University of Glasgow Department of Child Health, Royal Hospital for Sick Children, Glasgow G3 8SJ, UK.
BMJ. 2011 Apr 14;342:d1980. doi: 10.1136/bmj.d1980.
To examine the effect of oxandrolone and the timing of pubertal induction on final height in girls with Turner's syndrome receiving a standard dose of growth hormone.
Randomised, double blind, placebo controlled trial. Setting 36 paediatric endocrinology departments in UK hospitals.
Girls with Turner's syndrome aged 7-13 years at recruitment, receiving recombinant growth hormone therapy (10 mg/m(2)/week).
Participants were randomised to oxandrolone (0.05 mg/kg/day, maximum 2.5 mg/day) or placebo from 9 years of age. Those with evidence of ovarian failure at 12 years were further randomised to oral ethinylestradiol (year 1, 2 µg daily; year 2, 4 μg daily; year 3, 4 months each of 6, 8, and 10 μg daily) or placebo; participants who received placebo and those recruited after the age of 12.25 years started ethinylestradiol at age 14.
Final height. Results 106 participants were recruited, of whom 14 withdrew and 82/92 reached final height. Both oxandrolone and late pubertal induction increased final height: by 4.6 (95% confidence interval 1.9 to 7.2) cm (P = 0.001, n = 82) for oxandrolone and 3.8 (0.0 to 7.5) cm (P = 0.05, n = 48) for late pubertal induction with ethinylestradiol. In the 48 children who were randomised twice, the effects on final height (compared with placebo and early induction of puberty) of oxandrolone alone, late induction alone, and oxandrolone plus late induction were similar, averaging 7.1 (3.4 to 10.8) cm (P < 0.001). No cases of virilisation were reported.
Oxandrolone had a positive effect on final height in girls with Turner's syndrome treated with growth hormone, as did late pubertal induction with ethinylestradiol at age 14 years. However, these effects were not additive, so using both had no advantage. Oxandrolone could, therefore, be offered as an alternative to late pubertal induction for increasing final height in Turner's syndrome. Trial registration Current Controlled Trials ISRCTN50343149.
研究在接受标准剂量生长激素治疗的特纳综合征女孩中，氧雄龙和青春期诱导时机对最终身高的影响。
随机、双盲、安慰剂对照试验。地点为英国医院的 36 个儿科内分泌科。
入组时年龄为 7-13 岁的特纳综合征女孩，接受重组生长激素治疗（每周 10mg/m²）。
参与者从 9 岁开始随机接受氧雄龙（0.05mg/kg/天，最大 2.5mg/天）或安慰剂治疗。12 岁时出现卵巢功能衰竭的患者进一步随机接受口服乙炔雌二醇（第 1 年，每日 2μg；第 2 年，每日 4μg；第 3 年，每月各 6、8 和 10μg 6 个月）或安慰剂治疗；接受安慰剂的患者和在 12.25 岁后入组的患者在 14 岁时开始服用乙炔雌二醇。
最终身高。结果 106 名参与者入选，其中 14 名退出，82/92 名达到最终身高。氧雄龙和晚期青春期诱导均增加最终身高：氧雄龙组增加 4.6cm（95%置信区间 1.9 至 7.2cm；P=0.001，n=82），乙炔雌二醇组增加 3.8cm（0.0 至 7.5cm；P=0.05，n=48）。在 48 名接受两次随机分组的儿童中，与安慰剂和早期青春期诱导相比，氧雄龙单独、晚期诱导和氧雄龙联合晚期诱导对最终身高的影响相似，平均增加 7.1cm（3.4 至 10.8cm；P<0.001）。未报告有男性化病例。
氧雄龙和 14 岁时用乙炔雌二醇进行晚期青春期诱导均对接受生长激素治疗的特纳综合征女孩的最终身高有积极影响。然而，这些作用并非累加的，因此联合使用没有优势。因此，在特纳综合征中，为了增加最终身高，氧雄龙可以替代晚期青春期诱导。
当前对照试验 ISRCTN50343149。
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