恩他卡朋对帕金森病波动型和非波动型患者均有益：一项随机、安慰剂对照、双盲、为期六个月的研究。
Entacapone is beneficial in both fluctuating and non-fluctuating patients with Parkinson's disease: a randomised, placebo controlled, double blind, six month study.
作者信息
Brooks D J, Sagar H
机构信息
Division of Neuroscience, Faculty of Medicine, Imperial College, Hammersmith Hospital, Du Cane Road, London W12 0NN, UK.
出版信息
J Neurol Neurosurg Psychiatry. 2003 Aug;74(8):1071-9. doi: 10.1136/jnnp.74.8.1071.
OBJECTIVE
To study the effect of entacapone, a specific peripherally acting catechol-O-methyltransferase (COMT) inhibitor used in combination with levodopa treatment, in cases of Parkinson's disease with both fluctuating and non-fluctuating response to treatment.
METHODS
A randomised, placebo controlled, double blind, six month study was undertaken in 172 fluctuating and 128 non-fluctuating patients. The clinical efficacy and safety of 200 mg entacapone given with each daily levodopa dose was studied. Efficacy was examined using home diaries, the unified Parkinson disease rating scale (UPDRS), and recording of daily levodopa dose.
RESULTS
The primary efficacy variable for fluctuating patients-the proportion of daily ON time-showed a significant increase compared with placebo (p < 0.05). The absolute ON time (mean (SD)) increased from 9.5 (2.5) to 10.8 (2.4) hours (p < 0.01), and the daily OFF time was correspondingly reduced from 7.0 (2.6) to 5.9 (2.5) hours (p < 0.05 v placebo). This improvement was achieved despite a reduction in daily levodopa requirements. The effect was rapidly lost on withdrawal of entacapone. In non-fluctuating patients, the primary efficacy measure was part II of the UPDRS (activities of daily living; ADL). In this group of patients, ADL scores improved in the entacapone group (p < 0.01 v placebo), and there was also a 40 mg reduction in levodopa requirement (p < 0.01 v placebo). Entacapone was well tolerated by both fluctuating and non-fluctuating patients.
CONCLUSIONS
The ability of entacapone to provide additional benefits to levodopa treatment in increasing ON time in fluctuating Parkinson's disease patients was confirmed. A novel finding was that patients without fluctuations also obtained benefit from the addition of entacapone to their levodopa treatment, as evidenced by improved ADL scores and a relatively reduced levodopa requirement.
目的
研究恩他卡朋（一种用于左旋多巴治疗的外周特异性儿茶酚-O-甲基转移酶（COMT）抑制剂）对帕金森病患者治疗反应波动和不波动情况的影响。
方法
对172例治疗反应波动的患者和128例治疗反应不波动的患者进行了一项为期6个月的随机、安慰剂对照、双盲研究。研究了每次左旋多巴剂量联合使用200毫克恩他卡朋的临床疗效和安全性。使用家庭日记、统一帕金森病评定量表（UPDRS）以及记录每日左旋多巴剂量来检查疗效。
结果
治疗反应波动患者的主要疗效变量——每日“开”期时间比例——与安慰剂相比显著增加（p<0.05）。绝对“开”期时间（均值（标准差））从9.5（2.5）小时增加到10.8（2.4）小时（p<0.01），每日“关”期时间相应地从7.0（2.6）小时减少到5.9（2.5）小时（与安慰剂相比p<0.05）。尽管每日左旋多巴需求量减少，但仍实现了这种改善。停用恩他卡朋后效果迅速消失。在治疗反应不波动的患者中，主要疗效指标是UPDRS的第二部分（日常生活活动；ADL）。在这组患者中，恩他卡朋组的ADL评分有所改善（与安慰剂相比p<0.01），左旋多巴需求量也减少了40毫克（与安慰剂相比p<0.01）。治疗反应波动和不波动的患者对恩他卡朋的耐受性均良好。
结论
证实了恩他卡朋在增加帕金森病波动患者的“开”期时间方面能够为左旋多巴治疗带来额外益处。一个新发现是，治疗反应不波动的患者在左旋多巴治疗中加用恩他卡朋也能获益，这表现为ADL评分改善以及左旋多巴需求量相对减少。
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