Evaluating the stability of opioid efficacy over 12 months in patients with chronic noncancer pain who initially demonstrate benefit from extended release oxycodone or hydrocodone: harmonization of Food and Drug Administration patient-level drug safety study data.
Evaluating the stability of opioid efficacy over 12 months in patients with chronic noncancer pain who initially demonstrate benefit from extended release oxycodone or hydrocodone: harmonization of Food and Drug Administration patient-level drug safety study data.
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DOI：
10.1097/j.pain.0000000000002331
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发表时间：
2022-01-01
期刊：
影响因子：
7.4
通讯作者：
Gilron I
中科院分区：
文献类型：
--
作者：
Farrar JT;Bilker WB;Cochetti PT;Argoff CE;Haythornthwaite J;Katz NP;Gilron I
补充数字内容可在正文中找到。阿片类药物可以缓解急性疼痛，但几乎没有证据表明长期治疗慢性非癌症疼痛的益处是稳定的。以前的系统审查只考虑了小组一级公布的数据，没有提供足够的细节。我们的目标是使用患者水平的数据来探索使用羟考酮和氢可酮滥用威慑制剂治疗12个月的患者的疼痛稳定性、阿片类药物剂量以及身体功能或疼痛干预。食品和药物管理局文件存档、报告和监管跟踪系统中的所有可用研究都包括在内。患者水平的人口统计数据、基线数据、暴露情况和结果是一致的。根据疼痛、身体功能和疼痛干扰的线性模型计算单个患者的斜率，以确定随时间推移的反应。通过基线和最后一个月观察期间的变化来总结阿片类药物的剂量。疼痛稳定或较少、阿片类药物剂量稳定或较低、身体功能稳定或较好(如果有)的患者符合我们预先指定的标准，以维持长期受益于慢性阿片类药物。在3192名患者的完整数据集中，1422名(44.5%)维持他们的疼痛水平和阿片类药物剂量。在对985名接受身体功能测试的患者进行的二次分析中，338名(34.3%)患者除疼痛和阿片类药物剂量外，还保持了身体功能。在2040名接受疼痛干预的患者中，788名(38.6%)符合另外的标准。在一个精心控制的环境中，大约三分之一的患者成功地使用阿片类药物治疗慢性非癌症疼痛，显示出持续受益长达12个月。
Supplemental Digital Content is Available in the Text. Opioids relieve acute pain, but there is little evidence to support the stability of the benefit over long-term treatment of chronic noncancer pain. Previous systematic reviews consider only group level published data which did not provide adequate detail. Our goal was to use patient-level data to explore the stability of pain, opioid dose, and either physical function or pain interference in patients treated for 12 months with abuse deterrent formulations of oxycodone and hydrocodone. All available studies in the Food and Drug Administration Document Archiving, Reporting, and Regulatory Tracking System were included. Patient-level demographics, baseline data, exposure, and outcomes were harmonized. Individual patient slopes were calculated from a linear model of pain, physical function, and pain interference to determine response over time. Opioid dose was summarized by change between baseline and the final month of observation. Patients with stable or less pain, stable or lower opioid dose, and stable or better physical function (where available) met our prespecified criteria for maintaining long-term benefit from chronic opioids. Of the complete data set of 3192 patients, 1422 (44.5%) maintained their pain level and opioid dose. In a secondary analysis of 985 patients with a measured physical function, 338 (34.3%) maintained their physical function in addition to pain and opioid dose. Of 2040 patients with pain interference measured, 788 (38.6%) met criteria in addition. In a carefully controlled environment, about one-third of patients successfully titrated on opioids to treat chronic noncancer pain demonstrated continued benefit for up to 12 months.
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影响因子：
5.7
作者：
Nicol AL;Hurley RW;Benzon HT
通讯作者：
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影响因子：
2.6
作者：
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作者：
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通讯作者：
Sommerville, Kenneth W
影响因子：
2.9
作者：
Keller, S;Bann, CM;Cleeland, CS
通讯作者：
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影响因子：
45.3
作者：
Burris, HA;Moore, MJ;VanHoff, DD
通讯作者：
VanHoff, DD