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目的 观察肝龙胶囊联合拉米夫定片治疗慢性乙型肝炎的临床疗效。方法 选取2015年7月—2017年12月于东台市人民医院收治的116例慢性乙型肝炎患者作为研究对象,所有患者随机分为对照组和治疗组,每组各58例。对照组患者口服拉米夫定片,1片/次,1次/d;治疗组在对照组治疗的基础上口服肝龙胶囊,1粒/次,2次/d。两组均连续治疗12个月。观察两组患者的临床疗效,比较两组患者的乙肝病毒的脱氧核糖核酸(HBV-DNA)和乙型肝炎e抗原(HbeAg)转阴率、T淋巴细胞亚群水平、炎症因子水平、肝功能指标和肝纤维化指标。结果 治疗后,对照组和治疗组的总有效率分别为53.45%、82.76%,两组比较差异具有统计学意义(P<0.05)。治疗6、12个月后,两组HBV-DNA和HBeAg转阴率均显著升高,同组治疗前后比较差异具有统计学意义(P<0.05);治疗6、12个月,治疗组HBV-DNA和HBeAg转阴率显著高于同期对照组,两组比较差异具有统计学意义(P<0.05)。治疗3、6、12个月后,两组CD3+、CD4+、CD4+/CD8+水平均显著高于治疗前,同组治疗前后比较差异具有统计学意义(P<0.05);治疗3、6、12个月,治疗组T淋巴细胞亚群水平显著高于同期对照组,两组比较差异具有统计学意义(P<0.05)。治疗6、12个月后,两组肿瘤坏死因子-α(TNF-α)和白介素-2(IL-2)水平均较治疗前显著降低,而白介素-10(IL-10)水平显著升高,同组治疗前后比较差异具有统计学意义(P<0.05);治疗6、12个月后,治疗组炎症因子水平明显优于同期对照组,两组比较差异具有统计学意义(P<0.05)。治疗3、6、12个月后,两组丙氨酸氨基转移酶(ALT)、天冬氨酸氨基转移酶(AST)、总胆红素(TBIL)和谷氨酰转肽酶(GGT)水平均较治疗前显著降低,同组治疗前后比较差异具有统计学意义(P<0.05);治疗3、6、12个月后,治疗组肝功能指标水平显著低于同期对照组,两组比较差异具有统计学意义(P<0.05)。治疗3、6、12个月后,两组患者血清Ⅲ型前胶原(PC-Ⅲ)、IV型胶原(IV-C)、层黏连蛋白(LN)和透明质酸酶(HA)均较治疗前显著降低,同组治疗前后比较差异均有统计学意义(P<0.05);治疗3、6、12个月后,治疗组肝纤维化指标水平显著低于同期对照组,两组比较差异具有统计学意义(P<0.05)。结论 肝龙胶囊联合拉米夫定片治疗慢性乙型肝炎具有较好的临床疗效,能改善肝功能、肝纤维化和T淋巴细胞亚群表达,减轻炎症反应,具有一定的临床推广应用价值。
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[Abstract]
Objective To investigate the clinical efficacy of Ganlong Capsules combined with Lamivudine Tablets in treatment of chronic hepatitis B. Methods Patients (116 cases) with chronic hepatitis B in Dongtai People's Hospital from July 2015 to December 2017 were randomly divided into control and treatment groups, and each group had 58 cases. Patients in the control group were po administered with Lamivudine Tablets, 1 tablet/time, once daily. Patients in the treatment group were po administered with Ganlong Capsules on the basis of the control group, 1 grain/time, twice daily. Patients in two groups were treated for 12 month. After treatment, the clinical efficacy was evaluated, and the negative conversion rates of HBV-DNA and HBeAg, T lymphocyte subsets, inflammatory factor levels, liver function indexes, and liver fibrosis markers in two groups were compared. Results After treatment, the clinical efficacy in the control and treatment group were 53.45% and 82.76%, and there were differences between two groups (P<0.05). After treatment for 6 and 12 weeks, the negative conversion rates of HBV-DNA and HBeAg in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). After treatment for 6 and 12 weeks, the negative conversion rates of HBV-DNA and HBeAg in the treatment group were significantly higher than those in the control group of the same period, with significant difference between two groups (P<0.05). After treatment for 3, 6, and 12 weeks, the levels of CD3+, CD4+, and CD4+/CD8+ in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). After treatment for 3, 6, and 12 weeks, the T lymphocyte subsets levels in the treatment group were significantly higher than those in the control group of the same period, with significant difference between two groups (P<0.05). After treatment for 6 and 12 weeks, TNF-α and IL-2 levels in two groups were significantly decreased, but IL-10 levels were significantly increased, and there were differences in the same group (P<0.05). After treatment for 6 and 12 weeks, inflammatory factor levels were significantly better than those in the control group in the same period, with significant difference between two groups (P<0.05). After treatment for 3, 6, and 12 weeks, the levels of AST, ALT, TBIL, and GGT in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). After treatment for 3, 6, and 12 weeks, the levels of liver function indexes in the treatment group were significantly lower than those in the control group of the same period, with significant difference between two groups (P<0.05). After treatment for 3, 6, and 12 weeks, the levels of PC-Ⅲ, IV-C, LN, and HA in two groups were significantly decreased, and the differences was statistically significant in the same group (P<0.05). After treatment for 3, 6, and 12 weeks, the levels of liver fibrosis markers in the treatment group were significantly lower than those in the control group of the same period, with significant difference between two groups (P<0.05). Conclusion Ganlong Capsules combined with Lamivudine Tablets has significant clinical effect in treatment of chronic hepatitis B, can improve the liver function, liver fibrosis and the T lymphocyte subgroup expression, and reduce inflammatory reaction, which has a certain clinical application value.
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