Díaz S, Herreros C, Juez G, Casado M E, Salvatierra A M, Miranda P, Peralta O, Croxatto H B
Contraception. 1985 Jul;32(1):53-74. doi: 10.1016/0010-7824(85)90116-7.
The objective of this study was to test the influence of NORPLANT implants upon lactation and infant growth. The results obtained during the first postpartum year are reported. One-hundred women were enrolled in the implant group. The control group was formed by 100 women who received a Copper T IUD. Treatments were administered at day 55 +/- 3. At admission all subjects were in exclusive breastfeeding with an adequate weight increase of the infant. No significant differences were found between the treated and control groups in the percentage of women in full nursing at different postpartum intervals, except for the 12th month postpartum where a lower percentage of cases from the NORPLANT group was in the full nursing category. No difference was found in the time of weaning. The infants showed a normal weight gain rate in both groups although the girls from the NORPLANT group showed a significantly lower daily weight increase during the 4th month than the girls from the IUD group. No pregnancies were diagnosed. No women asked for implant removal during the first year. No serious side effects related to treatment were detected. Bleeding irregularities were rare during breastfeeding which is in contrast with what occurs in non-nursing women treated with NORPLANT implants. Levonorgestrel concentrations found in milk were variable and individual values ranged from 23 to 311 pg/ml. The dose received by the infant can be estimated around 15 to 18 ng/Kg/day during the first month of treatment when the higher plasma values of levonorgestrel are observed. These levels is conjunction with the clinical observations reported here minimize the potential problems associated with levonorgestrel transference through maternal milk. Nevertheless, long-term studies are required to settle this matter and until more information is available, NORPLANT implant use in lactating women should be limited to cases who require a highly effective contraceptive method and where non-hormonal methods of similar effectiveness are contraindicated or unacceptable.
本研究的目的是测试皮下埋植剂对哺乳及婴儿生长的影响。报告了产后第一年所获得的结果。100名妇女被纳入皮下埋植剂组。对照组由100名接受铜T宫内节育器的妇女组成。在产后55±3天进行治疗。入院时所有受试者均为纯母乳喂养，且婴儿体重增加适宜。在不同产后时间段，纯母乳喂养的妇女百分比在治疗组和对照组之间未发现显著差异，但在产后12个月时，皮下埋植剂组处于纯母乳喂养类别的病例百分比更低。断奶时间未发现差异。两组婴儿体重均呈正常增长速度，尽管皮下埋植剂组的女孩在第4个月时每日体重增加明显低于宫内节育器组的女孩。未诊断出妊娠。第一年没有妇女要求取出皮下埋植剂。未检测到与治疗相关的严重副作用。母乳喂养期间出血不规则情况很少见，这与接受皮下埋植剂治疗的非哺乳期妇女的情况形成对比。乳汁中左炔诺孕酮的浓度各不相同，个体值在23至311 pg/ml之间。在治疗的第一个月，当观察到左炔诺孕酮的血浆值较高时，婴儿摄入的剂量估计约为15至18 ng/Kg/天。这些水平结合此处报告的临床观察结果，将与左炔诺孕酮通过母乳转移相关的潜在问题降至最低。然而，需要进行长期研究来解决这个问题，在获得更多信息之前，哺乳期妇女使用皮下埋植剂应仅限于需要高效避孕方法且类似有效性的非激素方法禁忌或不可接受的情况。
