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采用开放与双盲试验的多中心性随访观察,对于302例海洛因依赖者脱毒治疗后服用纳曲酮进行的为期6个月观察,就纳曲酮对阿片类依赖者预防复吸的效能进行了研究。双盲组纳曲酮的服用剂量为50mg·d-1,开放试验的药物剂量随用药者的反应进行调整。双盲试验中,纳曲酮组和安慰剂组第6个月的保持率分别为28.57%和7.14%。开放组第6个月的纳曲酮保持率及平均保持时间分别为23.6%和3.16月,而该组人群既往脱毒后第6个月的操守率及平均操守时间分别为1.2%和0.5个月。双盲试验中服用纳曲酮组再吸海洛因后无舒适体验者占68.18%,安慰剂组为33.3%;纳曲酮组尿吗啡检测阳性率(24.38%)低于安慰剂组(40.48%)。服药后出现的反应包括睡眠障碍、焦虑、食欲减退、无力、易激惹、腹痛和骨肌肉痛、发冷、恶心呕吐、紧张、腹泻、头晕、头痛、便秘和皮疹。这些症状中包括纳曲酮促发的稽延性戒断症状。少部分受试者出现肝脏功能异常及心电图异常。为达到充分阻断海洛因的作用,服用剂量以40-50mg·d-1为宜。本研究显示,纳曲酮对阿片类依赖者脱毒后预防复吸有一定的辅助作用,药物毒副作用较小,适于长期服用。
In a multicenter follow-up of open and double-blind trials, 302 patients with heroin addicts were treated with naltrexone for 6 months after detoxification. The efficacy of naltrexone on opioid-dependent relapse prevention Study. The dose of naltrexone in double-blind group was 50 mg · d-1. The dosage of open-label test was adjusted with the response of the patient. In the double-blind trial, the retention rates at 6 months in naltrexone and placebo groups were 28.57% and 7.14%, respectively. The naltrexone maintenance rate and mean retention time of the 6th month in the open group were 23.6% and 3.16 months, respectively, while those in the 6th month after the detoxification in the open group were 1 .2% and 0.5 months. In the double-blind trial, 68.18% of the patients took naltrexone after re-inhaling heroin and 33.3% of the patients in the placebo group. The positive rate of urine morphine in naltrexone group was lower than that of comfort (24.38%) Agent group (40.48%). Reactions that occur after taking medication include sleep disorders, anxiety, loss of appetite, weakness, irritability, abdominal and musculoskeletal pain, chills, nausea, vomiting, nervousness, diarrhea, dizziness, headache, constipation and rashes. These symptoms include naltrexone-induced protracted withdrawal symptoms. A small number of subjects showed abnormal liver function and abnormal ECG. In order to achieve the full block heroin effect, taking doses of 40-50mg · d-1 is appropriate. This study showed that naltrexone on opioid dependence to prevent relapse have some auxiliary role, drug side effects smaller, suitable for long-term use.