复方左旋18-甲基炔诺酮避孕片阴道持续和间断用药的临床比较  

Comparative Study on Intermittent Versus Continuous Use of a Contraceptive tablets(Combined L－Norgestrel)Administered by Vaginal Route

作　　者：曹霖[1] 徐阳 胡晓红[1] 游根娣 茅百勇 顾芝萍 

机构地区：[1]中国科学院上海药物研究所,上海200031

出　　处：《生殖与避孕》1997年第4期227-234,共8页Reproduction and Contraception

摘　　要：500例育龄妇女、志愿受试者，随机分为二组。阴道应用含左旋18－甲基炔诺酮0.25mg、炔雌醇0．05mg的避孕片。比较持续用药和间断用药的避孕效果、可接受性和副作用。间断用药组（249例）于每个月经周期的第5～25天，每天阴道塞药一片；连续用药组（251例）每天阴道塞药一片，二组的观察期都为一年。结果：两种给药法无一例因药物而失败。用药前后的血压、体重、血红蛋白含量、红细胞压积和红细胞数均无明显差异。月经周期在间断用药组与用药前比较无明显差异；但在连续用药组，多数对象在用药期间持续闭经，仅少数对象在头二个月中有月经。各种副作用的总发生率连续用药组高于间断用药组，主要副作用为恶心、乳房胀痛和腹痛等。用药后患宫颈炎的病例较用药前增加，但两组间无明显差别。两组相比，间断用药组的月经周期规则，点滴出血率低。因药物之故的停药率，两组间无明显区别。Five handred adult female volunteered(age,x±s=34．3±3．9) were randomly allocated to two groups(intermittent and continuous).Contraceptive tablets containing levonorgestrol 0．25mg and ethynyl－estradiol 0．05mg per tablet were used vaginally．The contraceptiive efficacy，acceptability and side effects were compared between intermittent and continuous group.In intermittent group,249 cases used the tablets daily from the 5th day to the 25th day of every menstrual cycle．In continuous group,251 cases use the pills daily with no interruption.The observation period was one year.Data indicated that no pregnancy occurred.Blood pressure,body weight,hemoglobin,hoematocrit and erythrocyte count had no significant change after one year use of tablets.Menstrual cycle had no significant change in intermittent group.In continuous group,most subjects amenorrhea appeared except in a few cases at the first two months．Complaints were more in continuous group than in intermittent group.The main side effects could be listed in decreasing order as nausea,mastodynia,abdominal pain etc.Occurrence of cervicitis were more frequently seen after one year tablet use,but without statistic significance.Above all,the present study confirmed the contraceptive efficacy of the tablets used by vaginal route.Among the two groups,the intermittent group had regular menstrual cycle and less spotting.The withdraw rate between the two groups had no significant difference.

关 键 词：复方 左旋 18甲基炔诺酮 阴道用药 避孕片 

分 类 号：R979.21[医药卫生—药品] R969.4[医药卫生—药学]