扶正化瘀胶囊治疗慢性血吸虫病肝纤维化临床研究

Clinical research of Fuzheng Huayu Capsule on chronic schistosomiasis liver fibrosis

目的:观察扶正化瘀胶囊治疗慢性血吸虫病肝纤维化的临床疗效。方法:对符合纳入标准的216例受试者按随机数字表法分为试验组和对照组,疗程6个月,治疗后第3个月随访1次。两组患者治疗前后观测症状体征(评分表)、肝纤维化病理检测、血清肝纤维化指标。结果:两组患者中医症状治疗前后疗效比较,试验组能显著改善主要症状,与对照组比较有显著性差异(P<0.05),试验组优于对照组。两组患者血清肝纤指标治疗前后疗效比较:试验组血清肝纤指标改善有效率高于对照组,具有统计学差异(P<0.05),试验组优于对照组。两组患者肝脏病理检查指标治疗前后疗效比较:试验组治疗后肝脏组织活检肝纤维化分期较对照组明显改善,差异具有统计学意义(P<0.05),试验组优于对照组。结论:扶正化瘀胶囊对慢性血吸虫病肝纤维化的疗效肯定,对防治肝纤维化的发生、发展有明显的疗效,其作用机制的研究取得了一定成果,为中医药临床防治慢性血吸虫病提供了医学依据。

Objective:To observe the clinical effect of Fuzheng Huayu Capsule in the treatment chronic schistosomiasis liver fibrosis.Method:216 cases of patients who met the inclusion criteria were randomly divided into two groups,the treatment group and the control group.The course of the treatment was 6 months,follow-up visits were considered after 3 month’treatment.Signs and symptoms(rating scale),liver fibrosis pathological detection and serum liver fibrosis indexes were observed before and after the treatment for the two groups.Result:In comparison of the symptoms of TCM before and after treatment,the main symptoms were relieved significantly in the treatment group,the difference was statistically significant(P<0.05).The treatment group was better than the control group.In comparison of the treatment of serum fibrosis indexes before and after treatment,the efficient of improvement for serum fibrosis indexes was higher in the treatment group,the difference was statistically significant(P<0.05).The treatment group was better than the control group.In comparison of the liver pathologic examination indexes,the liver biopsy of liver fibrosis stages were improved significantly in the treatment group,the difference was statistically significant(P<0.05).The treatment group was better than the control group.Conclusion:The therapeutic effect of Fuzheng Huayu Capsule on liver fibrosis of chronic schistosomiasis is positive,and it has obvious curative effect on the occurrence and development of liver fibrosis.The research on the mechanism of action has made certain achievements,which provides a medical basis for the clinical prevention and treatment of chronic schistosomiasis with traditional Chinese medicine.