Uehlinger C, Déglon J, Livoti S, Petitjean S, Waldvogel D, Ladewig D
Psychosocial Centre of Fribourg, Fribourg, Switzerland.
Eur Addict Res. 1998;4 Suppl 1:13-8. doi: 10.1159/000052036.
A three-centre, randomised, double-blind study was designed to compare the efficacy and safety of buprenorphine and methadone. This was the first European study to compare these agents and was based on a previous trial performed in the US. Opioid-dependent subjects were randomised to receive either sublingual buprenorphine or oral methadone daily. Both objective and subjective measures of efficacy were monitored weekly, and safety parameters were regularly monitored over the entire six-week study. Urinalysis showed that the two treatments were similar with a slight increase in opioid-negative urines noted in both groups. The retention rate in the buprenorphine group was lower than in the methadone group, although it has been suggested that the buprenorphine dose may have been too low for some patients. None of the side effects noted were considered serious and all were attributable to chronic opioid dependence. Experience of two years substitution treatment in Fribourg suggests that initial induction onto buprenorphine allows for patients to be subgrouped before being given the most appropriate maintenance agent. Further investigation is required into the different dose-related effects of buprenorphine seen in particular subsets of addicts.
一项三中心、随机、双盲研究旨在比较丁丙诺啡和美沙酮的疗效与安全性。这是欧洲第一项比较这两种药物的研究，其基于之前在美国进行的一项试验。阿片类药物依赖受试者被随机分组，分别每日接受舌下含服丁丙诺啡或口服美沙酮治疗。每周监测疗效的客观和主观指标，在为期六周的整个研究过程中定期监测安全参数。尿液分析显示，两种治疗方法相似，两组中阿片类药物阴性尿液均略有增加。丁丙诺啡组的留存率低于美沙酮组，不过有人认为，丁丙诺啡的剂量对某些患者而言可能过低。所记录的副作用均不被视为严重，且均归因于慢性阿片类药物依赖。弗里堡两年替代治疗的经验表明，在给予最合适的维持药物之前，初始采用丁丙诺啡诱导治疗可让患者进行亚组分类。对于在特定成瘾者亚组中观察到的丁丙诺啡不同剂量相关效应，还需要进一步研究。
