Key Laboratory for Mental Health, Ministry of Health, Institute of Mental Health, Peking University, China.
J Clin Psychiatry. 2011 May;72(5):615-21. doi: 10.4088/JCP.09m05125yel. Epub 2010 Sep 21.
Free radicals may be involved in the pathogenesis of tardive dyskinesia (TD). Extract of Ginkgo biloba (EGb) is a potent antioxidant possessing free radical-scavenging activities. The aim of the study was to evaluate the efficacy of EGb-761, a standardized extract given in capsule form, in treating TD in schizophrenia patients.
Inpatients with DSM-IV-diagnosed schizophrenia and TD (n = 157) in a mainland China Veterans Affairs psychiatric hospital were randomly assigned to 12 weeks of treatment with either EGb-761, 240 mg/d (n = 78) or a placebo (n = 79) in a double-blind manner. Primary outcome measures were (1) change from baseline in the Abnormal Involuntary Movement Scale (AIMS) score and (2) proportion of patients with a ≥ 30% reduction in their AIMS total score at week 12. Secondary outcome measures included the Positive and Negative Syndrome Scale (PANSS) and cognitive performance as measured by the Continuous Performance Test-37 Version and the 3-card Stroop task. Patients were recruited for the study between December 2006 and May 2007.
Of the 157 patients who were randomly assigned, 152 (96.8%) completed the study. EGb-761 treatment significantly decreased the AIMS total score in patients with TD compared to those who were given a placebo (2.13 ± 1.75 vs -0.10 ± 1.69; P < .0001), with 40 (51.3%) and 4 (5.1%) patients achieving response in the EGb-761 and placebo treatment groups, respectively. There were no between-group differences in the PANSS total score or cognitive measures from baseline to week 12.
EGb-761 appears to be an effective treatment for reducing the symptoms of TD in schizophrenia patients, and improvement may be mediated through the well-known antioxidant activity of this extract.
clinicaltrials.gov identifier: NCT00672373.
自由基可能参与迟发性运动障碍（TD）的发病机制。银杏叶提取物（EGb）是一种有效的抗氧化剂，具有自由基清除活性。本研究的目的是评估 EGb-761（一种以胶囊形式给予的标准化提取物）治疗精神分裂症患者 TD 的疗效。
中国大陆退伍军人事务部精神病院符合 DSM-IV 诊断的精神分裂症和 TD 住院患者（n = 157）被随机分配接受 12 周的治疗，分别给予 EGb-761（n = 78）或安慰剂（n = 79）治疗，采用双盲法。主要结局指标为：（1）从基线开始，异常不自主运动量表（AIMS）评分的变化；（2）第 12 周时，AIMS 总分降低≥30%的患者比例。次要结局指标包括阳性和阴性症状量表（PANSS）和认知表现，通过连续绩效测试-37 版本和 3 卡 Stroop 任务进行测量。患者于 2006 年 12 月至 2007 年 5 月间入组该研究。
157 名随机分配的患者中，152 名（96.8%）完成了研究。与安慰剂组相比，EGb-761 治疗可显著降低 TD 患者的 AIMS 总分（2.13 ± 1.75 对-0.10 ± 1.69；P <.0001），分别有 40 名（51.3%）和 4 名（5.1%）患者在 EGb-761 和安慰剂治疗组中获得缓解。从基线到第 12 周，两组之间的 PANSS 总分或认知测量均无差异。
EGb-761 似乎是治疗精神分裂症患者 TD 症状的有效方法，改善可能是通过该提取物的已知抗氧化活性介导的。
clinicaltrials.gov 标识符：NCT00672373。
