[Multicenter clinical study about the action of Fuzheng Huayu Capsule against liver fibrosis with chronic hepatitis B]
| Autor: | Jun Ye, Mo-Bin Wan, Ke-Wei Sun, Cheng Liu, Yi-Yang Hu, De-Chang Hu, Cheng-hai Liu, Xia-Qiu Zhou, Lie-Ming Xu, Xiong Cai, Zhi-Qing Zhang, Ping Liu, Bao-Zhang Tang, You-Kuan Yin, Jia He |
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| Rok vydání: | 2004 |
| Předmět: |
Adult
Liver Cirrhosis medicine.medical_specialty Renal function Gastroenterology law.invention Randomized controlled trial Double-Blind Method Liver Function Tests law Internal medicine medicine Humans Aspartate Aminotransferases Gamma-glutamyltransferase Adverse effect Aged medicine.diagnostic_test biology business.industry Alanine Transaminase gamma-Glutamyltransferase Middle Aged Treatment Outcome Complementary and alternative medicine Alanine transaminase Liver Liver biopsy biology.protein Liver function Liver function tests business Drugs Chinese Herbal Phytotherapy |
| Zdroj: | Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine. 1(2) |
| ISSN: | 1672-1977 |
| Popis: | OBJECTIVE: To study the efficacy and safety of Fuzheng Huayu Capsule (FZHY Capsule) against liver fibrosis with chronic hepatitis B. METHODS: Multicentric, randomized, double blinded and paralleled control led trial was conducted on patients (aged between 18 and 65) with liver fibrosis in chronic hepatitis B Indexes observed: (1) hepatic histological changes and HBV markers were observed at 0 and 24th week during the treatment; serological indexes (HA, LN, P-III-P, IV-C) were determined and B ultrasound examination of spleen and liver was taken at 0, 12th, 24th week; liver function (during the period of follow-up, liver function and serological indexes for liver fibrosis were evaluated) were observed at 0, 6th, 12th, 18th, 24th week; (2) indexes for safety: blood and urine routine tests, renal function and ECG were examined. RESULTS: (1) Enrollment and demographic data: There was no significant difference between the trial (110 cases) and control group (106 cases) in demographic feature, vital signs, course of illness, history for drug anaphylaxis, history of previous therapy, liver function, serological indexes for liver fibrosis, liver histological examination (99 cases for test group, 96 cases for control group), HBV markers, and renal function, etc. (2) Histological pathological examination: 93 cases of liver histological examination were taken, of these 50 cases for the trial group and 43 cases for control group which turned out to be at S mean value of 2.33 and 2.11 respectively pretreatment according to criteria for liver fibrosis staging. Post-treatment, the trial showed a significant decrease with S value of 1.80 compared to that of pretreatment; however, there was no significant improvement in control group before and after the treatment with S mean value of 2.14. There was significant difference in reversing rate (decrease at least 1 stage according to criteria for liver fibrosis staging) between the trial (52%) and control (23.3%) after liver biopsy. The trial had a rather good effect on improving inflammatory activity and was superior to control group with a marked decrease of mean value of inflammatory activity and score of inflammation (P |
| Databáze: | OpenAIRE |
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