八宝丹胶囊治疗慢性乙型肝炎病毒感染合并胆囊息肉的效果及安全性分析OA

Objective To investigate the efficacy and safety of Babaodan Capsule(BBD)in the treatment of patients with chronic hepatitis B virus(HBV)infection with damp-heat in the liver and gallbladder comorbid with gallbladder polyps.Methods A randomized,double-blinded,placebo-controlled single-center trial was conducted among 120 patients with chronic HBV infection who were admitted to Beijing YouAn Hospital,Capital Medical University,from August 2020 to April 2023,and they were divided into treatment group(BBD)and control group(placebo),with 60 patients in each group.The course of treatment was 24 weeks,and follow-up assessments were conducted every 4 weeks.The primary outcome measures were the number and maximum diameter of gallbladder polyps(assessed by ultrasound),and the secondary outcome measures included traditional Chinese medicine(TCM)syndrome score,blood lipid levels,and liver function parameters.The independent-samples t test or the Wilcoxon rank-sum test was used for comparison of continuous data between two groups,and the chi-square test or the Fisher's exact test was used for comparison of categorical data between two groups;the Wilcoxon rank-sum test was used for comparison of ranked data between two groups;the generalized estimating equation was used to analyze repeated measures data.Results After 8 weeks of treatment,the treatment group had a significantly smaller diameter of polyps and a significantly lower number of polyps than the control group(Z=-1.76 and -1.80,both P<0.05),and after 24 weeks of treatment,the treatment group had a significantly higher polyp reduction rate than the control group(30.51％vs 10.91％,P<0.05).The subgroup analysis showed that patients receiving combined antiviral therapy,male patients,patients with a diameter of polyps of<5 mm,and patients with multiple polyps tended to achieve significantly greater benefits.At week 8 of treatment,the treatment group had a significantly better TCM syndrome score than the control group(Z=-2.35,P<0.05);after treatment,compared with the control group,the treatment group had a significantly greater increase in high-density lipoprotein(Z=-1.85,P<0.05)and significantly lower levels of alanine aminotransferase(Z=-2.06,P<0.05),aspartate aminotransferase(Z=-2.13,P<0.05),total bilirubin(Z=-2.12,P<0.05),and direct bilirubin(Z=-3.09,P<0.05).No serious adverse events were reported in either group.Conclusion BBD can effectively reduce the size of gallbladder polyps,improve TCM syndrome score,and reduce the level of bilirubin in patients with chronic HBV infection with damp-heat in the liver and gallbladder,with a favorable safety profile,and it may be more suitable for patients receiving combined antiviral therapy and specific subgroups(male patients,patients with a diameter of polyps of<5 mm,and patients with multiple polyps.