补肾法治疗慢性HBV携带者的多中心、随机、双盲、安慰剂对照临床研究OA

Objective:The objective of this study was to evaluate and compare the clinical efficacy of Bushen Shugan Decoction and Bushen Jianpi Decoction in chronic hepatitis B virus(HBV)carriers.Methods:From November 2018 to December 2021,a total of 362 chronic HBV carriers aged between 30 and 65 years were enrolled across 14 clinical centers in China.Participants were randomly assigned to three treatment groups:Group A received the Bushen Shugan Decoction,Group B received the Bushen Jianpi Decoction,and Group C received a placebo.Unblinded after 96 weeks of treatment and followed up for another 48 weeks.The primary outcome measures included serological response rates for HBsAg and HBeAg,as well as rates of HBV DNA suppression at week 48.Results:A total of 362 subjects were enrolled in the study,and 353 completed the 48-week treatment regimen.The distribution included 120 in Group A,115 in Group B,and 118 in Group C.In Groups A and B,the proportions of patients exhibiting a reduction in HBV DNA quantification of ≥ 2.0 lg IU/ml were 15.00％ and 17.39％,respectively.The proportions of patients achieving HBV DNA levels ≤4.0 lg IU/ml were 9.17％ and 13.91％,respectively.HBeAg seroconversion rates were observed in 7.5％ of Group A and 11.3％ of Group B.Furthermore,the proportions of patients with HBsAg reduction ≥1.0 lg IU/ml were 6.67％ and 9.57％,respectively,while reductions of ≥2.0 lg IU/ml were recorded at 4.17％ and 5.22％.All these outcomes showed statistically significant differences compared with Group C(P＜0.05).Conclusion:The Bushen therapeutic strategy demonstrates a notable clinical benefit for chronic HBV carriers.Moreover,the optimized formula integrating Bushen and Jianpi approaches shows superior efficacy compared to the combination of Bushen and Shugan strategies.