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[摘要]
目的 观察九味肝泰胶囊联合恩替卡韦治疗儿童慢性乙型肝炎的临床疗效。方法 选取2013年7月-2015年3月十堰市太和医院收治的慢性乙型肝炎患儿189例,随机分为九味肝泰组、恩替卡韦组和联合治疗组,每组各63例。九味肝泰组口服九味肝泰胶囊,1粒/次,3次/d。恩替卡韦组口服恩替卡韦分散片,0.5片/次,1次/d。联合治疗组口服九味肝泰胶囊和恩替卡韦分散片,用法用量同上。3组患者均治疗6个月。观察两组的临床疗效,比较两组肝功能、白细胞介素(IL-10)、透明质酸(HA)、转化生长因子-β1(TGF-β1)、乙型肝炎病毒脱氧核糖核酸(HBV-DNA)、谷胱甘肽(GSH)、丙二醛(MDA)和超氧化物歧化酶(SOD)的情况。结果 治疗后,九味肝泰组、恩替卡韦组和联合治疗组愈显率分别为73.01%、82.53%、95.23%,总有效率分别为88.88%、93.65%、98.41%,联合治疗组组愈显率和总有效率明显优于九味肝泰组和恩替卡韦组,3组比较差异有统计学意义(P<0.05)。治疗后,3组总胆红素(TBIL)、谷氨酸转移酶(GGT)、丙氨酸转氨酶(ALT)、总胆汁酸(TBA)和天氨酸转氨酶(AST)水平均显著降低,同组治疗前后比较差异有统计学意义(P<0.05);且联合治疗组这些观察指标的下降程度明显优于恩替卡韦组,两组比较差异具有统计学意义(P<0.05)。治疗后,3组IL-10、HA和TGF-βl水平均显著下降,而恩替卡韦组和联合治疗组HBV-DNA水平均显著下降,同组治疗前后比较差异有统计学意义(P<0.05);且联合治疗组这些观察指标的下降程度明显优于九味肝泰组和恩替卡韦组,3组比较差异具有统计学意义(P<0.05)。治疗后,3组GSH和SOD水平均明显升高,MDA水平均明显降低,同组治疗前后比较差异有统计学意义(P<0.05);且联合治疗组这些观察指标的改善程度明显优于恩替卡韦组,两组比较差异具有统计学意义(P<0.05)。结论 九味肝泰胶囊联合恩替卡韦治疗儿童慢性乙型肝炎具有较好的临床疗效,可显著改善肝功能,调节炎性反应,安全性较好,具有一定的临床推广应用价值。
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[Abstract]
Objective To observe the clinical effect of Jiuwei Gantai Capsules combined with entecavir in treatment of children with chronic hepatitis B. Methods Children (189 cases) with chronic hepatitis B in Taihe Hospital from July 2013 to March 2015 were randomly divided into Jiuwei Gantai, entecavir and combined treatment groups, and each group had 63 cases. Children in the Jiuwei Gantai group were po administered with Jiuwei Gantai Capsules, 1 grain/time, three times daily. Children in the entecavir group were po administered with Entecavir Dispersible Tablets, 0.5 tablet/time, once daily. Children in the combined treatment group were po administered with Jiuwei Gantai Capsules and Entecavir Dispersible Tablets, usage and dosage as above. Children among three groups were treated for 6 months. After treatment, the clinical efficacies were evaluated, and liver function, IL-10, HA, TGF-β1, HBV-DNA, GSH, MDA, and SOD in two groups were compared. Results After treatment, the healing rate in the Jiuwei Gantai and entecavir combined treatment groups were 73.01%, 82.53%, and 95.23%, respectively, the clinical efficacies in the Jiuwei Gantai and entecavir groups were 88.88%, 93.65% and 98.41%, respectively, and the healing rate and clinical efficacies in the combined treatment group were significantly better than those in Jiuwei Gantai and entecavir groups (P<0.05). After treatment, the levels of TBIL, GGT, ALT, TBA, and AST in three groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the combined treatment group were significantly lower than those in the entecavir group, with significant difference between two groups (P<0.05). After treatment, the levels of IL-10, HA, and TGF-βl in three groups were significantly decreased, but the levels of HBV-DNA in the entecavir and combined treatment groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the combined treatment group were significantly lower than those in the Jiuwei Gantai and entecavir groups, with significant difference among three groups (P<0.05). After treatment, the levels of GSH and SOD in three groups were significantly increased, but the levels of MDA in three groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the combined treatment group were significantly better than those in the Entecavir group, with significant difference between two groups (P<0.05). Conclusion Jiuwei Gantai Capsules combined with entecavir has clinical curative effect in treatment of children with chronic hepatitis B, can improve liver function, and regulate inflammatory response, with good safety, which has a certain clinical application value.
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