慢性全μ阿片受体激动剂治疗患者转口服丁丙诺啡耐受性评价

L. Webster, D. Gruener, Todd Kirby, Q. Xiang, E. Tzanis, A. Finn
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引用次数: 34

摘要

目的评估慢性疼痛患者口服相当于全μ-阿片类激动剂的80 ~ 220 mg硫酸吗啡是否可以在不引起阿片类戒断或牺牲镇痛效果的情况下,以约50%的全剂量过渡到丁丙诺啡。方法。一项随机、双盲、双虚拟、主动对照、两期交叉研究,研究对象是接受全天候阿片受体激动剂治疗并经纳洛酮刺激证实阿片依赖的成年患者。在每个患者的常规剂量计划中替换研究剂量。主要终点是临床阿片戒断量表评分≥13分(中度戒断)或使用抢救药物的患者比例。结果。每天服用≥80mg硫酸吗啡当量的35名受试者可评估阿片类戒断。口腔丁丙诺啡治疗组和50%全μ-阿片受体激动剂治疗组分别有1例和2例出现至少中等强度的阿片戒断。临床阿片类药物戒断量表的平均最大评分相似,并且在口腔丁丙诺啡组数值较低。两种治疗方法在疼痛评分上没有显著差异。口腔丁丙诺啡最常见的不良事件为头痛(19%)、呕吐(13%)、恶心、腹泻和停药综合征(各9%),全μ-阿片激动剂最常见的不良事件为头痛(16%)、停药综合征(13%)和恶心(6%)。结论。24小时全μ阿片受体激动剂治疗的慢性疼痛患者可以在约50%全μ阿片受体激动剂剂量的情况下改用丁丙诺啡(部分μ阿片受体激动剂),而不会增加阿片类药物戒断或失去疼痛控制的风险。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the Tolerability of Switching Patients on Chronic Full μ-Opioid Agonist Therapy to Buccal Buprenorphine
Objective Assess whether patients with chronic pain receiving 80 to 220 mg oral morphine sulfate equivalent of a full μ-opioid agonist could be transitioned to buccal buprenorphine at approximately 50% of their full dose without inducing opioid withdrawal or sacrificing analgesic efficacy. Methods. A randomized, double-blind, double-dummy, active-controlled, two-period crossover study in adult patients receiving around-the-clock full opioid agonist therapy and confirmed to be opioid dependent by naloxone challenge. Study doses were substituted at the time of the regular dose schedule for each patient. The primary endpoint was the proportion of patients with a maximum Clinical Opiate Withdrawal Scale score ≥ 13 (moderate withdrawal) or use of rescue medication. Results. 35 subjects on ≥ 80 mg morphine sulfate equivalent per day were evaluable for opioid withdrawal. One patient during buccal buprenorphine treatment and two during 50% full μ-opioid agonist treatment experienced opioid withdrawal of at least moderate intensity. The mean maximum Clinical Opiate Withdrawal Scale scores were similar, and numerically lower on buccal buprenorphine. There were no significant differences in pain ratings between treatments. The most frequent adverse events with buccal buprenorphine were headache (19%), vomiting (13%), nausea, diarrhea, and drug withdrawal syndrome (each 9%), and with full μ-opioid agonist were headache (16%), drug withdrawal syndrome (13%), and nausea (6%). Conclusions. Chronic pain patients treated with around-the-clock full μ-opioid agonist therapy can be switched to buccal buprenorphine (a partial μ-opioid agonist) at approximately 50% of the full μ-opioid agonist dose without an increased risk of opioid withdrawal or loss of pain control.
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