中成药治疗非酒精性脂肪性肝病临床综合评价  

Clinical Comprehensive Evaluation of Chinese Patent Medicines in the Treatment of Non-Alcoholic Fatty Liver Disease

作　　者：郭一娇 周一康 胡明[1] 杨男[1] GUO Yijiao;ZHOU Yikang;HU Ming;YANG Nan(West China School of Pharmacy,Sichuan University,Chengdu,Sichuan,China 610041)

机构地区：[1]四川大学华西药学院,四川成都610041

出　　处：《中国药业》2023年第20期130-135,共6页China Pharmaceuticals

基　　金：四川省中医药管理局科学技术研究专项[2018ZC004]。

摘　　要：目的为临床合理使用治疗非酒精性脂肪性肝病(NAFLD)的中成药提供参考。方法采用现存统计资料分析法、系统评价、网状Meta分析,从安全性、有效性、经济性、创新性、适宜性、可及性和中医药特色评价7个维度,对8种治疗NAFLD的中成药开展临床综合评价。结果安全性,8种中成药药品说明书记载不良反应和用药禁忌的分别有5种和6种;仅当飞利肝宁胶囊、壳脂胶囊文献报道了具体不良反应。有效性,各药降低总胆固醇和三酰甘油效果未明显优于安慰剂,且各中成药方案无明显差异(P>0.05)。经济性,最小成本分析结果显示,成本最高的为化滞柔肝颗粒,最低的为护肝片,当飞利肝宁胶囊居中。适宜性,8种中成药的服用方式及储存条件均相对简便快捷。可及性,疗程费用最高的化滞柔肝颗粒,最低的为护肝片,当飞利肝宁胶囊居中,整体可及性较好。创新性,5种中成药享有16项专利(其中2项为发明专利),整体创新性较好。中医药特色,8种中成药均符合中医药基础理论,且已在民间广泛使用,当飞利肝宁片/胶囊、化滞柔肝颗粒、壳脂胶囊已进行针对NAFLD的临床试验。结论当飞利肝宁胶囊治疗NAFLD,与同类型中成药的安全性、有效性相当,经济性适宜,且有较好的可及性。Objective To provide a reference for the clinical rational use of Chinese patent medicines in the treatment of non-alcoholic fatty liver disease(NAFLD).Methods The existing statistical data analysis,systematic review and network Meta-analysis were used to carry out the clinical comprehensive evaluation for eight Chinese patent medicines in the treatment of NAFLD from seven dimensions of safety,effectiveness,economy,innovation,suitability,accessibility and characteristics of traditional Chinese medicine(TCM).Results For safety,adverse reactions were included in five drug instructions,contraindications were included in six drug instructions,and specific adverse reactions were reported only in related studies of Dangfei Liganning Capsules and Kezhi Capsules.For effectiveness,various medicines were not significantly superior to placebo in reducing total cholesterol(TC)and triacylglycerol(TG),and there was no significant difference between the various medication regimens(P>0.05).For economy,the minimum-cost analysis showed the cost of Huazhi Rougan Granules was the highest,that of Hugan Tablets was the lowest,and that of Dangfei Liganning Capsules was medium.For suitability,eight Chinese patent medicines were relatively simple and fast to take and store.For accessibility,the treatment cost of Huazhi Rougan Granules was the highest,that of Hugan Tablets was the lowest,that of Dangfei Liganning Capsules was medium,and the overall accessibility was good.For innovation,there were 16 patents for five Chinese patent medicines(two of which were invention patents),and the overall innovation was good.For characteristics of TCM,the prescriptions of eight Chinese patent medicines were all based on the TCM basic theories,these medicines had been widely used in the folk society,and the clinical trials of Dangfei Liganning Tablets/Capsules,Huazhi Rougan Granules and Kezhi Capsules against NAFLD had been carried out.Conclusion Dangfei Liganning Capsules in the treatment of NAFLD is economical and accessible,its safety and effectiven

关 键 词：中成药 非酒精性脂肪性肝病 临床综合评价 多维度评估 

分 类 号：R969.3[医药卫生—药理学]