Introduction: While thymectomy is a recommended therapy for patients with Myasthenia Gravis (MG), there is insufficient evidence of its benefits over other therapies in patients in China, specifically, or of… Click to show full abstract
Introduction: While thymectomy is a recommended therapy for patients with Myasthenia Gravis (MG), there is insufficient evidence of its benefits over other therapies in patients in China, specifically, or of the most optimal timing for the procedure. Thus, there remains a clinical need for the investigation of these questions. Therefore, it is important to compare the clinical efficacy of thymectomy plus oral prednisone, an immunosuppressant protocol with prednisone, or immunosuppressants alone. Conclusion: We propose here to prospectively assess 822 cases of MG and 1886 medical records from individuals hospitalized at the First Affiliated Hospital of Guangzhou University of Chinese Medicine and follow them for 3 years. Inclusion criteria will include the following: a Myasthenia Gravis Foundation of America (MGFA) clinical classification between I and IV while on optimal anticholinesterase therapy with or without oral prednisone or immunosuppressive therapy, an MG history of longer than 3 years, being 18 to 60 years of age, and positive testing for serum acetylcholine receptor antibodies (AchR-Ab). Both thymomatous-naïve and non-naïve participants will be included. The primary outcomes will be: mortality, frequency of myasthenic crises, MGFA classification, and changes to the required dose of prednisone and immunosuppressants. Based on these outcomes, we will evaluate the efficacy of thymectomy as well as oral drugs in managing patients with nonthymomatous MG. As of September 2017, this study has been approved by the ethics committee of the First Affiliated Hospital of Guangzhou University of Chinese Medicine and the Registration number is ChiCTR1800017564(Version1.0, September 8,2017).
               
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