干扰素-α伍用益血生胶囊治疗慢性乙型肝炎

Interferon-alpha combined with YiXueSheng capsule for chronic hepatitis B

目的对比观察干扰素-α(IFN-α)伍用与不伍用益血生胶囊(YSX-C)治疗慢性乙型肝炎(CHB)疗效之差异,并观察YSX-C预防IFN-α治疗相关的骨髓抑制。方法181例经肝穿刺活检证实的HBeAg阳性CHB患者,给予IFN-α(每周3次,每次5MU)皮下注射,并采用个体化疗程。其中84例伍用YSX-C口服(联合治疗组),97例未伍用YSX-C(IFN-α单药治疗组)。YSX-C疗程3个月。治疗结束后随访至少6个月。结果治疗结束时,联合治疗组、IFN-α单药治疗组联合应答率分别为60.7%(51/84)和47.4%(46/97)(χ2=3.443,P=0.179),随访6月时分别为54.8%(46/84)和34.0%(33/97)(χ2=8.140,P=0.017),联合治疗组、IFN-α单药治疗组的复发率分别为9.8%(5/51)和28.3%(13/46)(χ2=5.452,P=0.020);联合治疗组治疗中血白细胞、中性粒细胞、血小板减少发生率分别为36.9%、65.5%(和9.5%,IFN-α单药治疗组分别为52.6%(χ2=4.462,P=0.035)、83.5%(χ2=7.833,P=0.005)和20.6%(χ2=4.238,P=0.040)。结论IFN-α伍用YSX-C治疗HBeAg阳性CHB可提高IFN-α的持续疗效、减少复发,并降低外周血白细胞、中性粒细胞和血小板减少的发生率。

Objective To assess the efficacy of interferon - alpha （ IFN -α） combined with YiXueSheng capsule （YSX -c） versus IFN -α alone for treatment of HBeAg- positive chronic hepatitis B （CHB）, and to investigate the efficacy of preventing from IFN -α - related myetosuppression. ：Methods A total of 181 consecutive patients with HBeAg - positive CHB proven by liver biopsy were enrolled in this study. Of them, 84 patients received combination therapy with 5 MU of IFN - crib subcutaneously thrice weekly for a tailored and prolonged course and, by their inten- tions. The YSX - C（ 1.0 g） orally thrice per day for 3 months in combination treatment group was given , and 97 pa- tients received IFN -crib alone in IFN -α monotherapy group. Normalization of alanine aminotransferase （ALT） level, loss of HBeAg with or without HBeAg seroconvertion, undetectable HBV DNA, altogether was considered as combined response. All patients were treatment - freely followed - up for at least 6 months. Results The combined response rates in combination treatment group and in IFN -α monotherapy group were 60.7 % （51/84 ） and 47.4% （46/97） at the end of treatment （X2 = 3. 443, P = 0. 179）, respectively, and were 54.8% （46/84）and 34.0% （33/97）at the end of 6 - months follow - up period （X2 = 8. 140, P = 0. 017 ）, respectively. The recurrence rate in combination treatment group and in IFN -α monotherapy group were 9.8 % （5/51 ） and 28.3 % （ 13/46 ） （X2 = 5. 452, P = O. 020）, respec- tively. Leucopenia, neutropenia and thrombocytopenia were observed in 36.9%, 65.5%, and 9.5% in combination treatment group, respectively, while in 52.6% （51/97, X2 =4.462,P =0. 035）, 83.5% （81/97,X2 =71 833 ,P = 0.005）, and 20. 6% （ 20/97 , X2 =4.238,P=O. O40）in IFN-α monotherapy group, respectively. Conclusions The combination treatment with IFN -crib and YXS -c for HBeAg -positive CHB may lead to a higher sustained response rate, and YXS - c treatment may be favourable to preventing from IFN-α - related myelosuppression.