目的 探討舒肝寧注射液聯(lián)合富馬酸丙酚替諾福韋治療慢性乙型病毒性肝炎的臨床研究。方法 選取2019年1月—2020年1月在南陽市中心醫(yī)院治療的112例慢性乙型病毒性肝炎患者，隨機分成對照組（56例）和治療組（56例）。對照組患者口服富馬酸丙酚替諾福韋片，1片/次，1次/d。治療組患者在對照組的基礎(chǔ)上iv舒肝寧注射液，20 mL加入5%葡萄糖注射液300 mL，1次/d。兩組均治療21 d。觀察兩組患者臨床療效，比較治療前后兩組患者肝功能指標(biāo)總膽紅素（TBIL）、丙氨酸氨基轉(zhuǎn)移酶（ALT）、天冬氨酸氨基轉(zhuǎn)移酶（AST）和總蛋白（TP），淋巴細胞亞群指標(biāo)CD4⁺、CD4⁺/CD8⁺和不良反應(yīng)。結(jié)果 治療組臨床總有效率為96.43%，明顯高于對照組的83.93%（P<0.05）。治療后，兩組TBIL、ALT、AST均顯著降低，而TP升高（P<0.05）；治療后，治療組患者TBIL、ALT、AST均低于對照組，而TP指標(biāo)高于對照組（P<0.05）。治療后，兩組CD83、CD86、MHC-DR、CD1a均顯著升高（P<0.05）；治療后治療組外周血樹突狀細胞水平高于對照組（P<0.05）。治療后，兩組患者CD4⁺、CD4⁺/CD8⁺升高，而CD8⁺指標(biāo)降低（P<0.05）；治療后，治療組淋巴細胞亞群優(yōu)于對照組（P<0.05）。治療組不良反應(yīng)總發(fā)生率為7.14%，低于對照組17.86%的不良反應(yīng)發(fā)生率（P<0.05）。結(jié)論 舒肝寧注射液聯(lián)合富馬酸丙酚替諾福韋片治療慢性乙型病毒性肝炎療效顯著，肝功能改善明顯，并能夠改善外周血樹突狀細胞和淋巴細胞亞群功能，增強機體免疫能力。

Objective To explore the clinical study of Shuganning Injection combined with tenofovir alafenamide fumarate in treatment of chronic hepatitis B. Methods Patients (112 cases) with chronic hepatitis B in Nanyang Central Hospital from January 2019 to January 2020 were randomly divided into control (56 cases) and treatment (56 cases) groups. Patients in the control group were po administered with Tenofovir alafenamide Fumarate Tablets, 1 tablet/time, once daily. Patients in the treatment group were iv administered with Shuganning Injection on the basis of the control group, 20 mL added into 5% glucose injection 500 mL, once daily. Patients in two groups were treated for 21 d. After treatment, the clinical efficacy was evaluated, and the liver function indexes of TBIL, ALT, AST and TP, the lymphocyte subgroup indexes of CD4⁺ and CD4⁺/CD8⁺, the dendritic cell content in peripheral blood and adverse reactions in two groups before and after treatment were compared. Results After treatment, the total clinical effective rate of the treatment group was 96.43%, which was significantly higher than 83.93% of the control group (P<0.05). After treatment, TBIL, ALT and AST in both groups were significantly decreased, while TP was increased (P<0.05). After treatment, TBIL, ALT and AST in the treatment group were lower than those in the control group, while TP in the treatment group was higher than those in the control group (P<0.05). After treatment, CD83, CD86, MHC-DR and CD1A in two groups were significantly increased (P<0.05); After treatment, the level of peripheral blood dendritic cells in treatment group was higher than that in control group (P<0.05). After treatment, CD4⁺ and CD4⁺/CD8⁺ in two groups were increased, while CD8⁺ indexes were decreased (P<0.05); After treatment, lymphocyte subsets in treatment group were superior to those in control group (P<0.05). The total incidence of adverse reactions in the treatment group was 7.14%, which was lower than 17.86% in the control group (P<0.05). Conclusion Shuganning Injection combined with tenofovir alafenamide fumarate is effective in treatment of chronic hepatitis B. The liver function is improved obviously, and the function of dendritic cells and lymphocyte subsets in peripheral blood can be improved, and the immune ability of the body can be enhanced.

R978

河南省醫(yī)學(xué)科技攻關(guān)計劃項目（2018020415）