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目的观察重组基因干扰素α-2b治疗慢性乙型病毒性肝炎(CHB)的临床疗效、影响因素及不良反应。方法选择我院门诊及住院患者74例,随机分成干扰素治疗组36例,保肝治疗组38例。干扰素治疗组给予重组基因干扰素α-2b,5 MU每日肌肉注射1次(15 d),以后改为隔日1次肌肉注射(6个月),保肝治疗组用常规保肝药物治疗。通过对肝功能、HBV血清标志物和HBV-DNA的检测,观察两组的疗效及不良反应等。结果干扰素治疗组在治疗期间ALT复常率在1,3,6个月时与对照组比较差异无统计学意义(P>0.05)。HBeAg阴转率、HBeAg血清转换率、HBV-DNA阴转率均较保肝治疗组高,差异均有统计学意义(P<0.01);干扰素治疗组治疗前HBVDNA≤106、5 ULN≤ALT<10ULN的患者对干扰素应答好,HBVDNA阴转率达70%,明显高于其它患者30.8%(P<0.01)。干扰素a-2b的不良反应主要有发热31例(占86.1%)、流感样症状22例(61.1%)、白细胞减少32例(占88.9%)等。不良反应一般经对症处理后能很快恢复正常。结论重组基因干扰素α-2b是目前治疗慢性乙型肝肝炎安全有效的药物,治疗前HBVDNA载量、ALT水平与干扰素的治疗效果有关。
Objective To observe the clinical efficacy, influencing factors and adverse reactions of recombinant interferon α-2b in the treatment of chronic hepatitis B (CHB). Methods Totally 74 outpatients and hospitalized patients were randomly divided into interferon therapy group (36 cases) and liver protection group (38 cases). Interferon treatment group given recombinant interferon α-2b, 5 MU intramuscular injection once a day (15 d), later changed to intramuscular injection every other day (6 months), liver protection group with conventional hepatoprotective drugs . Through the detection of liver function, HBV serum markers and HBV-DNA, the curative effect and adverse reactions of the two groups were observed. Results The rate of ALT normalization in the interferon treatment group at 1, 3 and 6 months was not significantly different from that in the control group (P> 0.05). HBeAg negative rate, HBeAg seroconversion rate and HBV-DNA negative rate were significantly higher than those in hepatoprotective therapy group (P <0.01); HBVDNA≤106,5 ULN≤ALT before treatment in interferon treatment group <10ULN patients respond well to interferon, HBVDNA negative rate of 70%, significantly higher than the other 30.8% (P <0.01). The main adverse reactions of interferon a-2b were fever in 31 cases (86.1%), flu-like symptoms in 22 cases (61.1%) and leukopenia in 32 cases (88.9%). Adverse reactions generally after symptomatic treatment can quickly return to normal. Conclusion Recombinant human interferon α-2b is a safe and effective drug for the treatment of chronic hepatitis B, and the serum HBV DNA level and ALT level before treatment are related to the therapeutic effect of interferon.