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.

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.

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).

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.