Testosterone therapy in men with Parkinson disease - Results of the TEST-PD study
Testosterone therapy in men with Parkinson disease - Results of the TEST-PD study
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DOI：
10.1001/archneur.63.5.729
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发表时间：
2006-05-01
影响因子：
--
通讯作者：
Crucian, G
中科院分区：
文献类型：
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作者：
Okun, MS;Fernandez, HH;Crucian, G
背景：帕金森病（PD）、阿尔茨海默病和亨廷顿舞蹈病患者中有报道存在睾酮缺乏症。目前尚不清楚睾酮治疗（TT）是否对边缘性性腺功能减退症和神经退行性疾病的男性有实质性益处。以前，我们曾报道过，与年龄匹配的对照组相比，PD患者中睾酮缺乏更为常见，我们还在2项小型开放标签研究中报道了TT对某些非运动症状的有利反应。目的：确定TT对PD和可能的睾酮缺乏男性患者的非运动和运动症状的影响。设计：双盲、安慰剂对照、平行组、单中心试验。患者：两个实验组：干预：参与者通过肌内注射（200 mg/mL庚酸睾酮，每2周持续8周）或安慰剂（等渗氯化钠溶液注射）接受研究药物。在每组患者中，在每次研究访视时获得睾酮血清浓度。在2个研究访问，睾酮水平进行了盲法评估和肌内睾酮剂量增加200毫克/毫升，如果游离睾酮值未能从基线value.Main结果的两倍措施：主要结果变量是圣刘易斯睾酮缺乏问卷，和次要结果的措施包括情绪，认知，疲劳，运动功能和不良事件的频率的措施。在双盲期结束时，所有患者均接受开放标签TT，并在3个月和6个月后进行随访。安慰剂组15例患者（平均年龄，69.9岁），接受平均总左旋多巴等效剂量为924 mg/d，基线游离睾酮水平为47.91 pg/mL，而TT组中有15例患者（平均年龄，66.7岁），接受平均总左旋多巴等效剂量为734 mg/d，基线游离睾酮水平为63.49 pg/mL。替吉奥通常耐受良好。TT组中发生下肢水肿的受试者更多（40% vs 20%）。在2例患者中，每组各1例，前列腺特异性抗原水平较基线升高。与安慰剂组相比，TT组在圣刘易斯睾酮缺乏量表上的改善（1.7 vs 1.1）无统计学显著性。此外，两组间PD的运动和非运动特征无显著差异，尽管少数分量表显示改善（霍普金斯言语学习测试，P
Background: Testosterone deficiency has been reported in patients with Parkinson disease (PD), Alzheimer disease, and Huntington disease. It is not known whether testosterone therapy (TT) in men with borderline hypogonadism and neurodegenerative diseases will be of substantial benefit. Previously, we reported that testosterone deficiency is more common in patients with PD compared with age-matched control subjects, and we also reported in 2 small open-label studies that some nonmotor symptoms responded favorably to TT.Objective: To define the effects of TT on nonmotor and motor symptoms in men with PD and probable testosterone deficiency.Design: Double-masked, placebo-controlled, parallel-group, single-center trial.Patients: Two experimental groups: patients with PD who were receiving either TT or placebo.Interventions: Participants received either the study drug by intramuscular injection (200 mg/mL of testosterone enanthate every 2 weeks for 8 weeks) or placebo (isotonic sodium chloride solution injections). In patients in each group, the testosterone serum concentration was obtained at each study visit. During 2 study visits, testosterone levels were blindly evaluated and the intramuscular testosterone dose was increased by 200 mg/mL if the free testosterone value failed to double from the baseline value.Main Outcome Measures: The primary outcome variable was the St Louis Testosterone Deficiency Questionnaire, and secondary outcome measures included measures of mood, cognition, fatigue, motor function, and frequency of adverse events. At the end of the double-blind phase, all patients were offered open-label TT and were followed up after 3 and 6 months.Results: Fifteen patients in the placebo group (mean age, 69.9 years), receiving a mean total levodopa equivalent dose of 924 mg/d, had a baseline free testosterone level of 47.91 pg/mL, compared with 15 patients in the TT group (mean age, 66.7 years), receiving an average total levodopa equivalent dose of 734 mg/d, who had a baseline free testosterone level of 63.49 pg/mL. Testosterone was generally well tolerated. More subjects in the TT group experienced lower extremity edema (40% vs 20%). In 2 patients, 1 in each group, prostate-specific antigen levels were elevated from baseline. The improvement in the TT group compared with the placebo group (1.7 vs 1.1) on the St Louis Testosterone Deficiency Scale was not statistically significant. In addition, there were no significant differences in motor and nonmotor features of PD between the 2 groups, although a few subscales showed improvements (Hopkins Verbal Learning Test, P