藤菔降压片联合缬沙坦/氨氯地平治疗2级高血压病肝阳上亢证的随机、双盲、多中心临床试验  

A Randomized,Double-blind,Multi-center Clinical Trial of Tengfu Jiangya Tablets Combined with Valsartan/Amlodipine in Treatment of Grade 2 Hypertension with Hyperactivity of Liver

作　　者：齐于辰 李运伦[2,3] 武玉洁 王海权 王宇 Yang QI Yuchen;LI Yunlun;WU Yujie;WANG Haiquan;WANG Yu(Shandong University of Traditional Chinese Medicine(TCM),Jinan 250355,China;Affiliated Hospital of Shandong University of TCM,Jinan 250014,China;Shandong Cardiovascular Disease Traditional Chinese Medicine Precision Treatment Engineering Laboratory,Jinan 250355,China)

机构地区：[1]山东中医药大学,济南250355 [2]山东中医药大学附属医院,济南250014 [3]山东省心血管病中医精准治疗工程实验室,济南250355

出　　处：《中国实验方剂学杂志》2024年第9期83-92,共10页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：山东省重点研发计划(重大科技创新工程)项目(2021LCZX06);山东省中西医结合高血压项目(2019-11);济南“高校20条”资助项目(2020GXRC017)。

摘　　要：目的:观察藤菔降压片联合缬沙坦/氨氯地平对2级高血压病肝阳上亢证的临床有效性及安全性。方法:按照随机、双盲、安慰剂平行对照方法,纳入7个分中心288例2级高血压肝阳上亢证的患者,随机分为观察组和对照组(各144例),分别给予藤菔降压片联合缬沙坦/氨氯地平和藤菔降压片安慰剂联合缬沙坦/氨氯地平治疗,干预4周后评估疗效。试验过程中记录受试者的安全性指标及不良反应事件等进行安全性评价,记录疗效性指标、中医证候积分等进行有效性评价,同时对血压达标率等主要疗效指标的统计结果进行敏感性分析,保证分析结果的准确性。纳入观察组和对照组血样各88组作为检测对象,在临床试验受试患者服药前1 d和服药结束后第1天分别采集患者空腹血样,对处理后血清使用酶联免疫吸附测定法(ELISA)进行检测,检测患者治疗前后血清中花生四烯酸(AA)、血栓素B2(TXB2)、前列腺素E2(PGE2)的含量,初步探讨藤菔降压片对机体炎症因子的调控。结果:最终共271例患者完成试验(观察组133例,对照组138例),两组患者安全性指标中血常规(白细胞、血红细胞、血小板)、尿常规(尿蛋白、尿血红细胞)、丙氨酸氨基转移酶、天冬氨酸氨基转移酶、肌酐、尿素、心电图异常情况在治疗前后差异均无统计学意义,未见严重不良反应;观察组患者治疗4周后收缩压差值、舒张压差值均大于对照组(P<0.01),根据降压疗效判定标准,观察组总有效率为89.47%(119/133),对照组患者总有效率为57.97%(80/138),观察组患者总有效率显著高于对照组(Z=2.593,P<0.01)。在血压达标率方面,收缩压达标率观察组为61.65%(82/133),对照组为37.68%(52/138);舒张压达标率观察组为78.20%(104/133),对照组为55.07%(76/138);血压整体达标率观察组为48.12%(64/133),对照组23.19%(32/138),观察组均高于对照组(χ^(2)=15.571、16.236、18.404,P<0.01)。根�Objective:To observe the clinical efficacy and safety of Tengfu Jiangya tablets combined with valsartan/amlodipine in the treatment of grade 2 hypertension with liver Yang hyperactivity syndrome.M ethod:According to a randomized,double-blind,and placebo parallel control method,288 patients with grade 2 hypertension with liver Yang hyperactivity from 7 subcenters were included.They were randomly divided into an observation group(144 cases)and a control group(144 cases),and then treated with Tengfu Jiangya tablets combined with valsartan/amlodipine and placebo combined with valsartan/amlodipine,respectively.The efficacy was evaluated after four weeks of intervention.During the experiment,the safety indicators and adverse reaction events of the subjects were recorded for safety evaluation,and the efficacy indicators and TCM syndrome scores were recorded for effectiveness evaluation.Sensitivity analysis was also conducted on the statistical results of the main efficacy indicators such as blood pressure(BP)compliance rate to ensure the accuracy of the analysis results.88 groups of blood samples from each of the treatment and control groups were included as test subjects.Fasting blood samples were collected from the patients in the clinical trial on the day before and after medication,and enzyme linked immunosorbent assay(ELISA)was performed on the treated serum.The levels of arachidonic acid(AA),thromboxane B2(TXB2),and prostaglandin E2(PGE2)in the serum of the patients before and after treatment were measured to explore the regulation of inflammatory factors in the body by Tengfu Jiangya tablets.Result:A total of 271 patients(133 in the observation group and 138 in the control group)completed the trial.There was no statistically significant difference before and after treatment in such safety indicators as the blood routine(white blood cells,red blood cells,and platelets),urine routine(urinary protein and urinary red blood cells),alanine aminotransferase,aspartate aminotransferase,creatinine,urea,and abnormal electro

关 键 词：藤菔降压片 2级高血压 肝阳上亢证 随机、双盲、多中心试验 

分 类 号：R242[医药卫生—中医临床基础] R2-031[医药卫生—中医学] R972.4R544.1