Qishen Liuwei Prescription Combined with Conventional Antihypertensive Therapy in Intervention of Senile Primary Hypertension Complicated with Frailty： A Randomized Controlled Trial
10.13422/j.cnki.syfjx.20260823
- VernacularTitle:芪参六味方联合常规降压治疗干预老年原发性高血压合并衰弱随机对照临床
- Author:
Hanxi CHAN
1
;
Yanran HUI
1
;
Lijun HUANG
2
;
Linbo YU
3
;
Huali XIAO
4
;
Kun ZHOU
5
Author Information
1. Graduate School of Beijing University of Chinese Medicine， Beijing 100029， China
2. Sichuan Province Orthopedic Hospital， Chengdu 610041， China
3. Zunyi Hospital of Traditional Chinese Medicine， Zunyi 563000， China
4. Sir Run Run Shaw Hospital， Affiliated with Zhejiang University School of Medicine， Xinjiang Corps， Alar Hospital， Alar 843300， China
5. Dongfang Hospital， Beijing University of Chinese Medicine， Beijing 100078， China
- Publication Type:Journal Article
- Keywords:
Qishen Liuwei presoription;
senile hypertension complicated with frailty;
Fried frailty phenotype;
traditional Chinese medicine （TCM） syndrome;
randomized controlled trial （RCT）
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(18):162-170
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the clinical efficacy and safety of the Qishen Liuwei presoription for senile hypertension complicated with frailty （of Qi deficiency and blood stasis pattern， or deficiency of both spleen and kidney pattern）. MethodsA single-center， randomized controlled clinical trial design was employed in this study. Sixty-four eligible patients， treated at the Cardiology Outpatient Clinic of Dongfang Hospital， Beijing University of Chinese Medicine between June 2024 and February 2025， were randomly allocated into an observation group or a control group， with 32 patients in each group. Both groups received standard conventional antihypertensive therapy， while the observation group additionally received the Qishen Liuwei Formula （one dose per day， in separate servings in the morning and evening）. For both groups， a treatment course consisted of 4 weeks， followed by a 2-month follow-up period. Then， the primary indicator （Fried frailty phenotype scores）， along with secondary indicators including traditional Chinese medicine （TCM） syndrome scores and changes in blood pressure were observed before and after treatment. ResultsRegarding Fried frailty phenotype scores， the observation group exhibited significantly improved grip strength， 4.57 m walk time， the duration of weekly walks， ''effort required for any activity''， and ''inability to walk forward'' after treatment， while only the latter two indicators were significantly improved in the control group （P<0.05）. Compared with the control group， the observation group demonstrated significantly superior improvement in the duration of weekly walks， ''effort required for any activity''， and frailty （P<0.05）. For total TCM syndrome scores， both groups displayed significantly decreased total TCM syndrome scores （P<0.05） after treatment， and the decrease was more significant in the observation group （P<0.05）. Regarding office blood pressure， both groups showed significantly decreased diastolic blood pressure and mean arterial pressure after treatment， while the observation group also showed significantly decreased systolic blood pressure （P<0.05）. During treatment， one case of facial rash occurred in the observation group， representing an adverse reaction rate of 3.13% （1/32）. The rash resolved one week after discontinuation of medication. No adverse reactions occurred in the control group during treatment. No statistically significant difference was observed in the incidence of adverse reactions between the two groups. ConclusionFor senile hypertension complicated with frailty， the Qishen Liuwei presoription effectively improves physical activity， muscle strength， frailty-related symptoms， and TCM syndrome remission. When combined with Western medicine， the Formula contributes to stable blood pressure control and demonstrates a favorable clinical safety profile， indicating its clinical application potential.
