Randomised controlled trial: effect of metformin add-on therapy on functional cure in entecavir-treated patients with chronic hepatitis B.

INTRODUCTION AND OBJECTIVES: Hepatitis B surface antigen (HBsAg) clearance, indicating functional cure or resolved chronic hepatitis B (CHB), remains difficult to achieve via nucleos(t)ide analogue monotherapy. We investigated whether metformin add-on therapy could help achieve this goal in entecavir-treated patients with hepatitis B e antigen (HBeAg)-negative CHB. PATIENTS AND METHODS: Patients with HBeAg-negative CHB who met eligibility criteria (entecavir treatment for > 12 months, HBsAg < 1000 IU/mL) were randomly assigned (1:1) to receive 24 weeks of either metformin (1000 mg, oral, once a day) or placebo (oral, once a day) add-on therapy. The group allocation was blinded for both patients and investigators. Efficacy and safety analyses were based on the intention-to-treat set. The primary outcome, serum HBsAg level (IU/mL) at weeks 24 and 36, was analysed using mixed models. RESULTS: Sixty eligible patients were randomly assigned to the metformin (n = 29) and placebo (n = 31) groups. There was no substantial between-group difference in the HBsAg level at week 24 (adjusted mean difference 0.05, 95% confidence interval -0.04 to 0.13, p = 0.278) or week 36 (0.06, -0.03 to 0.15, p = 0.187), and no significant effect of group-by-time interaction on the HBsAg level throughout the trial (p = 0.814). The occurrence of total adverse events between the two groups was comparable (9 [31.0%] of 29 vs. 5 [16.1%] of 31, p = 0.227) and no patient experienced serious adverse events during the study. CONCLUSION: Although it was safe, metformin add-on therapy did not accelerate HBsAg clearance in entecavir-treated patients with HBeAg-negative CHB.

The association between nutritional status and functional limitations among centenarians: a cross-sectional study.

BACKGROUND: Although there have been studies on the association between nutritional status and functional limitations, there were few studies on Asian centenarians in community. Therefore, this study aims to identify associations between nutritional status and functional limitations among centenarians in China. METHODS: This cross-sectional study was conducted with the data from the China Hainan Centenarian Cohort Study. These data ultimately included basic characteristics, hematologic indicators, and chronic disease status for 1,002 centenarians. The nutritional status was evaluated using the Mini Nutritional Assessment Short-Form scale. The functional limitations were assessed using the activities of daily living (ADL) scale, namely Barthel Index and Lawton Scale. The association between nutritional status and ADL was assessed using multivariate logistic regression models. RESULTS: In this study, the prevalence of malnutrition was 20.8 % among centenarians, basic ADL (BADL) limitation was 28.6 %, and instrumental ADL (IADL) limitation was 64.7 %. As the nutritional status deteriorated, the risk of ADL limitations increased in total population (BADL limitation: OR = 17.060, 95 % CI: 8.093-35.964; IADL limitation: OR = 11.221, 95 % CI: 5.853-21.511; p for trend < 0.001). Similar results were found in both men and women after stratifying sex but were more prominent in women. CONCLUSIONS: Malnutrition is associated with functional limitations among centenarians in China and more pronounced among women.

Incidence, clinical features, and risk factors of fluoroquinolone-induced acute liver injury: a case-control study.

BACKGROUND: Fluoroquinolone-related hepatotoxicity is rare but serious and is attracting increasing attention. We explored the incidence, clinical features and risk factors of acute liver injury associated with fluoroquinolone use. MATERIALS AND METHODS: Based on the Adverse Drug Events Active Surveillance and Assessment System that we developed, we carried out a case-control study by enrolling patients who were hospitalized and received fluoroquinolones to treat or prevent infections at the Chinese People's Liberation Army General Hospital from Jan 2016 to Dec 2017. The incidence of fluoroquinolone-induced acute liver injury was estimated, and logistic regression was used to reveal the risk factors of this adverse reaction. RESULTS: We found that 17,822 patients received fluoroquinolones, and 13,678 of them met the inclusion criteria. A total of 91 patients developed acute liver injury after receiving the medication, and 369 controls were matched to these patients. The overall incidence of fluoroquinolone-induced acute liver injury in the Chinese population is approximately 6-7 cases per 1,000 individuals annually. Multivariate logistic regression analysis showed that older age slightly decreased the risk of hepatotoxicity (OR, 0.98; 95% CI, 0.96-0.99). The male sex (OR, 2.19; 95% CI, 1.07-4.48), alcohol abuse (OR, 2.91; 95% CI, 1.39-6.11) and hepatitis B carrier status (OR, 2.38; 95% CI, 1.04-5.48) increased the risk of liver injury. Concurrent use of cephalosporins or carbapenems was also associated with an increased risk. CONCLUSION: Increased risk of fluoroquinolone-related hepatotoxicity may be associated with youth, the male sex, alcohol abuse, hepatitis B carrier status and the concurrent use of cephalosporins or carbapenems.