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醋酸甲孕酮(DMPA)于60年代中期开始用于避孕,现全世界每年约300万妇女用此避孕。尽管对其安全性有不同看法,近来动物和人体的资料及对其与肿瘤关系的研究表明DMPA是一安全和高度有效的能注射的避孕药。WHO在墨西哥和泰国对DMPA25、50、100和150mg的药代动力学和药效学进行了研究,发现DMPA100和150mg的90天抑制排卵率、血中MPA峰值及注后90天的MPA血浓度无显著差异。因此WHO决定在Ⅲ期随机临床试验中比较DMPA100mg和150mg的有效性及其副作用,以确定DMPA的合适剂量。
Medroxyprogesterone acetate (DMPA) began to be used in contraception in the mid-1960s and is now used by about 3 million women throughout the world every year. Despite their differing perceptions of safety, recent animal and human data and studies of their association with tumors have shown that DMPA is a safe and highly effective injectable contraceptive. WHO studied the pharmacokinetics and pharmacodynamics of DMPA 25, 50, 100 and 150 mg in Mexico and Thailand and found that the 90-day DMPA 100 and 150 mg inhibition of ovulation rate, MPA peak in blood, and MPA blood concentration 90 days after injection No significant difference. WHO therefore decided to compare the efficacy and side effects of 100 mg and 150 mg of DMPA in a phase III randomized clinical trial to determine the appropriate dose of DMPA.