含硫酸钡MCu375 IUD 200例Ⅱ期临床试验研究  

Study of Clinical Trial Ⅱ on 200 Cases Bearing MCu375(Ba)IUD

作　　者：沈和[1] 程渭玉[2] 韩丽晖[3] 左文莉[4] 王幼劬[1] 殷尔晶 于玲[2] 王芝芬[6] 李义[6] 马莹[6] 魏振河[5] 杜建秋[5] 楚素炜[5] 

机构地区：[1]国家人口计生委科学技术研究所,北京100081 [2]天津市人口计生委科学技术研究所 [3]北京妇产医院 [4]北京大学医学部第一附属医院妇儿医院 [5]天津市中心妇产医院 [6]天津市第一中心医院

出　　处：《中国计划生育学杂志》2005年第7期422-425,共4页Chinese Journal of Family Planning

摘　　要：目的:比较MCu375(Ba)和母体乐375两种IUD使用的有效性、安全性和副反应的发生率。方法:采用多中心、随机临床对比性研究方法,放置两种IUD各200例,并于置器后1、3、6和12个月进行随访,随访率99.2%。结果:第12个月末两组的累积续用率分别为97.5%和96.0%,两组间无显著性差异(P>0.05)。置器后月经量增多为主要副反应,两组在12个月末的副反应率十分相近,组间无显著性差异(P>0.05)。结论:两种IUD使用效果接近,通过X线片可辩别MCu375(Ba)的环型,加强针对性指导更有利于该IUD在农村推广。Objective: To Compare the effective, safety and side-action on women benring MCu375(Ba)and Mlcu 375. Methods: Multiple center random comparing clinical study was adopted, each 200 IUDs users in three Hospitals in Beijing and Tianjing was followed up after insertion of first, third, sixth and twelfth month, and its rate was 99.2%. Results: The cumulative continue rate was 97.5% and 96.0% at end of twelfth month, there was no significant different in two groups(P>0.05). The hypermenorrhea was the main side-action after insertion in users, the incidence rate of side-aetion was similar at end of 12 month in two groups, there was no different (P>0.05). Conclusion: The shape of Mcu375(Ba) was clear by the x-rays. To consulting and give some advice for the users was favourable to use Mcu375(Ba) at rural area.

关 键 词：含硫酸钡 MCu375 IUD 临床试验 有效性 安全性 宫内节育器 

分 类 号：R169.42[医药卫生—公共卫生与预防医学]