Dept. of Infectious Diseases and Hepatology, Collegium Medicum, N. Copernicus University, 85-090 Bydgoszcz, ul. Św.Floriana 12, Toruń, Poland.
Infection. 2011 Oct;39(5):433-7. doi: 10.1007/s15010-011-0135-3. Epub 2011 Jul 8.
The aim of the study was to evaluate the efficacy and safety of combined treatment with natural leukocyte interferon alpha (Alfaferone) plus ribavirin in patients with HCV-related cirrhosis.
Twenty-three patients (15 women, 8 men) aged 17-68 years hospitalized in 2005-2008 were included in the study. Seventeen patients who qualified for treatment were Child-Pugh class A patients and 6 others were class B. Seventeen patients had genotype 1b and 6 genotype 3a infection. Thirteen patients were naïve, retherapy concerned 8 patients, and in two cases the continuation of treatment had been stopped because of adverse events following the use of pegylated interferons. The treatment was continued for 48 weeks regardless of HCV genotype. Normalized AlAT activity (<40 U/l) was the measure of biochemical efficacy of the treatment, while virological efficacy was reflected by an undetectable viral load in plasma. Both measurements were conducted immediately after the end of treatment (EOT) and after a 6-month follow-up period (SVR). Therapeutic safety was evaluated by the monitoring of the adverse events of the treatment.
Abnormal AlAT levels prior to treatment were detected in 20/23 patients. During therapy normalized levels were achieved in 50% of them, and after 6 months they were sustained in 9/20. EOT was achieved in 6/19 patients and SVR in 3 patients. Mild psychiatric disorders were the most frequently detected adverse events (12 patients). Thrombocytopenia and leucopenia existing prior to treatment did not intensify during the treatment. Severe adverse events caused by the drug resulted in the discontinuation of treatment in three patients (urinary tract infections, depression, myasthenia gravis), of whom two patients were Child-Pugh class A and one was class B. In one patient treatment was discontinued because of HCC.
Natural leukocyte interferon alpha is well tolerated by patients with HCV-related cirrhosis and coexisting thrombocytopenia and leucopenia.
本研究旨在评估联合应用天然白细胞干扰素 alpha（Alfaferone）和利巴韦林治疗丙型肝炎相关肝硬化的疗效和安全性。
2005 年至 2008 年共纳入 23 例患者（15 名女性，8 名男性），年龄 17-68 岁。符合治疗条件的 17 例患者为 Child-Pugh 分级 A，其余 6 例为 B 级。17 例患者感染基因型 1b，6 例感染基因型 3a。13 例患者为初治患者，8 例患者为复治患者，2 例患者因使用聚乙二醇干扰素后出现不良反应而停止治疗。无论丙型肝炎基因型如何，治疗均持续 48 周。治疗的生化疗效以正常化 AlAT 活性（<40U/l）为衡量标准，病毒学疗效以血浆中不可检测到病毒载量为衡量标准。两种测量均在治疗结束后（EOT）和 6 个月随访期（SVR）进行。通过监测治疗不良反应评估治疗安全性。
23 例患者中有 20 例在治疗前出现异常 AlAT 水平。在治疗过程中，有 50%的患者 AlAT 水平恢复正常，20 例中有 9 例在 6 个月后持续正常。19 例患者中有 6 例达到 EOT，3 例达到 SVR。最常见的不良反应为轻度精神障碍（12 例）。治疗前存在的血小板减少症和白细胞减少症在治疗过程中并未加重。药物引起的严重不良反应导致 3 例患者停药（尿路感染、抑郁症、重症肌无力），其中 2 例为 Child-Pugh 分级 A，1 例为 B 级。1 例患者因 HCC 停药。
天然白细胞干扰素 alpha 对丙型肝炎相关肝硬化合并血小板减少症和白细胞减少症的患者具有良好的耐受性。
