中华中医药学刊

脑心通胶囊序贯间歇气压治疗对脑卒中后下肢功能障碍的协同效应研究

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黄娟 , 刘玲玲 , 赵凯

中华中医药学刊 | 国家项目点击 2026,44(8): 81-86

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中华中医药学刊 |国家项目点击 2026 , 44 (8) : 81 -86

脑心通胶囊序贯间歇气压治疗对脑卒中后下肢功能障碍的协同效应研究

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黄娟, 刘玲玲, 赵凯

作者信息

安徽医科大学第一附属医院北区，安徽　合肥　230000

通讯作者:

赵凯（1966-），男，安徽合肥人，主任医师，硕士，研究方向：康复运动医学。E-mail：zkfzr@163.com。

作者简介:

黄娟（1990-），女，安徽合肥人，主治医师，硕士，研究方向：康复医学。

Study on Synergistic Effect of Sequential Intermittent Air Pressure Therapy with Naoxintong Capsules (脑心通胶囊) on Lower Limb Dysfunction After Stroke: A Three-Arm Randomized Controlled Trial

Juan HUANG, Lingling LIU, Kai ZHAO

Affiliations

The First Affiliated Hospital of Anhui Medical University North District, Hefei 230000, Anhui, China

出版时间: 2026-08-10 doi: 10.13193/j.issn.1673-7717.2026.08.018

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摘要

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目的

探讨脑心通胶囊序贯间歇气压治疗对脑卒中后下肢功能障碍患者的临床疗效及安全性。

方法

选取2020年4月—2025年4月医院康复科189例脑卒中后下肢功能障碍患者，随机分为康复组（63例）、中药组（63例）和联合组（63例）。所有组均接受常规治疗，康复组加用安慰剂及真实间歇气压治疗；中药组加用脑心通胶囊及假间歇气压治疗；联合组加用脑心通胶囊及真实间歇气压治疗。3组患者疗程均为8周。通过观察3组患者治疗前、治疗4周后和治疗8周后的Fugl-Meyer评定量表下肢部分（Fugl-meyer assessment lower extremity，FMA-LE）、改良Ashworth痉挛评定量表（Modified ashworth scale，MAS）、改良Rankin量表（Modified rankin scale，mRS）、10 m步行时间（10-Meter walk test，10MWT）、6 min步行距离（6-Minute walk distance，6MWD）及不良事件等指标的差异，进而评估脑心通胶囊序贯间歇气压治疗对脑卒中后下肢功能障碍患者的临床疗效及安全性。

结果

在运动功能方面，治疗4周和8周后，3组患者FMA-LE评分均较治疗前显著提高（P<0.05），其中联合组患者改善最为显著[8周时（25.17±4.18）分vs中药组（23.22±3.44分）和康复组（21.44±3.76）分，P<0.001]。MAS评分显示联合组和中药组患者肌张力改善优于康复组[8周时联合组（1.25±1.09）分vs康复组（1.88±1.40）分，P=0.008]。在步行能力方面，联合组患者10MWT[8周时（16.33±5.66）s]和6MWD[8周时（254.95±46.55）m]改善最为显著（P<0.001）。mRS评分显示3组患者均有改善，但组间差异无统计学意义（P>0.05）。安全性分析显示总不良事件发生率为15.9%（30/189），组间差异无统计学意义（P=0.852）。联合组患者皮肤压伤发生率略高（7例，而康复组4例、中药组3例），但深静脉血栓风险未增加（仅1例），轻度过敏事件集中于中药相关组别（7/9例）。

结论

常规治疗的基础上，脑心通胶囊序贯间歇气压治疗可有效改善脑卒中后下肢功能障碍患者的下肢运动功能、下肢痉挛情况及下肢运动耐力，提高患者的生活质量。

关键词

脑心通胶囊 / 间歇气压治疗 / 脑卒中 / 下肢功能障碍 / 临床疗效 / 协同效应

Abstract

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Objective

To explore the clinical efficacy and safety of sequential intermittent air pressure therapy with Naoxintong Capsules (脑心通胶囊) in the patients with lower limb dysfunction after stroke.

Methods

A total of 189 patients with lower limb dysfunction after stroke were enrolled in the rehabilitation department of the hospital from April 2020 to April 2025 and randomly divided into a control rehabilitation group (63 cases), a Chinese medicine group (63 cases) and a combined treatment group (63 cases). All groups received conventional treatment. The control rehabilitation group received conventional treatment placebo and real intermittent air pressure therapy (basic drugs + rehabilitation training). The Chinese medicine group received Naoxintong Capsules and sham intermittent air pressure therapy. The combined treatment group received Naoxintong Capsules and real intermittent air pressure therapy. The treatment course of the three groups was 8 weeks. The clinical efficacy and safety of sequential intermittent pneumatic compression therapy of Naoxintong Capsules in the patients with lower limb dysfunction after stroke were evaluated by observing the differences in Fugl-meyer assessment lower extremity (FMA-LE), Modified ashworth scale (MAS), Modified rankin scale (mRS), 10-Minute walk time (10MWT), 6-Minute walk distance (6MWD) and adverse events among the three groups before treatment, 4 and 8 weeks after treatment.

Results

In terms of motor function, after 4 and 8 weeks of treatment, the FMA-LE scores of the three groups were significantly improved compared with those before treatment (P<0.05), among which the patients in the combined group had the most significant improvement [(25.17±4.18) points at 8 weeks vs (23.22±3.44) points in the Chinese medicine group and (21.44±3.76) points in the rehabilitation group, P<0.001]. The MAS score showed that the muscle tension of the combined treatment group and the Chinese medicine group was better than that of the control group [(1.25±1.09) points in the combined group vs (1.88±1.40) points in the rehabilitation group at 8 weeks, P=0.008]. In terms of walking ability, the 10MWT [(16.33±5.66) s at 8 weeks] and 6MWD [(254.95±46.55) m at 8 weeks] of the combined group were the most significantly improved (P<0.001). The mRS score showed that all three groups had improvement, but there was no statistically significant difference among the groups (P>0.05). Safety analysis showed that the total incidence of adverse events was 15.9% (30/189), with no significant difference between the groups (P=0.852). The incidence of skin pressure injury in the combined treatment group was slightly higher (7 cases vs.4 cases in the rehabilitation group and 3 cases in the Chinese medicine group), but the risk of deep vein thrombosis was not increased (only 1 case), and mild allergic events were concentrated in the Chinese medicine group (7/9 cases).

Conclusion

On the basis of conventional treatment, sequential intermittent air pressure therapy with Naoxintong Capsules can effectively improve the lower limb motor function, lower limb spasticity and lower limb exercise endurance in the patients with lower limb dysfunction after stroke, and improve the quality of life of the patients.

Key words

Naoxintong Capsules (脑心通胶囊) / intermittent air pressure therapy / stroke / lower limb dysfunction / clinical efficacy / synergistic effect

引用本文

黄娟, 刘玲玲, 赵凯. 脑心通胶囊序贯间歇气压治疗对脑卒中后下肢功能障碍的协同效应研究. 中华中医药学刊, 2026 , 44 (8) : 81 -86 . DOI: 10.13193/j.issn.1673-7717.2026.08.018

Juan HUANG, Lingling LIU, Kai ZHAO. Study on Synergistic Effect of Sequential Intermittent Air Pressure Therapy with Naoxintong Capsules (脑心通胶囊) on Lower Limb Dysfunction After Stroke: A Three-Arm Randomized Controlled Trial[J]. Chinese Archives of Traditional Chinese Medicine, 2026 , 44 (8) : 81 -86 . DOI: 10.13193/j.issn.1673-7717.2026.08.018

基金

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国家重点研发计划项目(2021YFC2500104)

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2026年第44卷第8期

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文章信息

doi: 10.13193/j.issn.1673-7717.2026.08.018

首发时间：2026-10-20
出版时间：2026-08-10

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基金

国家重点研发计划项目(2021YFC2500104)

作者信息

安徽医科大学第一附属医院北区，安徽　合肥　230000

通讯作者:

赵凯（1966-），男，安徽合肥人，主任医师，硕士，研究方向：康复运动医学。E-mail：zkfzr@163.com。

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https://castjournals.cast.org.cn/joweb/zhzyyxk/CN/10.13193/j.issn.1673-7717.2026.08.018

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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