强肝丸对慢性乙型肝炎患者获病毒学应答后的抗肝纤维化疗效及安全性分析  

Efficacy and safety of Qianggan Pills in treatment of hepatitis B-related liver fibrosis in patients achieving virological response: an observational study

作　　者：赵西太 聂青和 ZHAO Xi-tai;NIE Qing-he(Department of Infectious diseases,Chinese PLA Centre of Diagnosis and Treatment for Infectious Diseases~ Xi＇an 710038j China)

机构地区：[1]空军军医大学(原第四军医大学)唐都医院传染病科全军感染病诊疗中心,陕西西安710038

出　　处：《中国实用内科杂志》2018年第9期844-849,共6页Chinese Journal of Practical Internal Medicine

基　　金：国家科技重大专项(2013ZX10002004);第四军医大学科技发展基金(2017XC052)

摘　　要：目的探讨慢性乙型肝炎患者经核苷(酸)类似物(NA)治疗获病毒学应答后,加用强肝丸抗肝纤维化的疗效及安全性观察。方法纳入空军军医大学(原第四军医大学)附属唐都医院2016年1月至2017年12月就诊的伴肝纤维化慢性乙型肝炎患者398例,其中237例继续NA治疗加用强肝丸(A组),79例继续NA治疗加用复方鳖甲软肝片(B组),82例继续单一服用NA(C组)。随访至少48周,收集临床资料。比较3组间各指标差异。结果 3组患者基线资料差异无统计学意义(P>0.05)。48周后,A、B组患者肝脏硬度值下降程度高于C组(P<0.05);A、B组的APRI指数、FIB-4指数显著低于C组(P<0.05);3组血清白蛋白、血小板、白细胞、红细胞、血红蛋白无明显下降(P>0.05);A组不良事件发生率显著低于B组及C组(2.1%对8.9%,12.2%;P=0.013)。结论在NA有效抗病毒治疗的基础上,加用强肝丸具有显著抗肝纤维化、保护肝脏功能的作用,其抗肝纤维化作用优于复方鳖甲软肝片,且安全性良好。Objective To investigate the efficacy and safety of Qianggan Pills in treatment of hepatitis B-related liver fibrosis in patients achieving a virological response with nucleosid（t）e analogues （NAs） therapy. Methods Totally 398 cases of patients with chronic hepatitis B and liver fibrosis were included from Tangdu Hospital, Fourth Military Medical Universiy, from January 2016 to December 2017. Among them 237 cases （Group A） were treated with Qjanggan Pills and NAs, 79 cases （Group B） with Fufang Biejia Ruangan tablets, and 82 cases （group C） only with NAs.All patients were observed for 48 weeks, and data of FibroScan value, liver function, renal function, and hematology parameters were collected and compared among the three groups. Results There were no significant differences in baseline characteristics among three groups （P〉0.0S）. FibroScan values of group A and B （P〈0.05） were lower than group C （P〈0.05） at the end of observation period. APRI index and FIB-4 index were also decreased in both group A and B（P〈0.05）, while no differences were found in albumin, platelets, white blood cells, red blood cells or hemoglobin. Adverse events occurred less frequently in group A than in group B or C （2.1% vs. 8.9%, 12.2%; P=0.013, 〈0.001）. Conclusion On the basis of sustained virological response with NAs therapy, Qianggan Pills can alleviate hepatitis B-related liver fibrosis and prevent further deterioration of liver function. Ojanggan Pills exceeds Fnfang Biejia Ruangan tablets in the efficacy and safety in treating liver fibrosis.

关 键 词：慢性乙型肝炎 肝纤维化 强肝丸 Fibro Scan扫描 安全性 

分 类 号：R512.62[医药卫生—内科学]