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Abstract：
OBJECTIVE: Refractory cancer-induced bone pain (CIBP) affects a patient\'s functional capacity and quality of life, but there is limited evidence to guide opioid choice. We assessed the feasibility, tolerability and possible efficacy of methadone rotation (MR) compared to other opioid rotations (OOR) in this cohort.
METHODS: Adults with CIBP and worst pain intensity ≥ 4/10 and/or opioid toxicity graded ≥ 2 on the Common Terminology Criteria for Adverse Events were randomised 1:1 to methadone or another opioid rotation. Standardised assessment tools were used at pre-defined study time points up to 14 days.
RESULTS: Of 51 eligible participants, 38 (74.5%) consented, and 29 (76.3%, MR: 14, OOR: 15) completed the fourteen days follow-up post-opioid rotation. Both groups displayed significant reduction in average (MR: d = - 1.2, p = 0.003, OOR: d = - 0.8, p = 0.015) and worst pain (MR: d = - 0.9, p = 0.042, OOR: d = - 0.6, p = 0.048) and total pain interference score (MR: d = - 1.1, p = 0.042, OOR: d = - 0.7, p = 0.007). Oral morphine equivalent daily dose was reduced significantly in MR compared to the OOR group (d = - 0.8, p = 0.05). The incidence of opioid-related adverse events following MR was unchanged but lower in the OOR group (d = 0.9, 95% CI 0.1,1.7, p = 0.022). There were no within-group or between-group differences in satisfaction with analgesia at the end of the study.
CONCLUSIONS: This pilot study demonstrated that MR and OOR in patients with refractory CIBP are feasible, safe and acceptable to patients. Appropriately powered multi-centre randomised controlled studies are needed to confirm the efficacy of MR and OOR in this cohort.
BACKGROUND: ACTRN12621000141842 registered 11 February 2021.
METHODS: Adults with CIBP and worst pain intensity ≥ 4/10 and/or opioid toxicity graded ≥ 2 on the Common Terminology Criteria for Adverse Events were randomised 1:1 to methadone or another opioid rotation. Standardised assessment tools were used at pre-defined study time points up to 14 days.
RESULTS: Of 51 eligible participants, 38 (74.5%) consented, and 29 (76.3%, MR: 14, OOR: 15) completed the fourteen days follow-up post-opioid rotation. Both groups displayed significant reduction in average (MR: d = - 1.2, p = 0.003, OOR: d = - 0.8, p = 0.015) and worst pain (MR: d = - 0.9, p = 0.042, OOR: d = - 0.6, p = 0.048) and total pain interference score (MR: d = - 1.1, p = 0.042, OOR: d = - 0.7, p = 0.007). Oral morphine equivalent daily dose was reduced significantly in MR compared to the OOR group (d = - 0.8, p = 0.05). The incidence of opioid-related adverse events following MR was unchanged but lower in the OOR group (d = 0.9, 95% CI 0.1,1.7, p = 0.022). There were no within-group or between-group differences in satisfaction with analgesia at the end of the study.
CONCLUSIONS: This pilot study demonstrated that MR and OOR in patients with refractory CIBP are feasible, safe and acceptable to patients. Appropriately powered multi-centre randomised controlled studies are needed to confirm the efficacy of MR and OOR in this cohort.
BACKGROUND: ACTRN12621000141842 registered 11 February 2021.
摘要：
目的：难治性癌性骨痛（CIBP）会影响患者的功能和生活质量，但是指导阿片类药物选择的证据有限。我们评估了可行性，与其他阿片类药物轮换（OOR）相比，该队列中美沙酮轮换（MR）的耐受性和可能的疗效。
方法：在不良事件通用术语标准中，CI血压和最严重疼痛强度≥4/10和/或阿片类药物毒性分级≥2的成年人以1：1随机分配给美沙酮或另一种阿片类药物轮换。在长达14天的预定义研究时间点使用标准化评估工具。
结果：在51名符合条件的参与者中，38（74.5%）同意，和29（76.3%，MR：14，OOR：15）完成了阿片类药物旋转后14天的随访。两组均显示平均疼痛（MR：d=-1.2，p=0.003，OOR：d=-0.8，p=0.015）和最严重的疼痛（MR：d=-0.9，p=0.042，OOR：d=-0.6，p=0.048）和总疼痛干扰评分（MR：d=-1.1，p=0.042，OOR：d=-0.7，p=0.007）。与OOR组相比，MR中的口服吗啡等效日剂量显着减少（d=-0.8，p=0.05）。OOR组MR后阿片类药物相关不良事件的发生率没有变化，但较低(d=0.9,95%CI0.1,1.7,p=0.022)。在研究结束时，对镇痛的满意度没有组内或组间差异。
结论：这项初步研究表明，难治性CIBP患者的MR和OOR是可行的，患者安全且可接受。需要适当的多中心随机对照研究来确认该队列中MR和OOR的疗效。
背景：ACTRN12621000141842注册于2021年2月11日。
方法：在不良事件通用术语标准中，CI血压和最严重疼痛强度≥4/10和/或阿片类药物毒性分级≥2的成年人以1：1随机分配给美沙酮或另一种阿片类药物轮换。在长达14天的预定义研究时间点使用标准化评估工具。
结果：在51名符合条件的参与者中，38（74.5%）同意，和29（76.3%，MR：14，OOR：15）完成了阿片类药物旋转后14天的随访。两组均显示平均疼痛（MR：d=-1.2，p=0.003，OOR：d=-0.8，p=0.015）和最严重的疼痛（MR：d=-0.9，p=0.042，OOR：d=-0.6，p=0.048）和总疼痛干扰评分（MR：d=-1.1，p=0.042，OOR：d=-0.7，p=0.007）。与OOR组相比，MR中的口服吗啡等效日剂量显着减少（d=-0.8，p=0.05）。OOR组MR后阿片类药物相关不良事件的发生率没有变化，但较低(d=0.9,95%CI0.1,1.7,p=0.022)。在研究结束时，对镇痛的满意度没有组内或组间差异。
结论：这项初步研究表明，难治性CIBP患者的MR和OOR是可行的，患者安全且可接受。需要适当的多中心随机对照研究来确认该队列中MR和OOR的疗效。
背景：ACTRN12621000141842注册于2021年2月11日。
