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rhGH 兴奋剂检测:WADA 批准试剂盒的排泄研究。

Detection of doping with rhGH: excretion study with WADA-approved kits.

机构信息

China Anti-Doping Agency, Beijing, China.

出版信息

Drug Test Anal. 2011 Nov-Dec;3(11-12):784-90. doi: 10.1002/dta.359. Epub 2011 Dec 6.

Abstract

The detection of recombinant human growth hormone (rhGH) doping using the World Anti-Doping Agency (WADA) approved kits is reported in this research. Twenty-five young male students were selected and divided randomly into two groups with six belonging to the placebo and nineteen to the administration group. Thirteen volunteers in one group were administered with a Chinese preparation of rhGH while six volunteers included in the other group were given rhGH made in Switzerland. Both preparations were administered at a dose of 0.1 IU/kg body weight, one injection per day for 14 consecutive days. Blood samples were collected using WADA guidelines and all blood samples were analyzed with WADA-approved Kits 1 and 2. The time window for detection of rhGH doping using WADA-approved kits and criteria are discussed. Based on the comparison of the data obtained from this excretion study and from our routine (Chinese population as reference), consideration of the recent WADA criteria for rhGH AAF (Analytical Adverse Findings) is reported statistically. A comparison of data obtained from the two sample groups administered with pharmaceutical preparations, one Chinese rhGH (GenHeal®, S19990019, 1.6 mg (4 IU), Shanghai, China) obtained from prokaryotic cells and the other (Saizen®, S20080036, 1.33 mg (4 IU), Laboratoires Serone S.A., Switzerland) from eukaryotic cells is reported and did not show any significant difference for the detection of doping with rhGH.

摘要

本研究报道了世界反兴奋剂机构(WADA)批准试剂盒检测重组人生长激素(rhGH)兴奋剂的情况。选择了 25 名年轻男性学生,随机分为两组,每组 6 名属于安慰剂组,19 名属于给药组。一组中的 13 名志愿者接受了国产 rhGH 制剂治疗,另一组中的 6 名志愿者接受了瑞士产 rhGH 制剂治疗。两种制剂的剂量均为 0.1IU/kg 体重,每天注射一次,连续 14 天。按照 WADA 指南采集血样,并用 WADA 批准的试剂盒 1 和 2 对所有血样进行分析。讨论了使用 WADA 批准试剂盒和标准检测 rhGH 兴奋剂的时间窗口。根据本排泄研究和我们常规研究(以中国人群为参考)获得的数据比较,从统计学角度报告了最近 WADA 对 rhGHAAF(分析性不良发现)标准的考虑。对来自两组给药的制剂(来自原核细胞的国产 rhGH(GenHeal®,S19990019,1.6mg(4IU),上海,中国)和来自真核细胞的瑞士产 Saizen®(S20080036,1.33mg(4IU),Laboratoires Serone S.A.,瑞士))的数据进行了比较,在检测 rhGH 兴奋剂方面没有显示出任何显著差异。

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