Objective To standardize the selection of clinical research outcome indicators,which can objectively evaluate the clinical efficacy or effect of traditional Chinese medicine in the treatment of myasthenia gravis.This study aims to standardize the construction of the core outcome set of clinical research of traditional Chinese medicine in the treatment of myasthenia gravis.Methods We followed the core outcome set development specification(COS-STAD)to carry out research,established a research working group,which set up a Delphi-method advisory group.Two graduate students of working group conducted a document research and meetings of patients to establishe an outcome set item pool of myasthenia gravis in clinical trials of Chinese medicine under the instruction of other members.With the questionnaire based on the content of item pool,we then carried out Delphi-method expert consultations and a consensus meeting.Results The core outcome set of clinical research on myasthenia gravis treated with traditional Chinese medicine included five outcome domains:endpoint outcome,myasthenia gravis symptom evaluation,medication evaluation,quality of life evaluation and safety outcome;Nine outcome measures:recurrence rate,incidence of hormone complications,incidence of crisis,QMGS scale(MGFA quantitative myasthenia gravis score),daily activity scale of MG patients(ADL),analysis of immunosuppressant dosage,analysis of glucocorticoid dosage,analysis of cholinesterase inhibitor dosage,and incidence of adverse events.Conclusion The five outcome domains and nine outcome measures included in the core outcome set can be used as outcome options for the efficacy evaluation of myasthenia gravis clinical research.

ObjectiveThis study aimed to explore the correlation between the quality of life （QOL） and different traditional Chinese medicine （TCM） syndromes in patients with myasthenia gravis （MG）， identifying potential influencing factors to provide new insights for clinical interventions and improving the QOL of patients with MG. MethodsA questionnaire survey was conducted on 93 adults with MG who visited the Department of Neurology at the Affiliated Hospital of Changchun University of Chinese Medicine from March 2023 to January 2024. Statistical analysis was performed on the clinical data collected using SPSS 24.0 software. ResultsAmong the 93 patients with MG， the average score for myasthenia gravis quality of life-15 （MGQOL-15） was 17.65±6.27， and that for the 36-item short form health survey （SF-36） was （106.13±11.83） scores. The QOL was rated as good for 16 patients and moderate for 77 patients. There were no statistically significant differences in the scores of MGQOL-15， SF-36， and their individual scales by gender or education level. Age showed statistically significant differences in MGQOL-15 and the role physical （RP） scale （P<0.05）， and occupational type showed significant differences in the vitality （VT） scale （P<0.01）. The Myasthenia Gravis Foundation of America （MGFA） classification had statistical significance on the total SF-36 score （P<0.01）， VT scale （P<0.01）， role emotional （RE） scale （P<0.05）， social functioning （SF） scale （P<0.05）， and physical functioning （PF） scale （P<0.01）. Among patients with different TCM syndromes， there were significant differences in MGQOL-15 scores （F=4.919， P<0.01）. Moreover， significant differences were observed in SF-36 scores （P<0.01）， VT scale （P<0.01）， RE scale （P<0.05）， mental health （MH） scale （P<0.01）， and SF scale （P<0.05）. ConclusionFactors affecting the QOL of patients with MG include age， occupational type， and clinical classification of MG. Specifically， a greater impact on the QOL of older patients is observed， while physical laborers have a poorer QOL compared to non-physical laborers. Patients classified as MGFA type Ⅱ and higher have a poorer QOL. Additionally， there is a potential correlation between the QOL and TCM syndromes， with patients presenting with spleen and kidney Qi deficiency having a lower QOL than those with spleen and stomach Qi deficiency or Qi and Yin deficiency， which is particularly evident in the VT， RE， MH， and SF scales.