固定式铜宫内节育器与TCu380A宫内节育器的临床比较性研究

目的:探讨固定式铜宫内节育器(CuFixIUD)的避孕效果。方法:采用前瞻性临床对比性研究方法,共接收200例受试者,随机分为CuFixIUD组(n=100)和TCu380AIUD组(n=100),观察8年。结果:8年末随访率为95%。CuFixIUD组1例意外妊娠,无一例带器妊娠,而TCu380AIUD组8年累积妊娠率每百妇女为6.75。CuFixIUD组3个月随访时脱落率每百妇女为9.18,随访1年至5年各年的累积脱落率明显高于TCu380AIUD组,组间相比,差异有统计学意义(P<0.01)。8年末的累积脱落率组间差异无统计学意义(P>0.05)。组间各时期因症取出率以及续用率相比较差异无统计学意义(P>0.05)。结论:CuFixIUD为一种低妊娠率、高效和长效的IUD。     

不同时期放置宫内节育器TCu380A的临床效果比较

妇女年,但差异无统计学意义(P>0.05).结论 4种不同时期放置TCu380A IUD均安全可行,效果可靠.     

MCuⅡ与TCu 380A宫内节育器的临床比较性研究

目的:观察第二代爱母含铜宫内节育器(AiMu MCuⅡIUD)的临床效果。方法:对要求使用IUD避孕的825例育龄妇女,随机放置MCuⅡIUD(408例)与TCu380A IUD(417例),放置后3个月、6个月、12个月、24个月、36个月定期随访,记录IUD使用情况。结果:随访36个月时MCuⅡ与TCu380A组随访率分别为98.78%、98.57%。MCuⅡ组3个月、36个月的副反应主诉率分别为20.34%和8.28%,除了36个月外,4次随访副反应主诉率均低于TCu380A IUD组,差异有统计学意义(P<0.05)。随访12个月、36个月MCuⅡ组带器妊娠率分别为0.98/100妇女、1.96/100妇女,5次随访MCuⅡ组带器妊娠率均高于TCu380A IUD组,但无统计学差异(P>0.05)。MCuⅡ组6个月的因症取出率和36个月的终止率分别为7.60%和22.06%,MCuⅡ组因症取出率及终止率均低于TCu380A IUD组,除了3个月外,其余4次随访比较均有显著性差异(P<0.05)。结论:MCuⅡIUD副反应少、续用率高,避孕效果与TCu380A相当,是当前可供选择的有效IUD。     

第二代爱母牌功能性宫内节育器1000例临床应用研究

目的探讨第二代爱母牌功能性宫内节育器(MCuⅡIUD)的临床效果及安全性。方法 2005年12月至2006年3月在国内临床多中心按统一标准选择2000例要求使用IUD避孕的育龄妇女,随机放置MCuⅡIUD与TCu380AIUD各1000例,放置后1、3、6、12个月定期随访观察。结果放置满12个月时,MCuⅡIUD组与TCu380AIUD组比较,继续使用率分别为96.36%、92.15%,差异有统计学意义(P0.05);累积脱落率分别为0.51%、2.15%,差异有统计学意义(P0.05);累积带器妊娠率分别为0.41%、0.63%,差异无统计学意义(P0.05);因症取出率分别为2.01%、4.14%,差异有统计学意义(P0.05);4次随访主诉发生率差异均有统计学意义(P0.05)。结论 MCuⅡIUD脱落率低、抗生育效果好,置取方便,置器后副反应小,是效果比较理想的IUD。     

新型铜Flaxigard宫内节育器与TCu380A宫内节育器的临床对比研究

目的　了解新型铜FlaxigardIUD(CuFixIUD)的避孕效果和副反应 ,以TCu380AIUD为对照组进行临床实验。方法　采用前瞻性、随机分配原则 ,共接收 2 0 0例受试者。结果　 12个月内两组无一例发生妊娠 ,脱落率为每百妇女 10 2和 1 0 ,有明显统计学意义 (P <0 0 5 )。累积使用率为每百妇女 88 8和 97 0 ,两组无统计学意义 (P >0 0 5 )。 2 4个月时累积使用率两组分别为每百妇女 88 8和 93 0 ,36个月时随访率为 10 0 %。妊娠率两组分别为每百妇女 1 0和 3 0 ,因症取出率为每百妇女 2 0和 5 0。最常见的副反应为出血和疼痛。累积使用率分别为每百妇女 85 7和 89 0 ,两组无统计学意义 (P >0 0 5 )。结论　新型铜FlaxigardIUD为一种低妊娠率、高效和长效的IUD。TCu380A仍不失为一种高效、低副反应的IUD。     

含铜宫腔形宫内节育器临床研究

本文进行了宫铜器两年临床效果观察,一年半宫颈粘液中铜离子浓度及一年月经血量测定,并随机与宫形器和 TCu220C 进行了对比性研究。共接收对象660例,随访率为99.5%。三种 IUD 二年末每百妇女累积续用率分别为95.50、90.00和94.47,宫铜器与宫形器比较有显著差异(P<0.005);妊娠率宫铜器显著低于宫形器(P<0.001)和 TCu220C(P<0.05);脱落率和因出血/疼痛取出率宫铜器与后两种 IUD 比较无显著差异(P>0.05)。宫颈粘液铜离子浓度宫铜器组与 TCu220-C 组相似。月经血量宫铜器组略高于宫形器组,但无显著性差异(P>0.005)。     

人工流产术后即时放置三种宫内节育器的多中心随机对照研究

目的 了解3种常用宫内节育器(IUD)在人工流产术后即时放置的临床效果和安全性.方法 通过前瞻性随机对照临床研究,对来自全国7个省市的12个协作中心的1800例研究对象于人工流产术后即时放置IUD,放置的IUD类型分为宫形含铜IUD宫铜200、T形含铜IUDTCu380A和活性γ型IUD 3种,每种分别观察600例,并随访12个月.结果 1798例完成了使用12个月的随访,2例失访(失访率为0.11%,2/1800);17例不符合纳入标准的未产妇资料在进行数据统计分析时被剔除.3种IUD使用者均未发生妊娠(或带器妊娠),且均无子宫穿孔、IUD异位等并发症发生.活性γ型IUD的医疗原因终止率为1.02/百妇女年,低于宫铜200、TCu380A(分别为3.60/百妇女年、2.25/百妇女年),3者比较,差异有统计学意义(P=0.015).宫铜200、TCu380A和活性.y型IUD中,与IUD使用相关的终止率分别为7.58/百妇女年、7.30/百妇女年和3.72/百妇女年,3者比较,差异有统计学意义(P=0.008).结论 人工流产术后即时放置宫铜200、TCu380A和活性γ型IUD的避孕效果均良好,均安全可行,尤其是国产活性γ型IUD,值得推广.     

三种新型含铜宫内节育器宫底及宫颈部Cu2+浓度的初步探讨

目的 :研究三种不同含铜表面积的铜宫内节育器 (Cu IUD)对宫腔底部和宫颈部Cu2 浓度的影响。方法 :采集 6 0例置三种新型、高效的Cu IUD妇女不同时段宫腔底部和宫颈部粘液 ,用原子吸收 /火焰分光光度计法测定其Cu2 浓度。结果 :在置器后 6个月内含铜T形宫内节育器 (TCu380A IUD)和吉妮固定式宫内节育器 (GyneFixIN IUD)组不同时段宫腔底部和宫颈部Cu2 浓度差异无显著性 (P >0 0 5 )。在MCu功能性宫内节育器 (Mcu IUD)组 ,宫腔底部Cu2 浓度高于宫颈部 ,平均浓度分别为 2 8 10± 3 6 1μmol/L、6 91± 2 5 1μmol/L ,差异有显著性 (P <0 0 5 )。在置器 3个月后 ,TCu380A IUD和GyneFixIN IUD组宫颈部Cu2 浓度有一定程度下降 ,而MCu功能性IUD组下降不明显。结论 :含铜表面积小、纵径短的Cu IUD随置器时间延长仍能在宫腔底部释放较高的Cu2 ,而宫颈部Cu2 浓度变化相对不大。     

MCuⅡ IUD与MCu IUD及TCu220C IUD临床效果的比较研究

目的:探讨MCuⅡ功能性宫内节育器(MCuⅡIUD)的临床使用效果和安全性.方法:在我国不同地域进行多中心随机对照研究,分别放置MCuⅡIUD、MCu功能性宫内节育器(MCu IUD)及TCu220C IUD各500例,放置后1月、3月、6月、12月随访.结果:放置满12月,MCuⅡ IUD组累积带器妊娠率为0.20/百妇女,各组间比较,差异无统计学意义(P＞0.05).MCuⅡIUD组累积脱落率为0.20/百妇女,与MCu IUD组比较,差异无统计学意义(P＞0.05),与TCu220C IUD组比较,差异有统计学意义(P＜0.05).4次随访总的副反应发生率MCuⅡIUD组、MCuIUD组与TCu 220C IUD组间比较,差异均有统计学意义(P＜0.05),MCuⅡIUD组与MCu IUD 组间比较差异无统计学意义(P＞0.05);其副反应主要为月经异常、不规则流血、腰腹疼痛和白带增多.3组因症取出率依次为2.21/百妇女,2.42/百妇女,2.65/百妇女,各组间比较,差异无统计学意义(P＞0.05).结论:MCuⅡ IUD避孕效果好,脱落率低,放置后副反应发生率低,是比较理想的IUD.     

宫内节育器宫腔形Cu300、TCu220C、TCu380A放置10年的临床比较性研究

目的 了解宫腔形宫内节育器(Cu300)及TCu220C、TCu380A3种宫内节育器(IUD)放置10年的临床效果。方法 全国7个IUD临床应用中心,对2699例随机放置Cu300、TCu220C和TCu380A的农村妇女,共观察10年。结果 使用10年时,Cu300、TCu220C和TCu380A的带器妊娠率,分别为2．56、4．82和4．01／100妇女,Cu300明显低于其他两种IUD(P＜0．05)。脱落率分别为4．54、5．46和9．68／100妇女,TCu380A显著高于其他两种IUD(P＜0．001)。因出血、疼痛取出率分别为6．71、5．58和6．80／100妇女,3种IUD比较,差异无显著意义(P＞0．05)。使用10年时,3种IUD的续用率分别为74．86、66．22和63．56／100妇女,以Cu300续用率最高,TCu380A最低(P＜0．01)。结论 Cu300、TCu220C和TCu380A的避孕效果好,可推广使用。     

IUD appendicitis

A case of uterine perforation by an IUD with acute and chronic irritation of the appendix is presented. The patient, a 30-year old gravida 4, para 4, was admitted to the hospital with severe abdominal pain, fever, and diarrhea. A Lippes loop IUD had been inserted 3 years previously. The device could not be visualized at laparoscopy. At laparotomy the IUD was palpable within a large inflammatory mass in the right lower abdomen . Dissection of the adhesions revealed the IUD twisted around the appendix, and appendectomy was performed. This is the 1st reported case of a perforated, nonmedicated IUD causing appendicitis. The 2 cases of IUD appendicitis previously described in the literature involved Copper-7 devices, which have been shown to cause considerable tissue response when placed in the peritoneal cavity. Abdominal signs and symptoms associated with a missing IUD string should alert physicians to the possibility of IUD appendicitis.     

The IUD and pregnancy after inserting and removing the IUD]

The significance of IUD insertion on pregnancy and the effects of its removal on pregnancy are discussed. IUD insertion has 3 chief implications for pregnancy: 1) the risk of natural abortion increases with the insertion of an IUD, even for an IUD that remains in the proper position; 2) the percentage of women suffering abortions caused by uterine infection is higher among women with IUDs than for women without IUDs; and 3) pregnancy after insertion of an IUD can end in miscarriage or stillbirth, and often produces babies that weigh less than the standard weight for newborns. It is maintained that removal of the IUD has no harmful effects on fertility.     

Fertility after IUD removal

The article attempts to study the fertility pattern of 208 patients, previously wearers of IUD; the device was removed to permit pregnancy. 88% of patients became pregnant, most within 3 months, and 12% did not. Average retention time of IUD was 29.8 months for patients who got pregnant, and 25.1 for patients who did not. Age was 27.6 for patients in the first group, and 28.4% of pregnancies came naturally to term, with 7 multiple births. 10.4% of patients requested induced abortion. The possible difference in conception rate after use of medicated IUD in comparison with nonmedicated ones requires further investigation. Results of the study show that neither ability to conceive, nor outcome of pregnancy are modified by interruption of IUD use.     

含药含气IUD与TCu 380A IUD临床比较性研究

本文介绍一种新型合药含气IUD，系由硅橡胶、聚乙烯、聚氨酯构成，内含微小空气间隙和定量消炎痛。研究分为两组，组Ⅰ为含药含气IUD408例，与组ⅡTCu380A408例进行随机比较性研究，随访一年两组随访率达100％。结果显示：组Ⅰ与组Ⅱ粗累积存放率分别为97．8％、96．8％；累积妊娠率分别为0．99％和0．49％；累积脱落率分别为0．49％和1．24％。两组因疼痛和出血取出率分别为0．74％（Ⅰ）、1．5％（Ⅱ），上述两组均未显示统计学差异（P＞0．05）。表明含药含气IUD和TCu380AIUD均有较好的安全性、有效性和可接受性，而合药含气IUD出血量则显著低于TCu380A（P＜0．01）。     

IUD and gynecological infections

IUDs have assumed increasing importance as contraceptives. Better design and use of new materials has increased their safety and reduced their side effects. However, pathological problems are constantly reported in literature. They include menstrual alterations (menometrorrhagia), pelvic infection, ectopic pregnancies, and perforation of the uterus. Results of research conducted at the Gynecology and Obstetrics Clinic at the University of Pavia are reported. The pathogenesis and etiology of cervico-vaginitis, actinomyces infections, PID and septic abortion in patients using IUDs were examined. It is concluded that the use of the spiral IUD is contraindicated for women affected by immunodeficiency and for patients with diseases that require therapy with anti-inflammatory agents. Special attention should be given to nulliparous patients with cardiovalvular problems and to patients during the immediate postpartum period. The importance of performing a bacteriological cervico-vaginal examination before the insertion of the IUD is stressed. Aside from common aerobic germs, the patient should be examined for anaerobic germs and agents of sexually transmitted diseases. Any form of cervico-vaginitis should be treated prior to insertion. A bacteriological checkup should be performed continually in order to prevent possible phlogistic as well as asymptomatic or minor symptomatic complications. The IUD should be replaced within 2 years of insertion. If infections occur, the device must be removed and an antibiotic therapy initiated.