芫花酯甲药膜抗早早孕临床研究

Clinical investigation of yuanhuacine film to terminate early pregnancy

芫花酯甲药膜通过Ⅰ,Ⅱ期临床应用,选择出了抗早早孕的最佳剂量和观察方法。Ⅲ期临床在门诊用药,剂量为50μg/人次,共应用1306例。完全流产率为84.23％;出血量小于或等于月经量的占48.29％;但出血量大于月经量的病例中300ml以上者仅占0.64％,胚囊排出时间平均为33±SD24h,药物副反应主要为恶心、呕吐,占44.64％,其次为发热和寒战;置药前、后激素水平测定显示,E_2上升,P下降,PGF_2αM无明显改变;随访504例,40d内转经者占90.87％,经量大部分无变化。

Following a primary and a secondary studies to determine the optimal dosage and clinical procedure, a final clinical investigations of yuan-huacine film to terminate the early pregnancy, in 1306 cases with gestation from 36 to 42 days were studied again to confirm the chances of success, side effects, hormonal disturbances and also their recovery of normal menstruation. 50 μg of such preparation was given directly into uterine cavity. Among them, 1100 cases (84.23%) got complete abortion, 139 cases (10.64%)partial and 67 cases(5.13%) proved to be a failure.As the blood loss during the abortion concerned, following up 1257 cases, 378 cases(30.07%)had the same.650 cases(51.71%)greater than and 221 cases(17.58%)less than the normal menstrual amount. There were 8 cases (0.64%)only had the blood loss more than 300 ml. The mean time of embryo discharge was 33±33h(x±SD). The side effects of nausea and vomiting were 44.6%, fever and chill were rare.After its administration, plasma estradiol was elevat- ed, while progesterone decreased, PGF2α M had no significant change.504 cases had been followed up, 458 cases (90.87%) returned to their normal menstrual cycle within 40 days and most of them kept their amount of menstrual bleeding same as their usual.