To observe the adverse reactions of thalidomide in the reproductive system, such as menstrual disorders and ovarian reserve function, in women of childbearing age with rheumatic immune diseases and provide references for the safety of clinical medication.

A retrospective analysis was conducted on female patients aged 18~45 years with complete data who visited the Rheumatology and Immunology Department of the First Affiliated Hospital of Nanchang University and received thalidomide treatment from January 2018 to June 2023. The occurrence of menstrual disorders and levels of anti-Müllerian hormone (AMH) during thalidomide use were observed to analyze the potential adverse effects on reproductive system function and risk factors.

A total of 214 patients were included, with an average age of (34.81±6.45) years. The dosage of thalidomide ranged from 25 to 75 mg·d^-1, with a cumulative dose ranging from 750 to 81 000 mg. The treatment duration ranged from 1 to 36 months. The rate of menstrual cycle disorders in women of childbearing age during thalidomide use was as high as 79.59%, with a rate of amenorrhea of 18.37%. Univariate analysis showed a significant correlation between cumulative dose, treatment duration, and decreased AMH levels (P<0.05). The menstrual recovery rate after discontinuation of thalidomide was 62.5% in patients with AMH ≤ 2 ng·mL^-1, while it was 100% in patients with AMH>2 ng·mL^-1. The menstrual recovery time for both groups was within 1~2 months. Pearson correlation analysis showed a negative linear correlation between AMH and daily dose of thalidomide (r=-0.522, P<0.05), cumulative dose (r=-0.807, P<0.05), and treatment duration (r=-0.761, P<0.05). Cox regression analysis showed that a cumulative dose of thalidomide >9 g was an independent risk factor for adverse events in the reproductive system (HR=19.014, P<0.001).

The incidence of menstrual disorders and decreased ovarian reserve function is high in women of childbearing age using thalidomide. Therefore, the reproductive risks should be evaluated, and ovarian reserve function should be monitored to prevent ovarian dysfunction leading to amenorrhea and affecting fertility and quality of life.