[Analysis of spontaneous decline of HBV DNA in chronic hepatitis B patients in 12 weeks].

OBJECTIVE: To analyze the spontaneous decline of HBV DNA in chronic hepatitis B patients in 12 weeks. METHODS: Chronic hepatitis B patients not receiving antiviral treatment from 2003 to 2005 were divided into two groups according to the baseline value of ALT and TBil. Spontaneous decline of HBV DNA were retrospected, and the influence of the baseline value of ALT and TBil on spontaneous decline of HBV DNA was analyzed. RESULTS: Total of 213 chronic hepatitis B patients (male 174, female 39, aged from 18 to 65) were recruited in this study, including 124 mild and moderate type of hepatitis B, 89 severe type of hepatitis B, and 19 patients (8.92%) were lost at the end of the 12th week. The mean baseline value of HBV DNA of all the patients was (6.66+/-1.03) log10 copies/ml, at 12 week the mean value of HBV DNA of all the patients was (5.98+/-1.53) log10 copies/ml (compared to baseline P<0.01), the decline value of HBV DNA was (0.68+/-1.46) log10 copies/ml. The mean baseline value of HBV DNA of patients with the severe type of hepatitis B was lower than that with the mild or moderate type of hepatitis B patients [(6.45+/-0.99) log10 copies/ml and (6.81+/-1.04) log10 copies/ml respectively] (P<0.05). However, there was no significant difference in the mean and the declined value of HBV DNA between these two groups at the 12th week (P<0.05). At the 12th week, the baseline values of ALT and TBil were higher in patients with HBV DNA3 log10 copies/ml (P>0.05); And there were no significant difference in the baseline values of ALT and TBil between patients with the declined value of HBV DNA>or=2 log10 copies/ml and patients with declined value of HBV DNA less than 2 log10 copies/ml. At the 12th week, the mean and the declined value of HBV DNA were similar between the patients with ALT5xULN at baseline. The mean baseline value of HBV DNA of patients in the group of patients whose baseline value of ALT5xULN while TBil>5xULN, ALT5xULN, ALT>5xULN while TBil0.05 respectively). CONCLUSIONS: There is spontaneous decline of HBV DNA in patients with chronic hepatitis B in 12 weeks, but the level of liver injury is not correlated with the level of spontaneous decline of HBV DNA in chronic hepatitis B patients in 12 weeks.

[A multi-center clinical study of N-acetylcysteine on chronic hepatitis B].

OBJECTIVES: To evaluate the effectiveness and safety of N-acetylcysteine (NAC) in treating chronic hepatitis B patients. METHODS: 144 patients with chronic hepatitis B (total bilirubin, TBil>170 mmol/L) from several centers were chosen for a randomized and double blind clinical trial. The patients were divided into a NAC group and a placebo group and all of them were treated with an injection containing the same standardized therapeutic drugs. A daily dose of 8 microgram NAC was added to the injection of the NAC group. The trial lasted 45 days. Hepatic function and other biochemistry parameters were checked at the experimental day 0 and days 15, 30, 45. RESULTS: Each group consisted of 72 patients of similar demology and disease characteristics. During the trial, 28 cases of the 144 patients dropped out. In the NAC group, at day 0 and day 30, the TBil were 401.7 vs. 149.2 and 160.1+/-160.6. In the placebo group, the TBil on the corresponding days were 384.1+/-134.0 and 216.3+/-199.9. Its decrease in the NAC group was 62% and 42% in the placebo group. At day 0 and day 45 of treatment, the effective PTa increase rate was 72% in the NAC group and 54% in the placebo group. The total effective rate (TBil + PTa) was 90% in the NAC group and 69% in the placebo group. The parameters of the two groups showed a remarkable difference. The rate of side effects was 14% in the NAC and 5% in the placebo groups. CONCLUSION: NAC can decrease the level of serum TBil, increase the PTa and reduce the time of hospitalization. NAC showed no serious adverse effects during the period of our treatment. We find that NCA is effective and secure in treating chronic hepatitis B patients.

[Clinical investigation of famciclovir in chronic hepatitis B patients irresponsive to alpha interferon treatment].

OBJECTIVES: To evaluate the efficacy and safety of famciclovir on the decreasing levels of serum HBV-DNA and ALT and HBeAg/antiHBe seroconversion in chronic hepatitis B patients irresponsive to 3 months treatment with alpha interferon. METHODS: Two hundred and nineteen patients with chronic HBV infection, defined as positive HBsAg, HBeAg and HBV DNA, were enrolled and randomly half-and- half put into famciclovir and placebo groups. The two groups received either famciclovir 500 mg tid or a placebo treatment for 24 weeks, and then were followed-up for another 24 weeks with no treatment. RESULTS: At the end of 24 weeks, the log value of HBV DNA dropped from 6.54+/-1.26 to 5.70+/-2.03 in the famciclovirt group and were elevated from 6.30+/-1.32 to 6.51+/-1.65 in the placebo group (P < 0.01). The rate of cases with persistence HBV DNA dropped 2 log of quantity in the famciclovir group and was 28.28% (28/99); it was 9.47% (9/95) in the placebo group (P < 0.01). Those with persistence negative HBV DNA was 28.28% (28/99) in the flamciclovir treated group and 14.74% (14/95) in the placebo group (P < 0.05). Those persistently being HBeAg negative were 7.69% (7/91) in the famciclovir treated group and 3.33% (3/90) in the placebo group (P > 0.05). The HBeAg/antiHBe seroconversion was 4.40% (4/91) in the famciclovir group and 2.22% (2/90) in the placebo group (P > 0.05). The percentage of cases with normal of ALT level was 15.15% in the famciclovir group and 6.35% in the placebo group (P < 0.05). CONCLUSION: Famciclovir is effective in inhibiting HBV DNA replication and in decreasing serum ALT levels. The rate of HBeAg/antiHBe seroconversion in the famciclovir treated group was similar to that of the placebo group. Famciclovir was well tolerated without severe adverse effects during our treatment.

The natural history of chronic hepatitis B: a retrospective study.

OBJECTIVE: To clarify the natural history of chronic hepatitis B so as to evaluate its long-term therapeutic outcome of the patients and the efficacy of antiviral drugs. METHODS: A cohort of 183 biopsy-proven chronic hepatitis B patients (mean age of 31.75+/-8.03 years, male/female ratio: 152:31) and 247 controls were followed up retrospectively for 11.81+/-4.08 years. This study was focused on long-term clinical outcome including the rates of liver cirrhosis, hepatocellular carcinoma and death, apart from the long-term effect of antiviral drugs and prognostic factors. RESULTS: In the 183 chronic hepatitis B patients, 22 (12.02%) developed liver cirrhosis, 12 (6.56%) developed hepatocellular carcinoma, and 20 (10.93%) died. The 5-, 10- and 15-year survival rates were 97.27%, 91.62%, and 84.47%, respectively. The 5-, 10- and 15-year incidence rates of HCC were 0, 3.19%, and 11.56%, respectively. In the 247 controls, 6 (2.43%) died; none of them developed cirrhosis or HCC. The rates of death, liver cirrhosis, and HCC in the hepatitis B patients were markedly different (P<0.005) compared with the controls. The overall mortality of hepatitis B patients was 4.5-fold higher than the general population. Cox multiple regression analysis showed that old age, severe histological injury, and positive HBeAg were closely related to liver cirrhosis; old age, severe histological injury, and male were major factors leading to death. The independent variable of predicted HCC was not found. CONCLUSION: The long-term outcome of hepatitis B patients is poor and the efficacy of antiviral drugs needs further study.

[Clinical study of anti-hepatic fibrosis effect of IFN-gamma in patients with chronic hepatitis B].

OBJECTIVE: This was an open, random, control and multicenter clinical trial. In the study, the anti-hepatic fibrosis effect of rhIFN-gamma and its side reactions were evaluated. METHODS: A total of 289 patients enrolled in clinical trial, 153 patients in trial group and 136 patients in control group. The routine strategy is given in all patients. In addition, every patient in trial group received rhIFN-gamma at a dose of 1 MU intramuscularly daily for the first three months and 1 MU every other day for the following six months. Patients of two groups were followed up for another three months after the treatment. Histological indices, serum hepatic fibrosis indices, ultrasound B and symptoms and signs evaluated the effect. For patients who accepted two liver biopsies before and after treatment, the effect was determined by semiquantitative score system while for patients who did not accepted liver biopsy, serum hepatic fibrosis indices and ultrasound B were major criteria. RESULTS: The efficient of treatment were 66% in trial group vs. 16.2% in control group and the obviously efficient of treatment was 27.8% in trial group vs. 7.4% in control group (P < 0.001). For patients who accepted two liver biopsies before and after treatment, the efficient of treatment was 63% in trial group vs. 24.1% in control group and the obviously efficient of treatment was 27.8% in trial group vs. 13.8%. For patients who did not accepted liver biopsy, the efficient of treatment was 67.7% in trial group vs. 14.0% in control group and the obviously efficient of treatment was 22.2% in trial group vs. 5.6%. None of patients emerged serious side reactions during clinical trial. CONCLUSION: The results confirmed that rhIFN-gamma have a better anti-hepatic fibrosis effect to patients with chronic hepatitis B.

[The effect of artificial support system on serum cytokine in chronic severe hepatitis].

OBJECTIVE: To explore the changes of cytokines including TNFalpha, TGFbeta1 and nitrogen monoxide, and endotoxin in the serum of chronic severe hepatitis after the treatment of ALSS, and to evaluate further the value of ALSS in the treatment of chronic severe hepatitis. METHODS: Forty two patients were screened. The changes of TNFalpha, TGFbeta1, nitrogen monoxide and endotoxin were detected respectively. The relationship between the cytokines and the severity and prognosis were further analyzed. RESULTS: ALSS was effective to decrease the serum concentration of cytokines. TNFalpha dropped from (481.57+/-229.33) pg/ml to (156.46+/-78.12) pg/ml (P < 0.05). TGFbeta1 from (44.09+/-31.73) ng/ml to (27.77+/-23.28) ng/ml (P < 0.01), endotoxin from (1.05+/-0.37) Eu/ml to (0.28+/-0.22) Eu/ml (P < 0.001). NO from (71.15+/-33.09) micromol/L to (58.11+/-29.30) micromol/L (P < 0.001). Before the therapy endotoxin was related with TNFalpha and total bilirubin, while after the therapy, NO was related with protime and aminonemia. CONCLUSION: High level of endotoxin and nitrogen monoxide in serum plays an important role in hepatocyte damage of chronic severe hepatitis. The changes of serum endotoxin TNFalpha, TGFbeta1 and nitrogen monoxide level in patients with chronic severe hepatitis can be used to judge the severity and prognosis of severe hepatitis. ALSS is a reliable hepatic support device for chronic severe hepatitis

[The difference between the positive rate of anti-HCV in the patients with severe viral hepatitis detected by the first generation or second generation enzyme linked-immunosorbent assay].

OBJECTIVE: To compare the positive rate of antibody to hepatitis C virus (anti-HCV) in sera of patients with severe viral hepatitis between 1984-1990 year and 1997-2003 year. METHODS: Serum anti-HCV was detected by enzyme linked-immunosorbent assay (ELISA). It was detected by the first generation (1st) ELISA (Ortho Co. USA) in 79 cases of severe viral hepatitis during 1984-1990 year, and it was detected by the second generation (2nd) ELISA (Xiamen Xingchuang Co. China) in 251 cases of severe viral hepatitis during 1997-2003 year. RESULTS: The positive rate of serum anti-HCV was 51.9% detected by the 1st ELISA in 79 cases of severe viral hepatitis during 1984-1990 year, and it was 1.2% detected by the 2nd ELISA in 251 cases of severe hepatitis during 1997-2003 year (chi2 = 133.68, P

[The efficacy of two type of membrane plasma separator on the treatment of patients with chronic severe hepatitis B].

OBJECTIVE: In order to compare the efficacy of two kinds of membrane plasma separator on the treatment of patients with severe hepatitis B. METHODS: 63 cases suffering from chronic severe hepatitis B were divided into two groups, 25 cases were treated with plasma exchange using Evacure-4A membrane plasma separator (A group) or 38 cases were using PS-06 membrane plasma separator (B group). Both of them also were treated with similar basic medical treatment. The level of serum total bilirubin, non-conjugated bilirubin, prothrombin time and albumin were tested at baseline and the end of the treatment with PE. RESULTS: Evacure-4A and PS-06 membrane plasma separators can effientively remove bilirubin, the levels of serum total bilirubin, non-conjugated bilirubin of all patients were significantly decreased after treated with PE. In A group, the level of serum total bilirubin, non-conjugated bilirubin decreased from (464.2+/-193.8)micromol/L to (279.4+/-158.7)micromol/L, (293.5+/-129.1)micromol/L to (175.5+/-106.7)micromol/L (t=5.45, 10.36, P<0.01) respectively. In B group, the level of serum total bilirubin, non-conjugated bilirubin decreased from (493.2+/-126.9)micromol/L to (299.7+/-96.5)micromol/L, (300.2+/-74.3)micromol/L to (171.5+/-53.1)micromol/L (t=5.17, 12.04, P<0.01) respectively. The level of serum albumin increased after treated with PE in A and B groups, to contrast with PS-06, the increasing percentage of albumin was higher when the patients were treated with PE using Evacure-4A membrane plasma separator [(8.3+/-0.7) % vs. (3.4+/-9.3) %, t = 2.76, P<0.01]. CONCLUSION: Evacure-4A membrane plasma separator may be better than PS-06 membrane plasma separator on the treatment of patients with chronic severe hepatitis B.

[Long-term health-related quality of life in chronic hepatitis B patients].

OBJECTIVE: To evaluate their long-term outcome and the efficacy and economic significance of antiviral drugs by investigating the long-term health-related quality of life (HQL) in chronic hepatitis B (CHB) patients. METHODS: The HQL of 101 CHB patients with biopsy-proven 6 to 18 years ago and 105 persons of general population as control was studied with revised SF-36 questionnaire. RESULTS: The HQL in CHB patients was lower than that in general population in physical functioning, role physical, general health, mental health, and specific symptoms (mu > or = 2.10, P<0.05). CONCLUSIONS: The long-term HQL in chronic hepatitis B patients is poor.