ABSTRACT
OBJECTIVE@#To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue () and Tiaogan Jiedu Huashi () fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients.@*METHODS@#A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented.@*RESULTS@#The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P<0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns.@*CONCLUSION@#Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile (ChiCTR-TRC-11001263).
Subject(s)
Adult , Female , Humans , Male , Young Adult , Adenine , Therapeutic Uses , Antiviral Agents , Therapeutic Uses , Double-Blind Method , Drug Therapy, Combination , Drugs, Chinese Herbal , Therapeutic Uses , Hepatitis B e Antigens , Allergy and Immunology , Hepatitis B, Chronic , Drug Therapy , Allergy and Immunology , Medicine, Chinese Traditional , Organophosphonates , Therapeutic UsesABSTRACT
<p><b>OBJECTIVE</b>To analyse the relationships among HBV genotypes, HBV DNA levels and histopathological features of the livers of familial grouped hepatitis B patients in the Tianjin area.</p><p><b>METHODS</b>One hundred familial grouped hepatitis B (CHB) patients were enrolled in this study. Thirty-five of the 100 patients were chronic asymptomatic HBsAg carriers (ASC) and 65/100 were mild CHB patients. Their HBV genotypes and HBV-DNA levels were detected and liver biopsies were performed for analyzing the pathological features.</p><p><b>RESULTS</b>Seven patients were of HBV genotype B (7%), and most of them had a HBV DNA level in the middle 10(3-5) copies/ml (57.14%). The histopathological features of the livers were of different degrees of injury. Eleven patients HBV was of genotype BC (11%); their HBV DNA levels were from 10(3-5) copies/ml (45.45%) to 10(6-7)copies/ml (36.36%). Their liver pathology showed slight or severe injuries (< or = G2 90.91%, < or = S(2) 81.82%). Eighty-two patients HBV was of genotype C (82%), and among the 82, 29 were ASC and 53 were CHB. Among the ASC, most of them had a high HBV DNA level (72.41%), and all of them had different degrees of liver injury. Among the CHB, their HBV DNA levels were 10(6-7) copies/ml (39.62%) and more than or equal 10(8) copies/ml (49.06%). The liver histopathological features were > or = G(2) in 38 patients (71.70%), and > or = S(2) in 25 patients (47.17%).</p><p><b>CONCLUSIONS</b>(1) In the majority, HBV of the family gathered hepatitis B patients living in Tianjin is of genotype C and they have a high HBV-DNA level and severe liver pathological injuries. These features of the family gathered hepatitis B patients are the main factors causing the unfavorable prognosis of the patients. (2) There is inflammation of different degrees in the livers and high HBV DNA levels in all the family gathered ASC patients. Antiviral therapy should be planned according to the pathological features in patients livers. (3) Liver biopsies should be performed routinely before their antiviral therapy.</p>