丁丙诺啡 - 纳洛酮治疗阿片类药物依赖及肝酶升高风险：一项为期12个月的观察性研究结果
Buprenorphine-naloxone treatment in opioid dependence and risk of liver enzyme elevation: results from a 12-month observational study.
作者信息
Soyka Michael, Backmund Markus, Schmidt Peggy, Apelt Sabine
机构信息
Department of Psychiatry, Ludwig Maximilian University, Munich, Germany; Private Hospital Meiringen, Meiringen, Switzerland.
出版信息
Am J Addict. 2014 Nov-Dec;23(6):563-9. doi: 10.1111/j.1521-0391.2014.12131.x. Epub 2014 Sep 22.
BACKGROUND
Some case series mention possible liver toxicity in opioid-dependent patients under buprenorphine treatment.
METHODS
This 12-month prospective observational follow-up study in opioid-dependent patients under buprenorphine-naloxone treatment assessed outcome and safety issues. At baseline, 337 eligible datasets were available; 181 patients completed the 12-month study. Liver enzymes were tested at baseline and after 12, 24, and 52 weeks' treatment.
RESULTS
One to two percent of patients showed mostly discrete elevations of liver enzymes, but no patient met the criteria for drug-induced liver injury. No serious liver-related adverse events occurred, but two non-serious cases of liver enzyme increase were recorded. No patient dropped out of treatment for liver-related disorders.
CONCLUSION
This study is in line with some recent studies and provides further evidence that buprenorphine-naloxone is relatively safe with respect to liver injury.
背景
一些病例系列报道了接受丁丙诺啡治疗的阿片类药物依赖患者可能存在肝脏毒性。
方法
这项针对接受丁丙诺啡-纳洛酮治疗的阿片类药物依赖患者进行的为期12个月的前瞻性观察随访研究评估了治疗结果和安全性问题。基线时，有337个符合条件的数据集；181名患者完成了为期12个月的研究。在基线以及治疗12周、24周和52周后检测肝酶。
结果
1%至2%的患者肝酶大多有轻微升高，但无患者符合药物性肝损伤的标准。未发生严重的肝脏相关不良事件，但记录到两例非严重的肝酶升高病例。没有患者因肝脏相关疾病退出治疗。
结论
本研究与一些近期研究一致，进一步证明丁丙诺啡-纳洛酮在肝损伤方面相对安全。
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