Department of NEUROFARBA, Pharmacology Section, University of Florence, Florence, Italy.
AOUC Hospital, Medical Toxicology Unit, Florence, Italy.
Eur Addict Res. 2018;24(1):9-18. doi: 10.1159/000485029. Epub 2018 Jan 31.
We aimed to improve the retention in treatment and therapeutic outcome of methadone maintenance treatment (MMT) patients by adjusting the oral methadone dose in order to reach a "target" plasma R-methadone level (80-250 ng/mL).
A multicenter randomized controlled trial was organized.
The intention-to-treat statistical analysis showed that repeated dose adjustments performed in order to obtain therapeutic plasma R-methadone levels did not improve retention in treatment of heroin-dependent patients. However, patients having plasma methadone levels in the "target range" at the beginning of the study had a better retention in treatment than controls. Furthermore, patients succeeding in keeping plasma R-methadone target levels (per protocol analysis) remained in treatment and improved their social scores better than controls. -Conclusion: Although the primary endpoint of this study was not demonstrated, a post hoc and a per protocol analysis suggested that patients in MMT with plasma R-methadone concentrations in the target range have a better therapeutic outcome than controls.
通过调整口服美沙酮剂量以达到“目标”血浆 R-美沙酮水平（80-250ng/mL），从而提高美沙酮维持治疗（MMT）患者的治疗保留率和治疗效果。
组织了一项多中心随机对照试验。
意向治疗统计分析表明，为获得治疗性血浆 R-美沙酮水平而进行的重复剂量调整并未改善海洛因依赖患者的治疗保留率。然而，在研究开始时血浆美沙酮水平处于“目标范围”的患者比对照组有更好的治疗保留率。此外，成功维持血浆 R-美沙酮目标水平（按方案分析）的患者继续治疗并比对照组更好地改善了他们的社会评分。-结论：尽管本研究的主要终点未得到证实，但事后分析和按方案分析表明，MMT 中血浆 R-美沙酮浓度处于目标范围的患者比对照组有更好的治疗效果。
