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Abstract Objective: To observe the clinical effects of levonorgestrelintrauterine releasing system (LNGIUS) treating uterine fibroid patients, and to explore the influence of levonorgestrel on uterine leiomyoma cells (UtLMCs) proliferation and apoptosis. Methods: (1) LNGIUS were inserted in thirtysix patients with uterine fibroid who were scraped off most endometrium 35 days after menstruation. In the 1, 3, 12, 48month followed up, the menstrual blood volume, hemoglobin level, uterine volume, expulsion rate and adverse event rate were observed, and myoma volume measured by B ultrasound. (2) After LNG and E2 treatment, the growth rate of cultured primary uterine leiomyoma cell was detected by methyl thiazolyl tetrazolium (MTT) assay. Cell apoptosis rate was determined by morphological changes and flow cytometry. Results: (1) Menstrual blood volume was reduced significantly, the hemoglobin level significant rose, and the uterine volume decreased in the first month after the LNGIUS inserted. These clinical changes were more and more significant over time, which had significant different compared to patients inserted LNGIUS before（P=0.028）. However, there was no significant change in the volume of uterine fibroids. The rate of menstruation volume had reduced and amenorrhea had increased gradually with the time extension of LNGIUS inserted. (2) After 10μg/mL LNG treatment, the proliferation rate of uterine leiomyoma cells was suppressed. Low concentration of E2 (≤1 ng/mL) inhibited the proliferation of uterine leiomyoma cells, but high concentration of E2 (≥10 ng/mL) significantly promoted uterine leiomyoma cell proliferation. Flow cytometry analysis showed that compared with the control group, after LNG treatment, the apoptosis rate of the cell increased in a concentration dependent manner, with the correlation coefficient of r2=0.9799. After LNG (10 μg/mL) treatment 72h, the early leiomyoma cell apoptosis significant changed (P<0.05). Conclusion: LNGIUS can effectively reduce the patient's menstrual volume, improve symptoms of anemia, and reduce uterine volume with few systemic side effects. The mechanism might be that LNG can suppress the proliferation and induce apoptosis of the uterine leiomyoma cells.
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