In a retrospective study, 1863 EEG recordings made during clozapine treatment of 283 patients with normal pretreatment EEG evaluations were analyzed. Furthermore, they were compared to the EEGs of the same patients without clozapine (i.e., during other neuroleptic medication). Moreover, the data of all patients who had seizures during treatment with clozapine were evaluated in case reports. Classical clinical EEG evaluation criteria for normal versus abnormal were used (including diffuse slowing and grouped alterations according to Jung 1953 and Kugler 1983). Of the 283 patients investigated, 61.5% (174) showed at least one abnormal EEG under clozapine according to these criteria. Evaluating all recorded EEGs of these patients in order to get some longitudinal information, we found a rate of 53.4% abnormal EEG recordings during clozapine treatment. Most of the EEG changes were evaluated as slight (22.5%) to moderate (10.1%) diffuse slowing and some as groups of nonparoxysmal waves (39.8%) or sharp waves (16.2%) rendering the EEGs abnormal according to the above criteria. Potential signs of increased bioelectrical cerebral reagibility such as paroxysmal activity (4.3%) or severe diffuse slowing (0.2%) were rare. A nearly linear correlation with the daily dose was found in the range up to 300 mg clozapine/day for both diffuse and grouped alterations. Possibly due to selection, adaptive mechanisms/habituation, and/or other unknown factors, the rate of alterations decreased slightly at doses above 300 mg and rose again sharply for doses over 600 mg/d. Three of the clozapine-treated patients, equivalent to 1.1%, developed seizures.(ABSTRACT TRUNCATED AT 250 WORDS)
Summary:We conducted a dose-escalation study with antithymocyte globulin (ATG) in patients undergoing unrelated donor bone marrow transplantation (URD-BMT). This study analyzes the results for 97 patients with chronic myelogenous leukemia (CML) in first chronic phase. Median age was 36 years (16-51). In all, 40 patients were transplanted within 2 years after diagnosis and 57 later during disease. ATG-S (Fresenius) 20-120 mg/kg body weight (b.w.) was given prior to transplantation. A total of 31 patients received less than 60 mg/kg b.w. and 66 patients received 60 mg/kg b.w. or more. All patients except one were grafted with bone marrow, and graftversus-host disease (GVHD) prophylaxis consisted of cyclosporin A and methotrexate. Graft failure did occur in one patient. Grade II-IV acute GVHD developed in 56.7% and extensive chronic GVHD in 11.3% of the patients. The relapse rate was 13.4%. With a median follow-up of 5.8 years (1.5-12.1), 5-year disease-free and overall survival for all patients were 56 and 66%, and for patients transplanted within 2 years of diagnosis it was 72 and 82%. A lower dose of ATG was a significant risk factor for poor outcome. In summary, URD-BMT remains an excellent treatment option for patients with early phase CML, if a sufficient amount of ATG is included in the preparative regimen.
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