[Efficacy and safety of low-dose levonorgestrel-releasing intrauterine system in Chinese women: a multicenter, single-arm, open labeled interventional trial].

Objective: To evaluate the efficacy, bleeding profile and safety of low-dose levonorgestrel-releasing intrauterine system (LNG-IUS 8) in Chinese healthy women of childbearing age. Methods: A multi-center, open-label, single-arm clinical trial conducted at 16 centres in China enrolled 773 healthy women of childbearing age (mean age 31.6 years old, range 18 to 40 years old) , who demanded contraception, from April 2006 to June 2013. All women placed LNG-IUS 8 for 3 years and then been followed up at 3, 6, 9, 12, 18, 24, 30, 36 months. The efficacy variables including pregnancy rate and expulsion rate were analyzed using life table, while observing adverse events (AE) to evaluate the safety. The bleeding profile happened during the study was assessed using 90-day reference intervals (World Health Organization criteria) . Results: Eight pregnancies occurred among 773 women, resulting in a overall Pearl index of 0.42 per 100 women years. The 3-year cumulative pregnancy rate was 0.37 per 100 women years and the 3-year cumulative expulsion rate was 1.99 per 100 women years. The number of women with bleeding/spotting reduced and the bleeding/spotting days declined over time. Totally 219 AE were reported related to LNG-IUS 8 placements. The most common AE were vaginal bleeding (8.2%, 63/773) and the ovarian cyst (6.2%, 52/773) . LNG-IUS 8 had an improving effect on dysmenorrhea that the percentage of women with dysmenorrhea as well as the days of dysmenorrhea decreased over time. The percentage of women satisfied or very satisfied with LNG-IUS 8 was 87.2% (622/713) . Conclusion: LNG-IUS 8 is highly effective and safe for Chinese healthy women of childbearing age.

Alterations in the mortality and growth cycle of cervical cancer cells treated with electroporation at different electric strengths.

OBJECTIVE: To explore the biological effects of electric fields of various strengths on Hela cells. METHODS: Electroporation experiments were performed using Hela cells. Changes in cell mortality, cell vitality, cell cycle, and apoptosis status were examined. In addition, temperature changes in the surrounding tissue were measured. RESULTS: Cell proliferation was markedly inhibited after treatment with field strengths of 2-2.5 kV/cm. The expression of caspase-3 increased significantly in cells treated with field strengths of 1.5-2.5 kV/cm. Field strengths of 1.75-2.5 kV/cm produced complete cancer cell ablation. G2 phase frequency increased significantly after treatment with field strengths of 2-2.5 kV/cm. During this process, the maximum temperature increase in the pulsed electric field was 4.9 -/+ 1.17 degrees C under free air convection. CONCLUSIONS: IRE can be used alone for the treatment of cancer, and its thermal effect is negligible. Cell death was caused by the effects of IRE and apoptosis. The tumor cells must be destroyed completely, or the altered cell cycle may lead to tumor recurrence and accelerated growth.

Estradiol 1 mg and drospirenone 2 mg as hormone replacement therapy in postmenopausal Chinese women.

OBJECTIVES: Drospirenone is a novel progestogen that, combined with 17ß-estradiol, reduces the frequency and severity of menopausal vasomotor symptoms (VMS) in different populations. This double-blind, multicenter study compared the efficacy, safety and tolerability of 2 mg drospirenone/1 mg estradiol (DRSP/E2) vs. placebo in Chinese postmenopausal women with moderate to severe VMS. METHODS: Women, aged 45-65 years, were randomized to DRSP/E2 (n=183) or placebo (n=61) once daily for four 28-day cycles. Changes in the frequency and severity of hot flushes were analyzed as primary variables, together with other climacteric and urogenital symptoms, clinical global improvement, adverse events and physical/gynecological parameters. RESULTS: Relative changes in numbers of hot flushes/week were -80.4% for DRSP/E2 vs. -51.9% for placebo (treatment difference -28.5%, p<0.0001). There were trends toward a greater reduction in severity of hot flushes with DRSP/E2 treatment. Patients treated with DRSP/E2 were more often free from sweating episodes (p<0.0001) and vaginal dryness (p=0.0008). Other climacteric symptoms, including nervousness and pollakisuria, followed a trend of greater response with DRSP/E2. Similar to other combination HRT regimens, DRSP/E2 increased occurrences of bleeding, but these decreased over time. Adverse events in patients treated with DRSP/E2 were mostly mild to moderate and withdrawal rates were low. CONCLUSIONS: Daily treatment of postmenopausal Chinese women with DRSP/E2 for 16 weeks significantly reduced the incidence of hot flushes and demonstrated advantages vs. placebo for other climacteric symptoms. These results indicate that DRSP/E2 is effective, safe and well tolerated in postmenopausal Chinese women.