Crosby N J, Deane K H O, Clarke C E
Department of Neurology, City Hospital NHS Trust, Dudley Road, Birmingham, West Midlands, UK, B18 7QH.
Cochrane Database Syst Rev. 2003;2003(2):CD003467. doi: 10.1002/14651858.CD003467.
Abnormal involuntary movements known as dyskinesias are amongst the most disabling side-effects of levodopa therapy. It is thought that amantadine, an NMDA-receptor antagonist, may reduce dyskinesias in patients with Parkinson's disease without worsening Parkinsonian symptoms.
To compare the efficacy and safety of adjuvant amantadine therapy versus placebo in treating dyskinesia in patients with Parkinson's disease, already established on levodopa, and suffering from motor complications.
Electronic searches of The Cochrane Controlled Trials Register (The Cochrane Library Issue 3, 2001), MEDLINE (1966-2001), EMBASE (1974-2001), SCISEARCH (1974-2001), BIOSIS (1993-2001), GEROLIT (1979-2001), OLDMEDLINE (1957-1965), LILACS (1982-2001), MedCarib (17th Century - 2001), PASCAL (1973-2001), JICST-EPLUS (1985-2001), RUSSMED (1973-2001), DISSERTATION ABSTRACTS (2000-2001), SIGLE (1980-2001), ISI-ISTP (1990-2001), Aslib Index to Theses (2001), Clinicaltrials.gov (2001), metaRegister of Controlled Trials (2001), NIDRR (2001) and NRR (2001) were conducted. Grey literature was hand searched and the reference lists of identified studies and reviews examined. The manufacturers of amantadine were contacted.
Randomised controlled trials comparing amantadine with placebo in the treatment of dyskinesia in patients with a clinical diagnosis of idiopathic Parkinson's disease.
Data was abstracted independently by NC and KD onto standardised forms and disagreements were resolved by discussion.
Three randomised controlled trials were found comparing amantadine with placebo in the treatment of dyskinesia in patients with idiopathic Parkinson's disease. Three trials were excluded on the basis that they had no control group and a further three did not state whether they randomised the treatment that participants received. The included trials were double-blind cross-over studies involving a total of 53 patients. All three studies failed to present data from the first arm, instead presenting results as combined data from both treatment arms and both placebo arms. Two trials had no wash-out interval between the treatment periods. In view of the risk of a carry-over effect into the second arm, the results of these trials were not analysed. The final trial had a one week wash-out interval but only examined 11 participants. One study reported side-effects of amantadine in 8 of the 18 participants, including confusion and worsening of hallucinations. Another reported reversible edema of both feet in one of eleven participants.
REVIEWER'S CONCLUSIONS: Due to lack of evidence it is impossible to determine whether amantadine is a safe and effective form of treatment for levodopa-induced dyskinesias in patients with Parkinson's disease.
被称为运动障碍的异常不自主运动是左旋多巴治疗最致残的副作用之一。人们认为,作为一种N-甲基-D-天冬氨酸(NMDA)受体拮抗剂,金刚烷胺可能会减轻帕金森病患者的运动障碍,而不会加重帕金森症状。
比较辅助使用金刚烷胺治疗与使用安慰剂治疗已接受左旋多巴治疗且患有运动并发症的帕金森病患者运动障碍的疗效和安全性。
对Cochrane对照试验注册库(2001年第3期Cochrane图书馆)、MEDLINE(1966 - 2001年)、EMBASE(1974 - 2001年)、SCISEARCH(1974 - 2001年)、BIOSIS(1993 - 2001年)、GEROLIT(1979 - 2001年)、OLDMEDLINE(1957 - 1965年)、LILACS(1982 - 2001年)、MedCarib(17世纪 - 2001年)、PASCAL(1973 - 2001年)、JICST - EPLUS(1985 - 2001年)、RUSSMED(1973 - 2001年)、学位论文摘要(2000 - 2001年)、SIGLE(1980 - 2001年)、ISI - ISTP(1990 - 2001年)、阿斯利布论文索引(2001年)、Clinicaltrials.gov(2001年)、对照试验元注册库(2001年)、国家残疾与康复研究所(2001年)和国家康复研究(2001年)进行了电子检索,并手工检索了灰色文献,检查了已识别研究和综述的参考文献列表,还联系了金刚烷胺的制造商。
比较金刚烷胺与安慰剂治疗临床诊断为特发性帕金森病患者运动障碍的随机对照试验。
NC和KD独立将数据提取到标准化表格上,分歧通过讨论解决。
发现三项比较金刚烷胺与安慰剂治疗特发性帕金森病患者运动障碍的随机对照试验。三项试验因没有对照组而被排除,另外三项未说明是否对参与者接受的治疗进行了随机分组。纳入的试验为双盲交叉研究,共涉及53名患者。所有三项研究均未提供第一组的数据,而是将两个治疗组和两个安慰剂组的合并数据作为结果呈现。两项试验在治疗期之间没有洗脱期。鉴于存在对第二组产生残留效应的风险,未对这些试验的结果进行分析。最后一项试验有一周的洗脱期,但仅研究了11名参与者。一项研究报告18名参与者中有8名出现金刚烷胺的副作用,包括意识模糊和幻觉加重。另一项报告11名参与者中有1名出现双脚可逆性水肿。
由于缺乏证据,无法确定金刚烷胺对于帕金森病患者左旋多巴诱导的运动障碍是否为一种安全有效的治疗方式。