药铜环165、活性γ型和TCu220C宫内节育器的多中心比较性研究

目的：为防止放置宫内节育器（ＩＵＤ）引起的月经过多，扩大含消炎痛和铜的２种不锈钢ＩＵＤ即药铜环１６５和活性γ型ＩＵＤ（γ－ＩＵＤ）的临床试验，并观察５年的效果、副反应和月经血量情况。方法：由全国１２所医院随机放置药铜环１６５、γ－ＩＵＤ各１０００例，以ＴＣｕ２２０ＣＩＵＤ为对照；放置后定期随访达５年，以生命表法统计效果；对其中各２０名志愿者于放器前和放置后定期进行月经血量测定。结果：５年时每百妇女的妊娠率，药铜环１６５为３．２、γ－ＩＵＤ为２．７、ＴＣｕ２２０Ｃ为３．２；每百妇女的脱落率各为７．７、２．３和２．４；每百妇女的因症取出率各为５．０、３．８和６．４；每百妇女的续放率各为７９．８、８８．７和８４．９。第１年内平均出血天数以药铜环１６５最短；月经血量测定说明γ－ＩＵＤ放置后血量减少，而ＴＣｕ２２０Ｃ明显增加。结论：药铜环１６５效果好，平均出血天数少，放、取技术同金属单环，易为基层接受；γ－ＩＵＤ效果好、出血少。二者均可推广。     

固定式带铜宫内节育器的研制与试用

目的：对固定式带铜宫内节育器（ＦｃｕＩＵＤ）的临床避孕效果及其副作用和可接受性进行探讨。方法：通过离体子宫、动物实验、月经血测量及细菌培养以证实其效果的可靠性、安全性和可行性。结果：自１９９３年４月至１９９４年１２月共放置ＦｃｕＩＵＤ２４３例，总随访率９９．６２％。最短放置３５个妇女月，最长放置５５个妇女月。累计带器妊娠率２．４８％；脱落率与因症取出率各为３．０５％，１～４年续用率分别为９３．５０％、９２．１１％、９１．２５％及９０．８７％。结论：ＦｃｕＩＵＤ是一种脱落率低、副作用小、续用率高、安全性大的新型ＩＵＤ，对有频繁脱器史者更为适宜。     

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。     

含不同剂量消炎痛γ型IUD比较性研究

本研究对三种含不同剂量消炎痛的ｒ－ＩＵＤ进行比较性研究，即含消炎痛２５±３ｍｇ，１８±２ｍｇ和不含消炎痛的γ－ＩＵＤ对照组各３００例，共９００例，于１９９２年１０月～１９９３年５月放置，放置后进行定期随访，随访率１００％，资料按生命表法统计一年时三组ＩＵＤ累计妊娠和脱落率均甚低。因症取出率以无药组最高为３．０５，一年时继续存放率γ２５ＩＵＤ组为９８．６６，γ１８ＩＵＤ组为９８．３３均明显高于γ０ＩＵＤ组的９４．３２／１００妇女，三组各测月经血量１５例，均与放置前比较，γ２５ＩＵＤ组放置后３～１２月月经量可减少３３．５～５．２％，γ１８ＩＵＤ组无明显改变，γ０ＩＵＤ组月经量有所增加。研究结果说明在三种ＩＵＤ中γ２５ＩＵＤ组含消炎痛量为较合理的配伍剂量。     

含铜硅胶V形宫内节育器使用年限的研究

分析因各种原因取出的放置不同年限的含硐硅胶Ｖ形宫内节育器（ＶＣｕ２００ＩＵＤ）６６６个观察其铜丝不完整率和铜丝的腐蚀、耗铜、释铜、铜段脱落以及ＶＣｕ２００ＩＵＤ的制作材料变化。结果：ＶＣｕ ２００ＩＵＤ放置５￣１０年和１０￣１５年之间铜丝不完善率分别为１２．３６％、２５．５３％，二者差异有显著性（Ｐ〈０．００１）；整段铜丝脱落率分别为２．５４％、９．５７％，二者差异有显著性（Ｐ〈０．０５）。耗铜和     

药铜环165,活性γ型和TGu220C宫内节育器的多中心比较性研究

为防止放置宫节育器引起的月经过多，扩大含消炎痛和铜的２种不锈钢ＩＵＤ即药铜环１６５和活性γ型的临床试验，并观察５年的效果，副反应和月经血量情况。方法：由全国１２所医院随机放置药铜环１６５、γ－ＩＵＤ各１０００例，以ＴＣｕ２２０ＣＩＵＤ为对照；放置后定期随放达５年，以命表法统计效果；对其中各２０名志愿者于放器前和放置后定期进行月经血量测定。结果：５年时百妇女的妊娠率、药铜环１６５为３．２、γ－ＩＵＤ     

两种产后立即放置TCu380A宫内节育器方法的比较——910例12个月随访分析

目的：比较徒手和卵圆钳两种方法对产后立即放置（ＩＰＰＩ）宫内节育器（ＩＵＤ）效果的影响。方法：将９１０例阴道分娩产妇（其中９７．７％是首次分娩）随机分成两组，于胎盘娩出后１０分钟内放置ＴＣｕ３８０ＡＩＵＤ，其中４７０例徒手放置（手放组），４４０例用卵圆钳放置（钳放组）。随访１２个月，以生命表法统计、χ２检验比较两种放置方法的脱落率、妊娠率、因症取出率等。结果：６和１２个月的随访率分别为９５．１６％和９２．６４％。９１０例中未发生子宫穿孔和感染，仅手放组有１例带器妊娠。放置后主要停用原因是脱落，手放组与钳放组１２个月的粗累积脱落率分别为１５．８６／１００妇女和１５．８８／１００妇女，因症（出血、疼痛）取出率分别为２．１１／１００妇女和１．５７／１００妇女，差异无显著性（Ｐ均＞０．０５）。结论：徒手放置或卵圆钳放置对ＩＰＰＩ的效果无明显影响；ＴＣｕ３８０ＡＩＵＤ适合中国妇女产后立即放置。     

放置宫内节育器后子宫内膜螺旋动脉的三维空间形态

目的：研究不同宫内节育器（ＩＵＤ）对子宫内膜螺旋动脉形态的和要为防治出血副反应提供理论依据。方法：取未放置ＩＵＤ、放ＴＣｕ２２０ＣＩＵＤ及放γ消炎痛ＣｕＩＵＤ３个月后妇女各３例的晚期子宫内膜，应用电子计算机三维重建技术，重建子宫内膜螺旋动脉。结果：未放置ＩＵＤ的子宫内膜，螺旋动脉的螺旋盘风较均匀，平均管径２２．６９μｍ，曲率０．９６，桡率１．２７；放置ＴＣｕ２２０ＣＩＵＤ后，螺旋动脉盘曲不均匀，呈     

绝经后宫内节育器去留的安全性研究

自１９６０年全国推广宫内节育器（ＩＵＤ）至今己有千万妇女进入绝经期，绝经后ＩＵＤ应予取出，但因种种因素尚有相当比例绝经后妇女并未取出ＩＵＤ。作为异物的ＩＵＤ长期不取是否安全？尚未报道。本研究调查了普查对象中绝经后妇女２６５８例，其中未取ＩＵＤ者３０２例（ＩＵＤ组）和无ＩＵＤ妇女２５４例进行比较。通过病史询问和妇科检查结果提示：１．绝经后未取ＩＵＤ者平均绝经年龄为４９．７３岁，明显高于对照组（４８．９９）；子宫明显萎缩者与对照组相似；对健康情况无明显影响；患病史中ＩＵＤ组明显低于对照组。２．通过２７６例宫腔分泌物直接涂片检查，白细胞和细菌计数与对照组相似。３．１２８例同时取出ＩＵＤ，取器困难率于绝经＜２年者为５％，≥２年者１８％～３５％。根据本研究结果，绝经后未取ＩＵＤ者未见明显的危害性，但建议有条件取器者应在１年内取器，如绝经２年以上遇有取器困难而临床又无症状，不宜强行取器，以免造成严重创伤，可严密随访。     

四种节育器对月经影响的比较分析

目的 比较四种节育器放置１年对妇女月经的影响。方法 对药铜１６５ＩＵＤ、活性Ｖ形ＩＵＤ、ＭＬＣｕ３７５ＩＵＤ三种宫内节育器和甲硅阴道环四种节育器放置１年内情况进行追踪观察比较。结果发现活性Ｖ形ＩＵＤ放置１年月经变化和出血的发生率明显低于药铜１６５ＩＵＤ,ＭＬＣｕ３７５ＩＵＤ副反应与药铜１６５ＩＵＤ相似,三种宫内节育器中活性Ｖ形ＩＵＤ因症取出率最低,续存率最高。甲硅阴道环置于宫腔,放置１年内引起的月     

Evaluation of combined multiload copper IUD (MLCu250 and MLCu375).

An improved IUD design has been developed, called the Combined Multiload Copper IUD, whose properties combine an easy insertion procedure with a high resistance to expulsion. The new design features an improved polyethylene skeleton which decreases the need to extend the uterine cavity and also decreases the medical removal rate. The Combined Multiload Copper IUD (MLCu) is available with 250 mm copper or 375 mm copper wiring around the vertical stem. 18 months of multicenter comparative testing among the MLCu device, the Lippes D, and 2 older-model copper T devices showed the MLCu device to have much lower expulsion and much higher continuation rates without sacrificing in pregnancy-prevention performance. Results with the MLCu375 show even lower pregnancy rates with no more medical removals or expulsions than with the MLCu250. The added advantage of the MLCu375 is that there is no need for replacement before 5 years. Clinical tests of postplacental insertion of the MLCu250 were carried out on 78 women in Ghent, Belgium, with promising results. Multicenter trials are continuing.     

The first year of clinical experience with concurrent post abortal insertion of copper "T" 200

Immediate postabortion period is a strategic time for providing contraceptive protection, especially insertion of IUD concommitent with the abortion procedure. One can be reasonably safe in assuming that copper T 200 may be used with comparable degrees of clinical effectiveness in such situations. A higher incidence of IUD removals for bleeding and IUD displacements in the postabortal insertion is justifiable when it is considered that a greater number of women are reached and thus protected against the risks of an unwanted pregnancy. Major problems such as cervical or uterine perforations were not associated with this type of insertion. IUD removal was effected in 5.39% for bleeding, and in 4.69% of cases where there was either complete or incomplete expulsion of the device. Expulsion rate was high within the 1st week of insertion, and it is reasonable to believe that abortion complications were responsible for this high expulsion rate. Even though IUD removal was not required, about 15% of the patients had menstrual irregularities at the end of 1 year of use. Embedding of the copper device did not pose any problem for removal of the device after 1 year of use and no fragmentation of copper wire was found in the IUDs removed. In those who wanted, conception had occurred within 4 months of removal of the device. The follow-up data suggests that the use-effectiveness of the device gradually increase with the duration of use and is found to be highest after 1 year of use.     

Partial and complete expulsion of the Multiload 375 IUD and the levonorgestrel-releasing IUD after correct insertion

OBJECTIVE: The contraceptive efficacy of intrauterine devices (IUD) is thought to relate to the position of the IUD in the uterine cavity. Several trials examined the number of copper IUD expulsions, but none evaluated the partial and complete expulsion rate of the levonorgestrel-releasing device (LNG-IUD). STUDY DESIGN: This retrospective cohort study compares the dislocation rate of the Multiload 375 IUD (ML 375) and the LNG-IUD in 214 women (107 subjects with each IUD). Transvaginal ultrasound was used to monitor the IUD position immediately after insertion, after 6 weeks, and later on at intervals of 6 months. The observation period included 3631 cycles. RESULTS: We detected a significantly lower number of dislocations in LNG-IUD users. Previous expulsion was associated with a significantly higher risk for a re-expulsion in both IUD groups. Hypermenorrhea was not associated with an increased dislocation rate in LNG-IUD users. CONCLUSION: Expulsions are less likely to occur with the LNG-IUD, which might contribute to its contraceptive efficacy.     

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。     

Copper IUDs (author's transl)

Following initial development of the Grafenberg ring in the 1920's, IUDs fell into disuse until the late 1950s, when plastic devices inserted using new technology began to gain worldwide acceptance. Further research indicated that copper had a significant antifertility effect which increased with increasing surface area, and several copper IUDs were developed and adapted, including the Copper T 200, the Copper T 220C, and the Copper T 380 A, probably the most effective yet. The Gravigard and Multiload are 2 other copper devices developed according to somewhat different principles. Copper devices are widely used not so much because of their great effectiveness as because of their suitability for nulliparous patients and their ease of insertion, which minimizes risk of uterine perforation. Records of 2584 women using Copper IUDs for 7190 women-years and 956 women using devices without copper for 6059 women-years suggest that the copper devices were associated with greater effectiveness and fewer removals for complications. Research suggests that the advantages of copper IUDs become more significant with increased duration of use. Contraindications to copper devices include allergy to copper and hepatolenticular degeneration. No carcinogenic or teratogenic effect of copper devices has been found, but further studies are needed to rule out other undesirable effects. Significant modifications of copper devices in recent years have been developed to increase their effectiveness, prolong their duration of usefulness, facilitate insertion and permit insertion during abortion or delivery. The upper limit of the surface area of copper associated with increased effectiveness appears to be between 200-300 sq mm, and at some point increases in copper exposure may provoke expulsion of the IUD. The duration of fertility inhibition of copper IUDs is usually estimated at 2-3 years, but recent research indicates that it may be 6-8 years, and some devices may retain copper surface for as long as 20 years. Shorter and smaller versions of standard copper IUDs have been tested as they permit easier insertion, but high rates of pregnancy, expulsion, and removal have prevented their wider use. The discovery that the size of the uterine cavity is more important than its length has prompted the development of some promising uterine measuring instruments. Attempts to develop a device appropriate for postpartum use have been disappointing, and expulsion rates remain high. A few promising new forms of copper IUDs have been developed but not yet tested clinically.     

Rates of Intrauterine Device Expulsion Among Adolescents and Young Women

Study ObjectiveThe objective of our study was to determine the rate of intrauterine device (IUD) expulsion and risk factors for expulsion among adolescents and young adults.DesignRetrospective chart review.SettingIUD insertions were performed at a single children's hospital.ParticipantsEligible adolescent and young adult patients who underwent IUD insertion between August 2009 and March 2019.InterventionsIUD insertion.Main Outcome MeasuresPrimary outcome was the incidence of IUD expulsion in adolescents and young women. Secondary outcomes were risk factors for IUD expulsion including heavy menstrual bleeding, abnormal uterine bleeding (AUB), anemia, or a bleeding disorder diagnosis.ResultsSix hundred forty-two eligible patients underwent IUD insertion. The incidence of first IUD expulsion in this population was 58/642 (9.03%). Among those who chose to have a second IUD placed (n = 29), 8/29 (27.6%) had a second expulsion. Patients who expelled their IUD were more likely to have a history of AUB, heavy menstrual bleeding, anemia, or a bleeding disorder. When controlled for body mass index and age at insertion, history of AUB and anemia remained significant risks for IUD expulsion.ConclusionThis study similarly showed a higher risk of primary and secondary IUD expulsion in adolescents and young women. A history of AUB, anemia, bleeding disorder, and elevated body mass index are associated with higher risk for IUD expulsion. This population should be counseled that these conditions might place them at higher risk for expulsion.     

The role of copper-releasing intrauterine device or levonorgestrel-releasing intrauterine system on uterine bleeding and iron status (prospective study of 8 years)

BACKGROUND: The aims of this study were the effects of copper intrauterine device (Cu-IUD) compared to progesterone (PRG-IUS) or levonorgestrel releasing intrauterine system (LNg-IUS) on menstrual bleeding, menorrhagia and dysfunctional uterine bleeding. The authors evaluated the effect of copper surface area on uterine bleeding. METHODS: Between March 1992 and November 1999, 223 women, referred to I Institute of Obstetrics and Gynaecology University of Rome, were recruited in a prospective study with follow up at 3, 6 and 12 months to evaluate the incidence of endometrial pathology. The study includes 38 fertile women with regular menstruations and without intrauterine devices, as control group, and 185 patients with intrauterine devices, divides as follows: - 117 copper-releasing intrauterine devices: 30 with a copper (Cu) surface area =200 mm2, releasing 45 microgram Cu/24h (Nova T (R)); 27 with a copper surface area =250 mm2, releasing 50 microgram Cu/24h (Multiload 250 (R)); 25 with a copper surface area =375 mm2, releasing 65 microgram Cu/24h (Multiload 375 (R)); 20 with a copper surface area =384 mm2, releasing 100 microgram Cu/24h (No Gravid M (R)); 15 with a copper surface area =440 mm2, releasing 120 microgram Cu/24h (No Gravid 0,5 (R)). - 68 progesterone/levonorgestrel-releasing intrauterine devices: 40 progesterone-releasing intrauterine systems (Progestasert(R)); 28 levonorgestrel-releasing intrauterine systems 20 mg/24h (Mirena (R)). A total of 211 subjects had data that were valid for analysis: 12 women out of 223 (5,4%) were excluded from the prospective study lost to follow-up. A venous blood sample for serum ferritin (mg/l), iron (mg/dl), hemoglobin (g/dl), hematocrit (%), blood cell count, MCHC and MCV was taken during follow-up. RESULTS: PRG or LNg-IUSs determined a significant reduction in menstrual blood loss and in irregular bleeding by gradually reducing endometrial fitness and vascularisation. Serum ferritin significantly increased in women inserted with LNg- IUSs already after 6 months (26+/-22 e 28+/-14 microgram/l versus 32.5+/-19 e 34.5+/-25 microgram/l). Hemoglobin significantly increased (p>0.05) 6 months after insertion. On the contrary this did not occur with the insertion of Cu-IUDs. We observed that the increased amount of copper, released by IUD, causes increasing of bleeding. CONCLUSIONS: The LNg-IUS is a new contraceptive method combining the advantages of both hormonal and intrauterine contraception. In addition, it can be considered an alternative method in the treatment of menorrhagia and dysfunctional uterine bleeding. On the contrary, in women inserted with Cu-IUDs, the main reason of menorrhagia probably is due both to the shape of device and to copper surface area.     

IUD对子宫收缩的影响观察

本文重点研究妇女正常月经净后七天之内子宫收缩压力和频率,以及频脱器妇女与第一次置器妇女子宫收缩压及其相互间的差别。结果:(1)23例妇女月经净后七天之内子宫收缩压力为2.21～14.14mmHg/次,均值7.66±2.89mmHg/次。10分钟内子宫收缩28～76次,均值4.51±1.14次/分;(2)第一次置器妇女与频脱器妇女其置器前、后子宫收缩压力大小无显著差异(P>0.05)(3)子宫腔内有器子宫收缩压力比子宫腔内无器时大。两组子宫收缩压力t 检验结果(P<0.05)有显著差异:(4)第一次置(取)器前、后当时子宫收缩压力及频率大小皆有显著差异(P<0.05)。置(取)器后子宫收缩压力比置(取)器前大;(5)频脱组在置器前、后当时子宫收缩压力大小有显著差异(P<0.05),与第一次置器组相同;(6)本法测试子宫收缩压力达37～62mmHg/次时,部分受术者即有明显的下腹痛或痛感较强。     

在剖腹产时用缝合固定法放置宫内节育器的临床报告

利用剖腹产时子宫腔充分暴露这一的特定条件,本院对218例剖腹产妇女,在剖腹产同时,用铬制肠将宫内节育器固定在子宫后壁上。214例带器者作了产后42天、3个月和6个月的随访,相应的累积脱落率分别为0.46%、2%和2.3%,4例脱落均发生在子宫口开大的病例中。8例带器妊娠。6个月的继续存放率达91.77%。所有随访者无严重合并症和明显的副作用,恶露6～75天,平均32.8天,但均无月经血量过多。说明剖腹产时用缝合固定法放置节育器为一安全、有效和及时的方法。但存在带器妊娠率略高的问题有待进一步研究。     

Future of intrauterine contraception (IUDS)

Performance of IUDs has improved greatly in the past decade. The reasons for improvement include increased copper content and prevention of copper fragmentation, flexible frames that adapt to the endometrial cavity, better evaluation of the endometrial cavity before insertion, simplified insertion, selection of acceptors, and careful follow-up. NO significant modifications in IUD design have occurred since the use of copper was begun in the 1970s except for use of systems-releasing steroids. The use of copper improved efficacy and permitted use of smaller devices, reducing some side effects especially in small uteruses. The duration of use of copper IUDs has increased, and their efficacy has improved at the same time that modifications have permitted greater local tolerance with no increase in expulsion rate. Greater selectivity of IUD users has improved performance, taking into account known risks for major complications such as extrauterine pregnancy and infection. Prior use of IUD and conditions of follow-up should also be considered in candidate selection. The major weaknesses of IUDs at present are related to the introduction of a foreign body into the uterine cavity; IUD insertion entails potential risks of infection and perforation. However, the active substance should not cause damage to the endometrial mucus or induce cycle disturbances or diminished defenses against pain and infection. Research on IUD frames is oriented toward development of a device adaptable to specific conditions such as the postpartum. 1 new device would completely eliminate plastic and the related side effects. A new miniaturized device is under investigation along with a biodegradable device and an intracervical device. New substances under study for a better contraceptive effect include spermicides, immunological substances, and synthetic progestins. An intracervical device emitting a battery-driven weak electric field is intended to immobilize sperm. Most current research has as its goal the reduction of secondary effects of bleeding, pain, or risk of infection. Among the numerous substances utilized have been antifibrinolytics, prostaglandin inhibitors, sexual steroids, and antibiotics. These systems should provide constant release over a prolonged period, a goal not yet attainable for all these substances.