De Shantanu, Jain Raka, Ray Rajat, Dhawan Anju, Varghese Sunny T
National Drug Dependence Treatment Centre and Department of Psychiatry, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Pin 110029, India.
Indian J Physiol Pharmacol. 2008 Jan-Mar;52(1):53-63.
The aim of the present study was to evaluate, two different doses of sublingual buprenorphine (2 mg and 4 mg) among patients on maintenance treatment and to assess the relationship of steady state plasma level with craving. Twenty three male opioid dependent (ICD-10 DCR) subjects, were assigned to double blind randomized controlled trial of 2 and 4 mg/day doses of buprenorphine in an inpatient setting. They were evaluated thrice (2nd, 7th and 14th day) in 2 weeks for withdrawal symptoms (acute and protracted), sedation, euphoria, craving, side effects, global rating of well being and for measurement of plasma levels of buprenorphine. The data showed that there were no significant difference in scores of euphoria and sedation, protracted withdrawal symptoms and side effects, craving and overall well being and plasma level of buprenorphine among the subjects. However, both the groups had significant difference in score on almost all the measurements on final observation in comparison to initial observation. Both 2 mg/day and 4 mg/day dose of buprenorphine were effective in long term pharmacotherapy of opioid dependence without significant difference as compared by different measures used in the study.
本研究的目的是评估维持治疗患者中两种不同剂量的舌下丁丙诺啡(2毫克和4毫克),并评估稳态血浆水平与渴望之间的关系。23名男性阿片类药物依赖(ICD-10 DCR)受试者被分配到住院环境中进行的2毫克/天和4毫克/天剂量丁丙诺啡的双盲随机对照试验。在2周内对他们进行了三次评估(第2天、第7天和第14天),评估戒断症状(急性和迁延性)、镇静、欣快感、渴望、副作用、整体幸福感评分以及丁丙诺啡血浆水平的测量。数据显示,受试者在欣快感和镇静评分、迁延性戒断症状和副作用、渴望、整体幸福感以及丁丙诺啡血浆水平方面没有显著差异。然而,与初始观察相比,两组在最终观察时几乎所有测量指标的评分都有显著差异。2毫克/天和4毫克/天剂量的丁丙诺啡在阿片类药物依赖的长期药物治疗中均有效,根据本研究中使用的不同测量方法比较,二者没有显著差异。