Objective: To investigate the methods for qualitative pathological assessment of dynamic changes in liver fibrosis/cirrhosis after antiviral therapy in patients with chronic hepatitis B (CHB), since antiviral therapy can partially reverse liver fibrosis and cirrhosis caused by hepatitis B and semi-quantitative, rather than qualitative, pathological assessment is often used for the research on liver fibrosis regression. Methods: Previously untreated CHB patients with liver fibrosis and cirrhosis were enrolled, and liver biopsy was performed before treatment and at 78 weeks after the antiviral therapy based on entecavir. The follow-up assessment was performed once every half a year. Based on the proportion of different types of fibrous septum, we put forward the new qualitative criteria called P-I-R classification (predominantly progressive, predominantly regressive, and indeterminate) for evaluating dynamic changes in liver fibrosis. This classification or Ishak fibrosis stage was used to evaluate the change in liver fibrosis after treatment and Ishak liver inflammation score was used to evaluate the change in liver inflammation after treatment. Results: A total of 112 CHB patients who underwent liver biopsy before and after treatment were enrolled, and among these patients, 71 with an Ishak stage of ≥3 and qualified results of live biopsy were included in the final analysis. Based on the P-I-R classification, 58% (41/71) were classified as predominantly progressive, 29% (21/71) were classified as indeterminate, and 13% (9/71) were classified as predominantly regressive; there were no significant differences between the three groups in alanine aminotransferase, aspartate aminotransferase, albumin, HBeAg positive rate, HBV DNA, and liver stiffness (P < 0.05). After treatment, the proportion of predominantly progressive, indeterminate, or predominantly regressive patients changed to 11% (8/71), 11% (8/71), and 78% (55/71), respectively. Among the 35 patients who had no change in Ishak stage after treatment, 72% (25/35) were classified as predominantly regressive and had certain reductions in the Laennec score, percentage of collagen area, and liver stiffness. Conclusion: This new P-I-R classification can be used to assess the dynamic changes in liver fibrosis after antiviral therapy in CHB patients.
目的： 抗病毒治疗可以逆转部分乙型肝炎纤维化和肝硬化，但既往有关肝纤维化逆转的研究多采用病理半定量方法，而非定性评估。本研究旨在建立反映慢性乙型肝炎（CHB）抗病毒治疗后肝纤维化/肝硬化动态变化的病理定性评估方法。 方法： 入组CHB肝纤维化及肝硬化初治患者，以恩替卡韦为基础的抗病毒治疗前及治疗78周后行两次肝穿刺活组织学检查，每半年进行1次随访评估。根据不同纤维间隔所占比例，提出评估肝纤维化动态变化的定性新标准（P-I-R分类）：进展为主型（predominantly Progressive），逆转为主型（predominantly Regressive）和不确定型（Indeterminate），分别使用此分类标准和Ishak纤维化分期评估治疗前后纤维化变化，使用Ishak炎症活动度评分评估治疗前后炎症活动度变化。 结果： 共入组112例有治疗前后两次肝穿刺的CHB患者，其中71例Ishak≥3期且肝穿刺质量合格的患者纳入最终分析。根据P-I-R分类，治疗前，进展为主型、不确定型和逆转为主型患者比例分别为58%（41/71）、29%（21/71）和13%（9/71），三种类型间丙氨酸氨基转移酶、天冬氨酸氨基转移酶、白蛋白、HBeAg阳性率、HBV DNA和肝脏硬度值比较，差异有统计学意义（P < 0.05）；而治疗后，进展为主型、不确定型和逆转为主型患者比例变为11%（8/71）、11%（8/71）和78%（55/71）。在35例治疗前后Ishak分期无变化的患者中，72%（25/35）的患者治疗后P-I-R评分为逆转为主型，且这些患者的Laennec评分、胶原比例面积和肝脏硬度值治疗后均较治疗前有所下降。 结论： 新的P-I-R分类可用于评估CHB患者抗病毒治疗后肝纤维化的动态变化。.
Keywords: Anti-viral therapy; Ishak score; Liver fibrosis; Qualitative histological assessment.