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。     

固定式宫内节育器和TCu380A宫内节育器15年临床对比研究

目的:探讨固定式宫内节育器(固定式IUD)和TCu380A IUD远期应用的效果,观察15年IUD铜结构的保留状况.方法:采用前瞻性临床对比研究方法,共接收受试者200例,固定式IUD组和TCu380A组各100例.于置器后3个月、6个月、12个月及以后每年随访1次,15年时测定受试者血浆中的铜离子含量,并根据年龄设立对照组.整理全部资料,进行统计学分析.结果:两组受试者各年粗累积妊娠率比较,差异无统计学意义(P>0.05).妊娠与置器时年龄有关(P<0.05).固定式IUD第1年的粗累积脱落率显著高于TCu380A组(P<0.01).5年末、15年末两组的粗累积继续使用率比较,差异无统计学意义(P>0.05).15年末,两组各年主诉的发生率比较,差异无统计学意义(P>0.05).两组各年的粗累积因症取出率比较,差异无统计学意义(P>0.05).宫颈细胞学检查未见肿瘤细胞.使用超过15年的受试者血浆铜离子水平两组间比较差异无统计学意义(P>0.05),与正常对照组相比,差异亦无统计学意义(P>0.05).结论:固定式IUD和TCu380A IUD使用15年的避孕效果基本相似,均为高效、长效、安全的宫内节育器.     

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)。     

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。     

放置宫形Cu300宫内节育器200例5年临床效果观察

目的了解宫形Cu300宫内节育器的5年临床效果。方法在农村妇女中随机放置宫形Cu300和对照组TCu380A与TCu220c各200例,共600例。观察5年。结果使用5年时三种IUD妊娠率每百妇女分别为6.96,9.19和8.05,三组间无显著差异;脱落率每百妇女分别为3.68、14.72和5.84,TCu380A明显高于其它两种IUD(P＜0.001);因出血疼痛取出率每百妇女分别为4.48,3.59和6.29,三组间无显著差异。使用5年时三种IUD续用率每百妇女分别为80.50、71.50和77.50,以宫形Cu300为高,但无统计学差异。结论宫形Cu300避孕效果好,适合在农村推广使用。     

金塑混合环等三种宫内节育器比较性研究

本文总结了不锈钢金属单环(金单)、金属塑料混合环(金塑)及TCu220C三种宫内节育器前瞻性观察3年的结果。共接收对象1,199例,3年中失访4例,随访率达99.67%。放置12、24与36个月时的每百妇女累积续用率分别为金单73.76%、66.73%与65.47%;金塑80.86%、72.33%与69.32%;TCu220 C 94.46%、88.42%与83.13%。TCu 220 C的脱落率和妊娠率非常显著地低于金单和金塑(P<0.01),金单的脱落率高于金塑(P<0.05～0.01),而两者的妊娠率无显著差异(P>0.05)。三种IUD因出血取出率均无显著差异(P>0.05)。     

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。     

活性γCu380 IUD与TCu380A IUD多中心比较性研究

本研究通过增加原γCu2 0 0 IUD的铜表面积至 380 mm2 ,以期在不增加副反应的基础上进一步降低带器妊娠率 (包括异位妊娠 ) ,而达到与 TCu380 A IUD相似的避孕效果 ,并保持原来的低副反应发生率。方法 :1 998年 1～ 5月由全国五个中心参加的随机比较性研究 ,共随访 1 2个月。每个中心分别放置γCu380与 TCu380 A IUD各 1 0 0例 ,共 1 0 0 0例。结果 :1 2个月末 γCu380与 TCu380 A IUD脱落率每百妇女分别为 0 .80和 1 .99(P>0 .0 5)。带器妊娠率每百妇女均为 0 .2 0。异位妊娠率每百妇女分别为 0 .2 0和 0 .0 0 (P>0 .0 5)。因症取出率每百妇女分别为 1 .0 0和 2 .6 0 (P>0 .0 5)。结论 :γCu380 IUD临床效果与 TCu380 A IUD相似 ,而 γCu380 IUD副反应发生率明显低于 TCu380 A IUD。本研究结果证实载高铜面积 γCu380 IUD是一种优质的 IUD。     

活性γ型IUD(记忆合金)与TCu380AIUD的多中心随机对照临床研究

目的:观察活性γ-IUD(记忆合金)的妊娠率、脱落率、因症取出率和续用率、副作用及对生活质量的影响。方法:采用多中心随机对照的研究方法,对活性γ-IUD(记忆合金)与TCu380AIUD作临床效果比较。按常规要求放置IUD,在置器后的第3、6、12个月进行随访,观察临床效果和副作用。结果:共接纳对象1 987例,活性γ组993例,T-IUD组994例,对象的临床特征组间基本相似。置器后12个月的随访率活性γ组和T-IUD组分别为87.0%和86.6%;置器1年净累积续用率活性γ-IUD组为93.40%,T-IUD组为88.67%(P<0.01)。置器1年时粗累积脱落率活性γ-IUD组和T-IUD组分别为每100妇女年1.57和1.91(P>0.05),带器妊娠率分别为每100妇女年0.68和0.12(P<0.01);因IUD下移停用率分别为每100妇女年1.88和4.20(P<0.01);因出血停用率分别为每100妇女年1.13和4.10(P<0.01);因疼痛而停用、因症取出及非因症取出率组间相似。置器后各阶段副反应主诉的发生率活性γ-IUD组均明显低于T-IUD组(P<0.05)。生活质量均得到改善。结论:活性γ-IUD(记忆合金)比TCu380AIUD续用率高,下移和出血副反应少,是一种临床效果较好、副反应发生率较低的新型IUD。     

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.     

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）。     

Ectopic pregnancy among past IUD users.

The relationship between return to fertility and pregnancy outcome in women with IUD removal for planned pregnancy as well as the frequency of ectopic pregnancy among all former IUD users in comparison with the general population was studied. The cumulative conception rate in the group of women with IUD removal for planned pregnancy (n = 748) was 93.7% after 5 years, 93.4% being intrauterine and 0.3% ectopic. Rates of ectopic pregnancy in women with IUD removed for planned pregnancy were 2.7/1000 women, 3.6/1000 deliveries and 2.9/1000 pregnancies vs. 3.9, 13.4 and 5.6 in the general population. Only when the number of deliveries is used as denominator, have these differences reached statistical significance (P less than 0.05). Except for bleeding/pain and PID removals (6.0 vs. 3.9), in all other groups of former IUD users the incidence of ectopic pregnancy was also lower than in the control group. From the results of this study it was concluded that former IUD users are not at an increased risk for ectopic pregnancy.     

Ectopic IUD complicating pregnancy. A case report

BACKGROUND: For the most part, intrauterine devices (IUDs) have a low complication rate and minimal side effects. However, one of the most common reasons for contraceptive failure while using an IUD is its translocation or extrauterine migration. Pregnancy complicated by translocation or an ectopic IUD can present a formidable clinical challenge. CASE: A 23-year-old woman, gravida 3, para 2, using a copper-7 IUD for contraception, presented at 7 weeks' gestation. Transvaginal sonogram confirmed the presence of a fetal pole with cardiac activity; however, the IUD was not detectable. An anteroposterior roentgenogram showed 90 degrees counterclockwise rotation of the IUD relative to the normal position. Laparoscopy was performed at 14 weeks. The IUD was extrauterine, buried in omental adhesions attached to the anterior abdominal wall. The IUD was dissected free and removed without difficulty. The remainder of the pregnancy was uncomplicated. CONCLUSION: Uterine perforation is a recognized and potentially hazardous complication of IUD use. Localization of a lost IUD should follow an organized and systematic approach utilizing an assortment of radiologic and operative techniques. We report the third known case utilizing laparoscopy to remove an ectopic IUD complicating early pregnancy. Laparoscopy, even during pregnancy, has proven to be a safe and simple tool for managing a variety of surgical conditions.     

放置含铜宫内节育器的五年临床观察

对２００例放置金属宫内节育器（ＩＵＤ）失败的妇女，随机放置含铜ＭｕｌｔｉｌｏａｄＣｕ２５０ＩＵＤ（ＭＬＣｕ２５０）和ＶＣｕ２００ＩＵＤ（ＶＣｕ２００）各１００例。临床观察５年，随访率９７．５％。结果表明：ＭＬＣｕ２５０和ＶＣｕ２Ｏ０的５年累积脱落率为１．０／每百妇女（下同）、８．１；妊娠率为１２．０、４．１；因出血和疼痛取出率为６．０、６．１；继续存放率为８０．０、８１．７。ＭＬＣｕ２５０脱落率明显低于ＶＣｕ２００，两者比较，差异有非常显著意义。提示：ＭＬＣｕ２５０和ＣＶｕ２００５年存放率高，避孕效果好，两种ＩＵＤ均适合于放置金属ＩＵＤ失败者。ＭＬＣｕ２５０至少可使用５年，如增加其铜表面积，有可能使妊娠率进一步降低。     

宫腔镜子宫中隔切除术后3种治疗方法预防宫腔粘连的疗效及生殖预后观察

目的:探讨宫腔镜下子宫中隔切除(transcervical resection of septum,TCRS)术后预防宫腔粘连形成及改善妊娠结局的最佳治疗方案。方法:TCRS术后患者116例随机分为4组:A组(n=30),术后行人工周期;B组(n=31),术后宫腔放置宫内节育器(IUD);C组(n=27),术后放置IUD+行人工周期;D组(n=28),术后不采取任何干预措施。术后3个月再次行宫腔镜检查,观察宫腔是否发生粘连及粘连分布,随访至术后24个月,记录月经恢复情况及妊娠结局。结果:A组排除9例(6例失访,3例漏服药物),B组排除6例(4例失访,2例IUD脱落),C组排除2例(1例失访,1例IUD下移),D组排除5例(均为失访)。4组术后3个月宫腔粘连发生率依次为:14.2%(1/7)、37.5%(3/8)、22.2%(2/9)、9.1%(1/11);随访至术后24个月,妊娠率分别为:33.3%(7/21)、32.0%(8/25)、36.0%(9/25)、47.8%(11/23);流产率分别为:4.8%(1/21)、12.0%(3/25)、8.0%(2/25)、4.3%(1/23),宫腔粘连发生率、妊娠率和流产率组间均无统计学差异(P>0.05)。结论:TCRS术后进行人工周期、IUD、IUD+人工周期3种治疗方法对防止宫腔粘连形成及提高妊娠率、改善妊娠结局方面无明显益处,且治疗效果差别不大,术后不必将其作为常规治疗方法。     

GyneFix IN与TCu 380A宫内节育器的随机比较性临床研究

目的观察新型ＧｙｎｅＦｉｘＩＮ宫内节育器（ＩＵＤ）的临床性能。方法采用随机对比性多中心临床研究方法,对６０７例健康经产妇女由经过培训的专人以随机方法于月经间期放置ＧｙｎｅＦｉｘＩＮＩＵＤ３２０例（ＧｙｎｅＦｉｘＩＮ组）及ＴＣｕ３８０ＡＩＵＤ３０５例（ＴＣｕ３８０Ａ组）,于放器后１、３、６和１２个月随访,以生命表法统计两种ＩＵＤ的终止情况。结果ＧｙｎｅＦｉＸＩＮ组使用１年无妊娠发生,脱落和因症取出率分别为每百妇女２６７和１０２,与ＩＵＤ使用有关的终止率为每百妇女３６６,明显低于ＴＣｕ３８０Ａ组的每百妇女７８８（Ｐ＜００５）。ＧｙｎｅＦｉｘＩＮ组疼痛的主诉率也低于ＴＣｕ３８０Ａ组。结论此种无支架、铜表面积大并有固定系统的ＩＵＤ,由经过培训的人员放置,具有低脱落率和改善疼痛副反应的特点,有推广前景。     

Expression of leukaemia inhibitory factor (LIF) during the window of implantation in copper T380A intrauterine device users.

OBJECTIVE: The mechanism of action of intrauterine devices (IUDs) is not well understood. This investigation was intended to gain further insight into the role of leukaemia inhibitory factor (LIF) in intrauterine contraception. We evaluated the immunohistochemical distribution patterns of LIF in women wearing a copper T380A IUD. METHODS: The immunohistochemical distribution patterns of LIF in women who had been using a copper T380A IUD for different periods of time, two months after removal of the IUD, and in normal fertile women were evaluated. Endometrial biopsies were obtained from four groups of patients according to the duration of T Cu380A IUD use (group I: <5 years, n = 15, and group II: > or = 5 years, n = 15), after IUD removal (group III, n = 15) and normal fertile women (controls, n = 15) during the window of implantation (WOI). Staining intensity of LIF was evaluated using semi-quantitative IRS-scores. RESULTS: The lowest expression of LIF was observed in women using a copper T380A IUD, being statistically significant compared with the control group (p < 0.05). LIF immunostaining remained abnormal two months after IUD removal. CONCLUSIONS: Copper IUDs can inhibit expression of LIF and they may cause inhibition of the implantation stage, which is crucial for pregnancy.     

For and against the IUD in diabetics

Studies of the relative efficacy of IUD use in diabetic women are few and are all retrospective. A study by Wiese in which the experience of 118 insulin-treated diabetic women using the inert IUD Antigone was compared with that of 914 nondiabetic women using the same device showed a cumulative pregnancy rate of 3.5/100 woman years at 2 years for the diabetic women, compared to 5.2 among the nondiabetic. Wiese concluded that the use of the Antigone is as satisfactory in diabetic women as in nondiabetic and is suitable for all diabetic women except those with vascular complications and those with 2-3 children among whom sterilization is preferrable. A study by Gosden et al. published in 1982 gave a pregnancy rate of 36.6/100 woman years among insulin dependent IUD users compared to 4 among nondiabetic women. 11 of the 30 diabetic women became pregnant, of whom 5 used Gravigardes, 5 used Saf-T-Coils, and 1 used a Dalkon Shield. The authors concluded that IUD use is inappropriate for diabetic women. A study by Skouby showed no differences at 12 months in rates of accidental pregnancy, expulsion, or infection among 105 insulin dependent diabetic women and 119 nondiabetic women using Copper T 200s. New results published by Lawless and Vessey on 13 diabetic women in the Oxford Family Planning Association study gave a pregnancy rate of 2/100 woman years, comparable to that found in nondiabetic women. Kurz reported no pregnancies after a total of 136 woman years of IUD use by 4 insulin dependent diabetic women, and Buchsenschutz reported a pregnancy rate of 1.7% among 56 diabetic women. In view of methodological criticisms of the Gosden study and confirmation by the remaining studies of the efficacy of IUDs in diabetic women, it is concluded that IUD use is appropriate for such patients provided that the disease is properly treated and constant close surveillance is provided.