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含铜宫内节育器或左炔诺孕酮宫内缓释系统对子宫出血和铁状态的作用(8年前瞻性研究)

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

作者信息

Imperato F, Perniola G, Mossa B, Marziani R, Perniola F, Stragapede B, Napolitano C

机构信息

II Facoltà di Medicina e Chirurgia, Istituto di Ostetricia e Ginecologia, Università degli Studi La Sapienza, Rome, Italy.

出版信息

Minerva Ginecol. 2002 Jun;54(3):271-8.

Abstract

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.

摘要

背景

本研究旨在比较铜宫内节育器(Cu-IUD)与孕激素(PRG-IUS)或左炔诺孕酮宫内缓释系统(LNG-IUS)对月经出血、月经过多和功能失调性子宫出血的影响。作者评估了铜表面积对子宫出血的影响。

方法

在1992年3月至1999年11月期间,223名转诊至罗马大学第一妇产科研究所的女性被纳入一项前瞻性研究,在3、6和12个月时进行随访,以评估子宫内膜病变的发生率。该研究包括38名月经规律且未使用宫内节育器的可育女性作为对照组,以及185名使用宫内节育器的患者,分组如下:- 117个释放铜的宫内节育器:30个铜(Cu)表面积=200平方毫米,每24小时释放45微克铜(Nova T(R));27个铜表面积=250平方毫米,每24小时释放50微克铜(Multiload 250(R));25个铜表面积=375平方毫米,每24小时释放65微克铜(Multiload 375(R));20个铜表面积=384平方毫米,每24小时释放100微克铜(No Gravid M(R));15个铜表面积=440平方毫米,每24小时释放120微克铜(No Gravid 0.5(R))。- 68个释放孕激素/左炔诺孕酮的宫内节育器:40个释放孕激素的宫内缓释系统(Progestasert(R));28个每24小时释放20毫克左炔诺孕酮的宫内缓释系统(Mirena(R))。共有211名受试者的数据可用于分析:223名中有12名(5.4%)被排除在前瞻性研究之外,失访。在随访期间采集静脉血样本检测血清铁蛋白(毫克/升)、铁(毫克/分升)、血红蛋白(克/分升)、血细胞比容(%)、血细胞计数、平均红细胞血红蛋白浓度和平均红细胞体积。

结果

PRG或LNG-IUS通过逐渐降低子宫内膜适应性和血管化程度,显著减少了月经失血和不规则出血。插入LNG-IUS的女性在6个月后血清铁蛋白就显著升高(26±22和28±14微克/升,而插入前为32.5±19和34.5±25微克/升)。插入后6个月血红蛋白显著升高(p>0.05)。相反,插入Cu-IUDs后未出现这种情况。我们观察到,宫内节育器释放的铜量增加会导致出血增加。

结论

LNG-IUS是一种结合了激素避孕和宫内避孕优点的新型避孕方法。此外,它可被视为治疗月经过多和功能失调性子宫出血的替代方法。相反,对于插入Cu-IUDs的女性,月经过多的主要原因可能既与节育器的形状有关,也与铜表面积有关。

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