目的 探討肝達(dá)康膠囊聯(lián)合恩替卡韋治療慢性乙型肝炎的臨床療效。方法 選取2018年1月-2019年6月于新鄉(xiāng)醫(yī)學(xué)院第一附屬醫(yī)院感染科就診的124例慢性乙型肝炎患者，隨機(jī)分為對(duì)照組和治療組，每組各62例。對(duì)照組口服馬來(lái)酸恩替卡韋片，1片/次，1次/d。治療組在對(duì)照組治療的基礎(chǔ)上口服肝達(dá)康膠囊，8粒/次，3次/d。兩組均連續(xù)治療3個(gè)月。觀察兩組的臨床療效，比較兩組治療前后肝功能指標(biāo)、肝纖維化指標(biāo)、Th1和Th2細(xì)胞百分比和細(xì)胞因子水平的變化情況。結(jié)果 治療后，治療組和對(duì)照組的總有效率分別是95.16%、82.26%（P<0.05）。治療后，兩組患者血清丙氨酸氨基轉(zhuǎn)氨酶（ALT）和天門冬氨酸氨基轉(zhuǎn)移酶（AST）同各組治療前相比均顯著降低（P<0.05）；與對(duì)照組相比，治療后治療組患者血清ALT和AST水平降低更加明顯（P<0.05）。治療后兩組患者血清層黏連蛋白（LN）、透明質(zhì)酸（HA）、Ⅲ型前膠原N端肽（PCIII）、Ⅳ型膠原（IV-C）水平均明顯下降（P<0.05）；且治療后治療組上述指標(biāo)同對(duì)照組相比降低更加明顯（P<0.05）。治療后，兩組Th1、Th1/Th2顯著降低，而Th2顯著升高（P<0.05）；與對(duì)照組相比，治療后治療組Th1、Th1/Th2顯著更低，而Th2顯著更高（P<0.05）。治療后，兩組患者γ干擾素（IFN-γ）、腫瘤壞死因子α（TNF-α）水平均顯著下降，而白細(xì)胞介素4（IL-4）、白細(xì)胞介素6（IL-6）水平均顯著升高（P<0.05）；治療后，治療組患者IFN-γ、TNF-α水平低于對(duì)照組，而IL-4、IL-6水平高于對(duì)照組（P<0.05）。結(jié)論 肝達(dá)康膠囊聯(lián)合恩替卡韋治療慢性乙型肝炎具有較好的臨床療效，能顯著改善患者肝臟損傷情況，可能與改善Th1/Th2細(xì)胞失衡有關(guān)，具有一定的臨床推廣應(yīng)用價(jià)值。

Objective To explore the efficacy of Gandakang Capsules combined with entecavir in treatment of chronic hepatitis B. Methods A total of 124 patients with chronic hepatitis B who were treated in the Department of Infectious Diseases of the First Affiliated Hospital of Xinxiang Medical University from January 2018 to June 2019 were randomly divided into control group and treatment group, with 62 patients in each group. Patients in the control group were po administered with Entecavir Maleate Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Gandakang Capsules on the basis of the control group, 8 grains/time, three times daily. Patients in two groups were treated for 3 months. After treatment, the clinical efficacy was evaluated, and the changes of liver function indexes, liver fibrosis indexes, Th1 and Th2 cell percentage and cytokine levels before and after treatment were compared between two groups. Results After treatment, the total effective rate of treatment group and control group was 95.16% and 82.26%, respectively (P<0.05). After treatment, the levels of ALT and AST in both groups were significantly reduced compared with those before treatment (P<0.05). Compared with the control group, the serum ALT and AST levels in the treatment group were significantly reduced after treatment (P<0.05). After treatment, LN, HA, PCIII, and IV-C in two groups were significantly decreased (P<0.05). After treatment, the above indexes in the treatment group were significantly lower than those in the control group (P<0.05). After treatment, Th1 and Th1/Th2 in both groups were significantly decreased, but Th2 was significantly increased (P<0.05). Compared with the control group, Th1 and Th1/Th2 in the treatment group were significantly lower after treatment, while Th2 was significantly higher (P<0.05). After treatment, the levels of IFN-γ and TNF-α were significantly decreased, but the levels of IL-4 and IL-6 were significantly increased in both groups (P<0.05). After treatment, the levels of IFN-γ, and TNF-α were lower than those in the control group, but IL-4, and IL-6 levels were higher than the control group (P<0.05). Conclusion Gandakang Capsules combined with entecavir has good clinical effect in treatment of chronic hepatitis B, and can significantly improve the patient's liver injury, may be related to the improvement of Th1/Th2 cell imbalance, which has a certain clinical application value.

R978

河南省衛(wèi)生科技攻關(guān)工程資助項(xiàng)目（182102311234）