Hu Yi-Yang, Liu Ping, Liu Cheng
Institute of Liver Disease, Shanghai University of Traditional Chinese Medicine, Shanghai.
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2006 Jan;26(1):18-22.
To investigate the indication of Fuzheng Huayu Capsule (FHC) against hepatic fibrosis and its non-invasive efficacy evaluation parameters.
Data involving hepatic fibrotic patients received twice liver biopsy before and after FHC treatment were received from multi-center, randomized, double-blind, controlled clinical trials and analyzed. The changes of indexes related to inflammation of hepatic tissue and liver function, serological and virologic parameters of fibrosis, blood routine test, hepatic ultrasonic test as well as clinical symptoms and signs of patients were compared between patients alleviated (assigned to the effective group) and un-alleviated (assigned to the ineffective group) by the treatment.
(1) The degree of liver fibrosis, ALT activity and the scores of symptoms of hypochondriac pain and dry mouth before treatment were remarkably higher in the effective group than those in the ineffective group. (2) Level of ALT activity decreased in both groups after treatment. In the effective group, the grading scores of hepatic inflammatory significantly decreased after treatment (P < 0.01), levels of AST and GGT decreased after 3 months' treatment, and levels of GGT and PT significantly decreased after treated for 6 months, as compared to those in the ineffective group, showing significant difference. (3) Levels of serum hyaluronic acid (HA) and collagen type III (P-III-P) remarkably decreased after 12 weeks' treatment in the effective group. (4) Symptoms and signs were improved at various degrees in the two groups, but the improvement in dim and blackish complexion was more significant in the effective group than that in the ineffective group. (5) The changes in virologic parameters of hepatitis B virus, blood routine and hepatic ultrasonic test between the two groups showed no significant difference respectively.
(1) FHC showed better effect against hepatic fibrosis in patients of fibrotic stage around S3, with obvious active hepatic inflammation and symptoms of hypochondriac pain and dry mouth, which could be taken as a referential index in clinical practice for indication decision. (2) The increase of serum albumin, decrease of GGT, AST, PT, HA, and P-III-P as well as the improvement of signs of dim and blackish complexion could be regarded as the referential indexes of effectiveness of FHC against hepatic fibrosis. These parameters are valuable non-invasive indices for diagnosis of hepatic fibrosis and efficacy evaluation of its treatment.
探讨扶正化瘀胶囊（FHC）抗肝纤维化的适应证及其非侵入性疗效评估指标。
收集多中心、随机、双盲、对照临床试验中接受FHC治疗前后两次肝活检的肝纤维化患者的数据并进行分析。比较治疗后病情缓解（归入有效组）和未缓解（归入无效组）患者肝组织炎症及肝功能相关指标、纤维化的血清学和病毒学参数、血常规检查、肝脏超声检查以及患者临床症状和体征的变化。
（1）有效组治疗前肝纤维化程度、谷丙转氨酶（ALT）活性以及胁肋疼痛和口干症状评分显著高于无效组。（2）两组治疗后ALT活性均下降。有效组治疗后肝脏炎症分级评分显著降低（P < 0.01），治疗3个月后谷草转氨酶（AST）和γ-谷氨酰转肽酶（GGT）水平下降，治疗6个月后GGT和凝血酶原时间（PT）水平显著下降，与无效组相比，差异有统计学意义。（3）有效组治疗12周后血清透明质酸（HA）和Ⅲ型胶原（P-Ⅲ-P）水平显著下降。（4）两组症状和体征均有不同程度改善，但有效组面色晦暗改善程度优于无效组。（5）两组乙型肝炎病毒病毒学参数、血常规和肝脏超声检查变化差异均无统计学意义。
（1）FHC对S3左右纤维化阶段、伴有明显活动性肝炎症以及胁肋疼痛和口干症状的患者抗肝纤维化效果较好，可作为临床实践中适应证判断的参考指标。（2）血清白蛋白升高、GGT、AST、PT、HA和P-Ⅲ-P降低以及面色晦暗体征改善可作为FHC抗肝纤维化疗效的参考指标。这些参数是肝纤维化诊断和治疗疗效评估有价值的非侵入性指标。
