BACKGROUND No guideline recommends antiviral therapy for hepatitis B e antigen(HBeAg)-positive chronic hepatitis B patients with persistently normal alanine aminotransferase levels and a high hepatitis B virus(HBV)DNA...BACKGROUND No guideline recommends antiviral therapy for hepatitis B e antigen(HBeAg)-positive chronic hepatitis B patients with persistently normal alanine aminotransferase levels and a high hepatitis B virus(HBV)DNA viral load.AIM To evaluate the feasibility and safety of a Chinese herbal formula as a therapeutic option for chronic HBV infection.METHODS In total,395 patients(30–65 years old)with confirmed HBeAg-positive chronic hepatitis B infection and persistently normal alanine aminotransferase were randomized to receive either Chinese herbal formula or placebo for 96 wk.Endpoints to evaluate therapeutic efficacy included:(1)HBV DNA levels decreased to less than 4 log10 IU/mL at weeks 48 and 96;and(2)HBeAg clearance and seroconversion rates at weeks 48 and 96.RESULTS HBV DNA levels≤4 log10 IU/mL were 10.05%at week 48 and 18.59%at week 96 in the treatment group.The HBeAg clearance and conversion rates were 8.54%and 8.04%at week 48 and 16.08%and 14.57%at week 96,respectively.However,HBV DNA levels≤4 log10 IU/mL were 2.55%and 2.55%at weeks 48 and 96,respectively,and the HBeAg clearance rates were 3.06%and 5.61%at weeks 48 and 96,respectively,in the control group.The quantitative hepatitis B surface antigen and HBeAg levels at baseline and changes during the treatment period as well as the alanine aminotransferase elevation at weeks 12 and 24 were strong predictors of HBeAg clearance.CONCLUSION High rates of HBV DNA reduction,HBeAg clearance and seroconversion could be achieved with Chinese herbal formula treatments,and the treatments were relatively safe for HBeAg-positive chronic hepatitis B-infected patients with persistently normal alanine aminotransferase.The ability of the compound to modulate host immune function probably contributed to this effect.展开更多
Objective:This study aimed to explore the efficacy and safety of Qingxin Fupi Jieyu formula(the herbal formula has the function of clear away the heart fire,tonify spleen,and relieve depression,QXFPJYF)in treating dig...Objective:This study aimed to explore the efficacy and safety of Qingxin Fupi Jieyu formula(the herbal formula has the function of clear away the heart fire,tonify spleen,and relieve depression,QXFPJYF)in treating digestive tract cancer-related cognitive impairment(CRCI).Methods:28 subjects with digestive tract CRCI were treated with QXFPJYF for 6 weeks.The scores of Montreal Cognitive Assessment and Mini-Mental State Examination were observed at four-time points(baseline,week 2,week 4,week 6).Besides,anxiety and depression scores and tumor markers were measured.Results:The scores of Montreal Cognitive Assessment and various fields were elevated steadily after treatment,such as visuospatial/executive,attention,language,delayed recall,and orientation.The differences were statistically significant(P<0.05)besides language score.The scores of Mini-Mental State Examination and various factors were elevated gradually at week 2,week 4 and week 6,including language and praxis,attention and calculation,recall and orientation,and the differences were statistically significant(P<0.05)except for recall score.The results also showed the change of tumor markers were not obvious,but anxious and depressed emotions were improved.More importantly,no subjects developed with obvious adverse reactions during the study.Conclusion:The finding indicated that QXFPJYF treated digestive tract CRCI with great efficacy and safety,which improved cognitive function from several fields.Nevertheless,the current study was limited by sample and medical ethics,and which was a self-control trial,some limitations needed to be acknowledged,further high-quality research is required to explore and verify it.展开更多
基金Supported by the National Natural Science Foundation of China,No.81174263National Science and Technology Major Project during the 12th Five-year Plan Period,No.2012ZX1005006+1 种基金Sanming Project of Medicine in Shenzhen,Guangdong Province,China,No.SZSM201612074and Science and Technology Planning Project of Guangdong Province,China,No.2017A020213016.
文摘BACKGROUND No guideline recommends antiviral therapy for hepatitis B e antigen(HBeAg)-positive chronic hepatitis B patients with persistently normal alanine aminotransferase levels and a high hepatitis B virus(HBV)DNA viral load.AIM To evaluate the feasibility and safety of a Chinese herbal formula as a therapeutic option for chronic HBV infection.METHODS In total,395 patients(30–65 years old)with confirmed HBeAg-positive chronic hepatitis B infection and persistently normal alanine aminotransferase were randomized to receive either Chinese herbal formula or placebo for 96 wk.Endpoints to evaluate therapeutic efficacy included:(1)HBV DNA levels decreased to less than 4 log10 IU/mL at weeks 48 and 96;and(2)HBeAg clearance and seroconversion rates at weeks 48 and 96.RESULTS HBV DNA levels≤4 log10 IU/mL were 10.05%at week 48 and 18.59%at week 96 in the treatment group.The HBeAg clearance and conversion rates were 8.54%and 8.04%at week 48 and 16.08%and 14.57%at week 96,respectively.However,HBV DNA levels≤4 log10 IU/mL were 2.55%and 2.55%at weeks 48 and 96,respectively,and the HBeAg clearance rates were 3.06%and 5.61%at weeks 48 and 96,respectively,in the control group.The quantitative hepatitis B surface antigen and HBeAg levels at baseline and changes during the treatment period as well as the alanine aminotransferase elevation at weeks 12 and 24 were strong predictors of HBeAg clearance.CONCLUSION High rates of HBV DNA reduction,HBeAg clearance and seroconversion could be achieved with Chinese herbal formula treatments,and the treatments were relatively safe for HBeAg-positive chronic hepatitis B-infected patients with persistently normal alanine aminotransferase.The ability of the compound to modulate host immune function probably contributed to this effect.
文摘Objective:This study aimed to explore the efficacy and safety of Qingxin Fupi Jieyu formula(the herbal formula has the function of clear away the heart fire,tonify spleen,and relieve depression,QXFPJYF)in treating digestive tract cancer-related cognitive impairment(CRCI).Methods:28 subjects with digestive tract CRCI were treated with QXFPJYF for 6 weeks.The scores of Montreal Cognitive Assessment and Mini-Mental State Examination were observed at four-time points(baseline,week 2,week 4,week 6).Besides,anxiety and depression scores and tumor markers were measured.Results:The scores of Montreal Cognitive Assessment and various fields were elevated steadily after treatment,such as visuospatial/executive,attention,language,delayed recall,and orientation.The differences were statistically significant(P<0.05)besides language score.The scores of Mini-Mental State Examination and various factors were elevated gradually at week 2,week 4 and week 6,including language and praxis,attention and calculation,recall and orientation,and the differences were statistically significant(P<0.05)except for recall score.The results also showed the change of tumor markers were not obvious,but anxious and depressed emotions were improved.More importantly,no subjects developed with obvious adverse reactions during the study.Conclusion:The finding indicated that QXFPJYF treated digestive tract CRCI with great efficacy and safety,which improved cognitive function from several fields.Nevertheless,the current study was limited by sample and medical ethics,and which was a self-control trial,some limitations needed to be acknowledged,further high-quality research is required to explore and verify it.