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中国循证儿科杂志

中国循证儿科杂志 ›› 2023, Vol. 18 ›› Issue (2): 102-105.DOI: 10.3969/j.issn.1673-5501.2023.02.004

• 论著 • 上一篇    下一篇

促性腺激素释放激素类似物应用国际共识（2019）推荐的促黄体生成素值对中国女童中枢性性早熟的诊断准确性研究

林一凡1a,2,张英娴1a,2,付东霞1a,袁淑娴1a,侯玉玮1b,卫海燕1a   

  1. 1 郑州大学附属儿童医院郑州，450018，a 内分泌遗传代谢科，b 河南省儿童遗传代谢性疾病重点实验室；2 共同第一作者
  • 收稿日期:2023-03-14 修回日期:2023-04-23 出版日期:2023-04-25 发布日期:2023-05-19
  • 通讯作者: 卫海燕

Diagnostic accuracy of luteinizing hormone value recommended by the international consensus updated in 2019 on the use of gonadotropin-releasing hormone analogs in children in Chinese grils with central precocious puberty

LIN Yifan1a,2, ZHANG Yingxian1a,2, FU Dongxia1a, YUAN Shuxian1a, HOU Yuwei1b, WEI Haiyan1a   

  1. 1 Children’s Hospital Affiliated to Zhengzhou University, Zhengzhou 450018,China,a. Department of Endocrinology, Genetics and Metabolism,b. Henan Key Laboratory of Children’s Genetics and Metabolic Diseases; 2 Co-first author
  • Received:2023-03-14 Revised:2023-04-23 Online:2023-04-25 Published:2023-05-19
  • Contact: WEI Haiyan, email: haiyanwei2009@163.com

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摘要： 背景：2019年促性腺激素释放激素类似物应用国际共识（简称国际共识）推荐的血清促黄体生成素（LH）对明确或排除中枢性性早熟CPP诊断有重要参考价值，但国内尚无验证。 目的：验证国际共识不同血清LH基础值截断值在中国CPP女童中的诊断水平，期望能减少不必要的促性腺激素释放激素（GnRH）兴奋试验。 设计：诊断准确性研究。 方法：以中国《中枢性性早熟诊断与治疗专家共识（2022版）》中LH（化学发光法）推荐值（LH峰值≥5 IU·L-1且LH峰/FSH峰值≥0.6时结合临床）作为CPP诊断的金标准，以国际共识推荐的2个LH截断值（0.83和0.20 IU·L-1）为待测标准，纳入符合性早熟诊断标准、无月经初潮的、乳房发育Tanner≤Ⅲ期的、行GnRH兴奋试验的4~9岁女童，排除外周性性早熟等。采集患儿的年龄、身高、体重、身体质量指数（BMI）、青春期Tanner分期、性腺轴激素及性激素、骨龄、垂体MR和子宫卵巢超声等临床资料。 主要结局指标：不同血清LH基础值截断值诊断CPP的敏感度和特异度。 结果：352例性早熟女童进入本文分析，金标准诊断CPP 203例，单纯乳房发育（PT）149例；352例平均年龄（7.3±1.0）岁，平均身高（130.6±10.3）cm；CPP女童的年龄、身高、骨龄、血清LH基础值、卵泡刺激素（FSH）基础值、LH/FSH和雌二醇均高于PT女童，差异均有统计学意义。血清LH基础值≥0.83 IU·L-1的特异度（100%，95%CI:97%~100%）高于血清LH基础值<0.20 IU·L-1 （45%，95%CI:37%~53%）和~0.82 IU·L-1（56%，95%CI:47%~63%）。血清LH基础值≥0.83 IU·L-1 的CPP女童乳房Tanner分期、骨龄、骨龄与实际年龄差值均高于＜0.83 IU·L-1的CPP女童，垂体高度小于＜0.83 IU·L-1的CPP女童，差异均有统计学意义（P<0.05）。 结论：采用化学发光法检测性早熟患儿性腺激素时，血清LH基础值≥0.83 IU·L-1时结合临床可诊断CPP，无需行GnRH兴奋试验；LH＜0.20 IU·L-1不能作为CPP的排除标准，需结合临床特征选择性行GnRH兴奋试验协助诊断。

关键词: 中枢性性早熟, 促黄体生成素, 促性腺激素释放激素兴奋试验, 性早熟

Abstract: Background：The 2019 international consensus on central precocious puberty (CPP) proposed that random serum luteinizing hormone (LH) has important reference value for the confirmation or exclusion of CPP, but there is no corresponding diagnostic criteria in China. Objective：By verifying the diagnostic value of the cutoff value of serum LH basal value proposed in the international consensus in 2019 for CPP, it is expected to reduce unnecessary GnRH stimulation tests and provide guidance for clinical practice. Design：Diagnostic accuracy study. Methods：According to the Chinese Expert Consensus on the Diagnosis and Treatment of Central Precocious Puberty (2022 edition) (referred to as the Chinese consensus), the recommended value of LH (chemiluminescence method) (peak LH ≥5 IU·L-1and peak LH /FSH ≥0.6 combined with clinical) was used as the gold standard for the diagnosis of CPP. According to the two cutoff values (0.83 and 0.20 IU·L-1) recommended by the international consensus, girls aged 49 years who met the diagnostic criteria of precocity, did not have menarche, had breast development Tanner stage Ⅲ or below, and underwent GnRH stimulation test were enrolled. Peripheral precocity was excluded. The clinical data of age, height, weight, body mass index (BMI), Tanner stage, gonadal axis hormones and sex hormones, bone age (TW3), pituitary MR and uterine and ovarian ultrasound were collected. Main outcome measures：Sensitivity and specificity of different basic luteinizing hormone cutoff values for diagnosing CPP. Results：A total of 352 girls with precocious puberty were included in the analysis. Among them, 203 cases were diagnosed as CPP and 149 cases were diagnosed as PT according to the gold standard. The average age of precocious puberty was (7.3±1.0) years, and the average height was (130.6±10.3) cm. The CPP girls had significantly higher mean age, height and bone age, and baseline serum LH, FSH, LH/FSH, and E2 levels than the PT girls. The differences were statistically significant. The specificity of baseline serum LH value ≥0.83 IU·L-1 (100%, 95%CI:97%100%) was better than that of baseline serum LH value <0.20 IU·L-1(45%, 95%CI:37%53%) and from 0.20 to 0.82 IU·L-1 (56%, 95%CI:47%63%). The CPP girls with a baseline LH level of ≥0.83 IU·L-1 had significantly higher breast Tanner stage, bone age, and bone agechronological age difference than those with a baseline LH level of <0.83 IU·L-1 (P<0.05), and a significantly lower pituitary height than those with a baseline LH level of < 0.83 IU·L-1 (P<0.05). Conclusions：When chemiluminescence method is used to detect gonadal hormone in children with precocious puberty, CPP can be diagnosed with serum LH base value ≥ 0.83 IU·L-1, and GnRH excitation test is not required LH <0.20 IU·L-1 cannot be used as the exclusion criteria for CPP, and sexual GnRH excitation test should be selected to assist diagnosis based on clinical characteristics.

Key words: Central precocious puberty, Luteinizing hormone, Gonadotropin-releasing hormone stimulation test, Precocious puberty