中西医结合治疗HBeAg阴性慢性乙型肝炎的临床研究

目的：观察中西医结合治疗HBeAg阴性慢性乙型肝炎的临床疗效及安全性。方法：将144例患者按照数字随机法以3：1的比例依次纳入观察对象，最后纳入评价者136例，其中治疗组102例给予疏肝扶正合剂，同时联用北京远策药业有限责任公司生产的远策素（干扰素IFN-α2b）5MU，6个月为1个疗程；对照组单用远策素（干扰素IFN-α2b）治疗，用法同治疗组。分别于治疗前后评价症状、体征、肝功能、HBV-DNA、影像学指标和临床综合疗效。结果：治疗组和对照组的近期（治疗6个月后）基本有效率分别为62．75％及41．18％，两组比较差异有显著性，治疗组明显高于对照组（P〈0．05），而总有效率差异无统计学意义（P〉0．05）；随访6个月时，治疗组HBV-DNA阴转率明显高于对照组（P〈0．05）；治疗6个月与治疗前比较，两组ALT、AST均有明显下降。差异有统计学意义（P〈0．01），组间比较差异无统计学意义（P〉0．05）。结论：中西医结合治疗HBeAg阴性慢性乙型肝炎疗效显著，安全性好。

Clinical Study of Treating Chronic Hepatitis B of Negative HBeAg with Integrative Chinese and Western Medicine

Objectives：to observe clinical effectiveness and safety of integrative Chinese and western medicine on treatment of chronic hepatitis B of negative HBeAg. Methods： 144 patients were randomly selected for trials in the ratio 3：1. Among final 136 subjects, 102 subjects were given Shugan Fuzheng Heji （Liver- soothing health restoring composition） plus IFN-α2b （manufacturer： Beijing Interferon Pharmaceuticals. Co. ） for a treatment course of 6 months ; the control group was treated with IFN-α2b only. Symptoms, physical signs, liver function, HBV-DNA, imageology index, and clinical effectiveness were observed before and after treatment. Results：after six months of treatment ,the effective rate of treatment group was 62.75% and the control group,41.18% with a significant difference （ P 〈 0. 05 ）, but total effective rates were not significantly different （ P 〉 0. 05 ）. In the six month follow-up, the treatment group had a significantly higher rate of HBV-DNA negative conversion rate in comparison with that of the control group（ P 〈0. 05 ） ; after treatment,ALT and AST levels were decreased in both groups （P 〈 0.01 ）, and there was no significant difference between two groups. Conclusion： integrated Chinese and western medical treatment is effective and safe for chronic hepatitis B of negative HBeAg.