扶正化瘀胶囊抗肝纤维化的适应症和疗效判断的非创伤性指征探讨——50例慢性乙型肝炎患者治疗前后肝活检资料分析

目的 探讨扶正化瘀胶囊抗肝纤维化的适应症和疗效判断的非创伤性指征。方法 根据扶正化瘀胶囊抗慢性乙型肝炎肝纤维化多中心、随机、双盲对照临床试验中实施治疗前后2次肝活检的疗效判定资料，将治疗后肝纤维化程度减轻和未减轻的病例分为两组，比较分析相关的肝组织炎症、肝功能、纤维化血清学指标、病毒学指标、血常规、肝脏B超、症状体征等变化。结果 （1）纤维化减轻组治疗前的肝纤维化程度、ALT活性及胁肋疼痛、口干咽燥症状积分显著高于未减轻组；（2）两组治疗后ALT活性均显著下降，但纤维化减轻组的肝脏炎症分级值显著下降（P〈0．01），同时血清AST、GGT活性治疗后3个月起显著下降，治疗6个月后的GGT活性和凝血酶原时间（PT）显著低于未减轻组；（3）纤维化减轻组的血清透明质酸（HA）和Ⅲ型前胶原氨基末端肽（P-Ⅲ-P）含量在治疗12周时即有显著下降；（4）两组的症状、体征均有不同程度的改善，但纤维化减轻组的面色晦暗体征改善显著。（5）两组之间及其治疗前后的乙肝病毒指标变化、血常规、肝脏B超结果等差异均无显著性。结论（1）扶正化瘀胶囊对肝纤维化程度接近S3，伴炎症活动明显及有胁痛、口干症状的慢性乙型肝炎患者，抗肝纤雏化作用显著，可作为临床应用参考指征；（2）治疗后血清Alb含量升高。GGT、AsT活性和HA、P-Ⅲ-P、PT下降以及面色晦暗体征的改善可作为扶正化瘀胶囊治疗肝纤维化有效的参考指征；上述指标对肝纤维化无创伤性诊断及临床疗效评定具有一定的应用价值。

Investigation on Indication of Fuzheng Huayu Capsule against Hepatic Fibrosis and Its Non-invasive Efficacy Evaluation Parameters:Data Analysis of Liver Biopsy of 50 Patients with Chronic Hepatitis B before and after Treatment

OBJECTIVE: To investigate the indication of Fuzheng Huayu Capsule (FHC) against hepatic fibrosis and its non-invasive efficacy evaluation parameters. METHODS: 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. RESULTS: (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. CONCLUSIONS: (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.