Nakanishi T, Mizuno Y, Goto I, Iwata M, Kanazawa I, Kowa H, Mannen T, Nishitani H, Ogawa N, Takahashi A
Department of Neurology, Tsukuba University, Japan.
Eur Neurol. 1988;28 Suppl 1:3-8.
Two prospective projects were started in May 1985 to evaluate the long-term effects of bromocriptine in patients with Parkinson's disease. One of the projects is to see if combination therapy with levodopa and bromocriptine is superior to levodopa alone with regard to the prevention of late side effects of levodopa therapy. The other is to see the long-term effects of bromocriptine monotherapy. Patients with Parkinson's disease were allocated randomly to either combination or levodopa group in the first project. Parkinsonian symptoms, disabilities of daily life and severity of late side effects of long-term levodopa therapy were evaluated by a semiquantitative rating scale. This communication represents the first interim report. Methods of the studies and synopsis of the results at the end of the 12th month are described. A total of 702 patients was enrolled in the study (combination therapy, n = 216; levodopa therapy, n = 200, bromocriptine monotherapy, n = 286). At the end of the 12th month, the numbers of patients who dropped out from the study were 19, 16 and 55 in the three groups, respectively. It appears to be too early to make any definite conclusion with regard to which mode of treatment is superior, however, some evidence suggesting a superiority of the combination therapy over levodopa alone was noted in managing wearing-off phenomenon and dyskinesia. As many patients are sticking to the originally intended mode of treatment, it appears to be possible to obtain more meaningful data in several years.
1985年5月启动了两项前瞻性项目，以评估溴隐亭对帕金森病患者的长期影响。其中一个项目是研究左旋多巴与溴隐亭联合治疗在预防左旋多巴治疗晚期副作用方面是否优于单独使用左旋多巴。另一个项目是观察溴隐亭单一疗法的长期效果。在第一个项目中，帕金森病患者被随机分配到联合治疗组或左旋多巴组。通过半定量评分量表评估帕金森病症状、日常生活能力以及长期左旋多巴治疗晚期副作用的严重程度。本报告为首次中期报告。描述了研究方法以及第12个月末的结果概要。共有702名患者参与了该研究（联合治疗组，n = 216；左旋多巴治疗组，n = 200；溴隐亭单一疗法组，n = 286）。在第12个月末，三组中退出研究的患者人数分别为19、16和55。然而，关于哪种治疗方式更优，现在得出任何明确结论似乎还为时过早，不过，在处理疗效减退现象和运动障碍方面，有一些证据表明联合治疗优于单独使用左旋多巴。由于许多患者坚持最初设定的治疗方式，几年后似乎有可能获得更有意义的数据。
