Rönnerdag M, Odlind V
Department of Women's and Children's Health, Section for Obstetrics and Gynecology, University of Uppsala, Sweden.
Acta Obstet Gynecol Scand. 1999 Sep;78(8):716-21.
This report comprises women from one center, who all participated in a larger European multi-center study, which included 2758 healthy women, of whom 1821 were randomly allocated to the levonorgestrel-releasing intrauterine system (Lng-IUS) and 937 to a copper-IUD (Nova-T). At the end of the 5 year study period, 109 of the 300 women, who originally were allocated to the Lng-IUS at this center, were still using the Lng-IUS. The women were offered the opportunity to continue the Lng-IUS and 100 women chose to do so. After a total period of almost 7 years of continuous use, a second Lng-IUS was offered and 82 of the women chose to start a second segment of Lng-IUS use. After another 5 years, 69 of the women were fitted with their third Lng-IUS.
These 82 women were examined yearly throughout the study period and bleeding pattern, hemoglobin, weight, blood-pressure, general well-being and intercurrent disease were analyzed to assess long-term effects.
No pregnancy occurred during the follow-up. One case of partial expulsion occurred and one case of pelvic inflammatory disease. Seventy-seven percent of the women did not report any health problems at all during the entire follow-up period of 13 years. At the end of the second period with the Lng-IUS, 60% reported amenorrhea, 12% infrequent, scanty bleeds and 28% regular, scanty bleeds. As a consequence, the hemoglobin values increased, with a mean increase, after 12-13 years, being 1.35 g/dl. Blood pressure increased slightly and body weight increased with a mean increase of 0.49 kg/year. Seven women became postmenopausal during the follow-up and started estrogen replacement therapy with the Lng-IUS in situ.
This follow-up study suggests that the Lng-IUS remains a safe and effective method of contraception, allowing women prolonged relief of menstrual problems, and for women in their late reproductive years, offering a convenient and bleeding-free transition into the menopause.
本报告纳入了来自一个中心的女性，她们均参与了一项更大规模的欧洲多中心研究，该研究共有2758名健康女性，其中1821名被随机分配至左炔诺孕酮宫内节育系统（LNG-IUS）组，937名被分配至铜宫内节育器（Nova-T）组。在5年研究期结束时，该中心最初被分配至LNG-IUS组的300名女性中，有109名仍在使用LNG-IUS。这些女性有机会继续使用LNG-IUS，100名女性选择了继续使用。在连续使用近7年后，提供了第二个LNG-IUS，82名女性选择开始第二阶段的LNG-IUS使用。再过5年后，69名女性安装了第三个LNG-IUS。
在整个研究期间，对这82名女性进行每年一次的检查，并分析其出血模式、血红蛋白、体重、血压、总体健康状况和并发疾病，以评估长期影响。
随访期间无妊娠发生。发生1例部分排出和1例盆腔炎。77%的女性在整个13年的随访期内未报告任何健康问题。在使用LNG-IUS的第二个阶段结束时，60%的女性报告闭经，12%报告月经稀少、量少，28%报告月经规律、量少。因此，血红蛋白值有所升高，12 - 13年后平均升高1.35 g/dl。血压略有升高，体重增加，平均每年增加0.49 kg。7名女性在随访期间进入绝经后状态，并在LNG-IUS原位的情况下开始雌激素替代治疗。
这项随访研究表明，LNG-IUS仍然是一种安全有效的避孕方法，能使女性长期缓解月经问题，对于处于生育后期的女性，提供了一种方便且无出血的绝经过渡方式。
