聚乙二醇干扰素联合复肝丸及拉米夫定治疗慢性乙型肝炎的疗效分析

Effective observation and analysis of combination therapy of pegylated interferon alpha-2a with Fugan pills and lamivudine for chronic hepatitis B patients

目的:观察聚乙二醇干扰素(PEG-IFN-2a)联合复肝丸或/和拉米夫定治疗慢性乙型肝炎的疗效,并探究复肝丸在治疗中的作用。方法:选择慢性乙型肝炎患者162例,随机分成3组,第一组患者采用PEG-IFN-2a联合拉米夫定治疗;第二组患者采用PEG-IFN-2a联合复肝丸治疗;第三组患者采用PEG-IFN-2a联合拉米夫定及复肝丸治疗。每组54例,治疗96周,并随访48周。结果:在96周时,HBV DNA转阴、ALT复常及肝纤维化指标三组两两比较(均<0.05):病毒转阴方面,仅第二组(64.8%)次于第一组(79.6%);而在改善肝功能、降低ALT及改善肝纤维化方面,仅第二组(ALT复常率85.1%,纤维化指标:HA:149.3±66.7、LN:101±35.3、IVC:105.5±63.8、PCIII:85.4±32.4)优于第一组(ALT复常率74.0%,纤维化指标:HA:213.3±99.2、LN:130.6±45.5、IVC:159.3±107.2、PCIII:117.2±57.7);但无论是改善肝功能、HBV DNA转阴还是改善肝纤维化方面,第三组效果最优。结论:复肝丸在改善肝功能及改善肝纤维化方面疗效确切,并在改善肝功能、HBV DNA转阴及改善肝纤维化方面与PEG-IFN-2a及拉米夫定有协同作用。三药合用可减轻拉米夫定疗效的反弹。

Objective：To observe the combination therapeutic efficacy of pegylated interferon alpha-2a（PEG-IFNα-2a）, Fugan pills and lamivudine（LAM） for chronic hepatitis B（CHB） patients. Also, the role of Fugan pills was especially observed and analyzed. Methods： One hundred and sixty-two CHB patients were selected according to the guidelines for prevention and treatment of chronic hepatitis B（2010 Edition）, and were divided into 3 groups evenly at random. The fist group was treated with PEG-IFNα-2a and LAM, the second group was treated with PEG-IFNα-2a and Fugan pills, and the third group was treated with PEG-IFNα-2a, Fugan pills and LAM. Treatment lasted for 96 weeks,and followed up was 48 weeks. Results： At the end of the 96 weeks treatment, it showed significant differences（ P〈0.05） in the aspect of hepatitis B virus clearance, alanine aminotransferase（ALT） normalization and anti-hepatic fibrosis among 3 groups according to the comparisons with each other by spss 19.0. The treatment with PEG-IFNα-2a and Fugan pills was less effective than that with PEG-IFNα-2a and LAM in HBV DNA clearance（64.8% 79.6%）. On the contrary, in the aspect of ALT normalization and anti-hepatic fibrosis, the treatment with PEG-IFNα-2a and Fugan pills was more effective than that with PEG-IFNα-2a and LAM（the former ALT normalization rate 85.1%, antihepatic fibrosis： HA 149.3±66.7, LN 101±35.3, IVC 105.5±63.8, PCIII 85.4±32.4 while the later ALT normalization rate 74.0%, anti-hepatic fibrosis：HA 213.3±99.2, LN 130.6±45.5, IVC 159.3±107.2, PCIII 117.2±57.7）. However, in the 3 aspects of HBV DNA, ALT normalization and anti-hepatic fibrosis, the treatment with the 3 medicines in third group was the most effective. Conclusion： Fugan pills was approved to be effective to normalize the liver function and reverse liver fibrosis. It revealed a synergistic action of Fugan pills with PEG-IFNα-2a and LAM in HBV DNA clearance, ALT normalization and anti-hepatic fibrosis. The combination of the 3 drugs could restrain the rebound after treatment with LAM.