目的 觀察白花香蓮解毒顆粒聯(lián)合恩替卡韋治療HBeAg陽性慢性乙型肝炎的臨床療效。方法 選取2018年1月-2019年1月就診于廣西中醫(yī)藥大學(xué)第一附屬醫(yī)院、田東縣中醫(yī)醫(yī)院、藤縣中醫(yī)醫(yī)院、那坡縣中醫(yī)醫(yī)院、南寧市武鳴區(qū)中醫(yī)醫(yī)院的HBeAg陽性慢性乙型肝炎患者320例，隨機(jī)分為對照組和治療組，每組各160例。對照組口服中藥安慰劑，2袋/次，2次/d，同時餐前或餐后2 h口服恩替卡韋分散片0.5 mg/次，1次/d。治療組在對照組服用恩替卡韋分散片基礎(chǔ)上口服白花香蓮解毒顆粒，2袋/次，2次/d。兩組患者均治療48周。觀察兩組患者臨床療效，同時比較治療前后兩組患者HBV DNA下降值、病毒應(yīng)答率、HBV DNA轉(zhuǎn)陰率、血清生化應(yīng)答率、HBeAg轉(zhuǎn)陰率、HBeAg血清轉(zhuǎn)換率和癥狀積分。結(jié)果 治療后，對照組臨床有效率為76.88%，顯著低于治療組的88.75%，兩組比較差異有統(tǒng)計學(xué)意義（P<0.05）。治療24、48周時，治療組癥狀積分與同組治療前比較差異有統(tǒng)計學(xué)意義（P<0.05），治療組癥狀積分與對照組治療同期比較差異有統(tǒng)計學(xué)意義（P<0.05）。治療12、24、48周時，兩組HBV DNA下降值均較同組治療前升高（P<0.05）。治療12、24、48周時，治療組HBV DNA下降值顯著高于對照組（P<0.05）。治療12、24周時，治療組病毒應(yīng)答率優(yōu)于對照組（P<0.05）。治療12、24、48周時，治療組HBV DNA轉(zhuǎn)陰率、血清生化應(yīng)答率均優(yōu)于對照組（P<0.05）。治療48周時，治療組HBeAg轉(zhuǎn)陰率優(yōu)于對照組（P<0.05）。治療24、48周時，治療組HBeAg血清轉(zhuǎn)換率優(yōu)于對照組（P<0.05）。結(jié)論 白花香蓮解毒顆粒能夠顯著提高HBV DNA轉(zhuǎn)陰率，增加HBeAg血清學(xué)轉(zhuǎn)換率，改善肝功能及臨床癥狀。

Objective To observe the clinical efficacy of Baihua Xianglian Jiedu Granules combined with entecavir in treatment of HBeAg positive chronic hepatitis B. Methods Patients (320 cases) with HBeAg positive chronic hepatitis B in the First Affiliated Hospital of Guangxi University of Chinese Medicine, Tiandong Hospital of Traditional Chinese Medicine, Tengxian Hospital of Traditional Chinese Medicine, Wuming District Hospital of Traditional Chinese Medicine and Napo Hospital of Traditional Chinese Medicine from January 2018 to January 2019 were randomly divided into control and treatment groups, and each group had 160 cases. Patients in the control group were po administered with placebo of traditional Chinese medicine, 2 bags/time, twice daily, and at the same time they were po administered with Entecavir Dispersible Tablets before or after meals, 0.5 mg/time, once daily. Patients in the treatment group were po administered with Baihua Xianglian Jiedu Granules on the basis of Entecavir Dispersible Tablets in the control group, 2 bags/time, twice daily. Patients in two groups were treated for 48 weeks. After treatment, the clinical efficacy was evaluated, and the HBV DNA descending value, virus response rate, HBV DNA negative conversion rate, serum biochemical response rate, HBeAg negative conversion rate, serum conversion rate of HBeAg and symptom scores in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control group was 76.88%, which was significantly lower than 88.75% in the treatment group, and there were differences between two groups (P < 0.05). After treatment for 24 and 48 weeks, the symptom scores in the treatment group were significantly different between before and after treatment, and there was a statistically significant difference in symptom scores between the treatment group and the control group over the same period (P < 0.05). After treatment for 12, 24 and 48 weeks, the HBV DNA descending value in two groups was significantly increased (P < 0.05), and which in the treatment was significantly higher than that in the control group. After treatment for 12 and 24 weeks, the virus response rate in the treatment was significantly better than that in the control group. After treatment for 12, 24 and 48 weeks, the HBV DNA negative conversion rate and serum biochemical response rate in the treatment were significantly better than those in the control group. After treatment for 48 weeks, the HBeAg negative conversion rate in the treatment was significantly better than that in the control group. After treatment for 24 and 48 weeks, the serum conversion rate of HBeAg in the treatment was significantly better than that in the control group. Conclusion Baihua Xianglian Jiedu Granules can significantly increase the negative conversion rate of HBV DNA, the serological conversion rate of HBeAg, and improve liver function and clinical symptoms.

R978.7

國家自然科學(xué)基金資助項(xiàng)目（81660827、81860889）；中國博士后科學(xué)基金面上資助項(xiàng)目（2019M653312）；廣西重點(diǎn)研發(fā)計劃項(xiàng)目（2017AB45166）；第二批廣西高層次骨干人才培養(yǎng)139計劃（桂衛(wèi)科教發(fā)[2018]22號）；廣西中醫(yī)藥大學(xué)研究生教育創(chuàng)新計劃項(xiàng)目（xjyb066）