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左炔诺孕酮宫内节育器与皮下埋植剂Norplant-2在中国的临床性能、避孕效果及可接受性比较。

Comparison of the clinical performance, contraceptive efficacy and acceptability of levonorgestrel-releasing IUD and Norplant-2 implants in China.

作者信息

Gao J, Wang S L, Wu S C, Sun B L, Allonen H, Luukkainen T

机构信息

Department of Female Clinical Research of Fertility Regulation, National Research Institute for Family, Beijing, China.

出版信息

Contraception. 1990 May;41(5):485-94. doi: 10.1016/0010-7824(90)90058-4.

Abstract

The levonorgestrel-releasing IUD (LNG-IUD, 20 micrograms/d) and the Norplant-2 implants were studied in a randomized comparative clinical trial with 200 women for one year. No pregnancy or expulsion occurred with the Norplant-2. In the LNG-IUD group, there was one pregnancy at the 12th month of use after an unnoticed expulsion. The net cumulative pregnancy and expulsion rates of LNG-IUD were 1.0 and 3.0. The removal rate due to menstrual disturbances in both LNG-IUD and Norplant-2 groups was 3.0. The use-related discontinuation rates were 9.0 and 3.0, and the continuation rates were 90.0 and 96.0, respectively. The differences were not statistically significant. Menstrual disturbance was the main side effect. It was improved after long time use, especially in the LNG-IUD group. After one year, the percentages of women with amenorrhea were 18.9 for the LNG-IUD and 8.3 for the Norplant-2. The menstrual blood loss was statistically significantly reduced in the LNG-IUD group, and blood haemoglobin concentration increased in both groups. The LNG-IUD and Norplant-2 are highly effective, safe, long-acting, and well accepted by the Chinese women.

摘要

对含左炔诺孕酮宫内节育器(LNG-IUD,20微克/天)和Norplant-2皮下埋植剂进行了一项随机对照临床试验,共有200名妇女参与,为期一年。使用Norplant-2皮下埋植剂的妇女未发生妊娠或脱落情况。在LNG-IUD组中,有1名妇女在未察觉节育器脱落的情况下于使用第12个月时妊娠。LNG-IUD的净累积妊娠率和脱落率分别为1.0和3.0。LNG-IUD组和Norplant-2皮下埋植剂组因月经紊乱导致的取出率均为3.0。与使用相关的停用率分别为9.0和3.0,持续使用率分别为90.0和96.0。差异无统计学意义。月经紊乱是主要的副作用。长时间使用后有所改善,尤其是在LNG-IUD组。一年后,LNG-IUD组闭经妇女的比例为18.9%,Norplant-2皮下埋植剂组为8.3%。LNG-IUD组的月经量显著减少,两组的血红蛋白浓度均升高。LNG-IUD和Norplant-2皮下埋植剂高效、安全、长效,深受中国妇女的接受。

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