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目的:探讨是否可用帕金森病修订的诊断、自主神经作用、心血管作用、更快的疾病进展或药物相互作用来解释服用左旋多巴和司来吉林随机试验病人的额外死亡。设计:采用开放、随机试验、双盲对照和对死亡原因重新再分组的方法进行研究,病人来源于1985～1990年间93所医院,统计截止于1993年12月前死亡的病人,分第一组和第二组。组织单位:英国研究对象:624例没有接受过多巴胺制剂治疗的早期帕金森病病人和在试验期间死亡的120例。研究方法:第一组服用左旋多巴和多巴脱羧酶抑制剂;第二组服用左旋多巴和多巴脱羧酶抑制剂并联合应用司来吉林;第三组单独服用溴隐亭。主要数据:第一、二组520例及由第三组随机分到第一、二组的104例病人的死亡原因。根据专家组意见、修订的诊断和疾病残疾程度、自主神经和心血管疾病记录的证据、死前其它临床特征和药物相互作用,分析死于原来第一、二组病例的特殊额外死因。结果:将随访延期到1995年9月底(平均6.8年),当第二组试验停止时,第二组的危险比与第一组相比是1.32(95%可信范围在0.98～1.79之间)。将第三组病例随机分入第二组后,其危险比是1.54(0.83～2.87)。当包括全部病例时,其危险比是1.33(1.02～1.74),调整其它基本因素后其危险比是1.30(0.99～1.72)。其额外死亡似乎在随访至第三或四年时为最高。病因特异性死亡率显示额外死亡仅源于帕金森病(其危险率是2.5(1.3～4.7))。修订的诊断、疾病的残疾记分、自主神经或心血管意外、其它临床特征或药物相互作用等均未发现有明显差异。第二组与第一组相比,发现第二组病人在死亡前多合并有可能的痴呆和摔倒史。结论:这些结果一致地显示服用左旋多巴和司来吉林联合治疗的病人有额外死亡。修订的诊断、自主神经和心血管意外或药物的相互作用都不能解释此所见,但摔倒和可能的痴呆在第二组中更常见。本试验结果不支持对早期诊断的帕金森病人进行联合治疗。在疾病晚期,对伴有体位性低血压、意识模糊或痴呆的病人,可以应用联合治疗。
PURPOSE: To examine if additional diagnoses of Parkinson’s disease revision, autonomic effects, cardiovascular effects, faster disease progression or drug interactions can be used to explain the additional deaths of patients randomized to levodopa and seretide in the trial. DESIGN: The study was conducted in an open, randomized, double-blind, and regrouping regimen of causes of death. The patients were recruited from 93 hospitals between 1985 and 1990 with a statistical breakdown of patients who died before December 1993 and were divided into the first group And the second group. Organizational unit: United Kingdom Study population: 624 patients with early Parkinson disease who did not receive dopamine treatment and 120 who died during the trial. Methods: The first group took levodopa and dopa decarboxylase inhibitors; the second group took levodopa and dopa decarboxylase inhibitors combined with the Division to Jilin; the third group took bromocriptine alone. Main data: The first and second groups of 520 cases and the third group randomly assigned to the first and second groups of 104 patients died of the cause. Based on expert panel comments, revised diagnoses and disease disability, evidence of autonomic and cardiovascular disease records, other clinical characteristics before death, and drug interactions, special additional causes of death from the first and second groups were analyzed. Results: The follow-up was postponed until the end of September 1995 (mean, mean duration, 6.8 years). When the second trial was stopped, the hazard ratio for the second trial was 1.32 (95% confidence interval, 0.98 to 1.79) ). After the third group of patients were randomly assigned to the second group, the hazard ratio was 1.54 (0.83 ~ 2.87). When all cases were included, the hazard ratio was 1.33 (1.02-1.74). After adjusting for other underlying factors, the hazard ratio was 1.30 (0.99-1.72). Its extra death appears to be the highest at follow-up to the third or fourth year. Etiopathic-specific mortality showed that extra death was due only to Parkinson’s disease (with a risk of 2.5 (1.3-4.7)). No significant differences were found in the revised diagnosis, disability score of the disease, autonomic or cardiovascular accident, other clinical characteristics or drug interactions. The second group compared with the first group, found that the second group of patients before the death combined with possible dementia and fall history. CONCLUSIONS: These results consistently show that there is an additional death in patients treated with levodopa and selegiline. Revised diagnosis, autonomic and cardiovascular accident or drug interactions can not explain this, but falls and possible dementia are more common in the second group. The results of this trial do not support the combination treatment of patients with Parkinson’s who are diagnosed early. In later stages of disease, combination therapy may be used in patients with orthostatic hypotension, confusion, or dementia.