中医辨证联合抗病毒治疗对乙型肝炎肝硬化发生率的影响

The Impact of the Combination of Traditional Chinese Medicine Therapy based on Syndrome Differentiation and Antiviral Therapy on the Incidence of Hepatic Cirrhosis after Hepatitis B

目的观察并评价中医辨证联合抗病毒治疗对乙型肝炎肝硬化发生率的影响。方法应用队列研究方法,回顾性选择、纳入至少接受≥2年口服抗病毒治疗,连续随访>3年的216例慢性乙型肝炎患者,根据是否接受中医辨证治疗,划分为中西医结合(中医辨证联合抗病毒治疗)队列和西医(单一抗病毒治疗)队列(111例VS 105例),观察、整理两组研究队列长期随访期间的肝功能、HBV DNA定量、乙肝两对半及肝脏影像学等主要临床病历资料。应用Epidata 3.1软件建立数据库,利用统计学SPSS 21.0软件统计描述和分析两组队列间间的肝硬化发病率。结果至随访终点,西医队列中位随访6.5年,111例CHB患者中13例(12.4%)发生肝硬化,随访7年、10年的肝硬化发病密度分别为2.05%(100人年)、1.69%(100人年);而中西医结合队列,中位随访7.2年,105例CHB患者中6例(5.7%)发生肝硬化,随访7年、10年的肝硬化发病密度分别为0.62%(100人年)、0.75%(100人年)。经统计学U检验显著性比较分析,随访7年、10年时,西医队列的肝硬化发病密度高于中西医结合队列组(P<0.05)。两组队列随访7年时,肝硬化发生的RR和AR分别为0.3和1%;随访10年的RR和AR分别则为0.4和1%;西医抗病毒治疗的基础上加用中医辨证治疗可以使肝硬化的发生率减少1.0%。结论中西医结合治疗(中医辨证联合抗病毒)在一定程度上可有效延缓肝硬化的发生。

Objective To observe and evaluate the impact of the combination of traditional Chinese medicine therapy based on syndrome differentiation and antiviral therapy on the incidence of hepatic cirrhosis after hepatitis B. Methods In accordance with the method of retrospective cohort study,a total of 216 patients of chronic hepatitis B,receiving at least more than 2 years of oral antiviral therapy,without other hepatitis virus infection and other chronic liver diseases,without the evidence of cirrhosis and hepatocellular carcinoma occurred in the first six months of antiviral therapy,with more than 3 years of continuous follow- up and complete medical records,are divided into integrated Chinese and Western medicine cohort（ TCM therapy and antiviral therapy）and Western medicine cohort（ single antiviral treatment）（ 111 cases VS 105 cases） according to whether or not to accept the treatment of TCM. Main clinical data,such as HBV DNA quantification,markers of HBV,liver function,and liver imaging examination before treatment and during the follow- up period,are collected to establish a database by Epidata 3. 1 software. Different baseline and treatment data are described and analyzed by using SPSS 21. 0 statistical software to observe and evaluate the incidence of cirrhosis. Results 1. Western medicine cohort is followed- up 6. 5 years（ median）,of which 13 cases（ 12. 4%）had cirrhosis,and incidence density of hepatic cirrhosis for 7 years and 10 years are respectively 2. 05%（ 100 years）,1. 69%（ 100 person years）. While the integrated Chinese and Western medicine cohort is followed- up 7. 2 years（ median）,of which 6（ 5. 7%） cases had cirrhosis,and ID of hepatic cirrhosis for 7 years and10 years are respectively 0. 62% %（ 100 years）,0. 75%（ 100 person years）. The result of U test of Statistics suggests,western medicine cohort has higher ID of hepatic cirrhosis than the integrated Chinese and Western medicine cohort（ P 0. 05）,when followed- up of 7 years and 10 years. 2. The relative risk（ RR） and attributable risk（ AR） of cirrhosis in the two cohorts are 0. 3 and 1%,when the two cohorts were followed up of 7years,and 0. 44 and 1%,when the two cohorts were followed up for 10 years. The added TCM syndrome differentiation and treatment based on antiviral therapy can reduce the incidence of cirrhosis by 1. 0%. Conclusion The treatment of integrated Chinese and Western medicine（ Combination of traditional Chinese Medicine Therapy based on syndrome differentiation and Antiviral Therapy） can effectively postpone the occurrence of cirrhosis to some extent.