目的评价IFN-α联合胸腺肽治疗慢性乙型肝炎(CHB)的疗效和安全性,探讨两者联合治疗的协同作用。方法 HBV DNA及HBeAg阳性的CHB患者215例,随机分为A,B两组。A组采用IFN-α和胸腺肽联合治疗,IFN-α3～5MU,1次·d~1im,15d后改为隔日一次im;胸腺肽100mg,1次·d~1静滴,1mo后改为20mg,1次·d~1im,疗程6mo,B组单用IEN-α,疗程6mo治疗结束后随访6mo,观察两组肝功能和乙肝病毒标志(HBVM及HBV DNA)的变化情况和不良反应。结果治疗结束时,两组临床症状均明显改善,A组中81例(63.3％)ALT恢复正常,而B组仅43例(49.4％)正常,两组有显著性差异(P<0.05);A组有70％HBV DNA阴转,59.4％HBeAg阴转,56.3％为近期完全应答(ALT复常,HBV DNA及HBeAg均阴转),B组分别为63.2％,48.3％和46.0％,两组无显著性差异(P>0.05)治疗结束后6mo,A组有65.6％ALT复常,68.8％HBV DNA阴转,66.4％HBeAg阴转,62.5％为持续完全应答;而B组则分别为31.0％,40.2％,37.9％和27.6％,两组有非常显著性差异(P<0.01)。治疗结束时已产生生化学和(或)病毒学应答的病例,随访期间A组有22.2％ALT又异常,23.3％HBV DNA再转阳,13.2％HBeAg再转阳,B组则分别为44.2％,41.8％和31.0％,B组生化学和病毒学复发率显著高于A组,具有显著性差异(P<0.05),治疗结束时无应答的病例中,随访期间A组有44.7％ALT复常,50％ HBV DNA阴转,36.5％ HBeAg阴转,而B组分别为6.8％,9.4％和8.9％,A组的生化学和病毒学滞后应答率显著高于B组,两组具有非常显著性差异(P均<0.01),治疗过程中,A组除出现与IFN-α治疗相关的初期副反应外,未发现其他副作用。结论 IFN-α与胸腺肽联合治疗CHB具有明显的协同作用,可明显改善肝功能,抗病毒效果好,明显优于单用IFN-α组,大大提高了IFN-α的远期疗效,使复发率明显降低,是CHB患者安全、有效的治疗方法,当然,62.5％的持续应答率远非理想效果,需要继续探索新的联合治疗方案。 Objective To evaluate the efficacy and safety of IFN-α combined with thymosin in the treatment of chronic hepatitis B (CHB) and to explore the synergistic effect of the combination therapy. Methods 215 patients with HBV DNA and HBeAg-positive CHB were randomly divided into A and B groups. Group A was treated with IFN-α and thymosin, IFN-α 3 ~ 5MU, once · d ~ 1im every 15 days and changed to im every other day; thymosin 100mg, once d · 1 intravenously, changed to 20mg after 1mo, The course of treatment was 6 months, while the group B was treated with IEN-α only for 6 months. After 6 months of treatment, the changes of liver function and HBV markers (HBVM and HBV DNA) and the adverse reactions were observed. Results At the end of treatment, the clinical symptoms of both groups were significantly improved. ALT of 81 cases (63.3%) in group A returned to normal, while only 43 cases (49.4%) of group B were normal. There was significant difference between the two groups (P <0.05). A group had 70% of HBV DNA negative conversion, 59.4% of HBeAg negative conversion, 56.3% of the recent complete response (ALT normalization, HBV DNA and HBeAg were overcast), B group were 63.2%, 48.3% and 46.0% There was no significant difference between the two groups (P> 0.05) 6 months after treatment, A group had 65.6% ALT normalization, 68.8% HBV DNA negative conversion, 66.4% HBeAg negative conversion, 62.5% sustained complete response; 31.0%, 40.2%, 37.9% and 27.6% respectively. There was a significant difference between the two groups (P <0.01). At the end of treatment, there were cases of biochemical and / or virological response. During follow-up, 22.2% of ALT was abnormal in group A, 23.3% of HBV DNA was positive, 13.2% of HBeAg was positive again, and 44.2% , 41.8% and 31.0% respectively. The recurrence rate of biochemistry and virology in group B was significantly higher than that in group A (P <0.05). In the group with no response at the end of treatment, 44.7% Often, 50% HBV DNA was negative and 36.5% HBeAg was negative, while those in group B were 6.8%, 9.4% and 8.9%, respectively. The response rate of biochemistry and virology in group A was significantly higher than that in group B, There was no significant difference (P <0.01). During the course of treatment, no side effects were observed in group A besides the initial side effects associated with IFN-α therapy. Conclusion IFN-α and thymosin combined treatment of CHB has a significant synergistic effect, can significantly improve liver function, anti-virus effect is better than single IFN-α group, greatly enhance the long-term efficacy of IFN-α, the recurrence rate Significantly lower, is a safe and effective treatment for CHB patients, of course, 62.5% of the continuous response rate is far from the desired effect, the need to continue to explore new combination regimens.