Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection.
Hepatic safety of injectable extended-release naltrexone in patients with chronic hepatitis C and HIV infection.
复制标题
慢性丙型肝炎和艾滋病毒感染患者注射缓释纳曲酮的肝脏安全性。
DOI：
10.15288/jsad.2012.73.991
复制
发表时间：
2012
影响因子：
3.4
通讯作者：
B. Silverman
中科院分区：
文献类型：
--
作者：
M. Mitchell;A. Memişoğlu;B. Silverman
目的
纳洛酮（Revia，Vivitrol）被认为具有潜在的肝毒性。我们评估了肌内缓释纳洛酮（XR-NTX）在接受阿片类药物依赖治疗的慢性丙型肝炎病毒（HC V）和HIV感染高患病率患者队列中的安全性。
方法
共有250名（88%为男性）阿片类药物依赖患者随机接受每月注射XR-NTX 380 mg或安慰剂。在250例受试者中，222例（88.8%）有HCV病史; 42%为HIV阳性。在筛选访视时、基线时和每月一次（最长6个月）进行天冬氨酸氨基转移酶（AST）、丙氨酸氨基转移酶（ALT）、总胆红素、γ-谷氨酰氨基转移酶（GGT）、碱性磷酸酶、血清白蛋白和总蛋白的肝化学检查。
结果
在一项纵向分析中，与安慰剂相比，XR-NTX治疗患者中AST、ALT和GGT升高超过正常上限（ULN）3倍的频率无统计学差异（p = .71）。大多数升高超过3倍ULN的患者为慢性HCV感染患者。在治疗后出现AST或ALT升高超过3倍ULN的患者中，具有可用随访数据的患者的转氨酶改善并恢复至基线水平。没有与ALT、AST或GGT升高相关的特定症状。与未感染艾滋病毒的患者相比，感染艾滋病毒的患者在治疗期间AST和ALT升高的频率没有显着差异。
结论
XR-NTX可以安全地用于符合条件的阿片类药物依赖患者，包括那些潜在的轻度至中度慢性HCV和/或HIV感染者。
OBJECTIVE
Naltrexone (Revia, Vivitrol) is recognized as having the potential for hepatotoxicity. We evaluated the safety of intramuscular extended-release naltrexone (XR-NTX) in a cohort of patients with a high prevalence of chronic hepatitis C virus (HC V) and HIV infection undergoing treatment for opioid dependence.
METHOD
A total of 250 (88% male) opioid-dependent patients were randomized to receive monthly injections of XR-NTX 380 mg or placebo. Of the 250 subjects, 222 (88.8%) had a history of HCV; 42% were positive for HIV. Liver chemistry tests for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, gamma-glutamyl aminotransferase (GGT), alkaline phosphatase, serum albumin, and total protein were obtained at the screening visit, at baseline, and monthly for up to 6 months.
RESULTS
In a longitudinal analysis, the frequency of elevations in AST, ALT, and GGT greater than three times the upper limit of normal (ULN) was not statistically different in patients treated with XR-NTX compared with placebo (p = .71). Most of the elevations greater than three times the ULN occurred in patients with chronic HCV infection. In patients who had a treatment-emergent elevation in AST or ALT greater than three times the ULN, the aminotransferases improved and returned toward baseline in those patients with available follow-up data. No specific symptoms were associated with any of the elevations in ALT, AST, or GGT. The frequency of elevations in AST and ALT during treatment in patients with HIV infection was not significantly different compared with that in patients without HIV infection.
CONCLUSIONS
XR-NTX can be used safely in eligible patients with opioid dependence, including those with underlying mild to moderate chronic HCV and/or HIV infections.