Fischer G, Gombas W, Eder H, Jagsch R, Stühlinger G, Aschauer H N, Kasper S
Klinische Abteilung für Allgemeine Psychiatrie, Drogenambulanz, Universitätsklinik für Psychiatrie, Wien.
Nervenarzt. 1999 Sep;70(9):795-802. doi: 10.1007/s001150050514.
The efficacy of buprenorphine in opioid dependent patients (n = 20) was compared to methadone maintained subjects (n = 20) in a randomized comparison trial. Sublingual application of buprenorphine as an alternative synthetical opioid is being compared to methadone during a 24 week study period. A trend (p = 0.06) could be found in the retention rate of investigated patients being maintained on a mean dosage of 63 mg oral applicable methadone (racemat of L- and D-methadone) in comparison to the group on a mean dosage of 7.3 mg buprenorphine (sublingual tablets). The dropout-rate of 11 subjects at the end of the study in the buprenorphine group was higher when compared to the dropout-rate of 5 in the methadone group. There was no significant difference between the two groups over the treatment period in respect to additional consumption of opiates, benzodiazepines and cocaine as evaluated through urine toxicology. The result in regard to compliance over the study period demonstrates that methadone appears to be the more successful oral opioid (p = 0.04). Nevertheless, efficacy of buprenorphine in maintenance could be demonstrated in the remaining subjects, and further studies with higher daily doses and a higher number of subjects have to be performed.
在一项随机对照试验中，将丁丙诺啡对阿片类药物依赖患者（n = 20）的疗效与美沙酮维持治疗的受试者（n = 20）进行了比较。在为期24周的研究期间，将丁丙诺啡作为替代合成阿片类药物的舌下给药与美沙酮进行了比较。与平均剂量为7.3 mg丁丙诺啡（舌下片）的组相比，在平均剂量为63 mg口服可用美沙酮（L-和D-美沙酮的消旋体）维持治疗的研究患者的留存率中发现了一种趋势（p = 0.06）。丁丙诺啡组在研究结束时11名受试者的脱落率高于美沙酮组的5名受试者的脱落率。通过尿液毒理学评估，在治疗期间两组之间在阿片类药物、苯二氮卓类药物和可卡因的额外消耗量方面没有显著差异。关于研究期间依从性的结果表明，美沙酮似乎是更成功的口服阿片类药物（p = 0.04）。然而，丁丙诺啡在维持治疗中的疗效可以在其余受试者中得到证明，并且必须进行更高日剂量和更多受试者的进一步研究。
