U.O.C. Dipendenze SerD Este, Padova, Italy.
Clin Drug Investig. 2010;30 Suppl 1:27-31. doi: 10.2165/11536030-000000000-00000.
Abuse and misuse of pharmacological therapies represent major challenges in the healthcare system, particularly in patients receiving long-acting opioid drugs for the treatment of heroin or opioid addiction. The partial mu-opioid receptor agonist buprenorphine is used to treat opioid dependence, but diversion and misuse may occur. The sublingual combination formulation of buprenorphine and the opioid receptor antagonist naloxone (buprenorphine/naxolone) is associated with a reduced abuse potential, and has been shown to have promising efficacy for the treatment of opioid dependence. This observational study assessed the safety and efficacy of sublingual buprenorphine/naloxone combination therapy in patients with opioid dependence after therapeutic switch from buprenorphine monotherapy. A total of 94 patients being treated with buprenorphine monotherapy (average dose 8 mg/day; mean duration of therapy 840 days) were switched to buprenorphine/naloxone combination therapy. Patients were asked to rate their level of satisfaction with buprenorphine/naloxone combination treatment with respect to the management of withdrawal symptoms, and urinary toxicology tests were carried out before and 14 days after switching to combination therapy. Within 3 months, 75/94 patients (80%) previously treated with buprenorphine monotherapy had switched to sublingual buprenorphine/naloxone combination treatment (average dose buprenorphine 8 mg). Among patients receiving combination treatment for >3 months, 83% were receiving medication either weekly or fortnightly, based on the results of toxicological testing. A reduction in positive urinary toxicology tests was observed in patients within two weeks after being switched to combination treatment (before switch: 28, 9 and 2 positive tests for heroin, cocaine and heroin + cocaine, respectively vs 11, 3 and 1 after switch) and a total of 64 patients of the 75 who switched to combination therapy (85%) were satisfied with the management of withdrawal symptoms during buprenorphine/naloxone treatment. Few adverse events were reported and no patients dropped out of treatment. This study shows that switching from buprenorphine monotherapy to sublingual buprenorphine/naloxone combination therapy is effective and well tolerated, and associated with good control of withdrawal symptoms in the majority of patients. In addition, combination therapy reduced illicit drug use (based on negative urinary toxicology texts) and allowed the time between clinic visits to be increased.
滥用和误用药物疗法是医疗保健系统面临的主要挑战，在接受长效阿片类药物治疗海洛因或阿片类药物成瘾的患者中尤其如此。部分μ-阿片受体激动剂丁丙诺啡用于治疗阿片类药物依赖，但可能会出现转移和滥用。丁丙诺啡和阿片受体拮抗剂纳洛酮的舌下组合制剂与降低滥用潜力相关，并已显示出治疗阿片类药物依赖的有前途的疗效。这项观察性研究评估了在接受丁丙诺啡单一疗法治疗的患者中，从丁丙诺啡单一疗法转为丁丙诺啡/纳洛酮联合治疗后的安全性和疗效。共有 94 名接受丁丙诺啡单一疗法治疗的患者（平均剂量 8 毫克/天；平均治疗时间 840 天）转为丁丙诺啡/纳洛酮联合治疗。要求患者就丁丙诺啡/纳洛酮联合治疗对戒断症状的管理的满意度进行评分，并在转为联合治疗前和治疗后 14 天进行尿液毒理学测试。在 3 个月内，94 名曾接受丁丙诺啡单一疗法治疗的患者中有 75 名（80%）转为丁丙诺啡/纳洛酮舌下联合治疗（丁丙诺啡平均剂量 8 毫克）。在接受联合治疗超过 3 个月的患者中，根据毒理学测试结果，83%的患者每周或每两周接受一次药物治疗。在转为联合治疗后的两周内，患者的尿液毒理学检测阳性率降低（转换前：海洛因、可卡因和海洛因+可卡因的阳性检测分别为 28、9 和 2，转换后为 11、3 和 1），共有 75 名转为联合治疗的患者中有 64 名（85%）对丁丙诺啡/纳洛酮治疗期间的戒断症状管理感到满意。报告的不良事件很少，没有患者退出治疗。这项研究表明，从丁丙诺啡单一疗法转为丁丙诺啡/纳洛酮舌下联合疗法是有效且耐受良好的，并与大多数患者戒断症状的良好控制相关。此外，联合治疗减少了非法药物的使用（基于尿液毒理学检测阴性），并允许增加就诊之间的时间。
