WHO 86925 Norplant上市后监测(中国部分)

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。

Post - Marketing Surveillance of Norplant in China.

The main objective of this study is to identify any major short to medium side effects of Norplant use that have not been identified in clinical trails. It is concurrent cohort study of 2996 women accepting Norplant implants (index subjects) and 3013women choseing IUD or sterilization(control subjects). The index and control subjects are being actively followed by means of six - monthly visits during five years irrespective of change of contraceptive methods. The follow - up rate is 99.9 % . Results show that the continuation rates of Norplant, IUD and sterilization are 76.3, 80. 9 and 98. 1/100 users respectively. The 5 - year cumulative pregnancy rate of Norplant users is 0. 6/100 users, much lower than that of IUD as 1. 24/1000WY. But the ectopic ratio per 100 pregnancies for Norplant is 31.6much higher than that of IUD as 6.7. Thus if pregnancy is occurred in Norplant users the possibility of ectopic pregnancy should be concerned. The menstrual problem is the main cause of termination of Norplant, but the level of hemoglubin is increased after 5 year of use, in comparison with that during admission, P < 0. 001. While after 5 years'use of IUD the hemoglubin decreased, with P < 0. 01. During 5 years of observation no significant excess of malignant neo-plastic diseases, cardiovascular events, or diabetes was observed in women using Norplant compared to that in women using IUD or sterilization. The incidence of cholecystitis, cholelithiasis and fibroadenoses of breast in Norplant group are higher than that in control group, P < 0. 01. There are no major healthy related problem observed. So the Norplant subdermal contraceptive implants used for 5 years is safe.