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Objective:To evaluate the efficacy and safety of drospirenone and ethinylestradiol tablets (Ⅱ) in Chinese women with dysmenorrhea.Methods:This was a single-arm, open-label, interventional, multicenter, post-authorization safety/effectiveness study of drospirenone and ethinylestradiol tablets (Ⅱ) across 6 treatment cycles, a total of 526 patients were included in the dysmenorrhea subgroup. Visual analog scale (VAS) was used to assess the severity of menstrual pain. Secondary outcomes included unintended pregnancies, bleeding pattern, cycle control and safety.Results:After treated with drospirenone and ethinylestradiol tablets (Ⅱ), VAS of pain had decreased significantly compared with baselines [(49.5±23.7) vs (32.3±24.9) vs (20.7±19.4) vs (18.4±18.7) mm, P<0.01]. From the second cycle to the fifth cycle, the incidence of scheduled bleeding increased from 93.9% (450/479) to 96.4% (431/447). The duration of scheduled bleeding decreased from (5.7±2.7) to (5.4±1.8) days. The incidence of intermenstrual bleeding decreased from 9.0% (43/479) to 5.6% (25/447). 17.5% (92/526) patients reported adverse drug reactions, most frequently reported adverse events were breast pain, nausea, breast swelling, headache, and uterine bleeding. No death occurred during the study. Conclusion:Drospirenone and ethinylestradiol tablets (Ⅱ) is effective for the treatment of dysmenorrhea and has good safety.
RESUMO
Objective To study the value of tubal catheterization and hydrotubation using hysteroscopy in the assessment of tubal patency after laparoscopic operations for ectopic pregnancy.Methods Hysteroscopic tubal catheterization and hydrotubation was carried out for evaluating tubal patency in 56 cases of ectopic pregnancy at 2~24 months after laparoscopic salpingectomy or salpingotomy. Results Of 15 cases of salpingectomy,unilateral complete tubal unobstructedness was achieved in 9 cases(60.0%).Of 41 cases of linear salpingotomy,bilateral tubal unobstructedness was found in 18 cases(43.9%) and unilateral in 18 cases(43.9%).A follow-up observation for 4~25 months(mean,10.8 months) in 37 women with childbearing demand showed normal intrauterine pregnancy in 20 cases(54.0%),intrauterine pregnancy after in vitro fertilization(IVF) in 3 cases,and recurrent ectopic pregnancy in 1 case(2.3%).Conclusions Hysteroscopic tubal catheterization and hydrotubation is a direct and accurate procedure for evaluating tubal patency after laparoscopic operations for ectopic pregnancy.It may be taken as a guide in evaluating the possibility of normal intrauterine pregnancy.