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目的:①多中心观察B超监测下放置吉妮和TCu380A宫内节育器(IUD)并随访12月的临床效果;②探讨吉妮IUD近期脱落的原因。方法:随机分组并在B超监测下放置吉妮IUD289例,TCu380AIUD303例,术后1、3、6、12月定期妇科及B超随访,记录受试对象病史、术时和术后情况,用SPSS10.0软件包进行数据处理,以生命表方法统计结果并行显著性检验。结果:①术后疼痛症状发生情况TCu380AIUD组明显高于吉妮IUD组,差异有显著性(P<0.05);术后6、12月随访月经紊乱以TCu380AIUD组为高,差异有显著性(P<0.05)。②术后6月、12月生命表结果提示吉妮IUD组因出血和疼痛的终止率较TCu380AIUD组低,差异有显著性(P<0.05)。③子宫后位者易发生带器妊娠,脱落与月经量及置器医生放置IUD质量有关。结论:吉妮IUD的避孕效果与国际推荐使用的TCu380AIUD一致,置器后出血和疼痛副反应少于后者。引入B超监测IUD放置过程对杜绝放置的不安全隐患有重要作用,也是在监控和验证放置IUD质量、年轻医生的培训过程及基层推广应用中必须注意的问题。
PURPOSE: (1) To observe the clinical effect of Gynne and TCu380A intrauterine device (IUD) under follow-up of 12 months under multi-center observation in B-ultrasound; Methods: Randomly grouped and placed Gineni IUD289 cases, TCu380AIUD303 cases under the B-monitoring, regular gynecological and B-ultrasound follow-up after 1,3,6 months, recording the subjects’ history, operation and postoperative conditions, with SPSS10.0 software package for data processing, the statistical method of life table method parallel significance test. Results: (1) The incidence of postoperative pain in TCu380AIUD group was significantly higher than that in Gen Gi IUD group (P <0.05). The follow-up of 6 and 12 months after the operation was significantly higher in TCu380AIUD group than in TCu380AIUD group (P < 0.05). ② The results of life table at June and December after operation showed that the termination rate of bleeding and pain in genital IUD group was lower than that of TCu380AIUD group (P <0.05). ③ posterior uterine prone pregnancy occurs with the device, shedding and menstrual flow and placement of the quality of IUD placed on the doctor. CONCLUSIONS: The contraceptive efficacy of Gini IUD is consistent with the internationally recommended TCu380AIUD with less bleeding and pain side effects after device placement. The introduction of B-monitoring IUD placement process plays an important role in preventing the hidden dangers of placement. It is also a problem that must be paid attention to in monitoring and verifying the placement of IUD quality, the training process of young doctors and the grass-roots promotion and application.