<italic style="font-style: italic">Compound Tongluo Decoction</italic>（复方通络饮）in Treating Subcortical Ischemic Vascular Mild Cognitive Impairment with Liver-Kidney Deficiency and Phlegm-Stasis Obstructing Collateral Syndrome： A Randomized Controlled Trial

ZHOU Ziqin; DAI Longhua; FU Jiarong; WANG Jingqing; HUI Zhen

doi:10.13288/j.11-2166/r.2025.19.010

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Compound Tongluo Decoction（复方通络饮）in Treating Subcortical Ischemic Vascular Mild Cognitive Impairment with Liver-Kidney Deficiency and Phlegm-Stasis Obstructing Collateral Syndrome： A Randomized Controlled Trial

更新时间：2025-09-26

- Compound Tongluo Decoction（复方通络饮）in Treating Subcortical Ischemic Vascular Mild Cognitive Impairment with Liver-Kidney Deficiency and Phlegm-Stasis Obstructing Collateral Syndrome： A Randomized Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 66, Issue 19, Pages: 2023-2029(2025)
- 作者机构：
  
  1.南京中医药大学附属南京中医院，江苏省南京市秦淮区大明路157号，210001
  2.江苏省丹阳市中医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.19.010
  CLC：
- Received：10 May 2025，
  
  Revised：2025-07-02，
  
  Published：02 October 2025
- 稿件说明：
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周子钦,戴隆华,符加荣等.复方通络饮治疗皮质下缺血性血管性轻度认知障碍肝肾亏虚、痰瘀阻络证的随机对照试验[J].中医杂志,2025,66(19):2023-2029.

ZHOU Ziqin,DAI Longhua,FU Jiarong,et al.Compound Tongluo Decoction（复方通络饮）in Treating Subcortical Ischemic Vascular Mild Cognitive Impairment with Liver-Kidney Deficiency and Phlegm-Stasis Obstructing Collateral Syndrome： A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(19):2023-2029.
周子钦,戴隆华,符加荣等.复方通络饮治疗皮质下缺血性血管性轻度认知障碍肝肾亏虚、痰瘀阻络证的随机对照试验[J].中医杂志,2025,66(19):2023-2029. DOI： 10.13288/j.11-2166/r.2025.19.010.

ZHOU Ziqin,DAI Longhua,FU Jiarong,et al.Compound Tongluo Decoction（复方通络饮）in Treating Subcortical Ischemic Vascular Mild Cognitive Impairment with Liver-Kidney Deficiency and Phlegm-Stasis Obstructing Collateral Syndrome： A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2025,66(19):2023-2029. DOI： 10.13288/j.11-2166/r.2025.19.010.

摘要

目的

观察复方通络饮治疗皮质下缺血性血管性轻度认知障碍（SIVD-MCI）肝肾亏虚、痰瘀阻络证患者的临床疗效，并探讨相关作用机制。

方法

采用随机、平行、对照的临床试验方法，纳入110例SIVD-MCI肝肾亏虚、痰瘀阻络证患者，随机分为治疗组和对照组各55例，两组均给予基础治疗，对照组再给予口服尼莫地平片，每次30 mg，每日3次；治疗组再给予复方通络饮口服，每日1剂，早晚温服。两组均治疗12周。治疗前后比较蒙特利尔认知评估量表（MoCA）评分、简易精神状态检查量表（MMSE）评分、中医证候评分，治疗前后检测患者血清神经血管营养因子［血管内皮生长因子（VEGF）、脑源性神经营养因子（BDNF）、胰岛素样生长因子1（IGF-1）］水平，以及血清氧化应激相关指标［丙二醛（MDA）、活性氧（ROS）、超氧化物歧化酶（SOD）］水平，并于治疗前后检测血常规、肝功能、肾功能指标，记录试验期间不良反应的发生情况以判定安全性。

结果

最终完成试验患者共93例，其中治疗组47例，对照组46例。与本组治疗前比较，两组患者治疗后MoCA、MMSE评分和血清VEGF、BDNF、IGF-1、SOD水平均提高（

＜0.05），中医证候总评分和血清MDA、ROS水平均降低（

＜0.05）。与对照组治疗后比较，治疗组治疗后MoCA、MMSE评分和血清VEGF、BDNF、IGF-1、SOD水平均提高，中医证候总评分和血清MDA、ROS水平均降低（

＜0.05）。治疗期间两组患者均未出现严重肝肾功能损害或死亡等不良结局，实验室检测结果未见与试验药物相关且具有临床意义的变化。

结论

复方通络饮可能通过提高SIVD-MCI肝肾亏虚、痰瘀阻络证患者神经血管营养因子水平、抑制氧化应激反应，从而发挥提高患者认知功能、改善临床症状的作用。

Abstract

Objective

To explore the clinical effectiveness and potential mechanisms of

Compound Tongluo Decoction

（复方通络饮） in

treating patients diagnosed with subcortical ischemic vascular mild cognitive impairment （SIVD-MCI） with liver-kidney deficiency and phlegm-stasis obstructing collateral syndrome.

Methods

We conducted a randomized， parallel-controlled clinical trial involving 110 eligible SIVD-MCI patients with liver-kidney deficiency and phlegm-stasis obstructing collateral syndrome. Participants were randomly assigned to either treatment group （n=55） or control group （n=55）. Both groups received basic treatment. The control group additionally received oral nimodipine tablets at 30 mg for three times daily， and the treatment group additionally received

Compound Tongluo Decoction

orally， one dose daily， taken in the morning and evening. Both groups underwent treatment for 12 weeks. Montreal Cognitive Assessment （MoCA） scores， Mini-Mental State Examination （MMSE） scores， traditional Chinese medicine （TCM） syndrome scores， alterations in serum neurovascular nutrient factors including vascular endothelial growth factor （VEGF）， brain-derived neurotrophic factor （BDNF）， insulin-like growth factor-1 （IGF-1）， and serum oxidative stress-related markers shcu as malondialdehyde （MDA）， reactive oxygen species （ROS）， and superoxide dismutase （SOD） were compared before and after treatment； blood tests， liver/kidney function tests were also conducted at baseline and post-treatment； adverse reactions occurring during the trial were recorded to evaluate safety.

Results

A total of 93 patients completed the trial， including 47 in the treatment group and 46 in the control group. Compared with levels within the group， both groups showed significant increases in MoCA and MMSE scores， as well as serum VEGF， BDNF， IGF-1， and SOD levels after treatment （

＜0.05）， and significant decreases in total TCM syndrome scores and serum MDA and ROS levels （

＜0.05）. Compared with the control group after treatment， the treatment group showed increased MoC

A and MMSE scores， as well as elevated serum VEGF， BDNF， IGF-1， and SOD levels， and decreased TCM syndrome score and serum MDA and ROS levels （

＜0.05）. No adverse outcomes such as severe hepatic or renal dysfunction or mortality occurred in either group during treatment. Laboratory test showed no clinically significant changes related to the study medication.

Conclusion

Compound Tongluo Decoction

may exert its effects in enhancing cognitive function and alleviating clinical symptoms by elevating neurotrophic factor levels and suppressing oxidative stress in SIVD-MCI patients with liver-kidney deficiency and phlegm-stasis obstructing collateral syndrome.

关键词

Keywords

references

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Compound Tongluo Decoction（复方通络饮）in Treating Subcortical Ischemic Vascular Mild Cognitive Impairment with Liver-Kidney Deficiency and Phlegm-Stasis Obstructing Collateral Syndrome： A Randomized Controlled Trial

DOI：10.13288/j.11-2166/r.2025.19.010

摘要

Abstract

关键词

Keywords

references