Centre for Interdisciplinary Addiction Research, University Medical Center Hamburg-Eppendorf, Martinistr. 52, D-20246, Hamburg, Germany; University of Florence, Department of Psychiatry, AOU Careggi, Florence, Italy.
Centre for Interdisciplinary Addiction Research, University Medical Center Hamburg-Eppendorf, Martinistr. 52, D-20246, Hamburg, Germany.
J Pharmacol Sci. 2020 Sep;144(1):9-15. doi: 10.1016/j.jphs.2020.06.004. Epub 2020 Jun 12.
Since 2015 slow-release oral morphine (SROM) is approved for opioid substitution treatment (OST) in Germany. The SROMOS study (efficacy and tolerability of slow-release oral morphine in opioid substitution treatment) evaluates the efficacy and safety of SROM in routine care. This article describes the switching process from racemic methadone, levomethadone and buprenorphine to SROM. Between July 2016 and November 2017 180 patients in 23 study centers in Germany were included in the prospective, non-interventional, naturalistic observational study. Patients were already in OST and switched from a previous medication to SROM. The switching process was analyzed during a period of fourteen days. Data were available for 169 participants. The switching process had a different progression depending on premedication and pre dosage. On the fourteenth day of SROM treatment patients switched from racemic methadone took an average dosage of 922.2 mg/day, from levomethadone 801.0 mg/day and from buprenorphine 626.7 mg/day. Average conversion ratio racemic methadone to SROM was 1:11.8, levomethadone to SROM 1:17.4 and buprenorphine to SROM 1:58.0. This study provides the first data on the switching process from buprenorphine to SROM. Average dose ratio racemic methadone to SROM on the fourteenth day of treatment was considerably higher than recommended in the prescribing information.
自 2015 年以来，德国已批准缓释口服吗啡（SROM）用于阿片类药物替代治疗（OST）。SROMOS 研究（缓释口服吗啡在阿片类药物替代治疗中的疗效和耐受性）评估了 SROM 在常规治疗中的疗效和安全性。本文描述了从消旋美沙酮、左美沙酮和丁丙诺啡转换为 SROM 的过程。2016 年 7 月至 2017 年 11 月，德国 23 个研究中心的 180 名患者参与了这项前瞻性、非干预性、自然观察研究。这些患者已经接受 OST 治疗，正在从以前的药物转换为 SROM。转换过程在 14 天内进行分析。169 名参与者中有数据可用。转换过程因预处理和预剂量而异。在 SROM 治疗的第 14 天，转换为消旋美沙酮的患者平均剂量为 922.2mg/天，转换为左美沙酮的患者平均剂量为 801.0mg/天，转换为丁丙诺啡的患者平均剂量为 626.7mg/天。消旋美沙酮与 SROM 的平均转换比为 1:11.8，左美沙酮与 SROM 的平均转换比为 1:17.4，丁丙诺啡与 SROM 的平均转换比为 1:58.0。本研究首次提供了从丁丙诺啡转换为 SROM 的过程数据。治疗第 14 天，消旋美沙酮与 SROM 的平均剂量比明显高于说明书推荐的剂量比。
