慢性乙型病毒性肝炎免疫耐受期患者应否治疗:一项临床随机对照试验的分层分析结果  

Whether Patients in Immune Tolerant Phase of Chronic HBV Infection Should Be Treated: Stratified Analysis of a Clinical Randomized Controlled Trial

作　　者：施梅姐[1] 萧焕明[1] 谢玉宝[1] 黎胜[1] 池晓玲[1] SHI Meijie;XIAO Huanming;XIE Yubao;LI Sheng;CHI Xiaoling(The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangdong Hospital of Traditional Chinese Medicine,Guangzhou 510120)

机构地区：[1]广州中医药大学第二附属医院,广东省中医院,广州510120

出　　处：《中药药理与临床》2023年第1期62-66,共5页Pharmacology and Clinics of Chinese Materia Medica

基　　金：广东省中医药局科研项目(编号:20211189、20211167);国家“十三五”重大传染病专项课题(编号:2018ZX10725506-003、2018ZX10725505-004);广东省中医院临床研究专项(1010专项,编号:YN10101903);广东省中医院与上海芯片国家工程中心合作研究生物资源项目(编号:YN2016XP03)。

摘　　要：目的:基于前期一项临床随机对照试验的数据分层分析慢性乙型病毒性肝炎(HBV)免疫耐受期患者的病理学特征,并进一步分析中成药(安络化纤丸或复方鳖甲软肝片)辨证治疗抗肝纤维化的疗效,为该群患者应否治疗及如何治疗提供科学依据。方法:从前期中药辨证阻断轻症肝纤维化的随机对照临床研究病例中选取慢性HBV免疫耐受期的患者进行分层研究,共纳入130例患者(中药治疗组80例,安慰剂组50例)。根据患者中医证型的不同,中药治疗组给予安络化纤丸或复方鳖甲软肝片治疗,安慰剂组给予安慰剂治疗,疗程48 w。观察两组治疗前后病理ISHAK肝纤维化分期及肝脏硬度值(LSM)的变化。结果:纳入的130例慢性HBV免疫耐受期患者中有30.8%(40/130)表现为肝脏炎症分级G2,35.4%(46/130)表现为肝脏纤维化分期S2。中药治疗组的LSM值在治疗12 w后较治疗前显著减低(5.5 vs 5.0,P<0.01),其后一直到48 w治疗结束时LSM相对稳定,但安慰剂组的LSM值从0 w~48 w未发生明显变化。在病理方面,中药治疗组的肝纤维化改善率明显高于安慰剂组(37.0%vs 12.5%,P<0.05);并且其肝纤维化进展率低于安慰剂组(19.6%vs 41.7%,P<0.05);但中药治疗组的肝脏炎症改善率未明显高于安慰剂组(21.7%vs 12.5%,P>0.05)。结论:慢性HBV免疫耐受期患者约1/3患者存在显著的肝脏炎症及纤维化,确实需要得到积极治疗。中成药(安络化纤丸/复方鳖甲软肝片)辨证治疗可降低慢性HBV免疫耐受期患者LSM值、改善肝脏病理肝纤维化分期,可作为该群患者抗肝纤维化治疗的一种有益选择。Objective:To analyze the pathological characteristics and the anti-fibrosis efficacy of Chinese patent medicine-Anluohuaxian(安络化纤)Pill or Compound Biejia Ruangan(复方鳖甲软肝)Tablet-in patients in the immune tolerant phase of chronic HBV infection based on the data of a clinical randomized controlled trial.This study will provide a scientific basis for the treatment of these patients.Methods:From a randomized controlled clinical trial of mild liver fibrosis with traditional Chinese medicine(TCM)syndrome differentiation,the patients in the immune tolerant phase of chronic HBV infection were selected for this stratified study.A total of 130 patients were enrolled in this study,including 80 patients in the TCM group and 50 patients in the placebo group.According to the different TCM syndromes of patients,the TCM group was treated with Anluohuaxian Pill or Compound Biejia Ruangan Tablet,and the placebo group with placebo for 48 weeks.The changes of liver fibrosis stage based on Ishak score and liver stffness measurement(LSM)were observed before and afer treatment.Results:Among the 130 patients in the immune tolerant phase of chronic HBV infection,30.8%(40/130)showed liver inflammation grade G2 and 35.4%(46/130)were at liver fibrosis stage S2.The LSM value of the TCM group decreased significantly after 12 weeks of treatment compared with that before treatment(5.5 vs 5.0,P<0.01),and then remained relatively stable until the end of 48 weeks of treatment,while that of the placebo group did not change significantly from 0 to 48 weeks.In terms of pathology,the TCM group showed higher alleviation rate(37.0%vs 12.5%,P=0.032)and lower progression rate(19.6%vs 41.7%,P<0.05)of liver fibrosis than the placebo group.However,the alleviation rate of liver inflammation of the TCM group was only slightly higher than that of the placebo group(21.7%vs 12.5%,P>0.05).Conclusion:About 1/3 of patients in the immune tolerant phase of chronic HBV infection have significant liver inflammation and fibrosis,which needs active trea

关 键 词：安络化纤丸 复方鳖甲软肝片 慢性HBV 免疫耐受期 肝纤维化 

分 类 号：R512.62[医药卫生—内科学]