New England Research Institutes, Watertown, MA 02472, USA.
Aliment Pharmacol Ther. 2010 Apr;31(7):719-34. doi: 10.1111/j.1365-2036.2010.04235.x. Epub 2010 Jan 12.
Primary analysis of the Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) Trial showed long-term peginterferon therapy did not reduce complications in patients with chronic hepatitis C and advanced fibrosis or cirrhosis.
To assess the effects of long-term peginterferon therapy and disease progression on health-related quality of life (HRQOL), symptoms and sexual health in HALT-C patients.
A total of 517 HALT-C patients received peginterferon alfa-2a (90 microg/week); 532 received no additional treatment for 3.5 years. Patients were followed up for outcomes of death, hepatocellular carcinoma and hepatic decompensation. Sexual health, SF-36 scores and symptoms were serially assessed by repeated-measures analyses of covariance.
Patients with cirrhosis (n = 427) reported lower general well-being and more fatigue (P < 0.001) than patients with fibrosis (n = 622). Physical scores declined significantly over time, independent of treatment, and patients with cirrhosis reported lower scores. Vitality scores were lower in those with cirrhosis, and treated patients experienced a greater decline over time than untreated patients; HRQOL rebounded after treatment ended. Patients with a clinical outcome had significantly greater declines in all SF-36 and symptom scores. Among men, Sexual Health scores were significantly worse in treated patients and in those with a clinical outcome.
Clinical progression of chronic hepatitis C and maintenance peginterferon therapy led to worsening of symptoms, HRQOL and, in men, sexual health in a large patient cohort followed up over 4 years (NCT00006164).
丙型肝炎抗病毒长期治疗肝硬化(HALT-C)试验的初步分析显示,长期聚乙二醇干扰素治疗并不能降低慢性丙型肝炎和晚期纤维化或肝硬化患者的并发症。
评估长期聚乙二醇干扰素治疗和疾病进展对 HALT-C 患者健康相关生活质量(HRQOL)、症状和性健康的影响。
共有 517 例 HALT-C 患者接受聚乙二醇干扰素 alfa-2a(90 μg/周)治疗;532 例患者在 3.5 年内未接受额外治疗。患者接受随访以评估死亡、肝细胞癌和肝功能失代偿的结局。通过重复测量协方差的分析,对性健康、SF-36 评分和症状进行了连续评估。
肝硬化患者(n = 427)报告的总体健康状况和疲劳感均低于纤维化患者(n = 622)(P < 0.001)。无论治疗与否,身体评分随时间显著下降,且肝硬化患者的评分较低。活力评分在肝硬化患者中较低,且治疗组患者的下降幅度大于未治疗组;治疗结束后 HRQOL 反弹。有临床结局的患者所有 SF-36 和症状评分的下降幅度显著更大。在男性中,治疗组和有临床结局的患者的性健康评分明显更差。
在随访 4 年以上的大型患者队列中,慢性丙型肝炎的临床进展和维持聚乙二醇干扰素治疗导致症状、HRQOL 恶化,并且在男性中还导致性健康恶化(NCT00006164)。