アルツハイマー型痴呆老人の樹木画テストにおける描画特徴の検討 : 数量化理論による分析

老年期に関する臨床心理学的研究は,幼児期や青年期に関する研究に比べてきわめて少なく,十分に検討されていないのが現状である。臨床現場においてよく用いられる人格検査の一つにバウム・テストがあるが,従来のバウム・テストに関する研究の基礎データには高齢者のデータは含まれてこなかった。そこで今回,われわれは重度痴呆性老人における樹木画の特徴を数量的に明らかにするとともに,多変量解析(数量化II類)により痴呆の重症度に関連のある樹木画の指標について検討した。その結果,(1)「幹の識別ができるもの」,「枝の識別ができるもの」,「樹木と識別できる描画」など,知覚や認知の正確さに関する分析項目と,(2)「用紙全体を使用した描画」など,意欲やエネルギーの程度に関する項目が,痴呆の重症度を判別する指標として有用と考えられた。The clinical psychological studies on the old age are extremely few as compared with the ones on the early childhood and youth. The Baum Test as one of the personality tests has often been used for the purpose of the medical practice. However, the results of the test for aged people have not been included in the past research. Thus, we tried quantitatively to clarify the feature of the tree drawings by elderly people who suffered from heavy dementia. In addition, we examined the index in the tree drawings that seen closely related with dementia of serious degree by the multivariate analysis (Hayashi\u27s second method of quantification). We found that the analysis items concerning the accuracy of perception and acknowledgment (recognizing the trunk, branch and tree) were useful as an index which gave a degree of seriousness of the dementia. We also found that the item concerning the level of the desire and energy (size of drawing) was useful as an index which judges the degree of dementia\u27s serious illness

Safety and efficacy of eculizumab in anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study

Background Complement is likely to have a role in refractory generalised myasthenia gravis, but no approved therapies specifically target this system. Results from a phase 2 study suggested that eculizumab, a terminal complement inhibitor, produced clinically meaningful improvements in patients with anti-acetylcholine receptor antibody-positive refractory generalised myasthenia gravis. We further assessed the efficacy and safety of eculizumab in this patient population in a phase 3 trial. Methods We did a phase 3, randomised, double-blind, placebo-controlled, multicentre study (REGAIN) in 76 hospitals and specialised clinics in 17 countries across North America, Latin America, Europe, and Asia. Eligible patients were aged at least 18 years, with a Myasthenia Gravis-Activities of Daily Living (MG-ADL) score of 6 or more, Myasthenia Gravis Foundation of America (MGFA) class II\ue2\u80\u93IV disease, vaccination against Neisseria meningitides, and previous treatment with at least two immunosuppressive therapies or one immunosuppressive therapy and chronic intravenous immunoglobulin or plasma exchange for 12 months without symptom control. Patients with a history of thymoma or thymic neoplasms, thymectomy within 12 months before screening, or use of intravenous immunoglobulin or plasma exchange within 4 weeks before randomisation, or rituximab within 6 months before screening, were excluded. We randomly assigned participants (1:1) to either intravenous eculizumab or intravenous matched placebo for 26 weeks. Dosing for eculizumab was 900 mg on day 1 and at weeks 1, 2, and 3; 1200 mg at week 4; and 1200 mg given every second week thereafter as maintenance dosing. Randomisation was done centrally with an interactive voice or web-response system with patients stratified to one of four groups based on MGFA disease classification. Where possible, patients were maintained on existing myasthenia gravis therapies and rescue medication was allowed at the study physician's discretion. Patients, investigators, staff, and outcome assessors were masked to treatment assignment. The primary efficacy endpoint was the change from baseline to week 26 in MG-ADL total score measured by worst-rank ANCOVA. The efficacy population set was defined as all patients randomly assigned to treatment groups who received at least one dose of study drug, had a valid baseline MG-ADL assessment, and at least one post-baseline MG-ADL assessment. The safety analyses included all randomly assigned patients who received eculizumab or placebo. This trial is registered with ClinicalTrials.gov, number NCT01997229. Findings Between April 30, 2014, and Feb 19, 2016, we randomly assigned and treated 125 patients, 62 with eculizumab and 63 with placebo. The primary analysis showed no significant difference between eculizumab and placebo (least-squares mean rank 56\uc2\ub76 [SEM 4\uc2\ub75] vs 68\uc2\ub73 [4\uc2\ub75]; rank-based treatment difference \ue2\u88\u9211\uc2\ub77, 95% CI \ue2\u88\u9224\uc2\ub73 to 0\uc2\ub796; p=0\uc2\ub70698). No deaths or cases of meningococcal infection occurred during the study. The most common adverse events in both groups were headache and upper respiratory tract infection (ten [16%] for both events in the eculizumab group and 12 [19%] for both in the placebo group). Myasthenia gravis exacerbations were reported by six (10%) patients in the eculizumab group and 15 (24%) in the placebo group. Six (10%) patients in the eculizumab group and 12 (19%) in the placebo group required rescue therapy. Interpretation The change in the MG-ADL score was not statistically significant between eculizumab and placebo, as measured by the worst-rank analysis. Eculizumab was well tolerated. The use of a worst-rank analytical approach proved to be an important limitation of this study since the secondary and sensitivity analyses results were inconsistent with the primary endpoint result; further research into the role of complement is needed. Funding Alexion Pharmaceuticals