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目的探讨MCuⅡ功能性宫内节育器(intrauterine contraceptivedevice,IUD)的临床效果和安全性。方法在我国不同地域选择9省91个中心的健康育龄妇女放置MCuⅡIUD,放置后1、3、6、12月随访。结果放置满12个月,MCuⅡIUD累积带器妊娠率为0.29/百妇女年,累积脱落率为0.28/百妇女年,因出血/疼痛累积终止率2.15/百妇女年,各省间同项停用率差异无统计学意义(P>0.05);放置后不良反应主要为月经异常、不规则阴道出血、腰腹疼痛和白带增多,随放置时间的延长逐渐缓解。结论 MCuⅡIUD避孕效果好,脱落率低,不良反应发生率低,是比较理想的IUD,推广使用中需规范临床操作。
Objective To investigate the clinical efficacy and safety of MCUⅡ functional intrauterine contraceptive device (IUD). Methods Healthy women of childbearing age in 91 centers of 9 provinces in different regions of China were placed in MCuⅡIUD and were followed up 1, 3, 6, 12 months after placement. The results were placed over 12 months, MCu Ⅱ IUD cumulative with pregnancy rate of 0.29 per hundred female bulls, the cumulative shedding rate of 0.28 per hundred women, the cumulative bleeding / pain rate of 2.15 per hundred women, There was no significant difference between the two groups (P> 0.05). Adverse reactions were mainly irregular menstruation, irregular vaginal bleeding, abdominal pain and leucorrhea after placement, and gradually relieved with prolonged storage time. Conclusion MCu Ⅱ IUD contraceptive effect, shedding rate is low, the incidence of adverse reactions is low, is an ideal IUD, the need to promote the use of standardized clinical practice.