Garza-Flores J, Moraks del Olmo A, Fuziwara J L, Figueroa J G, Alonso A, Monroy J, Perez M, Urbina-Fuentes M, Guevara S J, Cedeno E, Barrios R, Ferman J J, Medina L M, Velazquez E, Perez-Palacios G
Departmento de Biologia de la Reproduccion, Instituto Nacional de la Nutricion Salvador Zubirõn, México D.F.
Contraception. 1998 Jul;58(1):7-12. doi: 10.1016/s0010-7824(98)00062-6.
A large introductory study of Cyclofem, a once-a-month injectable contraceptive, was conducted in three Mexican provinces. A total of 3457 healthy women participated: 640 women from rural areas (community-based component) and 2817 women from urban and suburban areas (health center-based component). A total of 20,316 women-months of treatment experience were accumulated during a one year period. Cyclofem proved its use-effectiveness (pregnancy rate of 0.03%) and its safety under routine service conditions of family planning facilities in Mexico. The overall life table continuation rate at 1 year was 26.1%. Higher continuation rates were observed in the community-based component (36.6%) as compared to the health center component (23.7%). The most common reason for method discontinuation was change of address. Only 15% of the discontinuations were attributable to the injectable contraceptive method, with the overall 1 year discontinuation rate for bleeding problems (including amenorrhea) was < 11%. These observations underscore the importance of appropriate counseling and follow-up measures, providing convenient access to repeat injections, and other service delivery issues related to continuation of Cyclofem. The results of this trial have once again demonstrated that Cyclofem is a highly effective method with an acceptable side effect profile. In addition, the study provided the elements for its approval by local health authorities and its inclusion into the Ministry of Health Family Planning Program.
对一种每月注射一次的避孕针剂Cyclofem进行了一项大型的初步研究,该研究在墨西哥的三个省份开展。共有3457名健康女性参与:640名来自农村地区(社区部分),2817名来自城市和郊区(基于健康中心部分)。在一年期间共积累了20316个女性 - 月的治疗经验。Cyclofem在墨西哥计划生育机构的常规服务条件下证明了其使用效果(妊娠率为0.03%)和安全性。1年时的总体生命表持续率为26.1%。与基于健康中心部分(23.7%)相比,在基于社区部分观察到更高的持续率(36.6%)。方法停用的最常见原因是地址变更。只有15%的停用归因于注射避孕方法,1年时因出血问题(包括闭经)的总体停用率<11%。这些观察结果强调了适当咨询和随访措施、提供方便的重复注射途径以及与Cyclofem持续使用相关的其他服务提供问题的重要性。该试验结果再次表明Cyclofem是一种高效且副作用可接受的方法。此外,该研究为其获得当地卫生当局的批准并纳入卫生部计划生育项目提供了依据。