Adler L A, Rotrosen J, Edson R, Lavori P, Lohr J, Hitzemann R, Raisch D, Caligiuri M, Tracy K
Psychiatry Service, New York Department of Veterans Affairs Medical Center, NY 10010, USA.
Arch Gen Psychiatry. 1999 Sep;56(9):836-41. doi: 10.1001/archpsyc.56.9.836.
Several short-term, controlled trials have documented the efficacy of vitamin E in treating tardive dyskinesia. However, the persistent nature of the disease prompted us to perform a multicenter, longer-term trial of vitamin E.
The study was a prospective, randomized, 9-site trial of up to 2 years of treatment with d-vitamin E (1600 IU/d) vs matching placebo. One hundred fifty-eight subjects with tardive dyskinesia who were receiving neuroleptic medications were enrolled. The blinded assessments performed were clinical (Abnormal Involuntary Movements Scale, Barnes Akathisia Scale, and Modified Simpson-Angus [for Extrapyramidal Symptoms] Scale) and electromechanical assessments of movement disorders, psychiatric status (Brief Psychiatric Rating Scale), and functioning (Global Assessment of Functioning). There were no significant differences in baseline demographic characteristics or in study assessments between the group that received vitamin E and the group that received placebo.
Vitamin E was well tolerated and subject compliance with medication was good and similar between treatment groups. One hundred seven subjects (70% of those receiving vitamin E and 66% of subjects receiving placebo) completed at least 1 year of treatment. There were no significant effects of vitamin E on total scores or subscale scores for the AIMS, electromechanical measures of dyskinesia, or scores from the other 4 scales.
This long-term, randomized trial of vitamin E vs placebo found no evidence for efficacy of vitamin E in the treatment of tardive dyskinesia.
多项短期对照试验已证明维生素E治疗迟发性运动障碍的疗效。然而，该疾病的持续性促使我们开展一项关于维生素E的多中心、长期试验。
本研究为前瞻性、随机、9个中心的试验，采用d-维生素E（1600 IU/天）与匹配的安慰剂进行长达2年的治疗。招募了158名正在接受抗精神病药物治疗的迟发性运动障碍患者。进行的盲法评估包括临床评估（异常不自主运动量表、巴恩斯静坐不能量表和改良辛普森-安格斯[锥体外系症状]量表）以及运动障碍的机电评估、精神状态（简明精神病评定量表）和功能（功能总体评定量表）。接受维生素E的组与接受安慰剂的组在基线人口统计学特征或研究评估方面无显著差异。
维生素E耐受性良好，各治疗组患者的药物依从性良好且相似。107名受试者（接受维生素E的受试者中的70%和接受安慰剂的受试者中的66%）完成了至少1年的治疗。维生素E对异常不自主运动量表的总分或子量表分数、运动障碍的机电测量结果或其他4个量表的分数均无显著影响。
这项维生素E与安慰剂的长期随机试验未发现维生素E治疗迟发性运动障碍有效的证据。
