Immediate post-abortal insertion of the frameless GyneFix IUD: initial experience in China

The promising results obtained with the frameless GyneFix IUD for interval insertion led to the belief that the technology could be useful for immediate post-abortal application to reduce the number of induced and repeat abortions. IUDs have many advantages and the method is acceptable and safe. However, side effects and expulsion of conventional IUDs remain a problem. In an attempt to minimise these problems, the frameless GyneFix IUD was developed. Clinical studies conducted over the past 14 years have shown that the principles on which the device is based are valid. An increasing bulk of clinical evidence shows that the design characteristics of the device (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness, and high tolerance and continuation rates.1 Experience with the frameless IUD in China since 1989 confirms the international experience with the device. The present communication is a second report from China with the GyneFix IUD. In the present study the GyneFix IUD is inserted immediately following termination of pregnancy of less than 10 weeks amenorrhea. It is concluded that immediate post-abortal insertion of the frameless IUD is easy and safe, and appears to be as reliable and as effective as when it is inserted at interval. The GyneFix IUD could, therefore, constitute an important new option in the prevention of abortion.     

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.     

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.     

The force required to remove the frameless 0-suture IUD anchoring system: comparison between pre- and postmenopausal women

OBJECTIVE: The objective of this short communication is to measure and compare the force needed to remove the implanted "0-suture" GyneFix intrauterine contraceptive device (IUD) and the "0-suture" FibroPlant trade mark -LNG intrauterine system (IUS) from the uterus of pre- and postmenopausal women. STUDY DESIGN: A nonrandomized comparative study in 119 pre- and postmenopausal women. A dynamometer (Pesola) was used to measure the removal force in newtons. RESULTS: The results of this study show a mean removal force of 8.5 and 9.5 newtons, respectively (range, 3-11 and 4.5-11), in pre- and postmenopausal women, which is significantly different (p = 0.003). CONCLUSIONS: The force needed to remove the IUD/IUS anchored in the myometrium of the uterine fundus of pre- and postmenopausal women is higher than the removal force found in previous studies in which the IUD consisted of a slightly thinner anchoring thread (00 instead of 0 suture). The statistically significantly different removal force between the two groups has no clinical implications. The difference may reflect the increased compactness of the uterine tissue in the postmenopausal uterus.     

MCu IUD与TCu380A IUD多中心比较性研究

目的:观察新型MCuIUD的临床效果及安全性。方法:在国内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MCuIUD与TCu380AIUD各550例,定期随访观察。结果:放置满48个月时,MCuIUD组与TCu380A组的继续使用率分别为84.82/百妇女、81.62/百妇女,P>0.05;带器妊娠率分别为1.26/百妇女、1.72/百妇女,P>0.05;脱落率分别为0.42/百妇女、3.45/百妇女,差异显著,P<0.05;因症取出率分别为4.19/百妇女、5.82/百妇女,P>0.05;有主诉分别为3.77/百妇女、7.76/百妇女,差异显著,P<0.05;因计划妊娠取出后多在1年内妊娠。结论:MCuIUD脱落率极低、抗生育效果好,置、取方便,安全、有效,可逆行好,是目前比较理想的IUD,值得推广。     

去尾丝HCu280型花式IUD临床效果观察

目的:探讨放置去尾丝HCu280型花式宫内节育器(IUD)的临床效果,为推广使用提供科学依据。方法:21~45岁已婚已育且无放置IUD禁忌证妇女中,选择自愿放置去尾丝HCu280型花式IUD妇女200例为观察对象(HCu280IUD组),以选择放置TCu380AIUD妇女198例为对照(TCu380AIUD组),分别于放置后1、3、6和12个月进行随访,比较两组避孕效果、副作用主诉情况。结果:置器12个月HCu280IUD组和TCu380AIUD组带器妊娠率分别为每百妇女年0和0.5(P0.05);脱落率分别为每百妇年0.5和4.2(P0.05);与IUD使用相关终止率分别为每百妇女年3.5和9.6(P0.05);总终止率分别为每百妇女年4.0和10.1(P0.05);续用率分别为每百妇女年96.0和89.9。置器后1、3、6、12个月副作用主诉率,HCu280IUD组低于TCu380AIUD组。结论:HCu280型花式IUD避孕效果好,副作用主诉少,续用率高。     

Perspective on the historical development of radiation standards

This paper discusses the historical development of standards for limiting routine radiation exposures of workers and the public. The radiobiological and epidemiological basis for radiation protection standards and practices, as this basis has evolved over time, is emphasized. Difficulties with using dose equivalents and nominal risk factors, which were developed primarily for purposes of radiation protection (i.e., to establish dose limits), in estimating radiation risks at the low levels of exposure routinely experienced in the workplace and the environment are discussed. The increasing importance of the principle that exposures should be reduced as low as reasonably achievable (ALARA) in radiation protection of workers and the public is described.     

新型糖肽类抗生素——达巴万星

随着广谱抗菌药物及免疫抑制剂的使用,人口老龄化社会现象,抗菌药物耐药问题日益严重。和抗菌药物耐药相比,研制一种新型的抗菌药物的速度远远落后于前者。耐药的革兰阳性（G+）球菌是导致临床抗感染治疗失败的主要原因之一。达巴万星(dalbavancin)为Vicuron Pharmaceuticals公司开发的一种新型半合成糖肽类抗生素,为替考拉宁类似物A40926的衍生物,其化学结构式见图1。目前已完成了Ⅲ期临床试验,它对各类临床常见G+菌具有高度抗菌活性。达巴万星具有和替考拉宁相似的分子结构,但羧基肽基团末端的酰胺基修饰提高了达巴万星对葡萄球菌属,特别是凝固酶阴性葡萄球菌的抗菌活性;而亲脂支链和二聚体的形成提高了达巴万星的组织穿透性和与细菌细胞膜的亲和力。和替考拉宁等糖肽类抗生素一样,达巴万星通过与细菌细胞壁肽聚糖上D 丙氨酰 丙氨酸末端特异性结合,抑制细菌细胞壁肽聚糖的延伸和交联,阻止细胞壁合成而发挥杀菌作用。     

宫内节育器放置技术对使用效果的影响

本文以前瞻性研究方法收集北京市城乡两医院随机放置三种宫内节育器(上海165,北京金塑钢和TCu220C)随访一年的资料,分析结果显示两医院三种宫内节育器第12个月末净累积续用率分别为93.33/每百妇女和99.33/每百妇女,两院节育器使用效果有明显差别(X~2=12.22 P<0.01)。对终止率的影响因素依次为宫内节育器种类,使用妇女的末产结局和放置者的技术水平。TCu220C明显地影响终止率(OR=5.2),末产结局为人流术后的妇女终止的危险是正常分娩后妇女的3.2倍(95％CI1.31～8.0),放置者技术水平的提高对宫内节育器的终止呈现保护作用(OR=2.5)。