目的 探討和絡(luò)舒肝膠囊聯(lián)合雙環(huán)醇治療慢性乙型肝炎的臨床療效。方法 選取2015年5月—2016年5月于上海中醫(yī)藥大學附屬曙光醫(yī)院治療的88例慢性乙型肝炎患者，根據(jù)用藥的差別分為對照組（44例）和治療組（44例）。對照組口服雙環(huán)醇片，1片/次，3次/d。治療組在對照組治療基礎(chǔ)上口服和絡(luò)舒肝膠囊，5粒/次，3次/d。兩組均連續(xù)治療48周。觀察兩組的臨床療效，比較兩組治療前后肝纖維化指標、肝功能指標、血清細胞因子水平的變化情況。比較治療24、48周兩組HBV-DNA和HBeAg轉(zhuǎn)陰率。結(jié)果 治療后，對照組和治療組的總有效率分別為79.55%、93.18%，兩組比較差異具有統(tǒng)計學意義（P < 0.05）。治療24、48周，兩組患者血清透明質(zhì)酸（HA）、層粘連蛋白（LN）、Ⅳ型膠原（Ⅳ-C）、Ⅲ型前膠原（PC-Ⅲ）、丙氨酸氨基轉(zhuǎn)移酶（ALT）、天門冬氨酸氨基轉(zhuǎn)移酶（AST）、總膽紅素（TBIL）、腫瘤壞死因子-α（TNF-α）、白細胞介素-18（IL-18）均較治療前顯著降低，γ干擾素（IFN-γ）、白細胞介素-21（IL-21）顯著增高，同組治療前后比較差異有統(tǒng)計學意義（P < 0.05）；治療組治療24、48周HA、LN、PC-Ⅲ、IV-C、ALT、AST、TBIL、TNF-α、IL-18水平顯著低于對照組，IFN-γ、IL-21高于對照組，兩組比較差異具有統(tǒng)計學意義（P < 0.05）。對照組在治療24、48周時HBeAg陰轉(zhuǎn)率分別為61.36%、77.27%，HBV-DNA陰轉(zhuǎn)率分別為63.64%、79.55%；治療組在治療24、48周時HBeAg陰轉(zhuǎn)率分別為81.82%、93.18%，HBV-DNA陰轉(zhuǎn)率分別為86.36%、90.91%；治療組HBV-DNA和HBeAg轉(zhuǎn)陰率均顯著高于對照組，兩組比較差異具有統(tǒng)計學意義（P < 0.05）。結(jié)論 和絡(luò)舒肝膠囊聯(lián)合雙環(huán)醇片治療慢性乙型肝炎具有較好的臨床療效，可顯著改善患者肝功能，抑制肝纖維化，增強機體免疫能力，促進機體病毒清除率，具有一定的臨床推廣應(yīng)用價值。

Objective To investigate the clinical curative effect of Heluo Shugan Capsules combined with bicyclol in treatment of chronic hepatitis B. Methods Patients (88 cases) with chronic hepatitis b in Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from May 2015 to May 2016 were divided into control (44 cases) and treatment (44 cases) groups according to the medication regimen. Patients in the control group were po administered with Bicyclol Tablets, 1 tablet/time, three times daily. Patients in the treatment group were po administered with Heluo Shugan Capsules, 5 grains/time, three times daily. Patients in two groups were treated for 48 weeks. After treatment, the clinical efficacy were evaluated, and the changes of liver fibrosis indexes, liver function indexes, serum cytokine level in two groups before and after treatment were compared. Results After treatment, the clinical efficacy in the control and treatment groups were 79.55% and 93.18%, respectively, and there was difference between two groups (P < 0.05). Treatment for 24, 48 weeks, the levels of HA, LN, PC-Ⅲ, IV-C, ALT, AST, TBIL, TNF-α, and IL-18 in two groups significantly reduced, but IFN-γ and IL-21 were significantly increased, and the difference was statistically significant in the same group (P < 0.05). After treatment, HA, LN, PC-Ⅲ, IV-C, ALT, AST, TBIL, TNF-α, and IL-18 were lower than those in the control group, but IFN-γ and IL-21 were higher than those in the control group, and there was difference between two groups (P < 0.05). In the treatment of 24 and 48 weeks, HBeAg overcast rate in the control group was 61.36% and 77.27%, respectively, HBV-DNA overcast rate was 63.64% and 79.55%, respectively. HBeAg overcast rate in the treatment group was 81.82% and 93.18%, respectively, and HBV-DNA overcast rate was 86.36% and 90.91%, respectively. The overcast rates of HBeAg and HBeAg in the treatment group were significantly higher than those in the control group, and there was difference between two groups (P < 0.05). Conclusion Heluo Shugan Capsules combined with bicyclol has clinical curative effect in treatment of chronic hepatitis b, and can significantly improve the liver function, inhibit liver fibrosis, and can enhance the immune capacity, promote the clearance rate of the body virus, which has a certain clinical application value.

國家自然科學基金面上項目（81774256）