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本课题研究目的是对Norplant皮下埋植剂潜在副作用进行监测,以进一步证实其安全性。对使用Norplant和IUD或绝育术的妇女进行比较随访研究。每半年随访一次,详细记录所有健康情况,共随访5年。随访率达99.9％。结果:Norplant组及对照组IUD和绝育术的5年继续使用率分别为76.25、80.89、98.10/100使用者。Norplant的5年累计妊娠率为0.6/100使用者,远低于IUD的8.11/100使用者,宫外孕发生率为0.46/1000妇女年,低于IUD的1.24/1000妇女年,但宫外孕和妊娠之比在Norplant组为31.6:100,远高于IUD的6.7:100,如发生妊娠,要警惕宫外孕的可能。月经问题是Norplant的主要终止使用原因,但使用5年者,其血红蛋白均值上升,和接收时相比P<0.001,而IUD使用5年者,其血红蛋白均值下降,和接收时相比P<0.01。在观察5年中胆囊炎胆石症、纤维囊性乳腺病在Norplant使用者中的发病率高于对照组,P<0.05～0.001,但未发现重大健康问题。Norplant使用5年是安全的。
The purpose of this study is to monitor the potential side effects of Norplant implants to further confirm its safety. A follow-up study was performed on women who used Norplant and IUD or sterilization. Follow up every six months, all health records in detail, a total of 5 years of follow-up. Follow-up rate of 99.9%. Results: The five-year follow-up rates of IUD and sterilization in Norplant group and control group were 76.25, 80.89 and 98.10 / 100 respectively. Norplant’s 5-year cumulative pregnancy rate was 0.6 / 100 users, well below the 8.11 / 100 IUD users, with an ectopic pregnancy rate of 0.46 / 1000 women years and 1.24 / 1000 women years younger than IUD, but with ectopic pregnancy and gestational age Than in the Norplant group was 31.6: 100, much higher than IUD 6.7: 100, such as pregnancy, to guard against the possibility of ectopic pregnancy. Menstrual problems were the main reason for Norplant’s discontinuation, but after 5 years of use, mean hemoglobin increased, P <0.001 compared to reception, whereas for IUDs 5 years, mean hemoglobin decreased, P <0.01 compared to reception . In the observation of 5 years cholecystitis cholelithiasis, fibrocystic breast disease in Norplant users the incidence was higher than the control group, P <0.05 ~ 0.001, but no major health problems were found. Norplant is safe to use for 5 years.