关键词: 多囊卵巢综合征, 高雄激素血症, 液相色谱串联质谱, 游离睾酮, 化学发光免疫

Abstract: Objective  To explore the clinical significance of steroid hormones in the diagnosis of polycystic ovary syndrome (PCOS) and to improve the detection rate of hyperandrogenemia (HA) through liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). Methods  The study included 100 PCOS patients with clinical HA and 100 controls were recruited at the Department of Gynecology and Endocrinology of the Beijing Obstetrics and Gynecology Hospital, Capital Medical University from January to December 2023. The receiver operating characteristic (ROC) curve and area under curve (AUC) were used to evaluate the diagnostic efficacy of various androgen levels including total testosterone (TT), free testosterone (FT), bioavailable testosterone (BIO-T), androstenedione (A2), 17-Hydroxyprogesterone, dihydrotestosterone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, sex hormone-binding globulin for PCOS . The diagnostic value of chemiluminescence immunoassay (CLIA) and LC-MS/MS in detecting serum TT levels was compared with each other. The HA detection rate screened by LC-MS/MS and CLIA method was also compared. Results  Compared to the control group, patients with PCOS had a higher TT (P<0.05), luteal hormone (LH, P<0.05), LH/［follicle stimulating hormone, (FSH)］ (P<0.05), anti-Müllerian hormone (P<0.05), fasting insulin (P<0.05) and homeostasis models assessment-insulin resistance index (P<0.05)  measured by CLIA. The FT showed the highest diagnostic value with the AUC 86.4%（P<0.05, 95%CI: 0.815-0.912）, followed by TT with AUC 84.4% (P<0.05, 95%CI: 0.812-0.909), BIO-T with AUC 82.2% (P<0.05, 95%CI: 0.792-0.896) and A2 with AUC 84.2% (P<0.05, 95%CI: 0.790-0.895) in women with PCOS measured by LC-MS/MS. The TT detection by LC-MS/MS had the higher diagnostic sensitivity for PCOS than that by CLIA (AUC was 0.891 to 0.841). The HA detection rate by LC-MS/MS was significantly higher than that by CLIA in patients with PCOS (P<0.05). Conclusions LC-MS/MS is more sensitive and accurate than CLIA in the detection of various androgen indicators. The diagnosis value of FT is most effective for the diagnosis and early screening for HA of PCOS with the clinical manifestations of high androgen, which make it more suitable for clinical application . 

Key words: polycystic ovary syndrome, hyperandrogenemia, liquid chromatography-tandem mass spectrometry, free testosterone, chemiluminescence immunoassay