养血清脑丸联合苯磺酸氨氯地平片治疗血虚肝旺证高血压患者的疗效和安全性：一项多中心随机对照试验

WANG Fan; GAO Hai-qing; LYU Zhe; WANG Xiao-ming; HAN Hui; WANG Yong-xia; LU Feng; DONG Bo; PU Jun; LIU Feng; ZU Xiu-guang; LIU Hong-bin; YANG Li; ZHANG Shao-ying; YAN Yong-mei; WANG Xiao-li; CHEN Jin-han; LIU Min; YANG Yun-mei; LI Xiao-ying

doi:10.1007/s11655-024-4001-4

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养血清脑丸联合苯磺酸氨氯地平片治疗血虚肝旺证高血压患者的疗效和安全性：一项多中心随机对照试验

Original Article | Updated：2025-02-24

- 养血清脑丸联合苯磺酸氨氯地平片治疗血虚肝旺证高血压患者的疗效和安全性：一项多中心随机对照试验
- Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial
- 中国结合医学杂志（英文版） 2025年31卷第3期页码：195-205
- Affiliations：
  
  1.Department of the Cardiology, Chinese PLA General Hospital, Beijing (100853), China
  2.Department of Geriatric, Qilu Hospital of Shandong University, Jinan (250012), China
  3.Department of Encephalopathy, Zhumadian Traditional Chinese Medicine Hospital, Zhumadian, Henan Province (463000), China
  4.Department of Geriatric, Xijing Hospital of Air Force Medical University, Xi'an (710032), China
  5.Department of Geriatric, the First Affiliated Hospital of Harbin Medical University, Harbin (150001), China
  6.Department of the Cardiology, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou (450000), China
  7.Department of the Cardiology, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan (250014), China
  8.Department of the Cardiology, the Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenyang (110034), China
  9.Department of the Cardiology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan Province (637000), China
  10.Department of Geriatric, Guangzhou First People's Hospital, Guangzhou (510180), China
  11.Department of the Cardiology, the Second Hospital of Hebei Medical University, Shijiazhuang (050000), China
  12.Department of Geriatric, Yan'an Hospital of Kunming City, Kunming (650051), China
  13.General Department, the Central Hospital of Wuhan, Wuhan (430014), China
  14.Department of Encephalopathy, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shanxi Province (712000), China
  15.Department of Geriatric, the First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning Province (121001), China
  16.Healcare Department for Cadres, the First Affiliated Hospital of Xiamen University, Xiamen, Fujian Province (361003), China
  17.Specialized Department of Hypertension, Henan Provincial People's Hospital, Zhengzhou (450003), China
  18.Department of Geriatric, the First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou (310003), China
- Author bio：
  
  Prof. LI Xiao-ying, E-mail: xyli301@163.com
- Funds：
  
  the Geriatric Medicine Development Fund of the China Health Promotion Foundation(2020-SRXY-045)
- DOI：10.1007/s11655-024-4001-4
  中图分类号：
- 录用日期：2024-09-19，
  
  网络出版日期：2024-11-18，
  
  纸质出版日期：2025-03
- Accepted：
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养血清脑丸联合苯磺酸氨氯地平片治疗血虚肝旺证高血压患者的疗效和安全性：一项多中心随机对照试验[J]. 中国结合医学杂志（英文版）, 2025,31(3):195-205.

WANG Fan, GAO Hai-qing, LYU Zhe, et al. Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial[J]. Chinese journal of integrative medicine, 2025, 31(3): 195-205.
养血清脑丸联合苯磺酸氨氯地平片治疗血虚肝旺证高血压患者的疗效和安全性：一项多中心随机对照试验[J]. 中国结合医学杂志（英文版）, 2025,31(3):195-205. DOI： 10.1007/s11655-024-4001-4.

WANG Fan, GAO Hai-qing, LYU Zhe, et al. Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial[J]. Chinese journal of integrative medicine, 2025, 31(3): 195-205. DOI： 10.1007/s11655-024-4001-4.

摘要

目的

评价养血清脑丸联合苯磺酸氨氯地平片治疗1级高血压的临床疗效和安全性.

方法

采用多中心、随机、双盲、安慰剂对照的设计

将中医辨证为血虚肝旺证的1级成人高血压患者按1:1的比例随机分配至治疗组和对照组

治疗组予以养血清脑丸和苯磺酸氨氯地平片治疗

对照组予以养血清脑丸安慰剂和苯磺酸氨氯地平片治疗

疗程为180天

比较两组治疗前后血压水平变化、中医证候积分和症状改变及对靶器官保护的效果.

结果

共纳入662例受试者

其中608例 (91.8%) 完成试验 (治疗组306例

对照组302例) . 治疗180天时

治疗组收缩压和舒张压标准差、变异系数水平均小于对照组. 治疗组眩晕、头痛、失眠、腰酸的改善率高于对照组 (

0.05) . 治疗30天时

治疗组中医临床证候总体疗效优于对照组 (

0.05) . 治疗180天时

两组肱踝脉搏波速度、踝臂指数和尿微量白蛋白/肌酐水平均有所改善

但差异未达到统计学意义 (

0.05) . 研究期间未发生严重不良反应.

结论

养血清脑丸联合苯磺酸氨氯地平片方案可明显改善高血压患者眩晕、头痛等症状

降低血压变异率

并有降低尿微量白蛋白/肌酐水平的趋势. 研究表明

该方案具有较好的的临床疗效和安全性. (注册号: ChiCTR1900022470)

Abstract

Objective:

To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension.

Methods:

This is a multicenter

randomized

double-blind

and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate

while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure

Chinese medicine (CM) syndrome scores

symptoms and target organ functions before and after treatment in both groups. Additionally

adverse events

such as nausea

vomiting

rash

itching

and diarrhea

were recorded in both groups.

Results:

A total of 662 subjects were enrolled

of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment

the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness

headache

insomnia

and waist soreness were significantly higher in the treatment group compared with the control group (

0.05). After 30 days of treatment

the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (

0.05). After 180 days of treatment

brachial-ankle pulse wave velocity

ankle brachial index and albumin-to-creatinine ratio were improved in both groups

with no statistically significant differences (

0.05). No serious treatment-related adverse events occurred during the study period.

Conclusions:

Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache

reduced blood pressure variability

and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470)

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