欧洲自然计划生育多中心研究（1989 - 1995年）：有效性与退出情况。欧洲自然计划生育研究小组

European multicenter study of natural family planning (1989-1995): efficacy and drop-out. The European Natural Family Planning Study Groups.

出版信息

Adv Contracept. 1999;15(1):69-83.

Abstract

BACKGROUND

Effectiveness studies in natural family planning (NFP) published over the past 20 years have shown a wide range of contraceptive efficacy and acceptability. This seems to be due in part to different NFP methodologies. Consequently, we decided to carry out an effectiveness study in Europe to examine one group of the most widely spread NFP methods, the symptothermal methods.

METHODS

Between 1989 and 1995, 15 NFP groups from 10 European countries participated in a prospective European multicentre study. This paper reports on 1328 women aged between 19 and 45 years and willing to participate for at least 12 cycles. Two types of symptothermal methods were mainly used, the symptothermal double-check methods (1046 women, 16865 cycles of exposure, 34 unintended pregnancies) and the symptothermal single-check methods (214 women, 1495 cycles of exposure, 13 unintended pregnancies). The study was an observational study with prospectively collected data. The pregnancy rates, drop-out rates and lost-to-follow-up rates are presented separately for both subgroups according to the Kaplan-Meier method.

RESULTS

For the double-check methods, there was an unintended pregnancy rate of 2.61% at the end of the first 12 cycles of use (standard error or SE 0.55%), a drop-out rate for difficulties or dissatisfaction of 3.9% (SE 0.69%) and a lost-to-follow-up rate of 3.1% (SE 0.62%). In the single-check group, there was a total of 13 unintended pregnancies at the end of the first 12 cycles of study participation, giving an unintended pregnancy rate of 8.5% (SE 2.52%), a drop-out rate for difficulties or dissatisfaction of 3.0% (SE 1.76%) and a lost-to-follow-up rate of 23.4% (SE 4.35%). No pregnancy was observed in women over 40 years of age. Most pregnancies occurred because of deliberate unprotected intercourse in the fertile phase ('user failure').

CONCLUSIONS

The symptothermal double-check methods have proved to be effective family planning methods in Europe. The low drop-out-rate for difficulties or dissatisfaction with NFP shows the good acceptability.

摘要

背景

过去20年发表的关于自然计划生育（NFP）的有效性研究显示，其避孕效果和可接受性范围广泛。这似乎部分归因于不同的NFP方法。因此，我们决定在欧洲开展一项有效性研究，以考察一组传播最广泛的NFP方法，即症状体温法。

方法

1989年至1995年期间，来自10个欧洲国家的15个NFP小组参与了一项前瞻性欧洲多中心研究。本文报告了1328名年龄在19至45岁之间且愿意参与至少12个周期的女性情况。主要使用了两种类型的症状体温法，即症状体温双重检查法（1046名女性，16865个暴露周期，34例意外妊娠）和症状体温单一检查法（214名女性，1495个暴露周期，13例意外妊娠）。该研究是一项前瞻性收集数据的观察性研究。根据Kaplan-Meier方法分别给出了两个亚组的妊娠率、退出率和失访率。

结果

对于双重检查法，在使用的前12个周期结束时，意外妊娠率为2.61%（标准误或SE 0.55%），因困难或不满导致的退出率为3.9%（SE 0.69%），失访率为3.1%（SE 0.62%）。在单一检查组中，在参与研究的前12个周期结束时共有13例意外妊娠，意外妊娠率为8.5%（SE 2.52%），因困难或不满导致的退出率为3.0%（SE 1.76%），失访率为23.4%（SE 4.35%）。40岁以上女性未观察到妊娠。大多数妊娠是由于在排卵期故意无保护性交（“使用者失误”）导致的。