摘要
目的:通过分析基于真实世界的临床数据,评价贞术调脂胶囊用治高脂血症的长期疗效特点和安全性。方法:提取2011年11月至2020年12月在广东药科大学附属第一医院信息系统(HIS)中使用贞术调脂胶囊(1145例)和他汀类药物(2036例)的高脂血症患者信息,根据纳入、排除标准分为贞术调脂胶囊组和他汀组,通过1∶1倾向性评分匹配(PSM)法,比较两组治疗前后、组间的血脂和肝肾功能变化。结果:本研究纳入贞术调脂胶囊组56例和他汀组80例,经过PSM匹配38对。治疗后贞术调脂胶囊组的总胆固醇(TC)平均降低0.27 mmol/L,三酰甘油(TG)平均降低0.32 mmol/L,低密度脂蛋白胆固醇(LDL-C)平均降低0.14 mmol/L,非高密度脂蛋白胆固醇(Non-HDL-C)平均降低0.27 mmol/L;TC、TG和Non-HDL-C治疗前后比较有明显差异(P<0.05),LDL-C和HDL-C治疗前后比较无显著差异(P>0.05);与他汀组比较,贞术调脂胶囊组显著降低TG(P<0.01),两组比较TC和Non-HDL-C无显著差异(P>0.05);贞术调脂胶囊治疗后肝肾功能主要指标未见明显异常。结论:本研究发现贞术调脂胶囊可能通过降低Non-HDL-C发挥抗动脉粥样硬化的作用,在真实世界中应用贞术调脂胶囊可降低TC、TG和Non-HDL-C,调控脂质的作用确切,长期服用临床安全性好。
Objective:To evaluate the long-term efficacy and safety of Zhenzhu Tiaozhi Capsule in the treatment of hyperlipidemia based on the real-world clinical data.Methods:The information of patients receiving Zhenzhu Tiaozhi Capsule(1145 cases)or statins(2036 cases)for the treatment of hyperlipidemia recorded in the Hospital Information System(HIS)of the First Affiliated Hospital of Guangdong Pharmaceutical University from November 2011 to December 2020 was extracted.According to the inclusion and exclusion criteria,the cases were divided into the Zhenzhu Tiaozhi Capsule group and statin group.After 1:1 propensity score matching(PSM),the changes in blood lipid and liver and kidney functions before and after treatment between the two groups were compared.Results:A total of 56 cases were included in the Zhenzhu Tiaozhi Capsule group and 80 cases in the statin group.PSM yielded 38 pairs.After treatment,the total cholesterol(TC)in the Zhenzhu Tiaozhi Capsule group was reduced by an average of 0.27 mmol/L,triglyceride(TG)by an average of 0.32 mmol/L,low-density lipoprotein cholesterol(LDL-C)by an average of 0.14 mmol/L,and non-high density Lipoprotein cholesterol(Non-HDL-C)by an average of 0.27 mmol/L.There were significant differences in TC,TG and Non-HDL-C levels before and after treatment(P<0.05),but no significant difference in LDL-C or HDL-C(P>0.05).Compared with the statin group,the Zhenzhu Tiaozhi Capsule group exhibited a significant reduction in TG group(P<0.05)but no obvious change in TC and Non-HDL-C(P>0.05).After treatment with Zhenzhu Tiaozhi Capsule,there was no obvious abnormality in liver and kidney functions.Conclusion:Zhenzhu Tiaozhi Capsule has been proved to exert the anti-atherosclerosis effect by down-regulating Non-HDL-C.In the real world,Zhenzhu Tiaozhi Capsule is able to lower TC,TG,LDL-C,and Non-HDL-C,and its regulatory effect on lipid is exact.It is safe to be administered for a long time.
作者
陈滢宇
金英花
詹会霞
刘倩
杨进
彭柳芬
李雄
朴胜华
荣向路
郭姣
Chen Yingyu;Jin Yinghua;Zhan Huixia;Liu Qian;Yang Jin;Peng Liufen;Li Xiong;Piao Shenghua;Rong Xianglu;Guo Jiao(The First Affiliated Hospital of Guangdong Pharmaceutical University,Guangzhou 510080;Guangdong Metabolic Diseases Research Center of Integrated Chinese and Western Medicine,Guangzhou 510006;Key Laboratory of Glucolipid Metabolic Disorder,Ministry of Education,Guangzhou 510006;Institute of Traditional Chinese Medicine,Guangdong Pharmaceutical University,Guangzhou 510006;Guangdong Provincial Key Laboratory of Metabolic Disease Prevention and Treatment of Traditional Chinese Medicine,Guangzhou 510006;College of Medical Information Engineering,Guangdong Pharmaceutical University,Guangzhou 510006;School of Clinical Pharmacy,Guangdong Pharmaceutical University,Guangzhou 510006)
出处
《中药药理与临床》
CAS
CSCD
北大核心
2022年第1期163-167,共5页
Pharmacology and Clinics of Chinese Materia Medica
基金
广东省基础与应用基础研究重大项目(编号:2019B030302005)
国家重点研发计划“中医药现代化研究”重点专项(编号:2018YFC1704200)
国家自然科学基金重点项目(编号:81830113)
广东省自然科学基金项目(编号:2018A030313391)
关键词
贞术调脂胶囊
高脂血症
真实世界
临床疗效
倾向性评分匹配
Zhenzhu Tiaozhi Capsule
hyperlipidemia
real world
clinical efficacy
propensity score matching(PSM)
作者简介
通信作者:郭姣,二级教授、主任医师、博士研究生导师,从事中西医结合防治糖脂代谢性疾病临床及基础研究,E-mail:gyguoyz@163.com;陈滢宇,博士,主治医师,中西医结合防治糖脂代谢性疾病临床及基础研究,E-mail:17287424@qq.com。
