宫铜300宫内节育器脱落情况的系统评价

目的:系统比较宫铜300宫内节育器(IUD)和其他种类IUD的脱落情况。方法:检索PubMed、Embase、POPLINE等12个国内外数据库/网站,根据纳入与排除标准筛选文献,使用RevMan5.3.3对文献数据进行合并与分析。结果:共检索到6062篇中英文文献,最终纳入涉及脱落结局指标的19篇文献。分析结果显示:①与TCu220C IUD相比,2年随访时宫铜300 IUD脱落率显著增高,相对危险度(RR)及95%CI为2.33(1.43~3.80)(P0.05);②与MCu功能型IUD相比,6月、1年、2年随访时宫铜300 IUD脱落率显著增高,其RR及95%CI分别为5.86(1.89~18.14)、5.46(2.38~12.55)、4.00(1.94~8.25)(P0.05);③与TCu380A、元宫220、活性γ型、HCu280 IUD相比,宫铜300 IUD脱落率差异无统计学意义(P0.05)。结论:在脱落方面,宫铜300 IUD与TCu380A、元宫220、活性γ型、HCu280效果相近,高于TCu220C和MCu功能型IUD,临床使用时需综合宫铜300 IUD的其他临床效果评价指标以及置器对象的健康状况和使用需求进行选择。     

宫内节育器宫腔形Cu300、TCu220C、TCu380A放置10年的临床比较性研究

目的 了解宫腔形宫内节育器(Cu300)及TCu220C、TCu380A3种宫内节育器(IUD)放置10年的临床效果。方法 全国7个IUD临床应用中心,对2699例随机放置Cu300、TCu220C和TCu380A的农村妇女,共观察10年。结果 使用10年时,Cu300、TCu220C和TCu380A的带器妊娠率,分别为2．56、4．82和4．01／100妇女,Cu300明显低于其他两种IUD(P＜0．05)。脱落率分别为4．54、5．46和9．68／100妇女,TCu380A显著高于其他两种IUD(P＜0．001)。因出血、疼痛取出率分别为6．71、5．58和6．80／100妇女,3种IUD比较,差异无显著意义(P＞0．05)。使用10年时,3种IUD的续用率分别为74．86、66．22和63．56／100妇女,以Cu300续用率最高,TCu380A最低(P＜0．01)。结论 Cu300、TCu220C和TCu380A的避孕效果好,可推广使用。     

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。     

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。     

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。     

人工流产术后即时放置三种宫内节育器的多中心随机对照研究

目的 了解3种常用宫内节育器(IUD)在人工流产术后即时放置的临床效果和安全性.方法 通过前瞻性随机对照临床研究,对来自全国7个省市的12个协作中心的1800例研究对象于人工流产术后即时放置IUD,放置的IUD类型分为宫形含铜IUD宫铜200、T形含铜IUDTCu380A和活性γ型IUD 3种,每种分别观察600例,并随访12个月.结果 1798例完成了使用12个月的随访,2例失访(失访率为0.11%,2/1800);17例不符合纳入标准的未产妇资料在进行数据统计分析时被剔除.3种IUD使用者均未发生妊娠(或带器妊娠),且均无子宫穿孔、IUD异位等并发症发生.活性γ型IUD的医疗原因终止率为1.02/百妇女年,低于宫铜200、TCu380A(分别为3.60/百妇女年、2.25/百妇女年),3者比较,差异有统计学意义(P=0.015).宫铜200、TCu380A和活性.y型IUD中,与IUD使用相关的终止率分别为7.58/百妇女年、7.30/百妇女年和3.72/百妇女年,3者比较,差异有统计学意义(P=0.008).结论 人工流产术后即时放置宫铜200、TCu380A和活性γ型IUD的避孕效果均良好,均安全可行,尤其是国产活性γ型IUD,值得推广.     

活性γCu380IUD与TCu380AIUD临床比较性研究

本研究通过增加原γCu 2 0 0 IUD的铜表面积至 3 80 mm2 ,其目的为了进一步降低带器妊娠率 (包括异位妊娠 ) ,以期达到 TCu3 80 A IUD相似的避孕效果 ,而其副反应发生率明显低于 TCu3 80 A IUD。方法 :1 995年 8月～ 1 996年 6月由三个中心参加的随机比较性研究 ,共随访 2 4个月。每个中心分别放置γCu 3 80与 TCu 3 80 A IUD各 1 0 0例 ,共 6 0 0例。结果 :2 4个月末 γCu3 80与 TCu3 80 A IUD脱落率每百妇女分别为 0 .997和 2 .4 70 (P>0 .0 5)。带器妊娠率每百妇女分别为 0 .3 3 2和 2 .4 59(P<0 .0 5)。异位妊娠率每百妇女分别为 0 .1 6 1和 0 .3 3 0 (P>0 .0 5)。因症取出率每百妇女分别为 1 .6 6 1和 5.4 95(P<0 .0 5)。结论 :γCu 3 80 IUD临床避孕效果明显优于 TCu 3 80 A IUD;两种 IUD的异位妊娠率相似 ;γCu3 80 IUD的副反应发生率明显低于 TCu3 80 A IUD。本研究结果证实高铜面积 γCu3 80 IUD是一种优质的 IUD。     

宫内节育器(Cu-IUD)体外释放Cu~(2+)以及含药Cu-IUD体外释放吲哚美辛的研究

目的:比较含Cu及含消炎药IUD释放Cu2+和吲哚美辛(IMC)的释放行为。方法:通过模拟人体宫腔内环境,采用火焰原子吸收光谱仪和UV-752分光光度仪测定TCu380A IUD、MLCu375 IUD和元宫型药Cu365IUD 300d内Cu2+和320d内IMC的释放行为。结果:3种Cu-IUDs的Cu2+都呈现了双相的释放行为:初始阶段的快速释放与随后的稳定缓慢释放。元宫型药Cu365IUD的Cu2+释放为零级过程,其内IMC的体外释放结果符合Weibull方程。结论:3种型号中,元宫型药Cu365IUD中Cu2+的释放最为稳定。依据IMC的体外释放特点,可以解释含药Cu-IUD防治置IUD副作用的功能。     

三种新型含铜宫内节育器宫底及宫颈部Cu2+浓度的初步探讨

目的 :研究三种不同含铜表面积的铜宫内节育器 (Cu IUD)对宫腔底部和宫颈部Cu2 浓度的影响。方法 :采集 6 0例置三种新型、高效的Cu IUD妇女不同时段宫腔底部和宫颈部粘液 ,用原子吸收 /火焰分光光度计法测定其Cu2 浓度。结果 :在置器后 6个月内含铜T形宫内节育器 (TCu380A IUD)和吉妮固定式宫内节育器 (GyneFixIN IUD)组不同时段宫腔底部和宫颈部Cu2 浓度差异无显著性 (P >0 0 5 )。在MCu功能性宫内节育器 (Mcu IUD)组 ,宫腔底部Cu2 浓度高于宫颈部 ,平均浓度分别为 2 8 10± 3 6 1μmol/L、6 91± 2 5 1μmol/L ,差异有显著性 (P <0 0 5 )。在置器 3个月后 ,TCu380A IUD和GyneFixIN IUD组宫颈部Cu2 浓度有一定程度下降 ,而MCu功能性IUD组下降不明显。结论 :含铜表面积小、纵径短的Cu IUD随置器时间延长仍能在宫腔底部释放较高的Cu2 ,而宫颈部Cu2 浓度变化相对不大。     

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.     

Randomized comparative trial in parous women of the frameless GyneFix and the TCu380A intrauterine devices: long-term experience in a Chinese family planning clinic.

OBJECTIVE: To compare the clinical performance of two intrauterine devices (the frameless GyneFix intrauterine device (IUD) and the TCu380A IUD) during long-term use. STUDY DESIGN: This was a randomized comparative study. A total of 157 insertions of the GyneFix IUD were compared with 156 insertions of the TCu380A IUD in the Tianjin Municipal Institute for Family Planning, China. Only parous women were included in the study. Insertions were conducted by the first three authors. The trial extended over a 9-year period, with over 10,000 woman-months of experience. RESULTS: The study showed that both devices are highly efficacious. No pregnancies occurred with the GyneFix IUD (cumulative pregnancy rate 0.0), compared to one pregnancy with the TCu380A IUD (cumulative pregnancy rate 0.64). The cumulative expulsion rate with the GyneFix IUD was 1.91 (three expulsions occurred, two of which were during the first 6 months), compared to a cumulative expulsion rate of 5.13 (eight expulsions) with the TCu380A (p = 0.1112). The total use-related discontinuation rate (terminations were mainly due to bleeding disturbances) was significantly lower (p = 0.0051) with the GyneFix IUD (4.46) than with the TCu380A IUD (14.10) and resulted in a higher rate of continuation with the GyneFix IUD compared to the TCu380A IUD (92.36 versus 83.97). Neither perforations nor cases of pelvic inflammatory disease were encountered with either device in this study, demonstrating the safety of the anchoring system. CONCLUSION: The results of the present clinical trial are in agreement with the findings of other multicenter, randomized, comparative, clinical trials that have investigated these two IUDs in China, as well as with the findings of other large-scale international studies conducted with the frameless IUD.     

Comparison of three different models of the copper T intrauterine contraceptive device.

A random sequential comparative study of three models of the Copper T intrauterine contraceptive device (IUD) was undertaken in 1,792 women. For 7 months, the TCu 300 and TCu 220C were randomly inserted, and then the TCu 380A and 220C were randomly inserted for the next 12 months. The log-risk method of life-table analysis of event rates was performed at the end of each of the first 3 years of use of each device. The TCu 380A had the lowest pregnancy rate during each year of use, although the difference was not significant. At the end of each of the first 2 years, the TCu 300 was removed significantly less than the TCu 220C and TCu 380A for bleeding and pain. At the end of three years, the rates of removal for bleeding and pain for the TCu 380A and TCu 300 were similar and lower than that for the TCu 220C, but the overall difference was not significant. There were no differences among the devices for any other relevant use-related reasons. The TCu 380A was removed for other medical reasons significantly more frequently than the other devices at the end of 2 and 3 years. Adjusting for parity did not alter the results. The findings of this study suggest that the copper sleeves along the horizontal arms together with copper wire on the vertical arm in the TCu 380A model provide greater protection against intrauterine pregnancy, whereas the copper sleeves along the vertical arm as in the TCu 220C caused increased removals for bleeding and pain. The TCu 380A should be studied in a larger number of patients for a longer period of time to determine its clinical effectiveness. It may become the IUD of choice for all women irrespective of parity.     

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）。     

Contraceptive efficacy of intrauterine devices

To compare the contraceptive efficacy of various types of intrauterine devices (IUD; copper devices, Nova-T, intrauterine contraceptive systems, levonorgestrel-releasing devices), we reviewed all relevant publications on this subject that have been published over the last 2 decades. The first point to be highlighted by this review is the excellent effectiveness of IUDs, with a global cumulative pregnancy rate <2% at 5 years, whatever the type of device used. We observed a large variation in efficacy rate according to the type of IUD and also according to study design. Nevertheless, of all the types of IUDs, the levonorgestrel-releasing IUD and to a lesser extent the TCu380A IUD seem to be the most effective, with a cumulative pregnancy rate at 5 years of <0.5% for the levonorgestrel-releasing IUD and between 0.3% and 0.6% for the TCu380A IUD.     

IUDs safe and effective at nine years of continuous use

The WHO Special Programme of Research, Development and Research Training in Human Reproduction has conducted long term studies on 2 copper releasing IUDs (TCu220C and TCu380A) in almost 2800 women which show that they are effective for 9 years. The pregnancy rates for TCu220C at 7 and 9 years are 4.9 and 5.4/1000 woman years respectively. Thus the annual risk of pregnancy is about 1%. The pregnancy rates for TCu380A are even lower (1.7 and 2.1 respectively), an annual rate of less than 0.5%. As a result of these studies, the US Food and Drug Administration sanctioned TCu380A use for 8 years up from 6 years. More than 80 million women worldwide, especially in developing countries (e.g., about 74 million in China), use the IUD. Researchers have analyzed data on 22,908 insertions from 12 trials to see whether IUD use is related to pelvic inflammatory disease (PID) and whether long term use causes more severe PID. They learned that the overall PID rate is 1.6/1000 woman years. The first 20 days after insertion carry a 7 times higher risk of PID, but the risk falls considerably thereafter and stays low for at least 8 years. Further, duration of IUD use does not increase the severity of PID. WHO is supporting research at 28 centers which are evaluating a new IUD which has copper sleeves hanging from a nylon suture (frameless IUD). During insertion, the clinician embeds the suture superficially into the top of the uterus so the IUD and the copper sleeves are suspended. WHO is also supporting research at up to 6 centers on 2 modified frameless IUDs designed to be inserted after delivery. The research want to determine whether the high expulsion rate of IUDs inserted during the postpartum period can be reduced.     

含铜宫内节育器家兔血清Cu~(2+)浓度的变化

目的:通过含铜宫内节育器(Cu-IUD)的Cu在家兔体内的血药浓度变化,为临床研究人体内Cu-IUD Cu释放过程和Cu~(2+)代谢规律提供方法和依据。方法:在家兔左侧子宫近阴道处作一切口,分别朝阴道方向插入改造后的人用TCu380A(Cu表面积约317mm~2,高剂量组)、TCu220C(Cu表面积约157 mm~2,低剂量组)和无铜支架(对照组),并将其固定于子宫壁上,在植入32周内的不同时间点,通过原子吸收火焰法测定家兔血清和局部宫腔液的Cu~(2+)浓度,分析统计Cu~(2+)的吸收代谢规律。结果:TC220C组和TCu380A组家兔在放置IUD不同时间点,局部宫腔液维持在高水平(P<0.01),同时血清Cu~(2+)浓度则维持在较低且恒定的范围,各组家兔血清Cu~(2+)水平在各放置时间点均无明显差异(P>0.05)。结论:Cu-IUD各组家兔在各时间点血药浓度均维持在较低且稳定的范围,提示其长期应用不会出现体内蓄积。