Barnwal Preeti, Das Saibal, Mondal Somnath, Ramasamy Anand, Maiti Tanay, Saha Arunava
Jamia Hamdard (Hamdard University) - Department of Medical Elementology and Toxicology, Faculty of Science, New Delhi, India.
Department of Pharmacology and Clinical Pharmacology, Christian Medical College, Vellore 632002, India.
Ther Adv Psychopharmacol. 2017 Mar;7(3):119-134. doi: 10.1177/2045125316681984. Epub 2016 Dec 19.
Opioid dependence leads to physical dependence and addiction which finally results in profound medical, psychological and social dysfunction. One of the useful medications for opioid dependence is buprenorphine, the partial opioid agonist, which is used alone or in combination with naloxone. However, buprenorphine is the victim of its own success due to its illicit use and accidental poisoning in children. Also, buprenorphine typically requires daily self-administration and its effectiveness heavily depends on patient adherence. So, poor treatment adherence results in ineffective treatment manifesting as craving and withdrawal symptoms. Short-term use of buprenorphine in opioid dependence is also often followed by relapse. Buprenorphine when used sublingually often results in inadequate or fluctuating blood concentrations and poorer treatment retention compared with methadone. All of these led to the development of Probuphine®, a polymeric matrix composed of ethylene vinyl acetate and buprenorphine in the form of implants, that are implanted subdermally in office practice and deliver the active drug over 6 months. Buprenorphine release from such implant is fairly consistent, avoiding plasma peaks and troughs, and the implant is also reported to be safe. In this review article, we have highlighted these aspects of treatment of opioid addiction, stressing on the pharmacology of buprenorphine and Probuphine®, and relevant clinical trials addressing the efficacy and safety of Probuphine®. This sustained-release implantable formulation of buprenorphine has the potential to be a suitable alternative to daily or alternate day sublingual buprenorphine which can thereby eliminate the need for daily supervision, minimizing fluctuations in plasma concentrations, and allowing these patients to reduce clinic or pharmacy visits.
阿片类药物依赖会导致身体依赖和成瘾,最终造成严重的医学、心理和社会功能障碍。用于治疗阿片类药物依赖的一种有效药物是丁丙诺啡,它是一种部分阿片类激动剂,可单独使用或与纳洛酮联合使用。然而,由于丁丙诺啡被非法使用以及儿童意外中毒,它成了自身成功的受害者。此外,丁丙诺啡通常需要每日自行给药,其疗效在很大程度上取决于患者的依从性。因此,治疗依从性差会导致治疗无效,表现为渴望和戒断症状。在阿片类药物依赖中短期使用丁丙诺啡后也常常会复发。与美沙酮相比,舌下含服丁丙诺啡往往会导致血药浓度不足或波动,治疗保留率也较低。所有这些促使了Probuphine®的研发,它是一种由乙烯醋酸乙烯酯和丁丙诺啡组成的聚合物基质植入剂,在门诊手术中皮下植入,可在6个月内持续释放活性药物。丁丙诺啡从这种植入剂中的释放相当稳定,避免了血药浓度的峰值和谷值,而且据报道这种植入剂也是安全的。在这篇综述文章中,我们重点介绍了阿片类药物成瘾治疗的这些方面,强调了丁丙诺啡和Probuphine®的药理学,以及涉及Probuphine®疗效和安全性的相关临床试验。这种丁丙诺啡的缓释可植入制剂有可能成为每日或隔日舌下含服丁丙诺啡的合适替代方案,从而无需每日监督,将血药浓度波动降至最低,并使这些患者减少门诊或药房就诊次数。