ABSTRACT
ObjectiveTo observe the effect of Chinese medicinal application at Yongquan (KI1) on hot flush and sweating brought by using GnRH-ain patients with endometriosis.MethodTotally 120 patients diagnosed with endometriosis of stageⅢ~Ⅳ were randomized into a treatment group and a control group. The control group started to receive GnRH-a(Goserelinum) at 3.6 mg/28 d since post-operational day 3, 4 times in total; the treatment group started to receive GnRH-a(Goserelinum) at 3.6 mg/28 d since post-operational day 3, 4 times in total; at the night of taking GnRH-a, the treatment group was also given Chinese medicinal application at Yongquan, a month as a treatment course, successively for 4 courses.ResultThe side effects of using GnRH-a, including hot flush and sweating, were significantly less in the treatment group than that in the control group (P<0.05).Conclusion Medicinal application at Yongquan can significantly reduce the side effects including hot flush and sweating brought by using GnRH-ain patients with endometriosis.
ABSTRACT
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 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 postmeuopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.