B超监测下吉妮和TCu 380 A宫内节育器592例临床分析

目的:①多中心观察B超监测下放置吉妮和TCu380A宫内节育器(IUD)并随访12月的临床效果;②探讨吉妮IUD近期脱落的原因。方法:随机分组并在B超监测下放置吉妮IUD289例,TCu380AIUD303例,术后1、3、6、12月定期妇科及B超随访,记录受试对象病史、术时和术后情况,用SPSS10.0软件包进行数据处理,以生命表方法统计结果并行显著性检验。结果:①术后疼痛症状发生情况TCu380AIUD组明显高于吉妮IUD组,差异有显著性(P<0.05);术后6、12月随访月经紊乱以TCu380AIUD组为高,差异有显著性(P<0.05)。②术后6月、12月生命表结果提示吉妮IUD组因出血和疼痛的终止率较TCu380AIUD组低,差异有显著性(P<0.05)。③子宫后位者易发生带器妊娠,脱落与月经量及置器医生放置IUD质量有关。结论:吉妮IUD的避孕效果与国际推荐使用的TCu380AIUD一致,置器后出血和疼痛副反应少于后者。引入B超监测IUD放置过程对杜绝放置的不安全隐患有重要作用,也是在监控和验证放置IUD质量、年轻医生的培训过程及基层推广应用中必须注意的问题。     

吉妮IN与TCu380A IUD三年观察结果

<正> 吉妮IN宫内节育器(IUD)是一种设计独特的新型IUD,旨在降低IUD的脱落率,并减少副反应。我国于1995～1997年对607例妇女随机放置吉妮IN IUD或TCu380A IUD,并进行了12个月的观察,初步显示吉妮IN IUD的脱落率和因症取出率均低于Tcu380A。为进一步了解吉妮IN IUD的远期安全性和有效性,现将此项研究的2年和3年的临     

三种宫内节育器临床效果观察

目的对比分析吉妮宫内节育器(IUD)、爱母IUD、TCu380A-IUD的临床疗效及安全性,为临床选择疗效最佳的IUD提供理论依据。方法将2009年1月—2011年5月在该院放置IUD的194例患者分为A组(74例)、B组(59例)、C组(61例),A组患者放置吉妮IUD、B组患者放置爱母IUD、C组患者放置TCu380A-IUD,所有患者均接受为期2年的随访,现对比分析3组患者的疗效。结果①三组患者随访期妊娠率、脱落率、因症取出率,随访期后续用率不全相等(P<0.05),A组患者随访期妊娠率、脱落率、因症取出率均显著低于B组患者与C组患者(P<0.05),而随访期后续用率显著高于B组患者与C组患者(P<0.05)。②三组患者随访期不良反应发生率不全相等(P<0.05),A组患者随访期不良反应发生率显著低于B组患者与C组患者(P<0.05)。结论相比爱母IUD、TCu380A-IUD,吉妮IUD的疗效最好,安全性最高,因此吉妮IUD是最佳选择。     

吉妮致美宫内节育器的临床应用效果观察

目的观察吉妮致美宫内节育器(IUD)的有效性、副反应和可接受性。方法对303例分别放置吉妮致美(观察组,145例)与TCu380A IUD(对照组,158例)的育龄妇女进行12个月随访。结果吉妮致美与TCu380A IUD比较:带器妊娠率分别为0.69%、1.27%,两者比较无统计学差异(p>0.05);脱落率分别为0.69%、3.80%,因症取出率分别为1.38%、4.43%,续用率分别为97.24%、90.51%,两者比较均有显著性差异(p<0.05)。结论吉妮致美避孕效果好,脱落率低,副反应少,续用率高,值得推广。     

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。     

放置两种吉妮IUD 18个月临床效果分析

目的:观察吉妮致美与吉妮宫内节育器(IUD)使用18月的临床效果。方法:随机分组分别放置吉妮致美IUD517例,吉妮IUD508例,分别于置器后1、3、6、18个月进行随访,记录病史、放置IUD手术时间及术后随访情况,对数据进行生命表分析和Logistic多因素分析。结果:①随访18个月吉妮致美和吉妮IUD的带器妊娠率分别为0.60/100妇女年和0.61/100妇女年(P>0.05);②置器后6月内月经周期缩短、经量增多、月经期延长情况吉妮致美组低于吉妮组(P<0.05),因出血终止使用的吉妮致美组(1.2/100妇女年)明显低于吉妮组(6.69/100妇女年),P<0.05;③两组均无因疼痛所致的终止。④带器妊娠的危险因素为子宫内口至子宫底外缘距离大和子宫后屈;⑤脱落的危险因素则为体力劳动和哺乳期置器者。结论:吉妮和吉妮致美IUD避孕效率高;吉妮致美IUD对减少置器后近期出血及因出血所致终止率有明显效果,为吉妮IUD系列的扩大应用提供了更多的选择。     

宫内节育器吉妮柔适与TCu380的临床效果比较

目的观察宫内节育器(intrauterine contraceptive device,IUD)吉妮柔适与TCu380的临床避孕效果。方法采用对比性研究,选取2007年1月至2008年1月在建湖县计划生育指导站自愿要求放置IUD、身体健康且无置器禁忌证的已婚育龄妇女800例,用知情选择与随机放置相结合的方法分成两组(各400例),分别放置吉妮柔适IUD和TCu380IUD,并进行12个月定期随访(术后1、3、6、12个月)。结果吉妮柔适IUD的脱落率(伴下移)和因症取出率显著低于TCu380IUD,而累积续用率显著高于TCu380IUD(P0.05)。结论吉妮柔适IUD避孕效果明显,具有脱落率低、不良反应少、累积续用率高的优点,可在临床推广使用。     

3种节育器放置后不良反应随访3年观察

目的比较吉妮、爱母和T型380三种宫内节育器(IUD)的放置后3年内不良反应情况。方法对自愿要求放置IUD避孕而无禁忌证的育龄妇女350例,随机分成3组,分别放置吉妮IN IUD(112例)、MCuIUD(120例)、TCu380AIUD(118例)。定期随访填写调查表。结果 3种IUD 3年累积吉妮组的带器妊娠率、脱落率、因症取出率最低(P<0.05);续用率最高(P<0.05)。经期延长、经量增多及不规则出血情况3种节育器在放置的前3个月内无明显差异,但随着时间的延长放置吉妮环者明显降低,与其他两种差异有统计学意义(P<0.05)。腰腹疼痛情况,吉妮组发生率明显少于其他两组,差异有统计学意义(P<0.05)。白带增多3组比较差异无统计学意义(P>0.05)。月经异常情况的发生率前屈及后屈位置子宫的发生率高于其他,但差异无统计学意义(P>0.05)。前屈后屈子宫较其他位置子宫更容易发生腰腹疼痛情况,差异有统计学意义(P<0.05)。结论吉妮节育器放置后的副反应发生率明显低于爱母和T型380节育器,且续用率最高。前屈后屈子宫较其他位置子宫更容易发生节育器放置后的副反应。     

哺乳期妇女放置吉妮致美和活性γ-Ⅱ型宫内节育器的临床效果观察

目的:观察哺乳期妇女放置吉妮致美和活性γ-Ⅱ型(安舒)宫内节育器(IUD)的临床效果。方法:431例哺乳期健康妇女自行决定选择放置吉妮致美IUD或安舒IUD,例妇女选择放置吉妮致美IUD,224例妇女选择放置207活性γ-Ⅱ型IUD,在放置后第3、12个月时各随访1次。结果:放置12个月时,吉妮致美组和安舒组的带器妊娠率6、分别为0.5/百妇女年和4.2/百妇女年,两组差异有统计学意义(P<0.05)。脱落率分别为1.5/百妇女年和2.7/百妇女年,因症取出率为1.0/百妇女年和1.8/百妇女年,两组差异均无统计学意义(P>0.05)。吉妮致美组的续用率为97.1/百妇女年,安舒组为91.5/百妇女年,两者差异有统计学意义(P<0.05)。结论:哺乳期放置吉妮致美或安舒IUD均安全有效,吉妮致美IUD对哺乳期妇女子宫的变化有更好的适应性,更适宜哺乳期妇女使用。     

人工流产术后即时放置活性γ型IUD、TCu 380 A宫内节育器的临床分析

目的:评价人工流产术后即时放置活性γ型IUD、TCu380AIUD的临床效果。方法:采用前瞻性、随机对比方法对100例健康已生育的早孕妇女,在人工流产术后即时放置活性γ型IUD50例(活性γ型IUD组)、TCu380A50例(TCu380A组),于放置后的1、3、6、12个月随访,以生命表法统计两种IUD的终止情况。结果:使用12个月时,活性γ型IUD、TCu380A的妊娠率均为0.01/100妇女;脱落率分别为6.0/100妇女、8.0/100妇女,两组比较差别无统计学意义(P>0.05)。结论:人工流产术后即时放置活性γ型IUD、TC380A避孕效果好,脱落率相对较低,续用率高,安全,可接受性强,值得推广应用。     

MCuⅡIUD与TCu380A IUD放置60个月临床效果对比研究

目的:观察放置MCuⅡ功能性宫内节育器(MCuⅡIUD)的临床效果及安全性。方法:国内多中心统一标准,选择2000例要求放置IUD避孕的妇女,随机放置MCuⅡIUD与TCu380A IUD各1000例,定期随访观察60个月。结果:放置满60个月,MCuⅡIUD与380ATCu IUD的带器妊娠率分别为1.83/百妇女年、2.10/百妇女年,差异无统计学意义(P>0.05);脱落率分别为0.72/百妇女年、3.03/百妇女年,差异有统计学意义(P<0.05);因出血/疼痛取出分别为4.54/百妇女年、6.12/百妇女年,副作用发生率分别为3.50%、3.80%,差异均无统计学意义(P>0.05);计划妊娠取器后两组妊娠率分别为86.6%、91.7%,差异无统计学意义(P>0.05)。结论:MCuⅡIUD避孕效应高,脱落率低,放置后出现副作用发生率低,可逆性好,是比较理想的IUD。     

Performance of the frameless GyneFix and the TCu380A IUDs in a 3-year multicenter, randomized, comparative trial in parous women

This study was conducted to evaluate a new and improved inserter (GyneFix) for the anchoring of the Frameless IUD in the uterine cavity. Previous studies conducted with a prototype inserter (Flexigard) did not show fully the advantages of the new anchoring concept because of the shortcomings of the Flexigard inserter and the complexity of the insertion technique. The GyneFix IUD was compared with the TCu380A IUD in six centers in China in approximately 300 women in each group. Only parous women were included in the study. The data from this 3-year, ongoing study demonstrate that the shortcomings of the inserter have been corrected, resulting in better performance and a much reduced rate of failed insertion/expulsion of the frameless and anchored device. The cumulative expulsion rate with the GyneFix IUD was 3.0 at 3 years (annual rates 2.67, 0.33, and 0.0, respectively) compared with a cumulative expulsion rate of 7.38 at 3 years with TCu380A (annual rates 4.63, 1.76, and 1.04, respectively). This difference is statistically significant. The majority of the expulsions with the anchored IUD occurred early in the study, indicating improper anchoring technique. The study also shows that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0 at 3 years) versus one pregnancy with TCu380A (cumulative pregnancy rate 0.34 at 3 years). The total use-related discontinuation rate at 3 years was significantly lower with the GyneFix IUD (8.34) than with the TCu380A IUD (14.13) and results in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (90.73 vs 85.25). Neither perforations nor pelvic inflammatory disease cases were encountered with either device in this study, demonstrating the safety of the anchoring system.     

不同分娩方式妇女放置三种IUD的术时评价

目的:研究不同分娩方式妇女放置三种新型含铜宫内节育器(CulUD)的术时评价。方法:将观察对象按经阴道和经剖宫产的不同分娩方式分为两组,每组均随机放置CyneFix IN IUD、MCu功能性IUD和TCu380A IUD,记录两组放置不同种IUD的扩宫情况、置器疼痛反应和置器时间。结果:放置GyneFix IN IUD和TCu380A IUD在不同分娩方式组中扩宫率、痛觉评分、置器时间无显著差异(P>0.05)。放置MCu功能性IUD在剖宫产分娩组扩宫率为92.5％,显著高于阴道分娩组的33.3％(P<0.05);痛觉评分为8.62±0.82分,显著高于阴道分娩组(P<0.01);置器时间为(9.62±3.15)min,较另两种IUD置器时间显著延长(P<0.05)。结论:GyneFix IN IUD和TCu380A IUD置器术时扩宫率低、费时少,疼痛反应轻,不受分娩方式影响。     

剖宫产妇女放置两种IUD临床效果观察

目的 :观察剖宫产妇女放置新型GyneFixIN宫内节育器 (IUD)的临床效果。方法 :采用随机对照临床研究方法 ,对 195例有剖宫产史的健康妇女于月经后或人工流产术毕即时放置GyneFixINIUD 99例 (吉妮组 )及TCu2 2 0CIUD 96例 (TCu2 2 0C组 ) ,于放器后 1、3、6、12和 2 4个月随访 ,以生命表法统计两种IUD的终止情况。结果 :吉妮组使用 2年脱落率和因症取出率分别为每百妇女 1.0 1和 2 .0 2 ,明显低于TCu2 2 0C组的每百妇女 10 .4 2和 8.33(P <0 0 1)。结论 :GyneFixINIUD无支架 ,铜表面积大并固定于子宫底 ,更适合有剖宫产史妇女放置     

TCu220 IUD、吉妮柔式IUD使用12个月临床效果观察

目的:评价TCu220、吉妮柔式两种宫内节育器(IUD)使用效果,为推广新型IUD提供依据。方法:采用整群抽样方法,选择本市13个县、市区在2006年1月~2007年1月放置TCu220、吉妮柔式IUD的所有已婚育龄妇女,随访1年,观察两种IUD使用效果及副反应发生情况。结果:放置TCu220IUD高孕次(>5次)妇女副反应发生率增加(P<0.05),放置吉妮柔式IUD妇女各孕次段副反应发生率比较差异均无统计学意义(P>0.05)。TCu220及吉妮柔式IUD使用满1年的妊娠率、脱落率、因症取出率、总终止率和续用率分别为每百妇女0.96、7.44、7.43、15.73、84.27及0.85、3.00、4.98、11.47、88.53,吉妮柔式IUD脱落率、因症取出率和总终止率明显低于TCu220IUD,差异均有统计学意义(P<0.05,P<0.01,P<0.01)。结论:两种IUD避孕效果可靠,孕次影响TCu220 IUD副反应的发生,吉妮柔式IDU在脱落和因症取出方面明显优于TCu220 IUD。     

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.     

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。     

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.