Stel'makh V V, Okovityĭ S V, Romantsov M G, Tuan N Kh, Oiungerel M
Georgian Med News. 2013 Jun(219):33-9.
647 patients with HBeAg positive chronic hepatitis B who have not previously received antiviral therapy were participated in randomized, post-marketing, double-blinded, placebo-controlled clinical trial. Interferon inducer cycloferon was presented as study drug. 323 patients with chronic hepatitis B (HBV) with "wild" HBeAg(+) strain of HBV were treated with cycloferon and Lamivudin for 48 weeks. Control group included 324 patients with similar pathology, treated with Lamivudin and placebo for 48 weeks. The study has shown the benefit of cycloferon+lamivudin treatment in comparison with lamivudin monotherapy. Improving of liver histology in 48 weeks of the therapy was observed in 71% of patients in Study group in comparison with 57% in control group (p<0.01). Combined therapy has resulted in decrease of relapse by 24 week of the follow-up period (13% vs. 86%, p<0.001). The higher efficacy of cycloferon+lamivudin in patients with HBeAg positive chronic hepatitis B has proven the role of own antiviral effect of interferon inducer cycloferon, interferon effect of cycloferon in the elimination of virus-infected hepatocytes, as well as the presence of an immunomodulatory effect of the preparation, aimed at the elimination of HBeAg and HBsAg with the following seroconversion. 48-week course of combined antiviral therapy of HBeAg-positive patients with chronic hepatitis B is recommended as first-line therapy for patients with HBeAg-positive chronic hepatitis B, who have not previously received nucleoside analogues, as well as alternative therapy of Lamivudin-refractory patients.
647例未曾接受过抗病毒治疗的HBeAg阳性慢性乙型肝炎患者参与了一项随机、上市后、双盲、安慰剂对照的临床试验。干扰素诱导剂环孢素被作为研究药物。323例携带“野生”HBeAg(+) HBV毒株的慢性乙型肝炎患者接受了环孢素和拉米夫定治疗48周。对照组包括324例具有相似病理情况的患者，接受拉米夫定和安慰剂治疗48周。研究表明，与拉米夫定单药治疗相比，环孢素+拉米夫定治疗具有优势。治疗48周后，研究组71%的患者肝脏组织学得到改善，而对照组为57%（p<0.01）。联合治疗使随访期24周时的复发率降低（13%对86%，p<0.001）。环孢素+拉米夫定在HBeAg阳性慢性乙型肝炎患者中的更高疗效证明了干扰素诱导剂环孢素自身抗病毒作用、环孢素在清除病毒感染肝细胞方面的干扰素作用，以及该制剂存在免疫调节作用，旨在清除HBeAg和HBsAg并实现后续血清学转换。对于未曾接受过核苷类似物治疗的HBeAg阳性慢性乙型肝炎患者，推荐将48周疗程的HBeAg阳性慢性乙型肝炎联合抗病毒治疗作为一线治疗，以及拉米夫定耐药患者的替代治疗。
