[Evaluation the efficacy and safety of estradiol and drospirenone tablets in the treatment of menopausal symptoms among postmenopausal Chinese healthy women:a randomized, multi-center, double-blind, placebo-controlled clinical study].

OBJECTIVE: To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq) in treatment of menopausal symptoms among postmenopausal Chinese healthy women. METHODS: Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned into estradiol and drospirenone (observation group, n = 183) or placebo group (n = 61) by the ratio of 3:1 for 16 weeks in this randomized multi-center double-blind placebo-controlled study. During the trial, the follow-up visits were conducted at week 4, 8, 12, 16 of treatment and 2 weeks after treatment respectively. Height, weight, vital signs, hot flushes, other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit, while the clinical global impression scale was assessed at 16 weeks as well. RESULTS: It showed that hot flushes were reduced significantly more in observation group than that in placebo group (P < 0.01), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by -0.6 ± 0.5 in observation group and -0.4 ± 0.4 in placebo group from baseline respectively, which reached significant difference (P < 0.05). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by -0.6 ± 0.8 in observation group and -0.3 ± 0.6 in placebo group from baseline respectively, which had no significant difference (P > 0.05). After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P < 0.01). During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48.9% (87/178) in observation group and 10.7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183). The level of serum potassium was in the normal range in observation group mostly.Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related. CONCLUSION: Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmenopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.

[Study on the relationship of MTHFR polymorphisms with unexplained recurrent spontaneous abortion].

OBJECTIVE: To assess the relationship of methylenetetrahydrofolate reductase (MTHFR) C677T genotypes to unexplained recurrent spontaneous abortion (URSA). METHODS: This study included two groups:57 currently non-pregnant women with a history of URSA (URSA group), and 50 currently non-pregnant women with a history of having given birth to at least one live baby and without any history of spontaneous abortion, still-born fetus, placental thrombosis and intrauterine growth retardation(IUGR)(control group). The fasting serum-Hcy was measured with high pressure liquid chromatography. Folic acid and vitamin B(12) were detected by radioimmune assay; antiphospholipid antibody (ACA) was detected by ELISA. MTHFR C677T gene polymorphisms were detected by the technique of polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). RESULTS: C/C genotype in URSA group was significantly lower than that in control group, the total mutant T allele frequency was significantly higher than that in control group. There was no significant difference in respect of "age, rural area/city, period, primary/secondary abortion" between the genotype distributions of MTHFR C677T. The T/T genotype and C/T+T/T genotypes frequencies for "abortion times>or=3" were higher than those for "abortion time <3". CONCLUSION: MTHFR C677T gene polymorphism is a genetic risk factor for URSA.

[Influences of active immunotherapy on T helper cell type 1 and 2 cytokines in women with unexplained habitual abortion].

OBJECTIVE: To investigate the influences of active immunotherapy on T helper cell (Th)1/Th2 type cytokines in women with unexplained habitual abortion (UHA). METHODS: A total of 55 patients with UHA were studied, including 30 cases after active immunotherapy (AIT) and 25 cases without any therapy (NAIT). Fifteen cases of normal nonpregnant (NNP) women were selected as control group. Supernatants from trophoblast-activated peripheral blood mononuclear cells (PBMC) of the three groups were tested by enzyme-linked immunosorbent assay (ELISA) for interferon gamma (IFN-gamma), interleukin-2 (IL-2), IL-4, IL-10. RESULTS: (1) The levels of IL-2 and IFN-gamma in AIT group [(108 +/- 37) ng/L and (110 +/- 52) ng/L, respectively] were lower significantly than those in NAIT group [(223 +/- 85) ng/L and (326 +/- 92) ng/L, respectively] (P < 0.05). The levels of IL-4 and IL-10 in AIT group [(50 +/- 11) ng/L and (140 +/- 37) ng/L, respectively] were higher than those in NAIT group [(23 +/- 11) ng/L and (52 +/- 28) ng/L] +/- (P < 0.05). The levels of IL-2 and IFN-gamma in NAIT group were higher than those in NNP group [(92 +/- 32) ng/L and (102 +/- 35) ng/L] (P < 0.05). The levels of IL-4 and IL-10 in NAIT group were lower than those in NNP group [(62 +/- 21) ng/L and (150 +/- 42) ng/L] (P < 0.05). The level of every cytokine had no difference in AIT group and NNP group (P > 0.05). (2) Twenty-six women in AIT group got pregnant, but 8 women experienced pregnancy loss repeatedly whose IL-2, IFN-gamma levels were higher than those in other 18 women got successful pregnancy and IL-4, IL-10 levels lower than the latter. CONCLUSIONS: UHA patients have Th1 type immunity to trophoblast and produce high-level Th1 type cytokines which probably result in pregnancy loss. Active immunotherapy could make a shift from Th1 to Th2 immunity, thus favoring the maintenance of pregnancy.