| BackgroundHepatitis B virus (HBV) infects more than 350 million people worldwide. China is a high incidence of HBV infection, there are about ninety seven million people.Since the nucleos(t)ide analogue was applied to the antiviral treatment of chronic hepatitis B infection, patients’ survival time and quality of life have greatly improved, but resistance, renal impairment and other adverse reactions have gradually gained more attention. Before ADV marketing, clinical trials have proved that it has potential nephrotoxicity. Because of its low price, and no location of cross resistance with lamivudine, ADV are used widely and long especially in primary hospitals in our country. Renal dysfunction and hypophosphatemia caused by long-term administration of low-dose ADV has been reported in recent years.ObjectiveThe aim of this Prospective Cohort study was to determine the incidence with renal safty and hypophosphatemia in patients with hepatitis B infection on 4-year treatment with ADV in China. the Cockcorft--Gault equation(CG equation), Modification of Diet in Renal Disease (MDRD) equation and CKD-EPI equation have been widely used to eGFR in patients with chronic kidney disease. This study aims to research the similarity and difference among different eGFR calculation equations.MethodsThe study was performed on 65 patients who were screened from the hepatitis B prevention and treatment comprehensive demonstration zones Shouguang and Zhangqiu of Shandong Province. All the groups of patients were given low-dose ADV(10mg/d).We evaluated serum creatinine, serum phosphate and serum cystatin C level at the start of ADV and every 6 months during 104-week follow-up treatment. According to the patient’s own situation, researchers proposed the next reasonable treatment after 104-week treatment. Patients chosen the treatment as their please, and serum creatinine(SCr), serum phosphate and serum cystatin C (Cys C) level at 156-week and 208-week. Paired t test and analysis of Variance(ANOVA) was used to analyze above indexes before treatment and at different time points during 208 weeks. This study also compared the similarities and differences of the eGFR was calculated by 4 equations.Results1. In the treated team, the incidences of renal impairment (the eGFR decreased>20%) at 52 weeks,104 weeks,156 weeks and 208 weeks were 1.64%(1/61),12.28%(7/57),18.61% (8/43) and 40%(8/20),respectively. The incidence of early renal impairment were 1.64% (1/61),3.51%(2/57),9.30%(4/43) and 15%(3/20).2. Treatment of 52 weeks,76 weeks and 104 weeks, SCr level on average increased significantly(P=0.04,0.01,0.00),compared with the baseline, there were no significant differences from baseline(P=0.17) at 24 weeks. Compared with week 156 weeks,208 weeks and the baseline period, respectively, SCr level on average increased significantly ADV treatment group (P=0.00,0.033) a3. Treatment of 24 weeks,52 weeks,76 weeks and 104 weeks, Cys C level on average decreased significantly(P=0.049,0.02,0.04,0.04),compared with the baseline. Compared with 156 weeks,208 weeks and the baseline period, respectively, cys C level on average increased significantly(P=0.01,0.01) in ADV treatment group.4. In this study, eGFR calculated use 4 different equations. Application of C-G equation, after 24 weeks, eGFR decreased statistically significant compared with baseline (P=0.018). Application of MDRD equation and CKD-EPI (SCr) equation, eGFR decreased statistically significant compared with baseline (P=0.003,P=0.001) after 52 weeks. Application of CKD-EPI (SCr-CysC) equation,, eGFR decreased statistically significant compared with baseline (P=0.049) after 104 weeks. HAt 104-week treatment, only 1 (1.67%) developed hypophosphatemia, no new case of hypophosphatemia was occurred between 104 weeks and 208 weeks in the patients treated with ADV.5. At 24 weeks,52 weeks,76 weeks and 104 weeks, the median of serum phosphorus decreased non-significantly(P=0.517,0.422,0.467,0.441).compared with the baseline. Compared with week 156 weeks,208 weeks and the baseline period, respectively, the median of serum phosphorus decreased significantly in ADV treatment group (P=0.051,0.296)ConclusionsADV-related renal function is time-dependent, the longer the application ADV, the higher the incidence of renal impairment. SCr and Cys C evaluation of renal impairment associated ADV there are some limitations, our kinds of formulas in the evaluation of renal damage associated ADV same time there are certain limitations, should be analyzed. When ADV treatment of CHB patients with a low incidence of hypophosphatemia, and the eGFR and other renal function parameters can be no exception. |
PDF Full Text Request