干扰素α-1b联合抗-HBV特异性主动免疫疗法治疗慢性乙型肝炎的临床研究

目的探讨普通干扰素α-1b（IFNα-1b）联合抗HBV特异性主动免疫疗法（SAI）治疗慢性乙型肝炎（CHB）患者的疗效。方法292例诊断为有活动性病毒复制（HBeAg阳性、HBVDNA〉1×10％opies／m1），ALT≥2×ULN）的慢性乙型肝炎患者，随机分为A、B、C、D4组。A组用IFNα-1b加SAI联合治疗；B、C两组分别用IFNα-1b与SAI单一疗法；D组作为对照组用常规保肝治疗。治疗前及治疗后第12月比较各组患者HBVDNA、HBeAg血清学转换及ALT复常，并在大部分患者比较治疗前后肝组织Knodell炎症坏死与Ishak纤维化计分情况。结果在治疗终点，A、B、C、D4组HBVDNA达到测不出水平的百分率分别为64．8％、32．4％、30．8％与2．8％；HBeAg血清转换分别为41．6％、27．0％、16．6％与5．6％；ALT复常率分别为89．2％、70．3％、83．3％与44．4％；Knodell与Ishak计分缓解率分别为45．8％、18．8％、12．9％、0．0％与39．4％、34．4％、30．4％、0．0％。结论IFNα-1b加SAI联合疗法对有活动性病毒复制的慢性乙型肝炎患者的疗效优于IFNα-1b或SAI单一疗法。

Clinical study on combination treatment using conventional interferon alpha-1b and anti-HBV specific active immunotherapy in patients with chronic hepatitis B

Objective To explore the efficacy of combination therapy using conventional interferon alpha-1b （IFNα-1b） or anti-HBV specific active immunotherapy （SAI） in the treatment of patients with chronic hepatitis B. Methods Total of 292 patients diagnosed as chronic hepatitis B with viral replication were randomly assigned into A,B,C and D groups. Patients in the group A were treated with IFN α-1b combined with SAI;cases in the groups B and C received IFN α-1b or SAI treatment alone,respectively;and ones in group D as a controlled group received a regular treatment for protection of liver function. The evaluation of the efficacies of the therapies as described above was based on the results of detections on serum HBV DNA,HBeAg seroeonversion,ALT normalization,and histological Knodell inflammatory and Ishak fibrosis score. Results The undetectable rates of HBV DNA,the serovonversion rates of HBeAg and the normalization rates of ALT in group A,B,C and D were 64.8%,32.4%,30.8%,2.8%;41.6%,27.0%,16.6%,5.6% and 89.2%, 70.3%,83.3% ,44.4% ,respectively. The percentages of Knodell necroinflammatory and Ishak fibrosis improvement in group A,B,C and D were 45.8%,18.8%,12.9%,0.0% and 39.4%,34.4%,30.4%,0.0%,respectively. Conclusion The effects of IFNα-1b combined with SAI therapy for chronic hepatitis B with active virus replication is better than IFNα-1b or SAI alone.