Department of Pediatrics, Kangbuk Samsung Hospital, School of Medicine, Sungkyunkwan University, Seoul, Republic of Korea.
Biostatistics Collaboration Team, Research Core Center, National Cancer Center, Goyang, Republic of Korea.
Front Endocrinol (Lausanne). 2023 Feb 17;14:1134977. doi: 10.3389/fendo.2023.1134977. eCollection 2023.
Triptorelin, a long-acting gonadotropin-releasing hormone (GnRH) agonist, is available in 1-, 3-, and 6-month formulations to treat central precocious puberty (CPP). The triptorelin pamoate 22.5-mg 6-month formulation recently approved for CPP offers greater convenience to children by reducing the injection frequency. However, worldwide research on using the 6-month formulation to treat CPP is scarce. This study aimed to determine the impact of the 6-month formulation on predicted adult height (PAH), changes in gonadotropin levels, and related variables.
We included 42 patients (33 girls and nine boys) with idiopathic CPP treated with a 6-month triptorelin (6-mo TP) formulation for over 12 months. Auxological parameters, including chronological age, bone age, height (cm and standard deviation score [SDS]), weight (kg and SDS), target height (TH), and Tanner stage, were evaluated at baseline, and after 6, 12, and 18 months of treatment. Hormonal parameters, including serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol for girls or testosterone for boys, were analyzed concurrently.
The mean age at treatment initiation was 8.6 ± 0.83 (8.3 ± 0.62 for girls, 9.6 ± 0.68 for boys). The peak LH level following intravenous GnRH stimulation at diagnosis was 15.47 ± 9.94 IU/L. No progression of the modified Tanner stage was observed during treatment. Compared to baseline, LH, FSH, estradiol, and testosterone were significantly reduced. In particular, the basal LH levels were well suppressed to less than l.0 IU/L, and the LH/FSH ratio was less than 0.66. The bone age/chronological age ratio remained stable with a decreasing trend (1.15 at the start of treatment, 1.13 at 12 months, 1.11 at 18 months). PAH SDS increased during treatment (0.77 ± 0.79 at baseline, 0.87 ± 0.84 at the start of treatment, 1.01 ± 0.93 at six months, and 0.91 ± 0.79 at 12 months). No adverse effects were observed during treatment.
The 6-mo TP suppressed the pituitary-gonadal axis stably and improved the PAH during treatment. Considering its convenience and effectiveness, a significant shift to long-acting formulations can be expected.
曲普瑞林是一种长效促性腺激素释放激素（GnRH）激动剂，有 1 个月、3 个月和 6 个月三种剂型，用于治疗中枢性性早熟（CPP）。最近批准用于 CPP 的曲普瑞林癸酸酯 22.5mg6 个月剂型通过减少注射频率，为儿童提供了更大的便利。然而，全球使用 6 个月剂型治疗 CPP 的研究很少。本研究旨在确定 6 个月剂型对预测成年身高（PAH）、促性腺激素水平变化及相关变量的影响。
我们纳入了 42 例特发性 CPP 患者（33 名女孩和 9 名男孩），均接受 6 个月曲普瑞林（6-moTP）治疗超过 12 个月。在基线时及治疗后 6、12 和 18 个月评估了包括身高（cm 和标准差评分[SDS]）、体重（kg 和 SDS）、靶身高（TH）和 Tanner 分期在内的生长参数。同时分析了血清黄体生成素（LH）、卵泡刺激素（FSH）和雌二醇（用于女孩）或睾酮（用于男孩）等激素参数。
治疗开始时的平均年龄为 8.6±0.83 岁（女孩为 8.3±0.62 岁，男孩为 9.6±0.68 岁）。静脉注射 GnRH 刺激后 LH 峰值为 15.47±9.94IU/L。治疗期间无改良 Tanner 分期进展。与基线相比，LH、FSH、雌二醇和睾酮均显著降低。特别是基础 LH 水平被很好地抑制到小于 1.0IU/L，LH/FSH 比值小于 0.66。骨龄/年龄比值保持稳定，呈下降趋势（治疗开始时为 1.15，12 个月时为 1.13，18 个月时为 1.11）。治疗期间 PAH SDS 增加（基线时为 0.77±0.79，治疗开始时为 0.87±0.84，6 个月时为 1.01±0.93，12 个月时为 0.91±0.79）。治疗期间未观察到不良反应。
6-moTP 稳定抑制垂体性腺轴，治疗期间改善 PAH。鉴于其便利性和有效性，预计长效制剂的应用会有显著增加。
