Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B
Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B
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DOI：
10.3748/wjg.v11.i19.2892
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发表时间：
2005-05-21
影响因子：
4.3
通讯作者：
Tang, Bao-Zhang
中科院分区：
文献类型：
--
作者：
Liu, Ping;Hu, Yi-Yang;Tang, Bao-Zhang
目的：研究妇正化瘀胶囊（FZHY胶囊，强体抗化瘀胶囊）治疗慢性乙型肝炎肝纤维化的疗效和安全性。方法：采用多中心、随机、双盲、平行对照试验，对18 ~ 65岁慢性乙型肝炎肝纤维化患者进行治疗第0周和第24周肝脏组织学改变和HBV标志物检测。测定血清学参数（HA、LM、P-III-P、IV-C），并于第0、12、24周行脾、肝B超检查。在第0、6、12、18和24周观察肝功能（肝纤维化的肝功能和血清学参数）。治疗前后检查血、尿常规、肾功能、心电图。结果：实验组（110例）与对照组（106例）在人口统计学特征、生命体征、病程、药物过敏史及既往治疗、肝功能、肝纤维化血清学指标、肝脏组织学检查（实验组99例，对照组96例）、HBV标志物、肾功能方面差异无统计学意义（p < 0.05）。按肝纤维化分期标准，实验组治疗后纤维化分期平均评分（1.80分）较治疗前（2.33分）明显降低
AIM: To study the efficacy and safety of Fuzhenghuayu capsule (FZHY capsule, a capsule for strengthening body resistance to remove blood stasis) against liver fibrosis due to chronic hepatitis B.METHODS: Multicenter, randomized, double blinded and parallel control experiment was conducted in patients (aged from 18 to 65 years) with liver fibrosis due to chronic hepatitis B. Hepatic histologic changes and HBV markers were examined at wk 0 and 24 during treatment. Serologic parameters (HA, LM, P-III-P, IV-C) were determined and B ultrasound examination of the spleen and liver was performed at wk 0, 12 and 24. Liver function (liver function and serologic parameters for liver fibrosis) was observed at wk 0, 6, 12, 18 and 24. Blood and urine routine test, renal function and ECG were examined before and after treatment.RESULTS: There was no significant difference between experimental group (110 cases) and control group (106 cases) in demographic features, vital signs, course of illness, history for drug anaphylaxis and previous therapy, liver function, serologic parameters for liver fibrosis, liver histologic examination (99 cases in experimental group, 96 cases in control group), HBV markers, and renal function. According to the criteria for liver fibrosis staging, mean score of fibrotic stage(s) in experimental group after treatment (1.80) decreased significantly compared to the previous treatment (2.33, P