Nakanishi T, Mizuno Y, Goto I, Iwata M, Kanazawa I, Kowa H, Mannen T, Nishitani H, Ogawa N, Takahashi A
Department of Neurology, Mishuku Hospital, Tokyo, Japan.
Eur Neurol. 1991;31 Suppl 1:3-16. doi: 10.1159/000116716.
The interim results of the nationwide collaborative study on the long-term effects of bromocriptine in patients with Parkinson's disease are reported. Four years ago, two prospective clinical studies were started to evaluate the long-term effects of bromocriptine in Parkinson's disease. The first was to investigate the long-term effects of bromocriptine monotherapy and the second to see the long-term effects of a combination therapy of bromocriptine with levodopa. Patients who had never been treated with levodopa were placed on bromocriptine monotherapy, and those who had been treated with levodopa for not more than 5 years were allocated randomly to either the combination or the levodopa group. Two hundred and eighty-six patients were enrolled in the former study and 416 in the latter. Among the 286 patients, 164 continued for further observation at the end of the fourth year, and 74 of them were still being treated with bromocriptine monotherapy. However, in 78, levodopa had to be added. Among the 416 patients in the second study, 216 were allocated to the combination group and 200 to the levodopa control group. At the end of the fourth year, 130 in the former and 140 in the latter group remained for further observation. In all three groups, a gradual loss of efficacy was noted. The rate of efficacy loss appeared largest in the monotherapy group and smallest in the combination group. Effects on tremor and rigidity are still maintained, but effects on akinesia and gait were lost by the end of the fourth year in all groups. Wearing-off and dyskinesias seem to be better managed by the combination therapy. The incidence of wearing-off was very small in the monotherapy group. No serious side effects were encountered except for 1 patient who died of pulmonary fibrosis in the combination group.
本文报告了关于溴隐亭对帕金森病患者长期影响的全国性合作研究的中期结果。四年前，启动了两项前瞻性临床研究，以评估溴隐亭对帕金森病的长期影响。第一项研究旨在调查溴隐亭单一疗法的长期效果，第二项研究则观察溴隐亭与左旋多巴联合疗法的长期效果。从未接受过左旋多巴治疗的患者接受溴隐亭单一疗法，而接受左旋多巴治疗不超过5年的患者则随机分配至联合治疗组或左旋多巴组。前一项研究招募了286名患者，后一项研究招募了416名患者。在286名患者中，164名在第四年末继续接受进一步观察，其中74名仍在接受溴隐亭单一疗法治疗。然而，有78名患者不得不加用左旋多巴。在第二项研究的416名患者中，216名被分配至联合治疗组，200名被分配至左旋多巴对照组。在第四年末，前一组有130名患者、后一组有140名患者仍在接受进一步观察。在所有三组中，均观察到疗效逐渐丧失。疗效丧失率在单一疗法组似乎最高，在联合治疗组似乎最低。对震颤和强直的效果仍得以维持，但到第四年末，所有组对运动不能和步态的效果均已丧失。联合治疗似乎能更好地控制剂末现象和异动症。单一疗法组剂末现象的发生率非常低。除联合治疗组有1名患者死于肺纤维化外，未遇到严重的副作用。
