Autoimmune Encephalitis Clinical Trial
Official title:
Prospective Randomized Controlled Trial of Plasma Exchange in Autoimmune Encephalitis
The study is to explore the treatment effects and long-term prognosis (12 months and 24 months after immunotherapy) by comparing the early plasma exchange (PE) combined with medication therapy with the PE after medication immunotherapy in autoimmune encephalitis (AE) patients, to make clear that the early PE can be more effective than the treatment of PE after medication immunotherapy. As well as, the study is to explore whether PE is also effective in AE with autoantibody synthesis in the sheath, positive cerebrospinal fluid antibody and seronegative.
Patients with AE will be randomly divided into the early PE group and the non-early PE group according to the random table. All patients will receive tumour screening, symptomatic supportive treatment, and immunotherapy. The immunotherapy includes high-dose corticosteroid, intravenous gamma immunoglobulin (IVIG; 0.4 g/kg/d for each course for 5 d), PE and immunosuppressants. The immunosuppressants will be given after enrolled 4 weeks. High-dose corticosteroid and PE will be given before IVIG in the early PE group. PE will be given after high-dose corticosteroid and IVIG 2 weeks in the non-early PE group. The mRS will be used for outcome evaluations. The outcomes will be evaluated after 2, 3, 6, 12, and 24 months respectively following immunotherapy. The evaluation standards were as follows: a mRS of 0-2 points is a favourable outcome, and 3-6 points is an unfavourable outcome. Statistically analyses will be employed to examine the differences in outcomes between the severe and non-severe groups. ;
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