综合 HCV 治疗对缓解吸毒者疲劳的疗效：一项随机对照试验。
The efficacy of integrated hepatitis C virus treatment in relieving fatigue in people who inject drugs: a randomized controlled trial.
机构信息
Department of Addiction Medicine, Haukeland University Hospital, Jonas Lies Vei 65, N-5021, Bergen, Norway.
Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.
出版信息
Subst Abuse Treat Prev Policy. 2023 Apr 24;18(1):25. doi: 10.1186/s13011-023-00534-1.
BACKGROUND
Most people who inject drugs (PWIDs) suffer from severe fatigue, and chronic hepatitis C virus (HCV) infection may play a role in this. However, there is scarce evidence about interventions that alleviate fatigue among PWIDs. The present study investigated the effect of integrated HCV treatment on fatigue in this population compared to the effect of standard HCV treatment, adjusted for sustained virological response of the HCV treatment.
METHODS
This multi-center, randomized controlled trial evaluated fatigue as a secondary outcome of integrated HCV treatment (the INTRO-HCV trial). From May 2017 to June 2019, 276 participants in Bergen and Stavanger, Norway, were randomly assigned to receive integrated and standard HCV treatment. Integrated treatment was delivered in eight decentralized outpatient opioid agonist therapy clinics and two community care centers; standard treatment was delivered in specialized infectious disease outpatient clinics at referral hospitals. Fatigue was assessed prior to treatment and 12 weeks after treatment using the nine-item Fatigue Severity Scale (FSS-9). We applied a linear mixed model to evaluate the impact of integrated HCV treatment on changes in FSS-9 (ΔFSS-9) sum scores.
RESULTS
At baseline, the mean FSS-9 sum score was 46 (standard deviation (SD): 15) for participants on integrated HCV treatment and 41 (SD: 16) for those on standard treatment. Twelve weeks after completed HCV treatment, the mean FSS-9 sum score for participants receiving integrated HCV treatment was 42 (SD: 15) and 40 (SD: 14) for those receiving standard HCV treatment. Integrated HCV treatment did not reduce the FSS-9 scores compared to standard HCV treatment (ΔFSS-9: -3.0, 95% confidence interval (CI): -6.4;0.4).
CONCLUSIONS
Fatigue is a common symptom among PWIDs. Integrated HCV treatment is at least equal to standard HCV treatment in improving fatigue.
TRIAL REGISTRATION
ClinicalTrials.gov.no NCT03155906, 16/05/2017.
背景
大多数吸毒者（PWIDs）都患有严重的疲劳症，慢性丙型肝炎病毒（HCV）感染可能在此方面发挥作用。但是，关于缓解 PWIDs 疲劳的干预措施，证据很少。本研究调查了与 HCV 治疗的标准治疗相比，综合 HCV 治疗对 PWIDs 疲劳的影响，该影响针对 HCV 治疗的持续病毒学应答进行了调整。
方法
这是一项多中心、随机对照试验，将疲劳作为综合 HCV 治疗（INTRO-HCV 试验）的次要结局进行评估。2017 年 5 月至 2019 年 6 月，挪威卑尔根和斯塔万格的 276 名参与者被随机分配接受综合和标准 HCV 治疗。综合治疗在 8 个分散的门诊阿片类药物激动剂治疗诊所和 2 个社区护理中心进行；标准治疗在转诊医院的专门传染病门诊进行。治疗前和治疗后 12 周使用九项疲劳严重程度量表（FSS-9）评估疲劳。我们应用线性混合模型评估综合 HCV 治疗对 FSS-9（ΔFSS-9）总分变化的影响。
结果
在基线时，接受综合 HCV 治疗的参与者的 FSS-9 总分平均值为 46（标准差（SD）：15），接受标准 HCV 治疗的参与者的 FSS-9 总分平均值为 41（SD：16）。完成 HCV 治疗后 12 周，接受综合 HCV 治疗的参与者的 FSS-9 总分平均值为 42（SD：15），接受标准 HCV 治疗的参与者的 FSS-9 总分平均值为 40（SD：14）。与标准 HCV 治疗相比，综合 HCV 治疗并未降低 FSS-9 评分（ΔFSS-9：-3.0，95%置信区间（CI）：-6.4；0.4）。
结论
疲劳是 PWIDs 的常见症状。综合 HCV 治疗在改善疲劳方面至少与标准 HCV 治疗相当。
试验注册
ClinicalTrials.gov.no NCT03155906，2017 年 5 月 16 日。
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