Objective

2

To observe the clinical efficacy and safety of

Sizi Powder

（四子散， SP） orientation osmotherapy in the treatment of stroke patients with hemiplegia.

Methods

2

In this study， 94 patients with post-stroke hemiplegia were randomly divided into a control group and a treatment group with 47 patients in each group. The control group received conventional treatment， nursing and rehabilitation training， while the treatment group was treated with SP orientation osmotherapy in addition to the treatments in the control group. The treatment consisted of 20 minutes per session， once daily， 5 times a week， 2 weeks per course， with a total of 2 courses. Before the intervention， after 2 weeks intervention and after 4 weeks intervention， the upper limb motor function was evaluated by using the Fugl-Meyer Assessment （U-FMA）. The modified Ashworth Scale （MAS） was used to assess upper limb spasticity， and joint range of motion was measured for shoulder flexion， extension， abduction， internal rotation， external rotation， elbow flexion， wrist palmar flexion， dorsiflexion， ulnar deviation， and radial deviation. Clinical efficacy for spasticity was evaluated after 2 and 4 weeks of treatment. Skin conditions， including burns， allergic reactions， and blisters， were monitored during the treatment process.

Results

2

A total of 44 patients in the treatment group and 45 patients in the control group completed the study. The results showe

d that after 2 and 4 weeks of intervention， the U-FMA scores of both groups increased， with the treatment group showing higher scores than the control group （

P

＜0.05）. After 4 weeks of treatment， the MAS score distribution improved significantly in both groups （

P

＜0.05）， although no significant difference was found between the groups after 2 and 4 weeks treatment（

P

＞0.05）. The total effective rate of spasticity clinical efficacy in the treatment group after 2 and 4 weeks was 15.91% （7/44） and 40.91% （18/44）， respectively， while in the control group， it was 11.11% （5/45） and 22.22% （10/45）. There was no significant difference after 2 weeks treatment （

P

＞0.05）， but the treatment group showed a significantly higher total effective rate after 4 weeks treatment （

P

＜0.05）. After 2 and 4 weeks of treatment， the joint range of motion in the upper limbs was greater in both groups （

P

＜0.05）. After 2 weeks of intervention， the treatment group showed greater range of motion in shoulder flexion， extension， and abduction than the control group， and after 4 weeks of intervention， the treatment group demonstrated greater range of motion in shoulder flexion， extension， abduction， internal rotation， external rotation， and elbow flexion compared to the control group （

P

＜0.05）. During the treatment， one patient in the treatment group experienced mild skin allergy， while no other severe adverse reactions， such as intense pain， itching， blisters， or infection， were observed in any patients.

Conclusion

2

SP orientation osmotherapy can effectively improve upper limb motor function and joint range of motion in stroke patients with hemiplegia. After 4 weeks of treatment， it can reduce upper limb spasticity and improve clinical efficacy， with good safety.