α-干扰素联合乙肝清热解毒颗粒治疗HBeAg阳性慢性乙型肝炎的多中心研究

目的观察α-干扰素联合乙肝清热解毒颗粒治疗HBeAg阳性CHB患者的临床疗效以及不良反应。方法选择符合干扰素应用指征并兼有湿热中阻证候的HBeAg阳性慢性乙型肝炎患者120例,分为三组,每组各40例,分别给予α-干扰素、α-干扰素联合乙肝清热解毒颗粒和乙肝清热解毒颗粒治疗,观察治疗前及治疗1、3、6个月后中医症候量化评分、不良反应和疗效。结果治疗24周后,联合组ALT复常率为52.5%,明显高于中药组的25.6%,而中药组症状改善优于干扰素组;联合用药组6个月时HBeAg转阴率较单用干扰素和乙肝清热解毒颗粒组明显增高,联合组HBVDNA转阴率和HBeAg/抗HBe转换率虽高于其他两组,但尚无显著性差异。结论α-干扰素联合乙肝清热解毒颗粒治疗HBeAg阳性慢性乙型肝炎可提高6个月时HBeAg转阴率,其安全性好,有必要扩大样本进一步验证。

A multicenter study of clinical effect of interferon combined with Yigan Qingre Jiedu Granula on HBeAg positive chronic hepatitis B

Objective To investigate the clinical effect of α interferon combination with Yigan Qingre Jiedu granula on HBeAg positive chronic hepatitis B. Methods Totally 120 patients with HBeAg positive chronic hepatitis B and having signs of internal accumulation of damp-heat type were divided into three groups,40 patients for each group receiving α interferon,α interferon combination with Yigan Qingre Jiedu granula and Yigan Qingre Jiedu granula treatment for six months. Results 3 cases in α interferon group and none in combination group were lost. Combination group was better than herbal group in ALT normalization and herbal group was better than interferon group in symptoms improvement after 6 months’treatment. Rate of HBeAg loss in combination group was better than in the other two groups,with higher HBeAg/Ab seroconversion and HBV DNA undetectable rate but without significant difference. Conclusion α interferon combination with Yigan Qingre Jiedu granula has good therapeutic effect on chronic hepatitis B without obvious adverse effect,but complete response rate needs to be further verification.