Jarquín González J D, Elda de Aguirre L, Rodríguez C, Abrego de Aguilar M, Carrillo F, León D A, Lima M, Trigueros S, Acosta R
Reproductive Health and Child Care Program, ISSS.
Adv Contracept. 1996 Sep;12(3):213-25. doi: 10.1007/BF01849664.
A survey among users and health personnel participating in the Salvadorian Social Security Institute (ISSS) Family Planning Program revealed interest in including a monthly preparation for injection as a contraceptive method offered by this Institution. The formulation containing dihydroxyprogesterone acetophenide (DHPA) 150 mg + estradiol enantate (E2EN) 10 mg was chosen for conducting an open and prospective study of efficacy and tolerability. Between January 1992 and March 1994, 7054 women were treated with this product for a total of 60010 months. A sample composed of 4505 women treated at this Institution confirmed that average users are young, have one or two children, do not show a particular geographical distribution and choose the monthly injection instead of oral contraceptives as the first contraceptive method or for the puerperium. The study formulation showed a high efficacy (Pearl Index: 0.018) and tolerability (general withdrawal rate throughout the study: 27.09%). The most frequent adverse events included bleeding disorders, headache and mastalgia; their incidence decreased spontaneously from the sixth month (3.9%), reaching 0% after two years. Treatment was discontinued due to adverse events in 3.47% of women. No significant bodyweight or systolic and diastolic blood pressure alterations were observed. Based on these results, the monthly injectable contraceptive was included in the basic product list at ISSS.
一项针对参与萨尔瓦多社会保障局（ISSS）计划生育项目的用户和卫生人员的调查显示，他们有意将每月注射制剂作为该机构提供的一种避孕方法。选择了含有150毫克醋炔诺酮（DHPA）+10毫克戊酸雌二醇（E2EN）的制剂进行疗效和耐受性的开放性前瞻性研究。在1992年1月至1994年3月期间，7054名妇女使用该产品进行了总计60010个月的治疗。由在该机构接受治疗的4505名妇女组成的样本证实，一般使用者较为年轻，育有一两个孩子，没有特定的地理分布，并且选择每月注射制剂而非口服避孕药作为首选避孕方法或用于产褥期。研究制剂显示出高疗效（Pearl指数：0.018）和耐受性（整个研究期间的总体停药率：27.09%）。最常见的不良事件包括出血紊乱、头痛和乳房疼痛；其发生率从第六个月起自发下降（3.9%），两年后降至0%。3.47%的妇女因不良事件而停药。未观察到显著的体重、收缩压和舒张压变化。基于这些结果，每月注射用避孕药被列入ISSS的基本产品清单。
