四种宫内节育器的对比研究

本研究用实验流行病学方法,按随机分配原则对比了TCu380A、TCu220三球头、MLCu375SL、含药宫铜IUD四种宫内节育器(以下简称IUD)在江苏省育龄妇女中的使用效果。从1991年10月至1992年3月随机放置四种IUD,其中:TCu380A 593例,TCu220三球头606例,MLCu375SL 600例,含药宫铜IUD601例,共计2400例,农村、城市受试对象各为1200例。置器24个月时四种IUD累积续用率分别为:TCu380A 87.34/百妇女年,TCu220三球头88.41/百妇女年,MLCu375SL 87.32/百妇女年,含药宫铜型88.18/百妇女年,组间比较无显著差异(P>0.05);因妊娠、脱落、出血/疼痛终止率,四种IUD间均无显著差异;含药宫铜IUD明显降低出血副反应的发生率;按城、乡分组在24个月时农村组续用率较高,对此结果进行了探讨。     

TCu380A、TCu220C和MLCu375宫内节育器系统评估

目的 :评价TCu380A、TCu2 2 0C、MLCu375三种宫内节育器的有效性、副反应和可接受性。方法 :见中国计划生育学杂志“我国常用口服避孕药和宫内节育器系统评估的方法概述”(2 0 0 5年 1期 17页 )。结果 :TCu380AIUD妊娠率及脱落率均低于MLCu375IUD ,副作用发生率高于MLCu375IUD ,续用率等同或高于MLCu375IUD ,临床综合效能与MLCu375IUD相近 ;TCu380AIUD妊娠率低于TCu2 2 0CIUD ,脱落率及安全性与TCu2 2 0CIUD相似 ,放置满 5年后续用率高于TCu2 2 0CIUD ;MLCu375IUD妊娠率略低于TCu2 2 0CIUD ,脱落率低于或等同于TCu2 2 0CIUD ,二者的副反应发生率相似 ,临床综合效能优于TCu2 2 0CIUD。建议 :可以继续使用TCu380AIUD、MLCu375IUD和TCu2 2 0CIUD ,并且加大TCu380AIUD和MLCu375IUD的使用份额。在总体上应优先考虑提供铜表面积≥ 30 0mm2 的宫内节育器     

活性γ-Ⅱ型宫内节育器避孕效果观察

目的:观察活性γ-Ⅱ型宫内节育器(IUD)的避孕效果。方法:随机放置活性γ-Ⅱ型IUD与MLCu375 IUD各854例,进行为期2年的随访观察。结果:24个月的带器妊娠率、IUD脱落率、因症取出率、累积续用率,活性γ-Ⅱ型IUD为每百妇女年0.7、0.23、2.22、96.7,MLCu375 IUD为每百妇女年0.47、4.44、7.02、87.9,带器妊娠率比较无差异(P(0.05),活性γ-Ⅱ型IUD脱落率及因症取出率低于MLCu375 IUD(P(0.05),累积续用率高于MLCu375 IUD(P(0.05)。结论:活性γ-Ⅱ型IUD较MLCu375 IUD具有脱落率和因症取出率低,累积续用率高等优点。     

5种IUD使用3年的临床效果分析

目的:观察5种宫内节育器(IUD)放置3年的临床效果。方法:回顾性分析放置爱母环、元宫220型、宫铜、TCu 380型、母体乐等5种IUD的672例观察对象,追踪使用IUD 3年的临床随访观察效果。结果:3年的随访结果表明,元宫220型的续用率最高(97.89%),妊娠率最低(0.70%),脱落率(0%)最低,异常出血(5.63%)和疼痛(3.52%)的发生率最低(P<0.05)。TCu 380型的续用率最低,妊娠率最高,脱落率以爱母环和元宫220型最低,TCu380型和母体乐最高。结论:活性元宫220型IUD较其他4种IUD具有副作用小、续用率高、避孕效果好等优点,可在临床广泛应用。     

γ药铜200(25)宫内节育器系统评估

目的:评价γ药铜200(25)宫内节育器(IUD)的有效性、副反应和可接受性。方法:电子及手工检索收集1985年1月~2006年5月国内外发表的相关文献,依照循证医学的方法对纳入的文献进行评价和分析。结果:共检索到34篇相关文献,6篇纳入本次评估。分析结果显示,置器后5年内,γ药铜200(25)IUD有效性优于TCu220CIUD,可接受性高于TCu220CIUD;置器后3年内,γ药铜200(25)IUD有效性优于MLCu375IUD,与宫铜300IUD、TCu380AIUD相似;可接受性高于MLCu375IUD和宫铜300IUD,与TCu380AIUD接近。γ药铜200(25)IUD副反应发生率,尤其是出血方面发生率,低于其他对照IUD,如TCu220CIUD、宫铜300IUD等。结论:γ药铜200(25)IUD是一种有效性、可接受性较好的IUD。     

浅谈几种宫内节育器的临床效果

目的了解不同宫内节育器的临床效果。方法选取接受宫内置器术的育龄妇女562例为观察对象,依实际情况分别使用TCu220CIUD、吉尼IUD、MLCu375IUD、Cu300IUD和γIUD。术后3年时间内我中心及时开展随访工作。结果脱落率吉尼组最低,Cu300组最高;带器妊娠率TCu220C组最低;续用率TCu220C组、吉尼组最高。结论不同宫内节育器具有各自的适用特点,医务工作者应根据受术者的实际情况,为其科学选择适合的宫内节育器。     

活性γCu380IUD与TCu380IUD及吉妮330IUD临床效果观察

目的观察比较活性γCu380IUD、TCu380IUD及吉妮330IUD临床避孕效果。方法2003年11月～2005年12月本院选择自愿放置IUD的已婚育龄妇女300例,随机分成三组(各100例),分别放置活性γCu380IUD、TCu380IUD及吉妮330IUD,并于放置后1、3、6、12、24个月进行随访。结果三种IUD放置24个月后比较其脱落率、带器妊娠率、因症取出率及累积续用率均无统计学差异(p>0.05)。结论三种IUD均具有脱落低、带器妊娠率低、因症取出率低及累积续用率较高的优点,其避孕效果良好,可在临床上推广使用。     

(药)铜165宫内节育器系统评估

目的:评价(药)铜165宫内节育器的有效性、副反应和可接受性,试图发现其与新型宫内节 育器使用效果的差别。方法:见本刊“我国常用口服避孕药和宫内节育器系统评估方法概述”(2005 年1期17页)。结果:与新型宫内节育器药铜γIUD、TCu220CIUD和MLCu375IUD相比,药铜165 IUD确实存在较高的脱落率和妊娠率;其续用率显著低于药铜γ和TCu220CIUD;其因症取出率高于 药铜γIUD,略低于TCu220CIUD。结论:新使用者不宜选用药铜165IUD,现用者不需取出药铜165 IUD,可继续使用。     

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。     

GyneFixIN与r型、MLCu IUD的临床对照分析

目的:观察新型GyneFixIN IUD的临床效果。方法:采用对比性研究,以随机方法给556例健康育龄妇女放置三种不同IUD,其中GyneFix IN IUD 220例,r型IUD 220例,MLCu IUD 116例,于放置后6个月及1、2、3年进行随访。结果:GyneFix IN IUD使用3年妊娠率、脱落率、因症取出率和续用率分别为0.5％、0.9％、3.2％、94.5％。GyneFixINIUD脱落率明显低于MLCuIUD的11.3％(P<0.01),也低于r型IUD的4.2％,但无明显差异(P>0.05)。三种IUD续用率分别为94.5％、88.7％和82.4％,GyneFix IN IUD续用率高于MLCu IUD(P<0.05)。结论:CyneFixIN IUD具有脱落率低、续用率高、副反应小的优点,值得临床推广。     

3种宫内节育器临床使用12个月避孕效果比较分析

目的:比较育龄妇女月经间期放置3种宫内节育器(IUD)的使用效果.方法:对2008年1月～2010年5月在本中心、青海红十字医院和乐都县计划生育服务站放置GyneFix330、TCu380A和MLCu375IUD共799例妇女进行1年随访,比较使用1年的临床效果和副反应.结果:GyneFix330、TCu380A和ML...     

A comparative clinical trial of the TCu 380A, Lippes Loop D and Multiload Cu 375 IUDs in Indonesia

The Copper T 380A (TCu 380A), Lippes Loop D (LLD) and the Multiload Cu 375 (MLCu 375) IUDs were evaluated for safety and efficacy in a multicenter randomized clinical trial in Indonesia. A total of 2992 women were enrolled into the study and data for 2845 women were analyzed (147 cases did not meet protocol criteria). Although study IUDs were randomly assigned, LLD users in this study were older and of higher parity than TCu 380A and MLCu 375 users. The 24-month gross cumulative life-table pregnancy rates for TCu 380A, LLD and MLCu 375 users were 1.2, 2.2 and 2.7, respectively. The 24-month expulsion rates for TCu 380A, LLD and MLCu 375 users were 6.7, 7.5 and 5.3, respectively. Overall, 24-month continuation rates were 85.5%, 85.0% and 85.4% for the respective device groups. Differences in both gross and age- and parity-adjusted life-tables rates for the major outcome variables were not statistically significant at 24 months postinsertion. The study suggests that the TCu 380A, LLD and MLCu 375 IUDs seem to be safe and effective contraceptive options for Indonesian women.     

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.     

剖宫产术后放置GeneFiex、TCu220C及活性165宫内节育器的临床效果比较

目的:观察剖宫产术后放置吉妮致美(GeneFiexIN)、TCu220C、活性165宫内节育器的临床效果。方法:对646例有剖宫产史的受术者,随机放置吉妮致美及TCu220C、活性165宫内节育器,随访1年后,观察效果。结果:放置吉妮致美随访一年后,带器妊娠为0.99/百妇女年,脱落率为0.98/百妇女年,因症取出率为2.93/百妇女年;TCu200c带器妊娠为5.36/百妇女年,脱落率为3.95/百妇女年,因症取出率为12.09/百妇女年;活性165带器妊娠为5.99/百妇女年,脱落率为3.68/百妇女年,因症取出率为11.06/百妇女年。结论:放置吉妮致美宫内节育器具有出血少,腹痛率低,脱落率低等优点,续用率及避孕效果均高于TCu220C及活性165宫内节育器,是剖宫产术后放置宫内节育器的首选。     

A randomized comparative trial of the MLCu375, TCu220C,Steel Ring and Uterine Cavity-Shaped IUDs

The Stainless Steel Ring, Uterine Cavity-Shaped Device, TCu220C and MLCu375 IUDs were evaluated in a randomized trial of 1536 women in Guangdong Province, China. The first-year continuation and expulsion rates were significantly lower (p<0.05) for the latter 3 IUDs than for the Stainless Steel Ring. The first year pregnancy rates for the MLCu375 (o.76 per 100 women) and TCu220C (1.2 per 100 women) were significantly lower (p<0.05) than those of the other two devices (6.1 and 4.1 per 100 women). The results of the study show that the MLCu375 and TCu220 are the most suitable IUDs for women in Guangdong Province.

---

Resumen Se realizó un estudio aleatorizado de 1536 mujeres de la provincia de Guangdong, China, a fin de evaluar el anillo anticonceptivo de acero inoxidable, un dispositivo que tiene la forma de la cavidad uterina y los dispositivos intrauterinos TCu220C y MLCu375. Los porcentajes de continuación relativos al primer año y los porcentajes de expulsión fueron significativamente inferiores (p<0,05) para los tres últimos que para el anillo de acero inoxidable. Los porcentajes de embarazo durante el primer año en el caso del MLCu375 (0,76 por cada 100 mujeres) y TCu220C (1,2 por cada 100 mujeres) fueron significativamente inferiores (p<0,05) que para los dos otros dispositivos (6,1 y 4,1 por cada 100 mujeres). Los resultados de este estudio demuestran que los DIU MLCu375 y TCu220C son los más adecuados para las mujeres de la provincia de Guangdong.

---

Resumé Une étude randomisée portant sur 1536 femmes a été effectuée dans la province de Guangdong (China) pour évaluer l'anneau contraceptif en acier inoxydable, un dispositif épousant la forme de la cavité utérine, ainsi que les dispositifs TCu220C et MLCu375. Les pourcentages de continuation pour la première année et les taux d'expulsion ont été significativement moins élevés (p<0,05) pour les 3 derniers que ceux pour l'anneau en acier inoxydable. Les taux de grossesse pendant la première année dans le cas du MLCu375 (0,76 par 100 femmes) et du TCu220C (1,2 par 100 femmes) ont été significativement plus faibles (p<0,05) que pour les deux autres dispositifs (6,1 et 4,1 par 100 femmes). Les résultats de cette étude montrent que les DIU MLCu375 et TCu220C sont les dispositifs qui conviennent le mieux aux femmes de la province de Guangdong.

     

Performance of the Frameless IUD (Flexigard prototype inserter) and the TCu380A after six years as part of a WHO multicenter randomized comparative clinical trial in parous women

The clinical performance of the new Frameless IUD was compared with the TCu380A, the most widely used copper IUD in the world today. Insertions of the Frameless IUD were conducted with a prototype inserter (Flexigard). We report on the 6-year results from a randomized comparative clinical trial conducted at the Shanghai Institute of Planned Parenthood Research, as part of an international multicenter WHO clinical trial, involving 200 women, respectively recruited for use of each device. The cumulative 6-year pregnancy rates were 0.0 per 100 women for the Frameless IUD and 3.3 for TCu380A. Termination due to partial expulsion was significantly less for the Frameless IUD as compared with TCu380A (0.0 and 4.3 per hundred women, respectively). Complete expulsion, bleeding, pain, bleeding and pain and other medical reasons for termination did not differ significantly between the two devices. The net cumulative continuation rates at six years per 100 women were 80.8 for TCu380A, and 83.0 for the Frameless IUD.Both Frameless IUD and TCu380A are highly effective, safe and acceptable contraceptive devices, because of low pregnancy rates (per 100 women), and low termination rates due to expulsion, pain, bleeding, and bleeding and pain. Due to its anchoring, the Frameless IUD is significantly more effective than the TCu380A IUD as regards proper retention of the IUD in the uterine cavity. This may also explain its lower failure rate.     

Effectiveness of IUDs: a review

Large, multicenter, randomized trials of IUDs conducted between 1970 and 1986 encompass more than 50,000 woman-years of experience in the two-year interval following device insertion. Taken singly and collectively, these trials demonstrate that IUD failure rates are strongly affected by the age of participants, notably by the proportion of women under age 25 admitted to the studies. Individual trials and overall comparisons indicate further that: 1. Non-medicated devices such as the Mahua steel ring and Lippes loop D have pregnancy rates above 2 per 100 woman-years. 2. The first approved copper IUDs, the Copper 7 and the TCu 200, do not markedly differ in pregnancy rates from standard plastic devices with rates significantly above 2 per 100 woman-years. 3. Five more recent, widely used copper IUDs have had failure rates significantly below 2 per 100 woman-years in multicenter trials. The point estimate of the failure rate was less than 1 pregnancy per 100 woman-years for three of these IUDs. One copper-bearing device had a failure rate significantly below 1 per 100 woman-years. 4. Devices releasing either 25 mcg/day of progesterone or 2 mcg/day of levonorgestrel have had significantly higher failure rates than the more effective copper-releasing IUDs; however, devices releasing 20 mcg/day of levonorgestrel appear at least as effective as the most effective copper IUDs. Long-term IUD failure rates derived from straight assignment as well as randomized trials indicate 4-year gross cumulative failure rates do not exceed 10 per 100 for any of the standard copper devices or the Lippes loop D. Point estimates of the four-year gross cumulative pregnancy rates have been below 5 per 100 users in studies of the TCu 220C, the Nova T, the TCu 380A, and the MLCu 375.