摘要
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。
AIM To study the efficiency and safety of combination therapy with Interferon alpha (IFN-α) and Thymopeptide in patients with HBV DNA and HBeAg positive chronic hepatitis B. METHODS Two hundred and fifteen patients were randomly divided into group A and B, and both groups were comparable (P>0.05) at baseline. The patients in both groups received iFN-α 3 5 MU each day for fifteen days, then three times weekly for six months. However, the patients in group A received coincidentally Thymopeptide 100 mg iv gtt each day for four weeks, then 20 mg im daily for six months. All patients were followed up for 6 months after the end of treatment. The results of the end of treatment and follow-up period between two groups were compared. RESULTS At the end of treatment, clinical symptoms recovered obviously in both groups, complete response (defined as ALT normalization and HBV DNA and HBeAg loss) occurred in 72 of 128 (56.3%) in group A and in 40 of 87 (46.0% ) in group B (χ~2=2.17,P>0.05). However, the rate of ALT normalization in group A was significantly higher than that in group B (63.3% vs 49.4%. respectively; χ~2 4.10, P<0.05). After a follow-up period of 6 months, a sustained complete response was observed in 80 of 128 (62.5%) in group A and in 24 of 87 (27.6%) in group B (χ~2 25.22. P<0.01). During the follow-up period, the rates of reappearance in elevated ALT. HBV DNA-positive and HBeAg-positive in the responded patients of two groups were 22.2% 23.3%, 13.2% vs 44.2%, 41.8%. 31%, respectively: χ~2=6.43. 5.5. 5.4. P<0.05. However. during the 6 months of follow-up, a significant higher rate of delayed response (ALT normalization. HBV DNA/ HBeAg negativization) occurred in group A compared with group B (44.7%. 50%. 36.5% vs 6.8%, 9.4%,8.9%, respectively; χ~2 16.76, 13.3. 10.29, P<0.01). Unlike IFN-α, Thymopeptide was well tolerated by all patients, with no side effects. CONCLUSION The combination therapy of IFN-αand Thymopeptide is effective and safe in CHB patients. And the combination therapy seems to induce a gradual and more sustained ALT normalization and HBV DNA and HBeAg loss. However, a response rate of 62.5% is still less than ideal.
出处
《世界华人消化杂志》
CAS
2001年第4期388-391,共4页
World Chinese Journal of Digestology
关键词
干扰素类
治疗应用
乙型肝炎
药物疗法
interferons/therapy use
thysomin/therapy use
hepatitis B, chronic/drug therapy
drug therapy, combination
