皮下注射曲普瑞林试验诊断女童中枢性性早熟的准确性明显优于 GnRH 激发试验。

High diagnostic accuracy of subcutaneous Triptorelin test compared with GnRH test for diagnosing central precocious puberty in girls.

机构信息

Hospital de Niños Dr. Ricardo Gutiérrez, División de Endocrinología, Centro de Investigaciones Endocrinológicas (CEDIE), Buenos Aires, Argentina.

出版信息

Clin Endocrinol (Oxf). 2013 Mar;78(3):398-404. doi: 10.1111/j.1365-2265.2012.04517.x.

DOI:10.1111/j.1365-2265.2012.04517.x

PMID:22845185

Abstract

CONTEXT

The GnRH test is the gold standard to confirm the diagnosis of central precocious puberty (CPP); however, this compound is not always readily available. Diagnostic accuracy of subcutaneous GnRH analogues tests compared to classical GnRH test has not been reported.

OBJECTIVE

To evaluate the diagnostic accuracy of Triptorelin test (index test) compared to the GnRH test (reference test) in girls with suspicion of CPP.

DESIGN

A prospective, case-control, randomized clinical trial was performed. CPP or precocious thelarche (PT) was diagnosed according to maximal LH response to GnRH test and clinical characteristics during follow-up.

PATIENTS AND INTERVENTIONS

Forty-six girls with premature breast development randomly underwent two tests: (i) intravenous GnRH 100 μg, (ii) subcutaneous Triptorelin acetate (0.1 mg/m(2), to a maximum of 0.1 mg) with blood sampling at 0, 3 and 24 h for LH, FSH and estradiol ascertainment.

MEASUREMENTS

Gonadotrophins and estradiol responses to Triptorelin test were measured by ultrasensitive assays.

RESULTS

Clinical features were similar between CPP (n = 33) and PT (n = 13) groups. Using receiver operating characteristic curves, maximal LH response (LH-3 h) under Triptorelin test ≥ 7 IU/l by immunofluorometric assay (IFMA) or ≥ 8 IU/l by electrochemiluminescence immunoassay (ECLIA) confirmed the diagnosis of CPP with specificity of 1.00 (95% CI: 0.75-1.00) and sensitivity 0.76 (95% CI: 0.58-0.89). Considering either LH-3 h or maximal estradiol response at 24 h (cut-off value, 295 pm), maintaining the specificity at 1.00, the test sensitivity increased to 0.94 (95% CI: 0.80-0.99) and the diagnostic efficiency to 96%.

CONCLUSION

The Triptorelin test had high accuracy for the differential diagnosis of CPP vs PT in girls providing a valid alternative to the classical GnRH test. This test also allowed a comprehensive evaluation of the pituitary-ovarian axis.

摘要

背景

促性腺激素释放激素（GnRH）试验是确诊中枢性性早熟（CPP）的金标准；然而，这种化合物并非总是易于获得。皮下 GnRH 类似物试验与经典 GnRH 试验相比的诊断准确性尚未得到报道。

目的

评估曲普瑞林试验（试验）与 GnRH 试验（参考试验）在疑似 CPP 女孩中的诊断准确性。

设计

进行了一项前瞻性、病例对照、随机临床试验。CPP 或早熟性乳房发育（PT）根据 GnRH 试验的最大 LH 反应和随访期间的临床特征进行诊断。

患者和干预措施

46 名乳房发育过早的女孩随机接受两项检查：（i）静脉内 GnRH 100 μg，（ii）皮下醋酸曲普瑞林（0.1 mg/m2，最大 0.1 mg），在 0、3 和 24 小时采血以测定 LH、FSH 和雌二醇。

测量

通过超灵敏测定法测定曲普瑞林试验的促性腺激素和雌二醇反应。

结果

CPP（n=33）和 PT（n=13）组的临床特征相似。使用受试者工作特征曲线，免疫荧光测定法（IFMA）下曲普瑞林试验中最大 LH 反应（LH-3 h）≥7 IU/l 或电化学发光免疫分析法（ECLIA）下≥8 IU/l 可确诊 CPP，特异性为 1.00（95%置信区间：0.75-1.00），灵敏度为 0.76（95%置信区间：0.58-0.89）。考虑到 LH-3 h 或 24 小时时的最大雌二醇反应（临界值，295 pm），在保持特异性为 1.00 的情况下，该试验的灵敏度提高至 0.94（95%置信区间：0.80-0.99），诊断效率提高至 96%。