左炔诺孕酮宫内节育系统的60000人年使用经验：芬兰的一项流行病学调查。

Backman T, Huhtala S, Tuominen J, Luoto R, Erkkola R, Blom T, Rauramo I, Koskenvuo M

Department of Public Health and Clinical Research Services, Turku University, Finland.

Eur J Contracept Reprod Health Care. 2001 Jan;6 Suppl 1:23-6.

OBJECTIVE

An epidemiological survey was carried out in Finland to establish the performance of the levonorgestrel intrauterine system (LNG-IUS) in a large population of women regularly using the system for contraception.

STUDY DESIGN

All women who had LNG-IUS inserted between 1990 and 1993 were sent a questionnaire with questions about general health status, reproductive and contraceptive history and gynecological problems and a set of questions about their experience on the LNG-IUS.

RESULTS

The women who had a LNG-IUS inserted between April 1990 and December 1993 were asked to participate in an epidemiological survey. At the insertion visit, the women were asked to fill in a questionnaire, to consent to further use of the information by signing their initials and to return the questionnaire to the manufacturer. The number of returned forms was 23,885. The names and addresses of these women were acquired from the National Register and a questionnaire with 75 questions was sent to them. Of the questionnaires, 75% were returned. Experience covered 58,600 woman-years. The mean age of the users of the LNG-IUS was 40 years. Most of them (99.3%) were parous, most often with two or three children. The cumulative 5-year Pearl index was 0.18 and there were 108 pregnancies in the study population during the use of the LNG-IUS. The continuation rates for 1, 2, 3, 4 and 5 years were 0.94, 0.87, 0.82, 0.76 and 0.65, respectively. Removal before the full 5 years was most common among the youngest age group. Bleeding disorders, infections and pain during LNG-IUS use were associated with the highest risk for discontinuation. The risk of premature removal was markedly diminished among women with totally or occasionally missed periods.

CONCLUSIONS

The response rate to the survey was high and the sample studied was exceptionally large. The continuation rate of LNG-IUS was high up to 5 years. The symptoms associated with premature removal agreed with results from earlier randomized studies of the LNG-IUS.

目的

在芬兰开展一项流行病学调查，以确定左炔诺孕酮宫内节育系统（LNG-IUS）在大量定期使用该系统进行避孕的女性中的性能表现。

研究设计

向所有在1990年至1993年间植入LNG-IUS的女性发送一份问卷，内容涉及一般健康状况、生殖和避孕史、妇科问题，以及一系列关于她们使用LNG-IUS体验的问题。

结果

邀请在1990年4月至1993年12月间植入LNG-IUS的女性参与一项流行病学调查。在植入时，要求这些女性填写一份问卷，通过签姓名首字母同意进一步使用其信息，并将问卷返还给制造商。返还的表格数量为23,885份。这些女性的姓名和地址从国家登记处获取，并向她们发送了一份包含75个问题的问卷。其中75%的问卷被返还。随访时间涵盖58,600妇女年。LNG-IUS使用者的平均年龄为40岁。她们中的大多数（99.3%）已生育，多数育有两三个孩子。累积5年的 Pearl 指数为0.18，在使用LNG-IUS期间研究人群中有108次妊娠。1年、2年、3年、4年和5年的续用率分别为0.94、0.87、0.82、0.76和0.65。在最年轻的年龄组中，在5年期满前取出的情况最为常见。使用LNG-IUS期间的出血紊乱、感染和疼痛与停用的最高风险相关。月经完全或偶尔不来的女性过早取出的风险明显降低。