| Objective:To evaluate the efficacy and safety of traditional Chinese medicine differentiation and treatment combined with immunosuppressive agents in the treatment of moderate to severe generalized myasthenia gravis in Lingnan region by retrospectively analyzing the clinical data of patients with moderate to severe generalized myasthenia gravis admitted to the First Affiliated Hospital of Guangzhou University of Chinese Medicine,and summarizing the characteristics of traditional Chinese medicine differentiation and treatment of moderate to severe generalized myasthenia gravis.Methods:The medical records of moderate to severe generalized myasthenia gravis hospitalized in the First Affiliated Hospital of Guangzhou University of Chinese Medicine from June 2011 to October 2017 were collected.Patients who met the diagnostic and exclusion criteria were included and a information database was established.Patients treated with different immunosuppressive agents were divided into different treatment groups.The efficacy and safety evaluation of each treatment group were evaluated by telephone follow-ups and reviews of patients' laboratory data in October 2018.The corresponding common prescriptions and herbs for each traditional Chinese medicine differentiation of moderate to severe generalized myasthenia gravis were summarized.Resu t:1.A total of 336 patients with moderate to severe generalized myasthenia gravis were followed up.Tacrolimus group had 109 patients,azathioprine had 121 patients and glucocorticoid group had 106 patients.2.There were no significant differences in gender,age,age of onset,duration of disease,thymectomy,previous myasthenia gravis crisis,Osserman classification,and ADL scores(P>0.05).The follow-up time and drug treatment time were significantly shorter in the tacrolimus group than those in the azathioprine group and the glucocorticoid group(P<0.05).3.At the end of follow-up,the ADL score of tacrolimus group was significantly lower than that of azathioprine group and glucocorticoid group(4.05±2.10 vs 4.88±2.40,5.26±2.43,P<0.05).At the end of follow-up,there was no significant difference in ADL scores(P>0.05)between azathioprine group and glucocorticoid group.At the end of follow-up,the difference of ADL score in the tacrolimus group was significantly greater than the azathioprine group and the glucocorticoid group(-5.23±1.93 vs-3.66±1.65,-2.97±2.43,P<0.05).The difference of ADL score in azathioprine group was significantly greater than the glucocorticoid group(P<0.05).4.At the end of follow-up,the Osserman classification of tacrolimus group was lower than the glucocorticoid group(P<0.05).There was no significant difference in the Osserman classification between the tacrolimus group and azathioprine group(P>0.05).There was no significant difference in the Osserman classification between the azathioprine group and the glucocorticoid group(P>0.05).5.The glucocorticoid dosage in the glucocorticoid group was significantly higher than the tacrolimus group and the azathioprine group(52.6±4.43 mg vs 43.93 ± 5.32 mg,45.00±7.60 mg,P<0.05).There was no significant difference between the azathioprine group and the tacrolimus group(P>0.05).At the end of follow-up,the glucocorticoid dosage in the glucocorticoid group was significantly higher than that in the tacrolimus group and the azathioprine group(23.32±12.08 mg vs9.36±6.89 mg,17.14±9.14 mg,P<0.05).At the end of follow-up,the glucocorticoid dosage in the azathioprine group was significantly greater than in the tacrolimus group(P<0.05).There were no significant differences in glucocorticoid reduction between the three groups(P>0.05).6.The number of myasthenia gravis crisis in the azathioprine group was significantly higher than the tacrolimus group and the glucocorticoid group(0.68±0.58 vs 0.18±0.55,0.34±0.59,P<0.05).There was no significant difference in the number of myasthenia gravis crisis between the tacrolimus group and the glucocorticoid group(P>0.05).During the follow-up period,the number of hospitalizations in the azathioprine group was significantly greater than the tacrolimus group and the glucocorticoid group(2.64±1.15 ks 1.13±1.12,2.00±1.16,P<0.05).The number of hospitalizations in the glucocorticoid group was significantly greater than the tacrolimus group(P<0.05).There were no significant differences in the number of deaths in the three groups(P>0.05).7.There were a total of 30 adverse drug reactions in the tacrolimus group,a total of 27 adverse drug reactions in the azathioprine group,and a total of 57 adverse drug reactions in the glucocorticoid group.No patients discontinued due to serious adverse reactions.8.Among the 336 patients,41(12.2%)patients were diagnosed as spleen-stomach deficiency type,170(50.6%)patients were diagnosed as spleen-kidney deficiency type,and 125(37.2%)patients were diagnosed as spleen-deficiency damp-heat type.The treatment of different patterns of myasthenia gravis in Lingnan region was based on nourishing spleen and stomach,focusing on eliminating dampness and made good use of Lingnan region herbs.The prescriptions were based on Buzhong Yiqi Decoction.Conclusion:The efficacy of tacrolimus combined with glucocorticoids and Chinese Medicine differentiation in the treatment of moderate to severe generalized myasthenia gravis in Lingnan region is better than glucocorticoid combined with Chinese Medicine differentiation,and is superior to azathioprine combined with glucocorticoids and Chinese Medicine differentiation.Different immunosuppressive agents were well tolerated,and no patients discontinued due to serious adverse reactions.The Chinese Medicine patterns of moderate to severe generalized myasthenia gravis in Lingnan region are mainly spleen-kidney deficiency type and spleen-deficiency damp-heat type.The treatment of different patterns of myasthenia gravis in Lingnan region was based on nourishing spleen and stomach,focusing on eliminating dampness and made good use of Lingnan region herbs.The prescriptions were based on Buzhong Yiqi Decoction. |
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