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Multicenter clinical study on Fuzhenghuayu capsule against liver fibrosis due to chronic hepatitis B

World Journal of Gastroenterology 2005年第19期11卷 2892-2899页

作者： PingLiu Yi-YangHu ChengLiu Lie-MingXu Cheng-HaiLiu Ke-WeiSun De-ChangHu You-KuanYin xia-QiuZhou Mo-BinWan XiongCai Zhi-QingZhang JUNYe Ren-XingZhou JiaHe Bao-ZhangTang InstituteofLiverDisease ShanghaiUniversityofTraditionalChineseMedicineShanghai201203China ShanghaiSecondMilitaryMedicalUniversity Shanghai200233China theAffiliatedHospital YunnanCollegeofTCMYunnan650000KunmingProvinceChina theAffiliatedHospital HunanCollegeofTCMChangsha410000HunanProvinceChina ZhongshanHospital FudanUniversityShanghai200032.China RuijinHospital ShanghaiSecondMedicalUniversityShanghai200025China ChanghaiHospital Shanghai200423China shanghaichangzhenghospital Shanghai200236China the4thPeopleHospitalofHuaianCity Huaian232000JiangsuProvinceChina theCentralHospitalofPutuoDistrict Shanghai200062China ShanghaiModemTechniqueCo. LtdforTCMShanghai200037China

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 observedat 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, meanscore of fibrotic stage(s) in experimental group after treatment (1.80) decreased significantly compared to the previous treatment (2.33, P＜0.05), but there was no significant difference in mean score of fibrotic stage(s) (2.11 and 2.14 respectively). There was a significant difference in reverse rate between experimental group (52%) and control group (23.3%) in liver biopsy. With marked effect on decreasing the mean value of inflammatory activity and score of inflammation (P＜0.05), Fuzhenghuayu capsule had rather good effects on inhibiting inflammatory activity and was superior to that of Heluoshugan capsule. Compared to that of pretreatment, there was a significant decrease in HA, LM, P-Ⅲ-P and Ⅳ-C content

关键词： Chronic hepatitis B Fuzhenghuayu capsule

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