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。     

MCu IUD放置8年多中心临床比较性研究

目的:观察MCu IUD的临床效果及安全性。方法:国内6个临床中心按统一标准选择1100例要求使用IUD避孕的妇女,随机放置MCu IUD与TCu380A IUD各550例,定期随访观察96个月。结果:放置满96个月时,MCu组与TCu380A组的继续使用率分别为每百妇女年77.09,72.18(P>0.05);带器妊娠率分别为每百妇女年2.50,3.42(P>0.05);脱落率分别为每百妇女年1.07,5.73,差异有极显著性意义(P<0.001);因出血/疼痛取出率分别为每百妇女年5.66,7.77(P>0.05);有副反应主诉分别为每百妇女年4.48,5.54(P<0.05);因计划妊娠取器后足月妊娠分娩两组分别为82.5%,81.08%,总妊娠率均在90%以上。结论:MCu IUD脱落率低、避孕效果和可逆性好,是比较理想的IUD。     

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。     

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。     

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     

The comparative trial of TCu 380A IUD and progesterone-releasing vaginal ring used by lactating women

The objective of this paper was to compare the efficacy, acceptability, safety, and bleeding patterns of TCu 380A intrauterine device (IUD) and progesterone-releasing vaginal ring used by breastfeeding women. The study population included 97 breastfeeding women using IUD and 100 women using vaginal ring. Of the IUD users, no insertion failure, perforation, or accidental pregnancy occurred in 12 months. There was one IUD expulsion. There were no discontinuations of IUD due to medical reasons other than expulsion. The total discontinuation rate was 2.3%. In the ring group, no accidental pregnancy occurred. The major reasons for discontinuation were ring use-related problems and vaginal problems. The total discontinuation rate was 65.4% within 1 year. The frequency of any one complaint among the ring users was higher than that among the IUD users. There were no differences in the proportion of women having no sexual activity and in the weight of their babies between the two groups. Compared with the IUD users, the median number of bleeding/spotting (B/S) episodes and B/S days of the vaginal ring users were fewer; consequently, the mean length of B/S-free interval was longer in all four reference periods; the mean length of B/S episode and segment were the same; the occurrence of amenorrhea was more frequent; in contrast, the proportions of normal bleeding patterns were fewer. The frequencies of prolonged bleeding, frequent bleeding, and infrequent bleeding patterns did not differ between the two groups. The percentage of irregular bleeding was fewer only in the first two reference periods. It is concluded that the TCu 380A IUD and progesterone-releasing vaginal ring used by breastfeeding women are safe and effective. The higher discontinuation rate of the ring users was mainly because of use-related problems. Breastfeeding women with TCu 380A IUD had better tolerance and acceptability. The TCu 380A IUD does not, but the progesterone-releasing vaginal ring does, suppress the recovery of ovarian function. However, once return of menstruation occurred, there were no differences in bleeding patterns between the two contraceptive methods.     

TCu 380A IUD: a reversible permanent contraceptive method in women over 35 years of age

OBJECTIVE: The objective of the study was to evaluate the performance of the TCu 380A IUD in women who had been using the device for more than 10 years and who were 35 years of age or more on completion of the 10th year of IUD use. METHODS: A total of 228 women who had an IUD inserted between 1987 and 1992 were included in the study. The cutoff date for analysis was January 31, 2004. Clinical performance was evaluated by life-table analysis. The mean age of women at 10 years of use was 38.8+/-0.4 years and mean parity was 2.2+/-0.08 (mean+/-SD). The duration of follow-up beyond 10 years ranged from 1 to 72 months. No pregnancy was observed in 366 woman-years of observation beyond 10 years of use. The main reason for discontinuation was removal of the device because the clients had previously been informed that the IUD was not approved for use beyond 10 years. This reason accounted for a gross cumulative 6 years discontinuation rate of 42.5 per 100 women beyond 10 years. The other main reasons for discontinuation beyond 10 years of use were surgical sterilization, menopause and expulsion with gross cumulative 6-year termination rates of 19.2, 11.0 and 21.2 per 100 women, respectively. The cumulative continuation rate beyond 10 years was 67.0 at the end of the first year of follow-up and 21.2 at the end of the sixth year. CONCLUSION: We found no evidence that the TCu 380A IUD loses its effectiveness after 10 years of use. RESULTS: The concept that women who have insertion of a TCu 380A IUD at the age of 25 years or older could use this IUD as a reversible but permanent method of contraception up to the menopause continues to be supported by the accumulation of evidence, although definitive evidence remains to be obtained.     

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.     

Menstrual problems and side effects associated with long-term TCu 380A IUD use in perimenopausal women

The study assessing menstrual problems and side effects associated with long-term TCu 380A intrauterine device (IUD) use in perimenopausal women is reported. Fifty perimenopausal TCu 380A IUD acceptors who had IUD inserted after age 40 and used IUD at least 36 months were recruited. The mean age of acceptors at time of insertion was 44.2 years with an average parity of two live births. The mean body weight at insertion was 62.13 kg. Most of the bleeding patterns were regular cycles. Intermenstrual bleeding and pelvic pain were the side effects most often reported. No pregnancies, pelvic inflammatory disease, or IUD expulsions occurred during the follow-up period. This study suggests that the use of TCu 380A IUD in perimenopausal women is safe and effective.     

月经间期放置MYCu宫内节育器临床效果的比较性研究

目的:了解第三代爱母宫内节育器(MYCu IUD)在月经间期放置的临床效果、副作用及对生活质量的影响。方法:对要求放置IUD避孕的育龄妇女,在月经间期随机放置MYCu IUD(MYCu组,368例)与TCu 380AIUD(TCu380A组,369例),放置后1、3、6、12个月随访观察,记录使用情况。结果:置器后12个月MYCu组与TCu 380A组随访率分别为99.45%、100.00%;置器12个月累积续用率分别为每百妇女年94.02、91.87(P0.05);带器妊娠率分别为每百妇女年0.56、0.00(P=0.1703);脱落率分别为每百妇女年0.57、1.95(P=0.0947);无因IUD下移而停用者;因症终止率分别为每百妇女年3.01、6.03(P=0.0849)。置器后1、3、6个月副作用发生率MYCu组明显低于TCu380A组(P0.05)。两组对象相关生活质量均得到改善。结论:放置MYCu IUD较TCu 380AIUD疼痛和出血的副作用少,续用率、避孕效果与TCu 380AIUD相当,是一种临床效果好、副作用发生率较低的新型IUD。     

Assessment of menstrual blood loss in Brazilian users of the frameless copper-releasing IUD with copper surface area of 330 mm2 and the frameless levonorgestrel-releasing intrauterine system

OBJECTIVE: This study was conducted to evaluate the effect of two types of IUDs on the amount of menstrual blood loss (MBL): the frameless copper-releasing intrauterine device (IUD) with copper surface area of 330 mm2 (GyneFix; Contrel Research, Ghent, Belgium) and the frameless levonorgestrel (LNG)-releasing intrauterine system (IUS) releasing 14 microg per day (FibroPlant-LNG; Contrel Research). Heavy and abnormal MBL is the main reason for discontinuation of intrauterine devices. METHODS: In 20 Brazilian women using GyneFix 330 and 32 using FibroPlant-LNG, respectively, MBL was measured by the quantitative alkaline hematin technique. In addition, ferritin levels were measured in GyneFix 330 and FibroPlant-LNG users. RESULTS: MBL with GyneFix 330, measured over a 24-month period, increased but was less when compared with TCu380A. Ferritin levels with GyneFix 330 were not affected in contrast with TCu380A. In FibroPlant-LNG users, mean MBL decreased by about 90% and ferritin levels increased significantly. CONCLUSIONS: The authors confirm earlier reports that, especially for women with low body iron stores and heavy menstrual bleeding, there is an order of preference for IUD use to minimize MBL. The choice should first be a progestin-releasing IUS, then a copper IUD, which has the least effect on menstrual bleeding, such as the frameless GyneFix IUD.     

B超监测下放置吉妮IN IUD的临床效果观察

目的:观察B超监测放置吉妮IN IUD宫内节育器的临床效果。方法:多中心随机分组在B超监测下放置吉妮IN IUD289例,TCu380A IUD 303例,分别于术后1、3、6、12、24、36个月行妇科及B超随访,以生命表方法统计结果并行显著性检验。结果:①术后疼痛TCu380A组明显高于吉妮IN组(P<0.05);术后6~36月,月经紊乱以TCu380A组为高(P<0.05)。②两组带器妊娠率均较低(吉妮IN组1.04/100妇女,TCu380A组1.32/100妇女,P>0.05);脱落率TCu380A组(6.60/100妇女)高于吉妮IN组(4.84/100妇女,P<0.05);吉妮IN组因出血和疼痛的终止率(2.77/100妇女)较TCu380A组(5.61/100妇女)低(P<0.05)。结论:吉妮INIUD具有与TCu380A IUD同样高的避孕效率,其在降低脱落率、因症取出率及副反应发生率方面优于TCu380A IUD。     

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。     

Arandomized multicentre trial of the Multiload 375 and TCu380A lUDs in parous women: three-year results

Two copper IUDs—the Multiload 375 and TCu380A—are being studied in a randomized multicentre study in parous women involving nineteen centres in nine countries. There have been 1,832 insertions of the Multiload 375 and 1,823 of the TCu380A. After three years of use, the Multiload 375 had a pregnancy rate that was significantly higher than the TCu380A (2.9 ± 0.4 vs. 1.6 ± 0.3 per 100 women). There were no differences at one, two and three years of use in the expulsion rates. It is concluded that the Multiload 375 shows no clinical advantages over the TCu380A and its extra cost should be an important consideration in the choice of the most appropriate IUD.     

Assessment of menstrual blood loss in Belgian users of the frameless copper-releasing IUD with copper surface area of 200 mm2 and users of a copper-levonorgestrel-releasing intrauterine system

OBJECTIVE: This study was conducted to evaluate the effect of a miniaturized frameless copper IUD (GyneFix 200 small) and a copper-levonorgestrel (GynePlant) intrauterine system (IUS) on the amount of menstrual blood loss (MBL). METHODS: In 60 Belgian women using GyneFix 200 and 21 using GynePlant, MBL was assessed with the visual assessment technique. RESULTS: MBL scores in GyneFix 200 users did not change from baseline during the mean observation period of 31 months. In GynePlant users, mean MBL scores decreased by at least 50% in all but one user. CONCLUSION: The impact of copper IUDs on MBL can be minimized by reducing the surface area of the foreign body. Reduction of MBL, without causing amenorrhea, can be obtained by adding levonorgestrel.     

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.     

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。     

The impact of clinician education on IUD uptake, knowledge and attitudes: results of a randomized trial

BACKGROUND: Many ministries of health worldwide would like to increase use of the intrauterine device (IUD) since it is very safe, effective and inexpensive to provide. Efforts to stimulate interest in the method have not been rigorously tested. METHODS: A randomized trial was conducted among 40 clinics in Nicaragua to test the impact of medical education on both IUD uptake and on provider knowledge/attitude toward the method. Two types of interventions were used: face-to-face medical training/education of providers and/or provision of an IUD checklist to help clinicians assess the medical eligibility of clients. RESULTS: The interventions had no impact on uptake of the IUD or on provider knowledge/attitude. CONCLUSION: While medical education and job tools (such as a checklist) for providers are indispensable for ensuring quality care, they may not be adequate to stimulate interest in the IUD on the part of clients.     

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.