Division of Gastroenterology, University of California-Irvine, Irvine, California, USA.
Gastroenterology. 2011 Sep;141(3):900-908.e1-2. doi: 10.1053/j.gastro.2011.06.007. Epub 2011 Jun 12.
BACKGROUND & AIMS: The gradual accumulation of hepatic fibrosis in chronic liver disease results in clinical complications. The rate of hepatic fibrosis score progression (RFSP) in predicting clinical outcomes was assessed by extending the 4-year Hepatitis C Antiviral Long-term Treatment Against Cirrhosis (HALT-C) Trial to include preenrollment liver biopsies.
The RFSP was calculated from the linear regression slope of Ishak fibrosis score vs time in 457 patients with liver biopsies (≥10-mm length) prior to the HALT-C Trial (575 biopsies) plus 1101 on-study biopsies (total 1676 biopsies). Individual slopes were calculated if duration from first to last biopsy was > 4 years.
The RFSP as average fibrosis score vs average time in intervals (0-3 and >3 years prestudy, screening, month 24 and 48 on-study) in 455 patients in cohorts of baseline Ishak score ranged from 0.005 with Ishak score 2 to 0.124 with Ishak 6. The RFSP in individual patients (-0.35 to +0.97 Ishak units/year) had a mean of 0.12 ± 0.23 in 344 patients with prestudy and on-study biopsies (group A) and only 0.17 ± 0.22 in 169 with prestudy and screening biopsies (group B). Group A patients with RFSP slope ≥ 0.2 (95 patients, 27.6%) had higher 7-year cumulative rates of non-hepatocellular carcinoma outcomes (46% vs 8%, respectively) and with a hepatocellular carcinoma (10% vs 3%, respectively) than RFSP slope < 02 (249 patients, 72.4%) (P < .0001). RFSP and screening Ishak score correlated independently (P <.0001) with clinical outcomes in multivariate analysis.
Rapid RFSP (>0.2), which occurred in 26.7% of HALT-C Trial patients, correlated strongly with clinical outcomes.
慢性肝病中肝纤维化的逐渐积累导致了临床并发症。本研究通过延长丙型肝炎抗病毒长期治疗肝硬化（HALT-C）试验，纳入试验前肝活检，评估肝纤维化评分进展率（RFSP）在预测临床结局方面的作用。
457 例（575 次活检）肝活检（长度≥10mm）患者在 HALT-C 试验前（共 1676 次活检）和研究期间（1101 次活检），采用 Ishak 纤维化评分与时间的线性回归斜率计算 RFSP。如果从第一次到最后一次活检的时间间隔>4 年，则计算个体斜率。
455 例基线 Ishak 评分队列患者（0-3 年和>3 年前研究、筛查、研究 24 个月和 48 个月）中，RFSP 与平均时间的平均纤维化评分在间隔内（0-3 年和>3 年前研究、筛查、研究 24 个月和 48 个月）的范围为 0.005（Ishak 2 分）至 0.124（Ishak 6 分）。在 344 例有前研究和研究活检的患者（A 组）中，患者个体 RFSP（-0.35 至+0.97 Ishak 单位/年）的平均值为 0.12±0.23，而在仅进行前研究和筛查活检的 169 例患者（B 组）中，平均值为 0.17±0.22。A 组 RFSP 斜率≥0.2（95 例，27.6%）的患者 7 年累积非肝细胞癌结局发生率（分别为 46%和 8%）高于 RFSP 斜率<0.2（249 例，72.4%）（P<.0001）。多变量分析显示，RFSP 和筛查 Ishak 评分与临床结局独立相关（P<.0001）。
在 HALT-C 试验患者中，26.7%发生快速 RFSP（>0.2）与临床结局密切相关。
