Xiao B L, Gu S J, Wang S L, Zhu P D, Shi S Q
National Research Institute for Family Planning, Beijing, People's Republic of China.
Ann Med. 1993 Apr;25(2):161-5. doi: 10.3109/07853899309164161.
NORPLANT was introduced into the Chinese family planning programmes in 1984 by the Population Council. After a pilot study of 1200 cases in four centres in China, the study was expanded to 12 centres with 10,718 cases of NORPLANT and 1208 cases of NORPLANT-2 followed up for more than 6 years. The 5 years net cumulative pregnancy rates were 0.5-1.2 and the net cumulative continuation rates were around 65-72 per 100 users. There were significant differences in pregnancy rates between different groups of body weight and age, i.e. the pregnancy rates were higher in groups with body weight over 70 kg and those aged below 25 years. The age, body weight and dependence on contraceptive effectiveness of NORPLANT should be taken into account in the selection of users. Nationwide large-scale studies in provincial and country rural areas and postmarketing surveillance are being carried out. Changes in ovarian function and endometrium have been studied. Levonorgestrel IUD (LNg-IUD) was introduced into China in 1985. Comparative clinical studies on NORPLANT and LNg-IUD, pharmacokinetic and pharmacodynamic studies and endometrial studies of LNg-IUD were performed. The higher percentage (55.1%) of ovarian suppression in Chinese users of LNg-IUD may be attributed to ethnic differences among Caucasian women in their susceptibility to steroid hormones. Results showed favourable acceptance of both devices among Chinese women. The studies promoted the incorporation of new long-acting contraceptive methods into the Chinese family planning programmes.
1984年,美国人口理事会将皮下埋植避孕剂引入中国计划生育项目。在中国四个中心对1200例进行试点研究后,该研究扩展至12个中心,对10718例皮下埋植避孕剂使用者和1208例皮下埋植Ⅱ型使用者进行了6年多的随访。5年净累积妊娠率为0.5%-1.2%,净累积续用率约为每100名使用者65%-72%。不同体重和年龄组的妊娠率存在显著差异,即体重超过70公斤的组和年龄在25岁以下的组妊娠率较高。在选择使用者时应考虑年龄、体重以及皮下埋植避孕剂对避孕效果的依赖性。正在全国范围内的省、县农村地区开展大规模研究以及上市后监测。已对卵巢功能和子宫内膜的变化进行了研究。左炔诺孕酮宫内节育器于1985年引入中国。开展了皮下埋植避孕剂与左炔诺孕酮宫内节育器的临床对比研究、左炔诺孕酮宫内节育器的药代动力学和药效学研究以及子宫内膜研究。中国左炔诺孕酮宫内节育器使用者中卵巢抑制率较高(55.1%),这可能归因于白种女性在甾体激素敏感性方面的种族差异。结果表明中国女性对这两种避孕器具的接受度都很高。这些研究促进了新的长效避孕方法纳入中国计划生育项目。