OBJECTIVETo evaluate the efficacy and safety of tenofovir disoproxil fumarate (TDF) in patients with chronic hepatitis B (CHB) after failure of nucleoside-analogues (NAs).

METHODSA total of 30 CHB patients who had been previously treated with NAs and had subsequently completed a 48-week course of TDF were retrospectively investigated. Patients' data of HBV DNA level (log10 copies/ml) and rate of undetectable HBV DNA at treatment weeks 0 (baseline), 4, 12, 24, 36 and 48 were collected for evaluation. The lower limit of HBV DNA detection was 100 IU/ml. The serum alanine aminotransferase (ALT) normalization rate, hepatitis B e antigen (HBeAg) seroconversion rate, viral breakthrough (VBT) rate, viral response (VR) rate, and adverse events were determined upon treatment completion. Statistical analyses were carried out using the Student's t-test, the x² test or the Kaplan-Meier method.

RESULTSOver the 48-week treatment period, HBV DNA levels declined significantly from baseline (week 4:(2.11 ± 0.38) log10 IU/ml, t =5.582; week 12:(0.93 ± 0.31) log10 IU/ ml, t =9.303; week 24:(0.75 ± 0.20) log10 IU/ml, t =3.123; week 36:(0.16 ± 0.19) log10 IU/ml, t =10.759; week 48:(0.14 ± 0.25) log10 IU/ml, t =12.202) (all P less than 0.01). However, the rates of HBV DNA reduction and of cumulative reduction were comparable at weeks 24, 36 and 48 (all P more than 0.05). The most robust decline in HBV DNA levels was observed at week 4 ((2.11 ± 0.38) log10 IU/ml) and the highest cumulative HBV DNA reduction was observed at week 24 ((3.79 ± 0.37) log10 IU/ml). The rate of undetectable HBV DNA at week 4 (26.7%) was significantly lower than that at weeks 24 (87.5%, P less than 0.01), 36 (80.0%, P=0.007), and 48 (88.9%, P=0.001). The median time to achieving undetectable HBV DNA was 10.4 weeks (range:3.43-34.0 weeks). At week 48, the rates of VR, HBeAg seroconversion, and VBT were 88.9% ,6.7%, and 0% respectively. During treatment, the levels of creatine kinase were more than two times the upper limit normal in 9.2% of the patients, and were comparable at each time point examined (all P more than 0.05). All patients showed a normal level of serum creatinine throughout the treatment period.

CONCLUSIONFor CHB patients with non-response to NAs, TDF can suppress HBV DNA replication very quickly and achieve a high rate of ALT normalization with a low rate of adverse events.

Adenine ; administration & dosage ; analogs & derivatives ; therapeutic use ; Adult ; Antiviral Agents ; administration & dosage ; therapeutic use ; DNA, Viral ; blood ; Female ; Hepatitis B e Antigens ; blood ; Hepatitis B, Chronic ; drug therapy ; Humans ; Male ; Middle Aged ; Organophosphonates ; administration & dosage ; therapeutic use ; Retrospective Studies ; Tenofovir ; Young Adult

OBJECTIVE To systematically evaluate the therapeutic effect of acupuncture on geriatric insomnia.METHODS Randomized controlled trials(RCTs)on acupuncture in the treatment of senile insomnia were searched in CNKI,VIP,Wanfang,China Biomedical Database,PubMed,Web of science,Embase and Cochrane Library databases from inception dates to June 24,2024.Litera-ture was screened and data were extracted based on the inclusion and exclusion criteria.The literature quality was evaluated according to the risk of bias table recommended by the Cochrane Collaboration Handbook 5.1.0,and the outcome indicators were graded using the GRADE system for the quality of evidence.RevMan5.4 software was used to evaluate the quality of the included literature,and Sta-ta18.0 software was used to conduct Meta-analysis on the included literature.RESULTS A total of 18 studies involving 1399 pa-tients were included.Meta-analysis showed that:compared with the simple western medicine treatment,acupuncture in the treatment of senile insomnia patients could improve the clinical effective rate[RR=1.18,95%CI(1.13,1.24),P<0.001],reduce the total PSQI score[MD=-1.10,95%CI(-1.25,-0.96),P<0.001],daytime dysfunction[MD=-1.38,95%CI(-1.59,-1.16),P<0.001],sleep latency[MD=-0.66,95%CI(-0.86,-0.47),P<0.001],sleep duration[MD=-0.45,95%CI(-0.64,-0.25),P<0.001],sleep efficiency[MD=-0.69,95%CI(-0.89,-0.49),P<0.001],sleep disorder[MD=-1.24,95%CI(-1.47,-1.01),P<0.001],sleep quality[MD=-0.84,95%CI(-1.05,-0.64),P<0.001].GRADE classification showed that the clinical efficacy was advanced evidence;the adverse reactions were intermediate evidence;the total score of PSQI,daytime dysfunction,sleep latency,sleep efficien-cy,sleep quality and sleep disorder were low evidence;sleep time was extremely low evidence.CONCLUSION Acupuncture inter-vention in senile insomnia patients is superior to the control group in clinical efficiency and various PSQI scores.Acupuncture interven-tion is worthy of further promotion and use in clinical practice as the complementary and alternative therapy for the conventional western medication treatment of senile insomnia.However,the evidence levels of some outcome indicators are relatively low,and more high-quality RCTs with large sample sizes are still needed to increase the strength of evidence.