北京地区宫外孕与节育方法使用关系的流行病学调查

本研究对北京地区1990年间272余万育龄妇女(15～49岁)进行宫外孕发生率监测,共收集确诊宫外孕1420例。在育龄妇女总人群中宫外孕发生率为0.52/1000育龄妇女年。使用节育方法人群中宫外孕发生率为0.54/1000育龄妇女;已婚未使用节育方法人群则为1.80/1000育龄妇女,为使用节育方法者三倍。又应用相对优势比(RO_(MH))与归因危险度(AR)定量综合评价宫外孕与节育方法使用的关系,结果显示有效使用各种节育方法均不增加宫外孕发生危险。各种节育方法因其避孕效果及在人群中使用比例不同,其降低宫外孕发生的程度亦不同。TCu IUD有效使用,明显降低宫外孕发生危险。     

IUD_s是安全、有效和可靠的

IUDs的抗生育作用机制迄今仍不明瞭,可能与改变或抑制精子在女性上生殖道内移行,受精和卵子输送有关,抑制受精和卵子输送可能比由于子宫内膜生物化学和组织学变化而防止受精卵着床的作用更为重要。新的含铜IUDs,如TCu220C等使用一年或二年后证实比早期的Cu7等更有显著的避孕效果。使用IUDs和异位妊娠之间没有因果关系。子宫穿孔率低于1/2000。终止使用IUDs,生育力迅速恢复。     

三种国产宫内节育器临床多中心比较性研究——八年随访总结

全国9省市16个单位,对不锈钢金属单环(金单)、VCu200及TCu220C三种宫内节育器(IUD)进行随机临床多中心比较性研究。自1983年7月1日至1984年3月31日共接受对象4490例。八年末随访率为90.33％。三种IUD间每百妇女累积续用率的差别后期有随使用时间的增长而缩小的趋势,但96个月时仍以金单为最低,47.08％,VCu200和TCu220C各为54.05％和61.14％。VCu20O和TCu220C的妊娠率分别为10.35％和8.94％,它们间差异较前期增大,并显著地低于金单的24.14％。96个月时,金单、VCu200和TCu220C的脱落率分别为21.69％、13.05％和7.48％,三者间呈显著性差异。因出血和/或疼痛取器,八年中金单最低,前期VCu200略低于TCu220C,96个月时仍以金单为最低,VCu200略高于TCu220C,但二种带铜IUD间无差别。三种IUD使用情况城市与农村比较,城市的累积续用率均高于农村;妊娠、脱落和个人原因停用农村均高于城市。用COX比例风险模型和似然比检验分析,发现妊娠和脱落均受年龄、过去使用IUD、本次IUD类型和孕次的影响,显示了两种带铜IUD的妊娠和脱落风险远小于金单;出血和/或疼痛受孕次和本次IUD类型的影响,金单的出血和/或疼痛风险小于两种带铜IUD,总的失败风险受年龄、本次IUD类型、过去使用IUD和孕次的影响,显示了直至使用八年金单的失败风?     

月经间期放置7种宫内节育器的临床效果比较

目的:比较月经间期放置7种宫内节育器(IUD)的使用效果。方法:采用多中心随机比较性的方法,在全国11个省市的42家计划生育服务和医疗机构,对符合本研究纳入标准的观察对象,随机放置TCu220C、TCu380A、母体乐375、宫铜300、宫铜200、元宫药铜220及活性γ型IUD中的一种,比较使用效果和副反应的发生情况。结果:自2004年7月1日～2005年6月30日,共接收观察对象6155例。1年末的随访率为99.5%。7种IUD的带器妊娠率、脱落相关终止率差异有统计学意义,TCu220C、元宫药铜220及活性γ型IUD的使用效果较好,母体乐375和TCu380AIUD的脱落相关终止率较高。结论:我国自行研发的元宫药铜220和活性γ型IUD在带器妊娠、脱落相关、因症终止等诸方面优于其他类型IUD,值得进一步推广使用。     

药铜环165、活性γ-IUD和TCu220C临床效果观察

1989年4～10月随机放置药铜165IUD 99例,活性γ型IUD 100例,TCu220C 101例,观察五年三种IUD的脱落率分别为11.1、1.0和1.98;带器妊娠率分别为6.1、2.0和4.95;宫外孕的发生危险性含消炎痛的药铜165和活性γ型与TCu220C相比并未增加,因症取出率γ型和药铜环相似,TCu220C最高11.88;五年内继续存放率,γ型最高87.0,TCu220C74.3,药铜环70.7,γ型与其它两种相比差异有显著性。结论:活性γ型IUD含有消炎痛与铜,经五年观察,临床效果优于药铜环与TCu220C,值得推广。     

脱环率较大的妇女放置吉妮和TCu220C宫内节育器避孕效果观察

<正>放置宫内节育器(IUD)是我国妇女使用最普遍的避孕方法。在各种常见IUD避孕失败的原因(脱落、下移取出、因症取出、带器妊娠、意外妊娠)中,置器12个月的累计脱落率最高[1,2]。因脱落失败在各种IUD不同,11种IUD分析报告显示5年脱落失败率在3.23%~10.83%[1,3],有报告可达到20%[4]。本文对首次放置IUD脱落后的妇女,再次重新选用吉尼IUD和TCu220CIUD的避孕效果进行观察。     

放置不同IUD妇女带器妊娠260例分析

目的:探讨放置金属单环、母体乐铜375环及TCu环妇女带器妊娠的有关因素,指导育龄妇女合理避孕。方法:对260例放置上述3种宫内节育器(IUD)妇女带器妊娠有关因素进行分析。结果:放置金属单环者带器妊娠比例明显高于放置母体乐铜375及TCu者;放置3种IUD妊娠者中50%以上有环移位;<35岁组带器妊娠比例明显高于≥35岁组;不同放置年限均可出现带器妊娠,且放置年限越长,带器妊娠比例越高。结论:在指导育龄妇女避孕时尽量选择活性IUD,定期检查环位,及时发现环移位,应根据不同IUD放置年限及时更换,同时提高操作人员技术水平,从而降低带器妊娠率。     

4种新型宫内节育器使用5年临床效果评价

为较好掌握新型 IUD 的优点和特征,便于医务人员根据不同育龄妇女身体状况选择适当的 IUD 类型,本课题对2400例育龄妇女随机放置 TCu380A、三球头 TCu220C、MLCu375SL 和含药宫铜4种新型 IUD 使用5年间的终止原因进行临床多中心研究分析。结果表明:第二代活性 IUD具有安全、高效、长效的优点,其中尤以 TCu380A 具有较高续用率(78.1/100妇女),其妊娠率(带器妊娠及意外妊娠)为4.9/100妇女,脱落率也最低,为6.9/100妇女(P<0.05);MLCu375SL 城市组使用效果明显优于农村组,其5年续用率分别为80.54/100妇女和66.89/100妇女(P<0.05);农村组脱落率最高,为14.6/100妇女(P<0.05);含药宫铜 IUD 置器后月经量增加的症状明显减少,因症取出率最低,5年末为3.7/100妇女(P<0.01);;三球头 TCu220C 具有低因症取出率和低脱落率的优点,但带器妊娠率最高,为8.4/100妇女(P<0.01)。结果提示:T 铜 IUD 的脱落率相对较低;三球头 TCu220C 的球头和含药宫铜 IUD 所含的消炎痛在减少副反应方面有一定的作用;ML-Cu375SL 适合城市妇女使用。     

宫内节育器使用者的衣原体血清学特征:铜对女性生殖道衣原体感染有抑制作用吗?

宫内节育器(IUDs)被认为是盆腔炎(PID)发生的一个主要危险因素,而衣原体则是PID,继而异位妊娠、输卵管性不孕症的一个主要病因。离体实验显示如果子宫内膜中铜的浓度与IUDs使用者宫腔中铜的浓度相似,则衣原体的生长受到抑制,这个结果提示铜的保护效应。本研究的目的在于评估含铜IUDs的使用与抗衣原体抗体水平二者之间的相关性。     

新型宫内节育器:安全、有效

1986年,WHO组织一专家组对宫内避孕的现状作了总结,肯定新型含铜宫内节育器(IUD)(如MLCu375和TCu380)在安全性和可靠性方面可与口服避孕药相比。同时也认为在安全性方面IUD使用者最主要的是盆腔炎(PID)危险性增加。其他如子宫穿孔、不良妊娠结局和带器异位妊娠危险增加,取器后不孕及月经量增加和贫血的危险。作者认     

An evaluation of the levonorgestrel-releasing IUD: Its advantages and disadvantages when compared to the copper-releasing IUDs

The levonorgestrel-releasing IUD (LNG-IUD-20), providing a daily dose of 20 ug, has recently been approved for marketing in Finland. The IUD's high efficacy in preventing accidental pregnancy and other numerous positive features make it a promising contraceptive device for worldwide use, just like the currently available T-shaped copper-releasing (TCu) IUDs.

This paper reviews published reports comparing the LNG-IUD-20 and the currently used TCu IUDs. The merits and disadvantages of the steroid-releasing IUD are evaluated in terms of its performance and other special features relative to the TCu IUDs. Also, a number of future studies with medical and programmatic importance are proposed. A broader understanding about these two IUD families will facilitate their use in a complementary way for family planning programs.     

Risk factors for intrauterine device failure: a review

After reviewing the literature on intrauterine devices (IUDs) published over the last 30 years, we selected and analyzed recent and most relevant (with appropriate methodology design) articles dealing with the risk factors for IUD failure. There is sufficient evidence to conclude that the TCu380 and levonorgestrel-releasing (LNG) IUD are the most effective, with a cumulative pregnancy rate of less than 2% at 12 years for the TCu380 and around 1% for the LNG IUD at 7 years. In addition, advancing age increases IUD effectiveness, and displacement of the IUD decreases effectiveness. The IUDs with the highest copper concentrations are clearly less prone to failure than those with lower copper concentrations.     

宫内节育器异位影响因素的分析

目的：了解宫内节育器（intrauterine device,IUD）异位的影响因素,降低IUD严重伤害事件的发生风险,为指导IUD的临床安全使用提供参考依据。方法：对国家人口计生委计划生育药具不良反应监测中心数据库中的IUD异位的前6种类型的IUD异位的不良事件进行分析,了解发生IUD异位事件的人群特征,并分析可能与IUD异位相关的风险因素。结果：数据库中记录发生异位的IUD前6种类型为：爱母功能型、TCu220C、活性165、元宫220、金属单环、宫铜200;236例IUD异位类型为：部分异位210例,占88.98%,完全异位有6例,占2.54%,子宫外异位20例,占8.48%;疼痛在所有临床症状中所占比例最高（38.98%）;随着放置时间增加,闭合型IUD发生异位的风险逐渐增加（趋势性检验P＜0.000 1）。结论：IUD异位可能与其种类、放置时间有关,疼痛可能是发现异位的主要线索,日常工作中要特别注意定期随访。     

3种宫内节育器临床避孕效果随访1年观察

目的观察GyneFix IN IUD、MCu IUD、TCu220C IUD的临床避孕效果。方法2003年6月~2006年6月本院采用对比性研究,以随机方法放置3种IUD635例,其中GyneFix IN IUD 212例,MCu IUD213例,TCu220C IUD 210例,于放置后1、3、6、12个月进行随访。结果3种IUD12个月的带器妊娠率、脱落率、因症取出率和累积续用率分别为GyneFix IN IUD0.47%,0.94%,0.47%,98.11%;MCu IUD0.94%,0.94%,1.41%,96.24%;TCu220C IUD0.95%,5.71%,4.29%,88.10%。3种IUD带器妊娠率比较,差异无显著性意义(P>0.05);GyneFix IN IUD和MCu IUD的脱落率低于TCu220C IUD,差异有非常显著性意义(P<0.01);GyneFix IN IUD和MCu IUD的因症取出率低于TCu220C IUD,差异有显著性意义(P<0.05);GyneFix IN IUD和MCu IUD的12个月的累积续用率高于TCu220C IUD,差异有非常显著性意义(P<0.01)。结论GyneFix IN IUD和MCuIUD具有脱落率低、因症取出率低、累积续用率高的优点,值得临床应用。根据对象的自身条件,选择合适的IUD,可提高避孕效果,减少副反应的发生。     

Statement on intrauterine devices (IUDs)

Topics covered in this statement on IUDs include: mechanism of action; contraindications; efficacy; duration of use; counseling; IUD selection; insertion; the complications of perforation, bleeding and pain, infection, pregnancy, ectopic pregnancies, and expulsion; removal; and follow-up care. The newer copper- and hormone-releasing IUDs have high continuation rates, and the pregnancy rates are low. The removal in February 1986 of the Lippes Loop, the Copper 7, and the Copper T200 from the US market was for commercial reasons and not because of concerns about safety and efficacy. The Food and Drug Administration (FDA) approves these IUDs, and it is likely that the already FDA-approved Copper T380A will be available in the US during 1988. In its December 1986 meeting, the World Health Organization (WHO) scientific group on the mechanism of action, safety, and efficacy of IUDs concluded that all IUDs stimulate a foreign body reaction in the endometrium which is potentiated by the action of copper, and progestagen-releasing IUDs produce endometrial suppression much as that seen when the drug is administered by other routes. Further, the scientific group indicated that it is unlikely that 1 single mechanism of action accounts for the anti-fertility effect of IUDs. Several absolute contraindications to IUDs are recognized, including: acute or chronic pelvic inflammatory disease (PID); known or suspected pregnancy; abnormal uterine bleeding; confirmed or suspected malignancy of the genital tract; and congenital uterine abnormalities or fibroids distorting the cavity in a manner incompatible with proper IUD placement. The newer copper devices (TCu220C, TCu380Ag, TCu380A, and Multiload 375) have the lowest failure rates. Counseling of the IUD user should include telling her about all alternative family planning methods and advising her of the type of IUD to be inserted and the proper time for replacement if it is a medicated device. The available evidence from many countries suggests that properly trained nonphysicians can insert IUDs as well as doctors. The IUD may be inserted at any time convenient to the user if it can reasonably be determined that she is not pregnant. The medical indications for removal are pregnancy, acute inflammatory disease, endometrial or cervical malignancy, perforation and partial expulsion of the IUD, and abnormal or excessive bleeding. Whenever possible, it is useful to examine IUD users 3 months after IUD insertion, and annual checks are useful to ensure the IUD is in place.     

放置元宫铜300、TCu380A及活性165 IUD 12个月效果观察

目的:观察元宫铜300、TCu380A和活性165宫内节育器(IUD)使用效果,探讨改善其使用价值的途径。方法:采用多中心随机比较性临床研究方法,自2007年7月3日~2008年11月21日,在全国6个省22家计划生育服务机构,对符合条件的健康育龄期妇女,随机分别放置元宫铜300、TCu380A或活性165IUD,比较避孕效果、失败率和不良反应的发生情况。结果:共接收观察对象3299例,放置元宫铜300、TCu380A和活性165IUD分别为1104、1104和1091例。12个月末失访率为0.24%(8/3299)。观察期间无子宫穿孔和盆腔感染发生。在IUD使用失败的各种原因中,3种IUD带器妊娠、下移取出终止率比较,差异均无统计学意义(P0.05);完全脱落以活性165最高(终止率为2.09/百妇女年),与元宫铜300(终止率为0.84/百妇女年)和TCu380AIUD(终止率为0.75/百妇女年)分别比较,差异均有统计学意义(P0.05);放置活性165IUD有4例发生意外妊娠(终止率为0.38/百妇女年),其他两种IUD各有1例(终止率均为0.11/百妇女年)。3种IUD中因出血和(或)疼痛的终止率以元宫铜300IUD最高,TCu380AIUD次之,活性165IUD最低,差异有统计学意义(P0.05)。结论:3种IUD各有优缺点,应综合考虑适用对象与IUD的特点,以提高IUD的实际使用价值。     

Copper-containing, framed intrauterine devices for contraception: a systematic review of randomized controlled trials

BACKGROUND: Intrauterine devices (IUDs) are safe and effective methods of long-term reversible contraception. The design and copper content as well as placement of the copper on IUDs could affect their effectiveness and side effect profile. We compared different copper IUDs for their effectiveness and side effects. STUDY DESIGN: We searched multiple electronic databases with appropriate keywords and names of the IUDs known to be on the market. We searched the reference lists of papers identified and contacted authors when possible. There was no language restriction. Randomized controlled trials comparing different IUDs that reported on clinical outcomes were considered for inclusion. Two reviewers independently extracted data on outcomes and trial characteristics. We combined the trial results in meta-analyses and expressed results as rate difference (RD) using a fixed-effects model with 95% confidence interval (CI). In the presence of significant heterogeneity, a random-effects model was applied. RESULTS: We included 35 trials, resulting in 18 comparisons of 10 different IUDs in approximately 48,000 women. TCu380A was more effective in preventing pregnancy than MLCu375 (RD 1.70%, 95% CI 0.07-2.95% after 4 years of use). TCu380A was also more effective than MLCu250, TCu220 and TCu200. There tended to be fewer pregnancies with TCu380S compared to TCu380A after the first year of use, a difference which was statistically significant in the fourth year (RD -1.62%, 95% CI -3.00% to -0.24%). This occurred despite more expulsions with TCu380S (RD 3.50%, 95% CI 0.36-6.63% at 4 years). MLCu375 was no more effective than TCu220 at 1 year of use, or MLCu250 and NovaT up to 3 years. Compared to TCu380A or TCu380S, none of the IUDs showed any benefits in terms of bleeding or pain or any of the other reasons for early discontinuation. None of the trials that reported events at insertion found one IUD easier to insert than another or caused less pain at insertion. There is no evidence that uterine perforation rates vary by type of device. There are minimal randomized data on IUD use in nulliparous women. CONCLUSIONS: TCu380A and TCu380S appear to be more effective than other IUDs. No IUD showed consistently lower removal rates for bleeding and pain in comparison to other IUDs. There is no evidence that any particular framed copper device is better suited to women who have not had children.     

四川省3个县农村育龄妇女宫内节育器使用情况调查

目的:了解四川省农村育龄妇女宫内节育器(IUD)使用情况。方法:采用多阶段分层整群抽样的方法,对四川省3个县农村,共2107例于2004年7月1日～2005年6月30日期间放置IUD妇女进行横断面及前瞻随访研究。结果:3个县育龄妇女普遍使用的3种IUD分别是:母体乐375、TCu380A、宫铜,不同地区使用种类不同(P<0.001)。平均续用率为86.9%,75.3%IUD在乡级服务机构放置。IUD使用失败原因前3类依次为脱落、因症取器和下移取器,分别占4.7%、2.8%、2.7%;带器妊娠率为1.0%。logistic单因素分析显示,防止IUD脱落的保护因素是施术者5年内接受培训(OR=0.817,P=0.007)。结论:建议引入以循证医学为基础的临床路径的管理模式,针对各型IUD特点制定相应的标准操作程序作为技术指南,促进服务质量提高。     

月经间期放置MYCu宫内节育器临床效果的比较性研究

目的:了解第三代爱母宫内节育器(MYCu IUD)在月经间期放置的临床效果、副作用及对生活质量的影响。方法:对要求放置IUD避孕的育龄妇女,在月经间期随机放置MYCu IUD(MYCu组,368例)与TCu 380AIUD(TCu380A组,369例),放置后1、3、6、12个月随访观察,记录使用情况。结果:置器后12个月MYCu组与TCu 380A组随访率分别为99.45%、100.00%;置器12个月累积续用率分别为每百妇女年94.02、91.87(P0.05);带器妊娠率分别为每百妇女年0.56、0.00(P=0.1703);脱落率分别为每百妇女年0.57、1.95(P=0.0947);无因IUD下移而停用者;因症终止率分别为每百妇女年3.01、6.03(P=0.0849)。置器后1、3、6个月副作用发生率MYCu组明显低于TCu380A组(P0.05)。两组对象相关生活质量均得到改善。结论:放置MYCu IUD较TCu 380AIUD疼痛和出血的副作用少,续用率、避孕效果与TCu 380AIUD相当,是一种临床效果好、副作用发生率较低的新型IUD。     

The frameless copper IUD (GyneFix) and the TCu380A IUD: results of an 8-year multicenter randomized comparative trial

Background

Clinical performance of the frameless copper IUD (GyneFix), designed to reduce side effects related to the frame of conventional IUDs, and TCu380A was compared.

Study Design

Randomized Multicenter randomized comparative trial. Parous women requesting and eligible to use IUD were admitted in 21 centers in eight countries in 1989-1993 and followed-up for up to 8 years.

Results

Two thousand twenty-seven women were randomized to the frameless IUD and 2036 to TCu380A; 43 insertions of the frameless IUD failed and none for TCu380A. First-year expulsion rate of the frameless IUD was 5.3 (95% CI: 4.4-6.4) per 100 and 2.5 (95% CI: 1.9-3.3) for the TCu380A; second- through eighth-year expulsion rates were not different. First-year pregnancy rates for the frameless IUD and TCu380A were 1.3 (95% CI: 0.9-2.0) and 0.5 (95% CI: 0.3-0.9), respectively; second- through eighth-year cumulative pregnancy rates were 1.2 (95% CI: 0.7-1.9) and 2.5 (95% CI: 1.8-3.4), respectively. The 8-year cumulative rates of ectopic pregnancy and IUD removal for pain were lower for the frameless IUD than for TCu380A. Removals for other reasons were not different.

Conclusions

The frameless IUD had more insertion failures, expulsions and pregnancies in the first year than TCu380A, but fewer pregnancies from the second through the eighth year, and by 8 years had fewer ectopic pregnancies and removals for pain.