Mannen T, Mizuno Y, Iwata M, Goto I, Kanazawa I, Kowa H, Nishitani H, Ogawa N, Takahashi A, Tashiro K
Department of Neurology, University of Tokyo, Japan.
Neurology. 1991 Oct;41(10):1598-602. doi: 10.1212/wnl.41.10.1598.
We report on the clinical efficacy of a slow-release formulation of bromocriptine studied in a multi-center, double-blind trial using standard bromocriptine as the control. We randomly allocated enrolled patients (N = 243) to either the slow-release or normal bromocriptine group. Sixty of them were de novo patients. The maintenance dose of slow-release bromocriptine was 14.2 +/- 0.7 mg/d and that of standard bromocriptine 13.5 +/- 0.7 mg/d (mean +/- SE). The slow-release formulation was taken twice and the standard three times a day. Forty-one percent of the patients treated with the slow-release bromocriptine and 32% of the patients treated with the standard bromocriptine showed moderate or marked improvement in the global improvement rating. There were no serious side effects, and the frequency of vomiting and epigastric discomfort was lower in the patients treated with the slow-release bromocriptine. Clinical efficacies for tremor, rigidity, akinesia, and gait disturbance were comparable between the two drugs tested. The slow-release bromocriptine seems to be a valuable drug for the treatment of Parkinson's disease with less severe side effects than regular bromocriptine.
我们报告了一项多中心、双盲试验中研究的溴隐亭缓释制剂的临床疗效,该试验以标准溴隐亭作为对照。我们将入选患者(N = 243)随机分配至缓释溴隐亭组或普通溴隐亭组。其中60例为初治患者。缓释溴隐亭的维持剂量为14.2±0.7mg/d,标准溴隐亭为13.5±0.7mg/d(均值±标准误)。缓释制剂每日服用两次,标准制剂每日服用三次。服用缓释溴隐亭的患者中有41%、服用标准溴隐亭的患者中有32%在整体改善评分上显示出中度或显著改善。未出现严重副作用,且服用缓释溴隐亭的患者呕吐和上腹部不适的发生率较低。两种受试药物在震颤、强直、运动不能和步态障碍方面的临床疗效相当。缓释溴隐亭似乎是一种治疗帕金森病的有价值药物,其副作用比常规溴隐亭轻。