A levonorgestrel-releasing intrauterine contraceptive device was used by 10 breast-feeding women beginning 6 weeks after delivery. Two models of IUD were used. One released 10 microgram (5 patients), the other 30 microgram (5 patients) of levonorgestrel per day. Plasma and milk samples were collected 8 times over a 3-month period and the concentrations of levonorgestrel determined by radioimmunoassay. An improved and sensitive method for the determination of levonorgestrel in milk was developed. A column chromatographic purification of a milk extract before radioimmunoassay made possible the use of large milk samples in order to improve the sensitivity. The plasma concentrations during the follow-up period were 207 +/- 64 pg/ml (mean + SD) in the 10 microgram and 235 +/- 87 pg/ml in the 30 microgram/day releasing IUD groups. The milk levonorgestrel concentrations were 56 +/- 35 and 57 +/- 34 pg/ml, respectively. The plasma to milk ratio of levonorgestrel was initially 10025. There were no significant differences in the milk and plasma concentrations between the study groups. The total amount of levonorgestrel excreted per day in 600 ml breast milk is approximately 0.1 per cent of a daily dose of 30 microgram.

译文

分娩后6周开始,有10名母乳喂养妇女使用了释放左炔诺孕酮的宫内节育器。使用了两种宫内节育器模型。一位每天释放10微克(5位患者),另一位每天释放30微克(5位患者)左炔诺孕酮。在3个月的时间内收集了8次血浆和牛奶样品,并通过放射免疫法测定了左炔诺孕酮的浓度。建立了一种测定牛奶中左炔诺孕酮的改进,灵敏的方法。放射免疫分析之前,对牛奶提取物进行柱色谱纯化,可以使用大牛奶样品,以提高灵敏度。在随访期间,释放IUD组的血浆浓度在10微克中为207 /-64 pg / ml(平均SD),在30微克/天中为235 /-87 pg / ml。牛奶左炔诺孕酮浓度分别为56 /-35和57 /-34 pg / ml。左炔诺孕酮的血浆/牛奶比率最初为10025。研究组之间的牛奶和血浆浓度没有显着差异。每天从600毫升母乳中排出的左炔诺孕酮总量约为每日30微克剂量的0.1%。

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