目的 探討參芪肝康片聯(lián)合恩替卡韋治療慢性乙型肝炎患者的臨床療效。方法 選取2017年6月—2019年6月于新鄉(xiāng)醫(yī)學(xué)院第一附屬醫(yī)院感染科住院治療的114例慢性乙型肝炎患者作為研究對(duì)象，按照住院時(shí)間和治療方式差異隨機(jī)將患者分為對(duì)照組（n=57）和觀察組（n=57）。對(duì)照組口服抗病毒藥物馬來(lái)酸恩替卡韋片，0.5 mg/次，1次/d。觀察組在對(duì)照組治療的基礎(chǔ)上口服參芪肝康片治療，2.1 g/次，3次/d。兩組療程均為6個(gè)月。觀察兩組患者的臨床療效，比較兩組治療前后的肝功能指標(biāo)、Th17細(xì)胞頻率、Treg細(xì)胞頻率、Th17/Treg細(xì)胞頻率比值、白細(xì)胞介素-17（IL-17）、轉(zhuǎn)化生長(zhǎng)因子-β（TGF-β）水平以及不良反應(yīng)發(fā)生率。結(jié)果 治療后，對(duì)照組和觀察組總有效率分別為77.19%和92.98%，兩組比較差異具有統(tǒng)計(jì)學(xué)意義（P<0.05）。與治療前相比，兩組丙氨酸氨基轉(zhuǎn)移酶（ALT）、天冬氨酸氨基轉(zhuǎn)移酶（AST）、總膽紅素（TBIL）水平均顯著降低，差異均具有統(tǒng)計(jì)學(xué)意義（P<0.05）；與對(duì)照組相比，觀察組治療后血清ALT、AST和TBIL均顯著降低，差異均具有統(tǒng)計(jì)學(xué)意義（P<0.05）。治療后，兩組患者Th17細(xì)胞頻率、Th17/Treg細(xì)胞頻率比值、IL-17水平均顯著下降，而Treg細(xì)胞頻率及TGF-β水平均顯著升高（P<0.05）；與對(duì)照組相比，治療后觀察組Τh17細(xì)胞頻率、Th17/Treg細(xì)胞頻率比值、IL-17水平顯著下降，而Treg細(xì)胞頻率及TGF-β水平均顯著升高（P<0.05）。對(duì)照組和觀察組兩組患者不良反應(yīng)發(fā)生率分別為10.53%和14.04%，兩組不良反應(yīng)率相比較無(wú)顯著差異。結(jié)論 參芪肝康片聯(lián)合恩替卡韋治療慢性乙型肝炎安全有效，能顯著改善肝功能，并降低血清炎癥因子水平，可能與影響Th17、Treg細(xì)胞頻率及降低Th17/Treg細(xì)胞頻率比值有關(guān)。

Objective To investigate the clinical efficacy of Shenqi Gankang Tablets combined with entecavir in treatment chronic hepatitis B. Methods A total of 114 patients with chronic hepatitis B from Xinxiang Medical University between June 2017 to June 2019 were collected. Patients (114 cases) with chronic hepatitis B in the department of infectious diseases, the First Affiliated Hospital of Xinxiang Medical University from June 2017 to June 2019 were selected as the research objects, and the patients were randomly divided into the control group (n=57) and the observation group (n=57) according to the differences in length of stay and treatment methods. Patients in the control group were po administered with Entecavir Maleate Tablets, 0.5 mg/time, once daily. Patients in the observation group were po administered with Shenqi Gankang Tablets on the basis of control group, 2.1 g/time, three times daily. Patients in two groups were treated for 6 months. The clinical efficacy in two groups was observed, and the liver function indicators, Th17 cell frequency, Treg cell frequency, Th17/Treg cell frequency ratio, Il-17, TGF-β levels, and the incidence of adverse reactions before and after treatment were compared in two groups. Results After treatment, the total effective rate in the control group and observation group was 77.19% and 92.98%, respectively, the difference between two groups was statistically significant (P<0.05). Compared with before treatment, the levels of ALT, AST and TBIL in two groups were significantly decreased after treatment, with statistically significant differences (P<0.05). Compared with the control group, the serum levels of ALT, AST and TBIL in the observation were significantly decreased after treatment, with statistically significant differences (P<0.05). After treatment, Th17 cell frequency, Th17/Treg frequency ratio, and IL-17 levels in two groups were decreased significantly, while Treg cell frequency and TGF-β levels were increased significantly (P<0.05). After treatment, compared with the control group, Th17 frequency, Th17/Treg cell frequency ratio, and IL-17 level in the observation group significantly decreased, while the levels of Treg cell frequency and TGF-β were significantly increased (P<0.05). The incidence of adverse reactions in the control group and the observation group were 10.53% and 14.04%, respectively, there was no significant difference between two groups. Conclusion Shenqi Gankang Tablets combined with entecavir in treatment of chronic hepatitis B is safe and effective, which can significantly improve liver function, and reduce the level of serum inflammatory factors, which may be related to the influence of Th17 and Treg cell frequency, and the reduction of Th17/Treg cell frequency ratio.

R975

河南省醫(yī)學(xué)科技攻關(guān)計(jì)劃普通項(xiàng)目（201303106）