Dorflinger L J
Family Health International, Research Triangle Park, NC 27709.
Contraception. 1994 May;49(5):455-68. doi: 10.1016/0010-7824(94)90004-3.
A number of once-a-month injectable contraceptives have been studied over the last 30 years and at least three different formulations are currently in use worldwide. Each of these formulations contains an ester of the natural estrogen, estradiol, and a synthetic progestin. This is in contrast to the combined oral contraceptives which contain synthetic analogs of both estradiol and progesterone. This paper considers medical contraindications or precautions related to the use of once-a-month injectable formulations and suggests some considerations for their programmatic use, particularly in the developing world. Because once-a-month injectables contain both an estrogen and a progestin, the precautions related to their use are similar to those of combined oral contraceptives; however, since the estrogen component is a natural estrogen, administration is parenteral and the circulating levels reach peaks that are in the range of those of the normal preovulatory phase of the menstrual cycle, some of these precautions may be very conservative. Absolute contraindications to the use of monthly injectables are current or suspected pregnancy, and estrogen-responsive tumors of the breast or genital tract. Other factors have been termed precautions for use rather than absolute or relative contraindications. Primary precautions are conditions under which a woman should probably not use monthly injectables, but if she does, she should be monitored closely. These include current or individual history of cardiovascular disease, current liver disease or liver tumors, and over age 40 if a smoker. Secondary precautions to use are those which should be considered very carefully and balanced against the risks of not using the particular method. These include suspicion of breast or genital tract cancer until cancer is ruled out, unexplained abnormal vaginal bleeding, use of drugs which might affect metabolism and decrease effective levels of circulating steroids, breastfeeding, and having combinations of several risk factors for cardiovascular disease. These precautions are categorized as proposed, based on the fact that most women in the developing world face a risk from pregnancy that is probably far greater than the risks from any of the present formulations of steroidal contraceptives. A key consideration during programmatic use of monthly injectables is attention to compliance with follow-up schedules to minimize the risk of pregnancy. Because little information on monthly injectables is available that is directly related to these precautions, additional research studies will be required in order to reconsider whether some of the listed precautions are valid or others should be considered.
在过去30年里,人们对多种每月注射一次的避孕药物进行了研究,目前全球至少有三种不同配方的此类药物在使用。每种配方都含有天然雌激素雌二醇的一种酯和一种合成孕激素。这与复方口服避孕药不同,复方口服避孕药含有雌二醇和孕酮的合成类似物。本文探讨了与每月注射一次的避孕配方药物使用相关的医学禁忌证或注意事项,并针对其在项目中的使用提出了一些考虑因素,特别是在发展中世界。由于每月注射一次的药物同时含有雌激素和孕激素,其使用相关的注意事项与复方口服避孕药类似;然而,由于雌激素成分是天然雌激素,通过肠胃外给药,且循环水平达到月经周期正常排卵前期范围内的峰值,其中一些注意事项可能过于保守。每月注射一次的避孕药物的绝对禁忌证包括当前或疑似怀孕,以及乳腺或生殖道的雌激素反应性肿瘤。其他因素被称为使用注意事项,而非绝对或相对禁忌证。主要注意事项是指女性可能不应使用每月注射一次的避孕药物的情况,但如果使用,应密切监测。这些情况包括当前或个人心血管疾病史、当前肝病或肝肿瘤,以及40岁以上的吸烟者。次要使用注意事项是那些应非常谨慎考虑并与不使用特定方法的风险相权衡的事项。这些包括在排除癌症之前怀疑患有乳腺或生殖道癌症、不明原因的异常阴道出血、使用可能影响代谢并降低循环类固醇有效水平的药物、母乳喂养,以及存在多种心血管疾病风险因素。基于发展中世界的大多数女性面临的怀孕风险可能远大于目前任何甾体避孕配方药物带来的风险这一事实,这些注意事项按上述方式进行了分类。在每月注射一次的避孕药物的项目使用过程中,一个关键考虑因素是注意遵守后续时间表,以尽量降低怀孕风险。由于几乎没有直接与这些注意事项相关的关于每月注射一次的避孕药物的信息,因此需要进行更多的研究,以便重新考虑所列的一些注意事项是否合理,或者是否应考虑其他注意事项。