Catlin D H, Leder B Z, Ahrens B, Starcevic B, Hatton C K, Green G A, Finkelstein J S
UCLA Olympic Analytical Laboratory, 2122 Granville Ave, Los Angeles, CA 90025, USA.
JAMA. 2000;284(20):2618-21. doi: 10.1001/jama.284.20.2618.
Several anabolic steroids are sold over-the-counter (OTC) in the United States, and their production is not regulated by the US Food and Drug Administration. Reports have suggested that use of these supplements can cause positive urine test results for metabolites of the prohibited steroid nandrolone.
To assess the content and purity of OTC androstenedione and to determine if androstenedione and 19-norandrostenedione administration causes positive urine test results for 19-norandrosterone, a nandrolone metabolite.
Randomized controlled trial of androstenedione, open-label trial of 19-norandrostenedione, and mass spectrometry of androstenedione preparations, conducted between October 1998 and April 2000.
Outpatient facility of a university hospital.
A total of 41 healthy men aged 20 to 44 years.
Participants were randomly assigned to receive oral androstenedione, 100 mg/d (n = 13) or 300 mg/d (n = 11) for 7 days, or no androstenedione (n = 13); in addition, 4 patients received 10 microg of 19-norandrostenedione.
Content of OTC androstenedione preparations; level of 19-norandrosterone in urine samples, determined by mass spectrometry, compared among the 3 randomized groups at day 1 and day 7, and among the participants who received 19-norandrostenedione from October 1998 to April 2000.
All urine samples from participants treated with androstenedione contained 19-norandrosterone, while no samples from the no-androstenedione group did. Urinary concentrations were averaged for day 1 vs day 7 measurements; mean (SD) 19-norandrosterone concentrations in the 100-mg/d and 300-mg/d groups were 3.8 (2.5) ng/mL and 10.2 (6.9) ng/mL, respectively (P =. 006). The 19-norandrosterone content exceeded the cutoff for reporting positive cases (>2.0 ng/mL) in 20 of 24. The androstenedione preparation used was pure at a sensitivity of 0.1%, but at 0.001% 19-norandrostenedione was found. For the 4 participants to whom 10 microg of 19-norandrostenedione was administered, 19-norandrosterone was found in all urine samples. Of 7 brands of androstenedione analyzed at the 1% level, 1 contained no androstenedione, 1 contained 10 mg of testosterone, and 4 more contained 90% or less of the amount stated on the label.
Our study suggests that trace contamination of androstenedione with 19-norandrostenedione is sufficient to cause urine test results positive for 19-norandrosterone, the standard marker for nandrolone use. Oral steroid doses as small as 10 microg are absorbed and excreted in urine. Some brands of androstenedione are grossly mislabeled. Careful analysis of androstenedione preparations is recommended in all studies of its biological effects. JAMA. 2000;284:2618-2621.
在美国，有几种合成代谢类固醇在非处方销售，其生产不受美国食品药品监督管理局监管。有报告表明，使用这些补充剂会导致尿液检测中违禁类固醇诺龙代谢物呈阳性结果。
评估非处方雄烯二酮的含量和纯度，并确定服用雄烯二酮和19-去甲雄烯二酮是否会导致尿液检测中诺龙代谢物19-去甲氢睾酮呈阳性结果。
1998年10月至2000年4月间进行的雄烯二酮随机对照试验、19-去甲雄烯二酮开放标签试验以及雄烯二酮制剂的质谱分析。
一所大学医院的门诊机构。
共41名年龄在20至44岁之间的健康男性。
参与者被随机分配接受口服雄烯二酮，100毫克/天（n = 13）或300毫克/天（n = 11），持续7天，或不服用雄烯二酮（n = 13）；此外，4名患者接受了10微克的19-去甲雄烯二酮。
非处方雄烯二酮制剂的含量；通过质谱法测定的尿液样本中19-去甲氢睾酮水平，在第1天和第7天对3个随机分组进行比较，并对1998年10月至2000年4月间接受了19-去甲雄烯二酮的参与者进行比较。
接受雄烯二酮治疗的参与者的所有尿液样本中均含有19-去甲氢睾酮，而未服用雄烯二酮组的样本中均未检测到。对第1天和第7天的测量结果计算尿液浓度平均值；100毫克/天组和300毫克/天组的平均（标准差）19-去甲氢睾酮浓度分别为3.8（2.5）纳克/毫升和10.2（6.9）纳克/毫升（P =.006）。24份样本中有20份的19-去甲氢睾酮含量超过了报告阳性病例的临界值（>2.0纳克/毫升）。所使用的雄烯二酮制剂在灵敏度为0.1%时是纯的，但在0.001%时检测到了19-去甲雄烯二酮。对于接受10微克19-去甲雄烯二酮的4名参与者，所有尿液样本中均检测到了19-去甲氢睾酮。在对7个品牌的雄烯二酮进行1%水平的分析中，1个品牌不含雄烯二酮，1个品牌含有10毫克睾酮，另外4个品牌的含量低于标签标注量的90%。
我们的研究表明，雄烯二酮被19-去甲雄烯二酮微量污染足以导致尿液检测中诺龙使用的标准标志物19-去甲氢睾酮呈阳性结果。低至10微克的口服类固醇剂量会被吸收并通过尿液排出。一些品牌的雄烯二酮存在严重的标签错误。在所有关于雄烯二酮生物学效应的研究中，建议对其制剂进行仔细分析。《美国医学会杂志》。2000年；284：2618 - 2621。
