GyneFix330和TCu220C、TCu380A宫内节育器比较的系统评估

目的:评价GyneFix330与TCu220C、TCu380A宫内节育器(IUD)的有效性、副反应和续用情况。方法:电子和手工检索1990年1月~2009年11月中英文发表的相关文献,按循证医学方法对纳入文献进行分析评价。结果:纳入26篇正式发表的随机对照临床试验文献。与TCu220C IUD相比,GyneFix330IUD的12个月和24个月带器妊娠率和脱落率较低;6个月、12个月和24个月的经期延长、经量增多、腰腹痛和不规则出血发生率较低;12个月因症取出率较低,续用率则较高。GyneFix330和TCu380A IUD12个月、24个月、36个月和9年的带器妊娠率均低于2.50/100妇女。两组6个月、12个月、24个月和36个月的月经量增多、白带增多和不规则出血发生率互有优劣。与TCu380A IUD相比,Gyne-Fix330IUD12个月和24个月的因症取出率接近,续用率略高。结论:GyneFix330IUD临床应用效果优于TCu220C IUD,与TCu380A IUD相差不大,仍需长期大样本临床观察予以确证。     

MCu110和TCu220C、TCu380A宫内节育器比较的系统评估

目的：评价MCu110功能性宫内节育器的有效性、副反应和可接受性。方法：通过电子和手工检索查阅2000年1月～2008年12月国内外发表的相关文献,并依照循证医学的方法对纳入评估的文献进行筛选、评价和分析。结果：共获得合格文献10篇,均为随机对照临床试验且正式发表。评估结果显示,置器后12月和24月,MCu110的临床综合效果优于TCu220C;脱落率略低于TCu380A,可接受性略优于TCu380A,副反应各项指标二者互有优劣,而带器妊娠率差别未发现有统计学意义。结论：与TCu380A相比,能够证实MCu110有效性、副反应和可接受性的多中心随机对照试验并不多,尤其是长期随访研究;建议由非MCu110研制单位组织开展多中心随机对照试验,观察年限不少于5年。     

爱母牌MYCu宫内节育器与TCu220C宫内节育器的临床应用对比

目的探讨爱母牌MYCu宫内节育器(intrauterin econtraceptive device,IUD)与TCu220C宫内节育器(TCu220CIUD)的临床应用效果。方法选择来嘉定中心医院要求放置IUD避孕的育龄妇女,随机放置MYCuIUD与TCu220CIUD各150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,MYCuIUD组与TCu220CIUD组累计带器妊娠率均为0.67/每百妇女年,累计脱落率分别为0.67/每百妇女年、2.00/每百妇女年;因不良反应取出率为2.01/每百妇女年、4.14/每百妇女年,差异均无统计学意义(P>0.05);续用率分别为96.00/每百妇女年、92.30/每百妇女年;4次随访主诉发生率MYCuIUD组低于TCu220CIUD组,差异有统计学意义(P<0.05),主诉中最常见的不良反应为出血和疼痛。结论 MYCuIUD抗生育效果好,脱落率低,置器后不良反应小,是效果理想的IUD,值得进一步推广应用。     

常用宫内节育器效能及影响研究进展

宫内节育器是一种避孕效果良好、安全、使用简便、经济、可逆的长效避孕方法,据估计,目前全世界有1.56亿妇女使用,其中中国占2/3,为1·04亿。目前,TCu380A、TCu220C、MLCu375、宫铜300、活性γ型IUD在我国农村广泛使用,为了解上述几种IUD的实际使用情况和有效性,本文就IUD避孕效果的影响因素和改进IUD的使用作一综述。一、常用IUD的效能指标及评价方法(一)效能指标IUD的效能指其避孕效果和使用性能。妊娠率是衡量IUD避孕效果的金标准;脱落率和因症取出率用于评价宫内节育器的性能。采用生命表法计算妊娠率、意外妊娠率、带器妊…     

(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。     

TCu220C宫内节育器脱落率影响因素的系统评价

目的:采用meta分析方法评价不同地区、不同放置时期对TCu220CIUD脱落率的影响,为IUD安全使用提供科学依据。方法:采用计算机检索PubMed、EMBASE、CENTRAL等9个数据库和WHO/FDA/IUD生产企业/临床试验注册相关网站,采用Openmeta analyst和RevMan5.3.3进行数据的分析与合并。结果:共检索到7726篇文献,根据纳入及排除标准,最终纳入31篇文献,均为RCT(随机对照试验)或准RCT。比较TCu220C和其它10种IUD分析结果显示:①不同放置时期的TCu220C脱落率中,人工流产术时放置TCu220C脱落率是月经间期放置的3.8倍(P0.05)。②在1年随访时TCu220C的脱落率高于爱母型IUD和MCuⅡIUD(P0.05)。在随访时,TCu220C的脱落率低于金属单环(P0.05);与活性165、MLCu250、活性γ型、V铜、宫铜300、MLCu375、TCu380A等7种IUD比较均无统计学意义。结论:本研究首次报告了基于RCT的TCu220C的脱落率影响因素定量分析的系统评价结果,国外的研究数据表明人工流产术时放置增加TCu220CIUD脱落的风险;在TCu220C的临床应用中应关注高风险人群,提高TCu220C的避孕效果。     

GyneFixIN与TCu220C宫内节育器临床使用效果比较观察

目的:比较吉妮固定式宫内节育器(IUD)和TCu220C IUD的临床使用效果。方法:选择自愿放置IUD的已婚育龄妇女600例,随机分成两组(各300例),分别放置吉妮IUD和TCu220C IUD,并进行24个月随访观察。结果:吉妮IUD的脱落率显著低于TCu220C IUD(P<0.05),妊娠率、因症取出率及终止率,吉妮IUD与TCu220C IUD比较,有显著性差异(P<0.05)。结论:吉妮IUD是避孕效果优于TCu220C IUD,可在临床上推广使用。     

HCu280宫内节育器与TCu380A宫内节育器临床效果观察

HCu280宫内节育器（IUD）是一种新型的宫内节育器,依据人体子宫生理形态和功能特点设计,整体呈“V”型,由尾部、体部、双臂三部分组成,双臂放开,规格适当,柔韧适中,弹性良好,可随子宫舒缩而变化,适合各类型子宫放置,是无避孕禁忌证的妇女普遍适用的宫内节育仪器。     

宫内节育器不同铜表面积对月经血量的影响

对健康妇女随机放置TCu380A和TCu220C IUD后的月经血量变化进行观察,放器前TCu380A和TCu220C组平均月经血量(MBL)为45.3±13.4ml和42.6±11.5ml,放器后1、3、6、12周期平均MBL分别为72.4±41.6ml和73.2+38.3ml;77.0±42.9ml和82.9±46.9ml;73.2±31.2ml和74.5±30.5ml及64.5±18.9ml和68.2±14.4ml;放置两种IUD后MBL较放器前明显增多(P<0.001),但两种IUD间比较,放器后各周期平均MBL无显著差别(P>0.05),提示在一定范围内增加铜的表面积对放器后MBL的增加程度并无显著影响。     

放置活性元宫IUD与TCu220C IUD24个月临床效果观察

目的 :观察活性元宫IUD的临床效果。方法 :对 10 6 0例分别放置活性元宫IUD和TCu2 2 0CIUD的育龄妇女 ,进行 2 4个月随访观察。结果 :活性元宫IUD 2 4个月的脱落率、妊娠率、因症取出率及终止率明显低于TCu2 2 0CIUD ,经检验有显著性差异 (P <0 0 5 )。讨论 :活性元宫IUD是避孕效果较理想的避孕措施     

FR药铜300C与MLCu375 IUD多中心随机比较性临床研究

目的:比较FR药铜300C与MLCu375两种IUD的避孕有效性、安全性和副反应的发生情况。方法:采用多中心随机比较性临床研究方法,分别放置两种IUD各500例,并于放置后3,6,12月门诊随访。结果:放置满12个月时,FR药铜300C与MLCu375IUD的续用率分别为94.18/百妇女、92.58/百妇女(P>0.05);带器妊娠率分别为0.00/百妇女、0.21/百妇女(P>0.05);脱落率分别为2.04/百妇女、2.66/百妇女(P>0.05);因症取出率分别为2.24/百妇女、3.50/百妇女(P>0.05);3、6个月随访时经量增多分别为14.6%,12.3%和21.2%、17.5%,两者差异有极显著和显著性意义(P<0.01,P<0.05);3个月随访时经期延长分别为6.0%和9.6%,两者差异有显著性意义(P<0.05)。其他副反应两组间差异无显著性意义(P>0.05)。结论:FR药铜300C IUD结构合理,避孕效果与ML-Cu375 IUD相似,副反应少于MLCu375 IUD。是目前比较理想的IUD。     

Continuation rates and reasons for discontinuing TCu380A IUD use in Tabriz, Iran

PURPOSE: The long-term effectiveness of copper-bearing intrauterine device (IUD) has been documented. This paper reports results from a 60-month study on the use of TCu380A IUD among 401 women in Tabriz, Iran. MATERIALS: In 2003, a 5% sample of women who had had an IUD inserted between May 1997 and May 1999 was taken. Analyses of discontinuation employed Tietze net rate life tables. RESULTS: Continuation of TCu380A IUD use by women at 1 month, 6 month, 1 year, 2 years, 3 years, 4 years and 5 years was 98.2, 89.3, 79.3, 68.3, 57.6, 49.5 and 45.0 per 100, respectively. Among women using the TCu380A IUD, the rate of termination due to pain/bleeding was significantly higher than the rate of termination due to other causes. Overall, two pregnancies were reported within 5 years after insertion. A third pregnancy occurred on Year 6. CONCLUSION: These findings indicate that family planning educators and health care providers should give more emphasis to counseling programs for women desiring IUD insertion and during follow-up.     

Long-term reversible contraception: Twelve years of experience with the TCu380A and TCu220C

Few data on the long-term efficacy of intrauterine devies (IUD) are available, and this article reports on the final 12-year experience with the TCu220C and TCu380A devices from two randomized, multicenter trials conducted in 24 centers. A total of 3,277 and 1,396 women, respectively, were recruited for use of each device between 1981 and 1986 and followed at 3, 6, and 12 months after insertion and yearly thereafter. At the end of 12 years, a total of 17,098 women-years of experience had been accumulated for the TCu220C and 7,159 women-years for the TCu380A. The cumulative 12-year intrauterine pregnancy rates were 7.0 (standard error [SE] 0.6) per 100 women for the TCu220C and 1.9 (SE 0.5) for the TCu380A (p < 0.001). Pregnancy rates were highest in the first years after insertion; the TCu220C had a consistently higher annual pregnancy rate than did the TCu380A at all intervals since insertion. No pregnancies were reported with the TCu380A after 8 years of use. Total medical removals were approximately 6% in the first year and dropped to approximately 4% per year for each device for up to 12 years of use (cumulative 12 year rates were 37.3 [SE 1.3] and 40.2 [SE 2.1] per 100 women for the TCu220C and TCu380A devices, respectively). The overall continuation rate at all intervals since insertion was higher with the TCu220C device, mainly due to higher removal rates for nonmedical reasons with the TCu380A. The cumulative ectopic pregnancy rates were 0.7 and 0.4 for the TCu220C and TCu380A, respectively. Pregnancy rates were higher in the Chinese compared with the non-Chinese centers for both devices, though the greater efficacy of the TCu380A was apparent in both groups of centers. The total medical and nonmedical removal rates were lower in the Chinese compared with the non-Chinese centers, and did not show any substantial differences between the devices. We conclude that both devices are safe and effective for at least 12 years of use and the low pregnancy rate with the TCu380A is comparable with that reported in the United States among women who had undergone tubal sterilization. The very high efficacy of the TCu380A makes it the IUD of choice, and it can be considered as a potentially reversible, nonsurgical alternative to sterilization for women requiring very long-term pregnancy protection.     

两种新型含铜IUD对宫颈沙眼衣原体阳性率影响的研究

本文报道了同期放置的TCu380A及GyneFix两种新型含铜宫内节育器在放置1年及2年时与对照组宫颈砂眼衣原体(CT)阳性率的比较。TCu380A组放置1年时阳性率为5.63％,2年时为4.92％;GyneFix组放置1年时阳性率为4.62％,2年时为5.08％,两组含铜IUD放置1年及2年时各组比较差别均无显著意义(P>0.05);对照组CT阳性率为15.18％,与上述各组比较差别均有显著意义(P<0.05)。本文结论认为含铜IUD对宫颈CT感染有抑制作用。