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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.

DOI:10.1111/j.1521-0391.2014.12131.x
PMID:25251050
Abstract

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.

摘要

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。

相似文献

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Buprenorphine-naloxone treatment in opioid dependence and risk of liver enzyme elevation: results from a 12-month observational study.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
Am J Addict. 2014 Nov-Dec;23(6):563-9. doi: 10.1111/j.1521-0391.2014.12131.x. Epub 2014 Sep 22.
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Hepatotoxicity in a 52-week randomized trial of short-term versus long-term treatment with buprenorphine/naloxone in HIV-negative injection opioid users in China and Thailand.在中国和泰国的HIV阴性注射阿片类药物使用者中进行的一项为期52周的丁丙诺啡/纳洛酮短期与长期治疗随机试验中的肝毒性。
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Sleep-disordered breathing in patients with opioid use disorders in long-term maintenance on buprenorphine-naloxone: A case series.长期使用丁丙诺啡-纳洛酮维持治疗的阿片类物质使用障碍患者的睡眠呼吸紊乱:病例系列
J Opioid Manag. 2015 Jul-Aug;11(4):363-6. doi: 10.5055/jom.2015.0285.
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Buprenorphine alone or with naloxone: Which is safer?丁丙诺啡单用或与纳洛酮联用:哪种更安全?
J Psychopharmacol. 2018 Mar;32(3):344-352. doi: 10.1177/0269881118756015. Epub 2018 Feb 13.
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The effects of buprenorphine/naloxone maintenance treatment on sexual dysfunction, sleep and weight in opioid use disorder patients.丁丙诺啡/纳洛酮维持治疗对阿片类药物使用障碍患者性功能障碍、睡眠和体重的影响。
Psychiatry Res. 2019 Feb;272:450-453. doi: 10.1016/j.psychres.2018.12.153. Epub 2018 Dec 29.
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Am J Addict. 2013 May-Jun;22(3):252-4. doi: 10.1111/j.1521-0391.2012.12005.x.
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Safety, effectiveness and tolerance of buprenorphine-naloxone in the treatment of opioid dependence: results from a nationwide non-interventional study in routine care.丁丙诺啡-纳洛酮治疗阿片类药物依赖的安全性、有效性和耐受性:一项全国性常规护理中非干预性研究的结果。
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Case series on the safe use of buprenorphine/naloxone in individuals with acute hepatitis C infection and abnormal hepatic liver transaminases.关于丁丙诺啡/纳洛酮在急性丙型肝炎感染且肝转氨酶异常个体中的安全使用的病例系列。
Am J Drug Alcohol Abuse. 2007;33(6):869-74. doi: 10.1080/00952990701653875.
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Time to include buprenorphine-naloxone combination in the WHO Model List of Essential Medicines.是时候将丁丙诺啡-纳洛酮组合纳入世界卫生组织基本药物示范清单了。
J Opioid Manag. 2013 Jul-Aug;9(4):237.

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Hepatic Safety of Buprenorphine in HIV-Infected and Uninfected Patients With Opioid Use Disorder: The Role of HCV-Infection.
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Subst Abuse Rehabil. 2015 Jan 6;6:1-14. doi: 10.2147/SAR.S45585. eCollection 2015.