Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.
Departments of Epidemiology and Biostatistics, University of Pittsburgh, Pittsburgh, USA.
Dig Dis Sci. 2023 Dec;68(12):4499-4510. doi: 10.1007/s10620-023-08108-8. Epub 2023 Oct 7.
Evaluate patient-reported liver symptoms during treatment for chronic hepatitis B viral (HBV) infection and associations between changes in symptoms and levels of alanine aminotransferase (ALT) and viral markers.
Data from 200 participants in the Hepatitis B Research Network Immune Active Trial who completed symptom assessments were analyzed. Patients were treated with tenofovir, with or without peginterferon (TDF + PegIFN vs. TDF alone) for 192 weeks. Participants completed a Symptom Checklist at baseline and every 4-12 weeks. A total symptom score was created, ranging from 0 (none) to 40 (severe). The SF-36 was completed every 48 weeks. Associations of symptom scores with ALT and viral markers were evaluated at baseline and end of treatment.
Participants were 65% male, 83% Asian, with a mean age of 42. Baseline symptoms were mild (median = 2, range 0-25) and associated with baseline ALT, HBV DNA levels and HBeAg + status. Patients on TDF alone experienced a more rapid and greater improvement in symptoms, but by week 192, symptom improvement was similar in both groups (54% vs 36%). Symptom improvements correlated with ALT and HBV DNA, most markedly among those with symptoms at baseline. Most patients (4 out of 6) who achieved HBsAg loss experienced symptom improvements. Overall, SF-36 scores did not change with treatment.
Reduction in ALT and HBV DNA levels with therapy are associated with significant improvement in liver symptoms such as fatigue and pain over the liver, especially among those with higher ALT, HBV DNA, symptoms and HBeAg + status prior to treatment.
评估慢性乙型肝炎病毒 (HBV) 感染患者在治疗过程中的肝脏症状，并探讨症状变化与丙氨酸氨基转移酶 (ALT) 和病毒标志物水平之间的关系。
分析了乙型肝炎研究网络免疫激活试验 200 名完成症状评估的参与者的数据。这些患者接受替诺福韦治疗，其中部分患者联合聚乙二醇干扰素（TDF+PegIFN）治疗，疗程为 192 周。患者在基线和每 4-12 周时完成症状检查表。创建了一个总分症状评分，范围从 0（无）到 40（严重）。SF-36 量表每 48 周完成一次。在基线和治疗结束时评估症状评分与 ALT 和病毒标志物之间的关系。
参与者中 65%为男性，83%为亚洲人，平均年龄为 42 岁。基线症状轻微（中位数=2，范围 0-25），与基线 ALT、HBV DNA 水平和 HBeAg+状态相关。单独使用 TDF 的患者症状改善更快且更明显，但在第 192 周时，两组的症状改善情况相似（54%比 36%）。症状改善与 ALT 和 HBV DNA 相关，在基线有症状的患者中最为显著。大多数（4 例中有 1 例）实现 HBsAg 丢失的患者经历了症状改善。总体而言，治疗后 SF-36 评分没有变化。
治疗后 ALT 和 HBV DNA 水平的降低与肝脏症状（如疲劳和肝区疼痛）的显著改善相关，尤其是在那些基线 ALT、HBV DNA、症状和 HBeAg+状态较高的患者中。
