| Objective:To observe the clinical effect and safeties of Songzi Pill on patients of humid heat heap and blood stasis with Chronic hepatitis C. Meanwhile this research try to investigate the functional mechanism of Songzi Pill and provide scientific clinical basic for its product and use.Methods:Adopted by the methods of random,double-blind and masculine medicine parallel contrast, 126 patients of humid heat heap and blood stasis with Chronic hepatitis C were randomly divided into 2 groups,one for treatment with 95 patients and the other for control with 31 patients.For the treatment group,treated by Songzi Pill,for the control group,treated by Ligan Long Tabs. 6 months for the course of treatment, 6 months for the treatment follow-up visit. Observing the clinical symptom physical sign,traditional Chinese medicine syndrome integral,Hepatic function(ALT,AST,TBil,A/G,GGT,AKP),HCV-RNA qualitation,liver spleen B supersonic wave change and safe index(blood,urine,stool routine and renal function,ECG), comparing the therapeutic efficacy of both drugs.Results:1.The cases selected:the treatment group had 2 shed off because of lose to visit, the control group had 1, The expulsion rate was 2.11% of the treatment group,3.23% of the control group, without rejected cases. There were 123 patients(93 of the treatment group, 30 of the control group)treated completely to press the research project for 6 months, 67 of the treatment group, 22 of the control group, carrying on respectively with follow-up visit for 6 months.2.synthetic therapeutic effect and traditional Chinese medicine syndrome therapeutic effect in clinic: 6 months after the treatment, comparing synthetic therapeutic effect in clinic,for the treatment group, the excellence rate was 21.50%, the total effective rate was 74.19%, for the control group, the excellence rate was 3.33%, the total effective rate was 26.67%, there were significant difference between two groups (P<0.01); Comparing traditional Chinese medicine syndrome therapeutic effect, for the treatment group, the excellence rate was 68.82%, the total effective rate was 91.40%, for the control group, the excellence rate was 16.67%, the total effective rate was 46.67%, there were significant difference between two groups(P<0.01).3.cardinal symptom physical sign amended: 6 months after the treatment, for the treatment group the symptom disappearance rate was 82.19%,57.65%,60.24% in nausea and vomitting,dry and bitter taste of mouth,gastric cavity and abdomen painful abdominal mass. Obviously exceeding the control group(P<0.01); the symptom disappearance rate was 58.67%,68.00%,66.67% in urine yellow,hepatic region pricking pain and splenohepatomegalia, exceeding the control group(P<0.05).4.Traditional Chinese medicine syndrome integral change: 3 months afterthe treatment, Compareing with the control group, the integral obviously decreased of the treatment group(P<0.01);Compareing with the control group after the treatment surplus, the integral obviously droped out of the treatment group(P<0.0I). 6 months after the treatment,the results were identical with 3 months after the treatment. 3 months after the follow-up visit, compareing with the same group after the treatment, the integral obviously decreased of the treatment group(P<0.01), compareing with the control group after the follow-up visit, the integral obviously droped out of the treatment group (P<0.01). 6 months after the follow-up visit, the results were identical with 3 months after the follow-up visit.5.The blood serum ALT change:3 months after the treatment, Compareing with the control group, the value of ALT of the treatment group obviously decreased(P<0.01); Compareing with the control group after the treatment surplus,the level of ALT of the treatment group obviously droped out(P<0.01).6 months after the treatment,the results were identical with 3 months after the treatment;Compareing with the same group before the treatment, the recovery rates of ALT were 49.46%, exceeded the control group(P<0.05). 3 or 6 months after the follow-up visit, the results were identical.6.The blood serum AST change. 3 months after the treatment, Compareing with the control group after, the value of AST of the treatment group decreased(P<0.05); Compareing with the control group after the treatment surplus, the level of AST of the treatment group droped out(P<0.05).6 months after the treatment,the results were identical with 3 months. Compareing with the same group before the treatment, the recovery rates of AST were 56.47%,obviously exceeded the control group(P<0.01). 3 or 6 months after the follow-up visit, the results were identical.7.The HCV-RNA darkening change:6 months after the treatment,there were darkening with 32 of the treatment group, the darkening rate was 34.41%, obviously exceeded the control group(P<0.01).6 months after the follow-up visit,there were darkening with 6 of the treatment group, the darkening rate was 13.95%, obviously exceeded the control group(P<0.01).8.The safety index: the two groups did not discover adverse reaction. In therapy AP detecting blood,urine,stool routine and renal function,ECG and so on,did not discover clinical abnormal change about medication.Conclusion: 1.The Songzi Pill and Ligan Long Tabs could well improve symptom,physical sign of patients with Chronic hepatitis C, depress the level ofALT,AST, lighten the damage of liver, but The Songzi Pill obviously surpassed to Ligan Long Tabs; Compareing to the synthetic therapeutic effect and traditional Chinese medicine syndrome therapeutic effect in clinic,the total effective rate of Songzi Pill was obviously better than Ligan Long Tabs; The darkening rate ofHCV-RNA, the Songzi Pill was also obviously better than Ligan Long Tabs,manifesting the superiority of the traditional Chinese medicine in restrainting virus replication.2.recommending the clinical direction and dosage of Songzi Pill :Take orally, 5 g of every time, 2 times on daily, the course of treatment was no less than 6 months.3.The clinical safety of Songzi Pill was better, did not discover adverse reaction about investigational drug, there were not harmful effects on blood,urine,stool routine and renal function,ECG of patients with Chronic hepatitis C. |
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