average pain intensity (API; 11-point numeric rating scale), pain interference (Brief Pain Inventory-Interference subscale [BPI-I]), physical and mental HRQL (36-item Short Form health survey Physical and Mental Component Summaries [PCS and MCS]), and sleep quality (Medical Outcomes Study Sleep Scale Sleep Problems Index [SPI]) from baseline to maintenance, and subgroup differences in adverse events.
All subgroups showed clinically meaningful improvements in API, BPII, and PCS scores; no subgroups showed improvements in MCS or SPI. Between subgroup comparisons found greater improvements for opioid-naïve patients and for patients with severe baseline pain. Incidence of adverse events differed minimally between subgroups.
Regardless of subgroup, patients with CNNP treated with HYD showed clinically meaningful improvements in pain intensity, pain interference, and physical HRQL, although not in mental HRQL or sleep quality. Improvements were generally larger for opioid-naïve patients and patients with severe baseline pain.
先前一项针对慢性非癌性、非神经性疼痛（CNNP）患者的为期52周的试验表明，每日服用缓释、每日一次的氢可酮（Hysingla(®) ER；HYD）酒石酸盐片进行治疗后，疼痛强度、疼痛干扰及与身体健康相关的生活质量（HRQL）在临床上有显著改善。
研究患者亚组内的治疗反应，并评估亚组间在疗效和副作用方面的差异。
数据来自一项开放标签的为期52周的试验，该试验使用HYD片（剂量为20 - 120 mg，每日一次）治疗中重度CNNP患者。针对以下六个因素定义了二元亚组：年龄、性别、阿片类药物使用经验、基线疼痛严重程度、抑郁病史以及在45天剂量滴定期结束时的稳定HYD剂量。单变量和多变量模型研究了从基线到维持期平均疼痛强度（API；11点数字评分量表）、疼痛干扰（简明疼痛问卷-干扰子量表[BPI-I]）、身体和心理健康相关生活质量（36项简短健康调查问卷身体和心理成分总结[PCS和MCS]）以及睡眠质量（医学结局研究睡眠量表睡眠问题指数[SPI]）的变化，以及不良事件的亚组差异。
所有亚组在API、BPII和PCS评分上均显示出临床上有显著意义的改善；没有亚组在MCS或SPI上有改善。亚组间比较发现，未使用过阿片类药物的患者以及基线疼痛严重的患者改善更大。亚组间不良事件发生率差异极小。
无论亚组如何，接受HYD治疗的CNNP患者在疼痛强度、疼痛干扰和身体HRQL方面均显示出临床上有显著意义的改善，尽管在心理HRQL或睡眠质量方面没有改善。未使用过阿片类药物的患者和基线疼痛严重的患者改善通常更大。
