A Single-case Randomized Controlled Trial Of Qiangji Jianli Capsules In The Treatment Of Myasthenia Gravis With Spleen-stomach Qi Deficiency

Objective:A single-case randomized controlled trial was conducted to study the clinical efficacy and safety of Qiangji Jianli Capsules in the treatment of myasthenia gravis due to spleen-stomach qi deficiency,providing strong clinical evidence for the treatment of myasthenia gravis by TCM syndrome differentiation,and exploring the treatment of Qiangji Jianli Capsules in the treatment of myasthenia gravis.Weak mechanism of action.Methods:Five patients with myasthenia gravis were collected from outpatient clinics and wards who met the inclusion criteria,Osserman's classification was type IIa or type IIb,and the TCM syndrome was spleenstomach-qi deficiency syndrome.This study used a single-case randomized controlled trial.The round of drug treatment program is 8 weeks,the treatment period and the control period are each 4 weeks,the treatment sequence is random,the intermediate drug wash-out period is 1 week,the treatment period: Qiangji Jianli Capsule + Western medicine basic treatment,the control period: placebo + Western medicine basic treatment,total treatment for 29 weeks.The differences of QMG score,MGC score and MG-PRO score between the two groups before and after medication were compared and analyzed.Results:A total of 5 subjects were included,of which 1 case fell off,and 4cases completed the test.Compared with before treatment,QMG,MGC,and MG-PRO after treatment with Qiangjijianli Capsule were significantly improved,and the difference was statistically significant;after placebo treatment,QMG,MGC,and MG-PRO did not change significantly,and there was no statistical difference.Scientific significance: The difference between the two groups after treatment with Qiangji Jianli Capsule and placebo is statistically significant.Subject 1's MGC and MG-PRO scores were significantly improved during the treatment period,and the difference was statistically significant(P<0.05);Subject 4's QMG scores during the treatment period were significantly reduced,and the difference was statistically significant(P<0.05);The scores of the rest of the subjects during the treatment period showed an improvement trend,but the difference was not statistically significant.There were no obvious adverse drug reactions during the treatment.Conclusion:Qiangji Jianli Capsules combined with western medicine in the treatment of myasthenia gravis due to spleen-stomach qi deficiency is significantly better than the western medicine group in terms of Chinese and Western medical efficacy assessment and improvement of the quality of life of patients,and it is safe and effective.There were no adverse reactions in the study.In the individualized efficacy evaluation,the efficacy difference between subjects is obvious.Due to the different conditions of individual patients,for some cases,there is no significant difference in QMG,MGC,and MG-PRO scores between Qiangjijianli Capsule and placebo.