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12. Seasonal Variation of Estradiol, Follicle Stimulating Hormone, and Dehydroepiandrosterone Sulfate in Women and Men
Åshild Bjørnerem, Bjørn Straume, Pål Øian, and Gro K. R. Berntsen
J Clin Endocrinol Metab 2006 91: 3798-3802; first published July 11 2006 as doi:10.1210/jc.2006-0866
Context: Seasonal variation in daylight regulates reproduction in animals living at higher latitude, but the influence of season on the sex hormones in humans remains unclear.
Objective, Design, and Participants: A cross-sectional population-based study in Tromsø, Norway (70° N) included 1651 women and 1540 men aged 25–84 yr. Circulating total estradiol (and calculated free levels), FSH, and dehydroepiandrosterone sulfate (DHEAS) were measured between September 1994 and September 1995 and provided a unique opportunity to study effects of extreme seasonal variations in the daylight on hormone levels in an arctic population.
Main Outcome Measure: Circulating total and free estradiol, FSH, and DHEAS were measured.
Results: Total and free estradiol showed differences between monthly means, with peak in June in postmenopausal women (P < 0.001), and in May in men (P = 0.002 and P < 0.001) by analysis of covariance. By cosinor analysis, a seasonal variation in total and free estradiol was evident in women (P = 0.02 and P = 0.03) and men (P = 0.004 and P = 0.001), but only 0.2–0.9% of the variation in total and free estradiol was explained by season. FSH and DHEAS showed no obvious seasonal variation in either sex.
Conclusions: Seasonal variations should be considered while designing studies and interpreting results of estradiol measurements to avoid bias in comparative studies
.
男女雌二醇、卵泡刺激激素和硫化脱氢表雄酮的季节变化

背景：白昼的季节变化调节生活在高纬度地区动物的生殖，但季节对人类性激素的影响还未明确。
目的、设计与对象：横断面人群队列研究。研究对象为挪威Tromsø (北纬70度)1651名女性与1540名男性，年龄25-84岁。检测1994年9月至1995年9月间循环中总雌二醇（并计算游离水平），FSH与硫化脱氢表雄酮（DHEAS）。本研究的独特优势为在北极人群中研究白昼的极端季节变化对激素水平的影响。
主要目标检测变量：测定循环中总的和游离雌二醇、FSH与DHEAS。
结果：协方差分析表明每月平均总的及游离雌二醇之间有差异，绝经后女性差异高峰在六月份(P<0.001)，男性差异高峰在五月份(P=0.002且P<0.001)。Cosinor分析表明女性及男性的总雌二醇及游离雌二醇均有明显季节性变化（P=0.02与P=0.03，女性；P=0.004，P=0.001，男性），但季节仅能解释总及游离雌二醇变化的0.2-0.9%。两种性别中FSH与DHEAS均无明显季节性变化。
结论：在研究设计及解释雌二醇检测结果时，应考虑到季节变化，以避免比较研究中的偏差。

2006-11-29 12:32

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40．Effect of Testosterone Replacement Therapy on Prostate Tissue in Men With Late-Onset Hypogonadism: A Randomized Controlled Trial
Leonard S. Marks; Norman A. Mazer; Elahe Mostaghel; David L. Hess; Frederick J. Dorey; Jonathan I. Epstein; Robert W. Veltri; Danil V. Makarov; Alan W. Partin; David G. Bostwick; Maria Luz Macairan; Peter S. Nelson
JAMA. 2006;296:2351-2361.
Context Prostate safety is a primary concern when aging men receive testosterone replacement therapy (TRT), but little information is available regarding the effects of TRT on prostate tissue in men.
Objective To determine the effects of TRT on prostate tissue of aging men with low serum testosterone levels.
Design, Setting, and Participants Randomized, double-blind, placebo-controlled trial of 44 men, aged 44 to 78 years, with screening serum testosterone levels lower than 300 ng/dL (<10.4 nmol/L) and related symptoms, conducted at a US community-based research center between February 2003 and November 2004.
Intervention Participants were randomly assigned to receive 150 mg of testosterone enanthate or matching placebo intramuscularly every 2 weeks for 6 months.
Main Outcome Measures The primary outcome measure was the 6-month change in prostate tissue androgen levels (testosterone and dihydrotestosterone). Secondary outcome measures included 6-month changes in prostate-related clinical features, histology, biomarkers, and epithelial cell gene expression.
Results Of the 44 men randomized, 40 had prostate biopsies performed both at baseline and at 6 months and qualified for per-protocol analysis (TRT, n = 21; placebo, n = 19). Testosterone replacement therapy increased serum testosterone levels to the mid-normal range (median at baseline, 282 ng/dL [9.8 nmol/L]; median at 6 months, 640 ng/dL [22.2 nmol/L]) with no significant change in serum testosterone levels in matched, placebo-treated men. However, median prostate tissue levels of testosterone (0.91 ng/g) and dihydrotestosterone (6.79 ng/g) did not change significantly in the TRT group. No treatment-related change was observed in prostate histology, tissue biomarkers (androgen receptor, Ki-67, CD34), gene expression (including AR, PSA, PAP2A, VEGF, NXK3, CLU [Clusterin]), or cancer incidence or severity. Treatment-related changes in prostate volume, serum prostate-specific antigen, voiding symptoms, and urinary flow were minor.
Conclusions These preliminary data suggest that in aging men with late-onset hypogonadism, 6 months of TRT normalizes serum androgen levels but appears to have little effect on prostate tissue androgen levels and cellular functions. Establishment of prostate safety for large populations of older men undergoing longer duration of TRT requires further study.
雄激素替代治疗晚发男性性腺功能低下对前列腺组织的影响
背景：老年男性接受睾酮替代治疗（TRT）是否会引起前列腺病变是值得关注的问题，但目前关于TRT对男性前列腺的影响报道很少。
目的：评价TRT治疗对于低雄激素血症老年男性前列腺的影响。
研究设计与对象：本研究为一项随机、双盲、安慰剂对照研究，共入组44例44－78岁的男性，其雄激素水平均低于300 ng/dL (<10.4 nmol/L)，且伴有相应症状，研究对象均来源于2003年2月至2004年11月的美国某社区研究中心的人群。
干预方案：研究对象随机分为150mg庚酸睾酮或安慰剂治疗组，每两周肌肉注射，共6月。
观察指标：主要观察指标是前列腺组织雄激素（睾酮和双氢睾酮）在6月间的变化；其他观察指标包括治疗前后6月与前列腺相关的临床特征变化，如组织学、生化指标及上皮细胞基因表达。
结果：在入组的44例患者中，共40例患者在治疗前后接受了前列腺活检(庚酸睾酮组21例; 安慰剂19例)。 TRT治疗使血清睾酮水平升高至中等正常水平，基值中位数282 ng/dL [9.8 nmol/L] ，治疗6个月后升至282 ng/dL [9.8 nmol/L] ；而安慰剂组治疗前后无变化。然而，TRT治疗后，前列腺组织的平均睾酮水平(0.91 ng/g)及双氢睾酮水平(6.79 ng/g)无显著性变化。睾酮治疗前后未发现前列腺组织、生化指标（雄激素受体、Ki-67, CD34）、基因表达（AR, PSA, PAP2A, VEGF, NXK3, CLU [Clusterin]）、肿瘤发生率及严重程度的差别。与治疗相关引起的前列腺大小、血清前列腺特异抗原、排空症状及尿流改变均很微弱。
结论：这些初步结果提示对于晚发男性性腺功能低下患者，6个月的TRT方案可使血清雄激素恢复正常，但对前列腺组织的雄激素水平及细胞功能无影响。在大样本的老年人群中，长期应用TRT方案治疗的对于前列腺是否会有不良影响，有待于进一步的研究来明确。

2006-11-29 12:54

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1.DHEA in Elderly Women and DHEA or Testosterone in Elderly Men
K. Sreekumaran Nair, M.D., Ph.D., Robert A. Rizza, M.D., Peter O'Brien, Ph.D., Ketan Dhatariya, M.D., M.R.C.P., Kevin R. Short, Ph.D., Ajay Nehra, M.D., Janet L. Vittone, M.D., George G. Klee, M.D., Ananda Basu, M.D., Rita Basu, M.D., Claudio Cobelli, Ph.D., Gianna Toffolo, Ph.D., Chiara Dalla Man, Ph.D., Donald J. Tindall, Ph.D., L. Joseph Melton, III, M.D., Ph.D., Glenn E. Smith, Ph.D., Sundeep Khosla, M.D., and Michael D. Jensen, M.D.
Background Dehydroepiandrosterone (DHEA) and testosterone are widely promoted as antiaging supplements, but the long-term benefits, as compared with potential harm, are unknown.
Methods We performed a 2-year, placebo-controlled, randomized, double-blind study involving 87 elderly men with low levels of the sulfated form of DHEA and bioavailable testosterone and 57 elderly women with low levels of sulfated DHEA. Among the men, 29 received DHEA, 27 received testosterone, and 31 received placebo. Among the women, 27 received DHEA and 30 received placebo. Outcome measures included physical performance, body composition, bone mineral density (BMD), glucose tolerance, and quality of life.
Results As compared with the change from baseline to 24 months in the placebo group, subjects who received DHEA for 2 years had an increase in plasma levels of sulfated DHEA by a median of 3.4 µg per milliliter (9.2 µmol per liter) in men and by 3.8 µg per milliliter (10.3 µmol per liter) in women. Among men who received testosterone, the level of bioavailable testosterone increased by a median of 30.4 ng per deciliter (1.1 nmol per liter), as compared with the change in the placebo group. A separate analysis of men and women showed no significant effect of DHEA on body-composition measurements. Neither hormone altered the peak volume of oxygen consumed per minute, muscle strength, or insulin sensitivity. Men who received testosterone had a slight increase in fat-free mass, and men in both treatment groups had an increase in BMD at the femoral neck. Women who received DHEA had an increase in BMD at the ultradistal radius. Neither treatment improved the quality of life or had major adverse effects.
Conclusions Neither DHEA nor low-dose testosterone replacement in elderly people has physiologically relevant beneficial effects on body composition, physical performance, insulin sensitivity, or quality of life.
DHEA对老年女性及DHEA或睾酮对老年男性（的作用）

背景：目前广泛提出脱氢表雄酮（DHEA）与睾酮可作为抗衰老补充剂，但是其远期受益和潜在危险究竟如何，目前仍不清楚。
方法：对87名有低硫酸化DHEA水平和低生物活性睾酮水平的老年男性和57名有低硫化DHEA水平的老年女性进行为期2年的安慰剂对照的随机双盲研究。男性中，29人使用DHEA，27人使用睾酮，31人使用安慰剂。女性中，27人使用睾酮，30人使用安慰剂。观察指标包括：运动耐力、体质组成、骨密度（BMD）、葡萄糖耐量和生活质量。

结果：与安慰剂组自基线至24个月的变化相比，使用DHEA 2年的受试者血浆硫化DHEA水平女性平均升高了3.4μg/ml（9.2μmol/l），男性平均升高了3.8μg/ml（10.3μmol/l）。使用睾酮的男性与对照组相比，有生物活性的睾酮水平平均升高了30.4ng/dl（1.1nmol/l）。将男女分开分析，发现DHEA对体质组成无显著作用。两个激素均不改变每分钟最大耗氧量、肌力或胰岛素敏感性。使用睾酮的男性去脂体重轻度增加，两个治疗组的男性股骨颈的BMD均增加。使用DHEA的女性桡骨远端BMD增加。治疗既未提高生活质量也没有明显的副作用。

结论：在老年人，采用DHEA或者小剂量睾酮替代治疗对于运动耐力、体质组成、胰岛素敏感性或生活质量均不能够对生理学带来益处。

2006-11-29 12:57

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11. Comparison of Methods to Measure Low Serum Estradiol Levels in Postmenopausal Women
Jennifer S. Lee, Bruce Ettinger, Frank Z. Stanczyk, Eric Vittinghoff, Vladimir Hanes, Jane A. Cauley, Walt Chandler, Jim Settlage, Mary S. Beattie, Elizabeth Folkerd, Mitch Dowsett, Deborah Grady, and Steven R. Cummings
J Clin Endocrinol Metab 2006 91: 3791-3797; first published August 1 2006 as doi:10.1210/jc.2005-2378
Context: Accurate measurement of low serum estradiol (E2 < 30 pg/ml or < 110 pmol/liter) is needed to study relationships between endogenous E2 and risks of diseases in older women.
Objective: The objective of this study was to determine whether an extraction-based (indirect) assay or a non-extraction-based (direct) assay correlates better with mass spectrometry and body mass index (BMI).
Design/Setting: In a pilot study of 40 postmenopausal women, endogenous E2 measurements from three indirect and four direct assay methods and gas chromatography-tandem mass spectrometry (GC-MS/MS) were compared. A confirmatory study compared an indirect and a direct assay, selected among those in the pilot study, to GC-MS/MS; this study was conducted in 374 postmenopausal women not taking hormone therapy from the Ultra Low-dose TRansdermal estrogen Assessment (ULTRA) trial.
Main Outcomes: Pearson correlation coefficients among E2 measurements by assay methods and BMI, and their confidence intervals, by bias-corrected bootstrap method, were used.
Results: In the pilot study, E2 by three indirect assays correlated better (P < 0.03) with GC-MS/MS and with BMI than measurements by four direct assays. In the confirmatory study, the indirect assay correlated better (P < 0.01) with GC-MS/MS and BMI than the direct assay. Measurements by the indirect and direct assays were overestimated, but deviations in direct assay measurements were less precise. Mean E2 by the indirect and direct assays were higher (by 14 and 68%, respectively) and less reproducible than by GC-MS/MS.
Conclusion: Until mass spectrometry is practical for wide use, extraction-based indirect assays may be preferable for measuring low postmenopausal serum E2.
测定绝经后女性血清低水平雌二醇的方法比较

背景：在老年女性中，研究内源性雌二醇(E2)与疾病危险性之间的关系需要能够快速测量血清低水平E2（E2<30pg/ml或110pmol/l）的方法

目的：明确基于萃取法（间接）的测定与不基于萃取法（直接）的测定哪种方法与质谱分析和体重指数的相关性更佳。

设计方法：初步研究中，以三种间接测定法和四种直接测定法及气相色谱－串联质谱法（GA-MS/MS）测定40名绝经后女性的内源性E2水平。从初步研究的方法中选择一种直接测定法和一种间接测定法与GC-MS/MS比较，进行验证性研究。验证性研究的对象为374名未接受激素治疗、经皮雌激素测定（ULTRA)试验结果为E2超低水平的绝经后女性。

主要结果：用偏倚校正自举法分析各种方法测定的E2值与BMI之间的Person相关系数及可信区间。

结果：初步研究中，三种间接法测得的E2值与GC-MS/MS及与BMI的相关性优于四种直接法测得的结果(P<0.03)。验证性研究中，间接法与GC-MS/MS的相关性优于直接法(p<0.01)。直接及间接测量法测定的结果偏高，，但直接测定法的偏差精确性较差。间接与直接测定法所得平均E2值较GC-MS/MS高(分别高14%和68%)，且重复性差。

结论：在质谱分析还不能广泛应用之前，基于萃取法的间接测定方法更适于用来测定绝经后血清低水平E2。

2006-11-29 12:59

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