细化慢性肝炎肝纤维化分期标准在药物疗效评定中的应用

Application of a refined fibrosis staging system to evaluate therapeutic efficacy in chronic viral hepatitis

目的细化慢性肝炎肝纤维化分期标准，并检测其在药物疗效判定中的有效性和敏感性。方法严格参照指南推荐标准，制定细化的分期标准并绘制模式图；分别按照指南推荐标准和细化标准对396例肝穿刺活组织标本进行纤维化分期判读。按照指南推荐标准药物治疗前后病例分布差异用X2检验进行分析；按照细化标准得到的治疗前后纤维化分期的差异进行赋值后，采用配对t检验进行比对，采用SPSS软件完成。结果参照指南推荐标准，治疗前后纤维化分期的改变不具有统计学意义，X2=3．144，P=0．534；按照细化标准，治疗前后纤维化分期的改变具有统计学意义，6．55±2．93对比6．19±2．945，P〈0．01。结论细化标准在药物疗效评定中有效，且较指南推荐标准对于药物疗效的评定具有更好的敏感性。

Objective To generate a refined staging system of fibrosis in chronic viral hepatitis and to assess its accuracy and sensitivity for evaluating therapeutic efficacy of anti-fibrosis drug treatments. Methods A refined fibrosis staging system was established according to the detailed characteristics of progressive fibrosis. A total of 396 liver puncture biopsy specimens were collected from patients before and after anti-fibrosis therapy and used to evaluate the refined staging system. According to the original fibrosis staging system and refined fibrosis staging system, fibrosis staging differences from before and after treatment were analyzed by Chi-squared test and paired-samples t-test respectively. Results The refined fibrosis staging system detected significant changes in fibrosis stage that occurred in response to treatment （before treatment： 6.55 ± 2.93 vs. after treatment： 6.19 ± 2.945, P 〈 0.01）. However, the original （unrefined） staging system was unable to differentiate therapy-related changes in fibrosis stage （X2 = 3.144, P = 0.534）. Conclusion The newly-developed refined fibrosis staging system was able to effectively evaluate the therapeutic efficacy of anti-fibrosis drug treatment and performed better than the original staging system.