Objective

2

To investigate the efficacy and safety of

Jianpi Bushen Yiqi Formula

（健脾补肾益气方， JBYF） as an adjuvant treatment for myasthenia gravis（MG）patients with spleen-kidney deficiency syndrome and to preliminarily clarify its possible mechanism.

Methods

2

A total of 54 MG patients with spleen-kidney deficiency syndrome were randomly assigned to either control group （28 cases） or treatment group （26 cases）. Both groups received oral pyridostigmine bromide and prednisone acetate tablets， while the treatment group additionally received JBYF. The treatment course for both groups was 12 weeks. Primary outcomes included Quantitative Myasthenia Gravis （QMG） score， traditional Chinese medicine （TCM） syndrome score， and overall clinical efficacy； secondary outcomes included Myasthenia Gravis Activities of Daily Living （MG-ADL） score， the rate of minimal symptom expression （MSE） after treatment， the Myasthenia Gravis Foundation of America Post-Intervention Status （MGFA-PIS） classification， MGFA clinical classification， baseline western medicine dosage， and serum anti-acetylcholine receptor antibody （AChR-Ab） levels. Safety evaluations were also performed.

Results

2

Two cases in the treatment group and four in the control group withdrew from the study， therefore， 24 cases in each group were included in the final analysis. The total clinical effective rate in the treatment group was 87.50% （21/24）， significantly higher than 25.00% （6/24） in the control group （

P

＜0.01）. After tr

eatment， both groups showed significant reductions in QMG scores， MG-ADL scores， serum AChR-Ab level and the dosages of pyridostigmine bromide and prednisone acetate （

P

＜0.05）. In the treatment group， the TCM syndrome score also decreased， and MGFA classification showed an increase in class Ⅰ and a decrease in classes Ⅱ， Ⅲ， and Ⅳ （

P

＜0.05）. The treatment group demonstrated significantly lower QMG score， TCM syndrome score， MG-ADL score， and western medication dosages compared to the control group， with more changes from baseline （

P

＜0.05 or

P

＜0.01）. The proportion of patients achieving MSE was 75.00% （18/24） in the treatment group， significantly higher 45.83% （11/24） in the control group （

P

＜0.05）. No significant difference was observed in MGFA-PIS classification between groups after treatment （

P

＞0.05）. There were 2 cases mild adverse events in the treatment group and 5 cases in the control group， none of which were serious.

Conclusion

2

JBYF can improve muscle weakness symptoms and TCM syndrome manifestations in MG patients with spleen-kidney deficiency， enhance daily living ability， promote transition to a stable disease state， and reduce the required doses of baseline western medications. Its mechanism may be related to the modulation of immune function by reducing serum AChR-Ab levels. The treatment demonstrates good safety and tolerability.