| Objective:The Clinical efficacy is studied through clinical observation of Modified Gexia Zhuyu Decoction in treating liver fibrosis of stagnant heat obstructing collaterals type, whose safety is under the objective evaluation.Methods:After screened by the traditional Chinese medicine diagnosis and western medicine diagnosis of liver fibrosis, the 70 outpatients and inpatients belonging to stagnant heat obstructing collaterals type are randomly divided into treatment group of 35 cases and control group of 35 cases. Every patient in treatment group is given oral 500 ml of Modified Gexia Zhuyu Decoction,one dose a day, morning and evening hours service; while every patient in control group is given oral Compound Biejia Ruangan tablets,4 pieces once, three times a day. Three months accounts for one course of treatment, and the total courses of treatment can last 24 weeks. Those patients are observed about liver fibrosis indexes, liver function, abdominal ultrasound, and the safety indexes for one month, all measurement information should be done normality test, if accord with normal distribution, the two samples are compared with two independent samples t test, multiple samples are compared using analysis of variance, and multiple comparison choose LSD test.If not, we can use nonparametric-test: two groups of level measurement data are compared using Wilcoxon rank sun test, multiple sets of level measurement data are compared using the Kruskal-Wallis H test.The comparation of count data (not including level data) such as constituent ratio can use chi-square test.All measurement data is expressed by "mean+/-standard deviation". The significance level of alpha in normality, homogeneity of variance and comparability test is 0.005, using SPSS17.0 statistical software.After the observation, all the data are collected for statistical analysis.Two sample measurement data are compared using t test, rate of two samples using chi-square test, two samples of level data using rank sum test.Results:Results:After the clinical observation, the statistical analysis results of the data through SPSS19.0 are as follows:1. Comparablity analysis:after statistics analysis, age, sex, course of the disease, and TCM symptom integral, liver function examination, serum liver fibrosis four examination and liver ultrasonic est before treatment in the two groups, have no statistical differences (P> 0.05) and are comparable.2. Curative effect analysis:1) the clinical curative effect of two groups of patients are analyzed with chi-square test. The total effective rate difference is statistically significant (P< 0.05). The Chinese crude drug group is higher than the Chinese patent medicine group, which suggests that the curative effect of Chinese crude drug is superior to the Chinese patent medicine. While, according to rank sum est, P< 0.05, the difference is statistically significant. The total clinical efficacy of the Chinese crude drug and the Chinese patent medicine in the treatment of liver fibrosis can be thought different and the curative effect of Chinese crude drug is better to the Chinese patent medicine.2) The changes of hepatic function indexes before and after the treatment of Chinese crude drug and Chinese patent medicine are analyzed by t test. The differences of ALT and AST in two groups before and after treatment are statistically significant (P< 0.05). And the ALT and AST of patients are decreased after treatment, Showing that the two treatments to improve liver function have certain effect.3)The hepatic function index before and after the treatment in two groups are analyzed by t test. The ALT and AST overall mean in the Chinese crude drug group are lower than that in the Chinese patent medicine group. And the differences are statistically significant (P<0.05), indicating that Chinese crude drug treatment is superior to Chinese patent medicine treatment to improve the liver function.4) The changes of liver fibrosis indexes before and after the treatment of Chinese crude drug and Chinese patent medicine are analyzed by t test. The differences of liver fibrosis indexes such as HA, PⅢP, CIV, LN in two groups before and after treatment are statistically significant. And the HA, PIIIP, CIV, LN of patients are decreased after treatment, showing that the two drug treatments are all have certain effect to improve liver fibrosis.5) The TCM symptoms curative effect after treatment of the two groups are analyzed using rank sum test. The results shows that P<0.05,and the difference is statistically significant.The TCM symptoms curative effect of the Chinese crude drug and the Chinese patent medicine in the treatment of liver fibrosis can be thought different and the curative effect of Chinese crude drug is better to the Chinese patent medicine.Conclusion:Modified Gexia Zhuyu Decoction conveys the functions of improving patients’ clinical symptoms, reducing the liver function, improving liver fibrosis indexes and the instantaneous elastic of liver under ultrasound, etc, which show this medicine’s safety and effectiveness in the clinical observation. |
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