Norwitz Errol R, Caughey Aaron B
Rev Obstet Gynecol. 2011 Summer;4(2):60-72.
Preterm birth is currently the most important problem in maternal-child health in the United States and possibly throughout the world. It complicates one in eight US deliveries, and accounts for over 85% of all perinatal morbidity and mortality. Although survival of preterm infants has increased steadily over the past four decades-due in large part to the use of antenatal corticosteroids, improvements in neonatal resuscitation, and the introduction of neonatal intensive care units-efforts to prevent preterm birth have been largely unsuccessful. On February 3, 2011, the US Food and Drug Administration (FDA) approved the use of progesterone supplementation (hydroxyprogesterone caproate) during pregnancy to reduce the risk of recurrent preterm birth in women with a history of at least one prior spontaneous preterm delivery. This is the first time that the FDA has approved a medication for the prevention of preterm birth, and represents the first approval of a drug specifically for use in pregnancy in almost 15 years. This article reviews the evidence behind the use of progesterone for the prevention of preterm birth, and provides guidelines for the use of progesterone supplementation in clinical practice. A number of areas of ongoing controversy are addressed, including the optimal formulation and route of administration, the safety of progesterone supplementation in pregnancy, and its proposed mode of action.
早产是目前美国乃至全球母婴健康领域最重要的问题。在美国，每八例分娩中就有一例因早产而变得复杂，并且早产占所有围产期发病率和死亡率的85%以上。尽管在过去四十年里，早产儿的存活率稳步上升——这在很大程度上归功于产前使用糖皮质激素、新生儿复苏技术的改进以及新生儿重症监护病房的设立——但预防早产的努力在很大程度上并未成功。2011年2月3日，美国食品药品监督管理局（FDA）批准在孕期使用孕激素补充剂（己酸羟孕酮），以降低有至少一次自发性早产史的女性再次发生早产的风险。这是FDA首次批准用于预防早产的药物，也是近15年来首次批准专门用于孕期的药物。本文回顾了使用孕激素预防早产的相关证据，并提供了临床实践中使用孕激素补充剂的指南。文中还讨论了一些仍存在争议的领域，包括最佳剂型和给药途径、孕期补充孕激素的安全性及其作用机制。
