Olanow C W, Myllylä V V, Sotaniemi K A, Larsen J P, Pålhagen S, Przuntek H, Heinonen E H, Kilkku O, Lammintausta R, Mäki-Ikola O, Rinne U K
Department of Neurology, Mount Sinai School of Medicine, New York, NY 10029, USA.
Neurology. 1998 Sep;51(3):825-30. doi: 10.1212/wnl.51.3.825.
The Parkinson's Disease Research Group of the United Kingdom (PDRG-UK) reported increased mortality in PD patients treated with levodopa plus selegiline compared with those treated with levodopa alone.
We performed a meta-analysis on five long-term, prospective, randomized trials of selegiline in patients with untreated PD. Included in the analysis were four randomized, double-blind, placebo-controlled studies and one randomized, double-blind, placebo-controlled study of 2 years' duration followed by long-term, open follow-up.
The mean duration of follow-up was 4.1 +/- 1.8 years. There were 14 deaths in 297 selegiline-treated patients (4.7%) and 17 deaths in 292 non-selegiline-treated patients (5.8%). The hazard ratio for mortality was 1.02 (95% CI 0.44 to 2.37; p = 0.96). An analysis restricted to patients receiving only levodopa with or without selegiline noted 11 deaths in 257 levodopa/selegiline-treated patients (4.3%) and 11 deaths in 254 patients treated with levodopa alone (4.3%). The hazard ratio was 1.06 (95% CI 0.44 to 2.55; p = 0.90). Death rate per 1,000 patient years was 11.4 in the selegiline group and 14.2 in the nonselegiline group. Kaplan-Meier survival curves reflecting pooled survival data showed no significant difference in duration of survival. The hazard ratio was 0.84 (95% CI 0.41 to 1.70; p = 0.63) for selegiline- versus non-selegiline-treated patients and 1.05 (95% CI 0.46 to 2.43; p = 0.91) for selegiline/levodopa- versus levodopa-treated patients.
These results contrast with those of the PDRG-UK study and demonstrate no increase in mortality associated with selegiline treatment whether or not patients also received levodopa.
英国帕金森病研究小组（PDRG-UK）报告称，与仅接受左旋多巴治疗的帕金森病患者相比，接受左旋多巴加司来吉兰治疗的患者死亡率有所增加。
我们对五项关于司来吉兰治疗未经治疗的帕金森病患者的长期、前瞻性、随机试验进行了荟萃分析。纳入分析的有四项随机、双盲、安慰剂对照研究，以及一项为期2年的随机、双盲、安慰剂对照研究，随后进行长期开放随访。
平均随访时间为4.1±1.8年。297例接受司来吉兰治疗的患者中有14例死亡（4.7%），292例未接受司来吉兰治疗的患者中有17例死亡（5.8%）。死亡风险比为1.02（95%可信区间0.44至2.37；p = 0.96）。对仅接受左旋多巴（无论是否联合司来吉兰）的患者进行的分析显示，257例接受左旋多巴/司来吉兰治疗的患者中有11例死亡（4.3%），254例仅接受左旋多巴治疗的患者中有11例死亡（4.3%）。风险比为1.06（95%可信区间0.44至2.55；p = 0.90）。司来吉兰组每1000患者年的死亡率为11.4，非司来吉兰组为14.2。反映汇总生存数据的Kaplan-Meier生存曲线显示，生存时间无显著差异。司来吉兰治疗组与非司来吉兰治疗组的风险比为0.84（95%可信区间0.41至1.70；p = 0.63），司来吉兰/左旋多巴治疗组与左旋多巴治疗组的风险比为1.05（95%可信区间0.46至2.43；p = 0.91）。
这些结果与PDRG-UK研究的结果形成对比，表明无论患者是否同时接受左旋多巴治疗，司来吉兰治疗均不会增加死亡率。
