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来曲唑用于输卵管妊娠单药治疗的超说明书用药并非甲氨蝶呤的替代方案:一项前瞻性队列研究。

Off-label letrozole for tubal pregnancy monotherapy is not an alternative to methotrexate: a prospective cohort study.

作者信息

Gawron Iwona M, Babczyk Dorota, Jach Robert

机构信息

Department of Gynecology and Obstetrics, Faculty of Medicine, Jagiellonian University Medical College, Cracow, Poland.

出版信息

Ginekol Pol. 2025;96(1):51-57. doi: 10.5603/gpl.100131. Epub 2024 Sep 17.

DOI:10.5603/gpl.100131
PMID:39287207
Abstract

OBJECTIVES

Inhibition of estradiol production by letrozole may interfere with physiological effects of progesterone necessary to maintain the pregnancy. Treatment of tubal pregnancy (TP) with letrozole would allow to avoid the disadvantages of methotrexate (MTX). The aim was to compare the effectiveness of letrozole with MTX in the management of TP.

MATERIAL AND METHODS

A prospective open-label cohort study was conducted among women with TP and increasing B-human chorionic gonadotropin (B-hCG) concentrations. MTX was administered in a single dose of 100 mg intravenously, while letrozole in a dose of 5 mg orally for 10 days. Blood parameters (B-hCG, hemoglobin, creatinine, urea, transaminases, bilirubin) were tested on days 0, 4 and 7.

RESULTS

Out of 22 eligible women, 14 received MTX and received 8 letrozole. Mean age, lesion diameter, gestation age in the MTX vs letrozole arm were: 31 vs 32 years (p = 0.3), 13.2 vs 16.3 mm (p = 0.1), 7 + 1 vs 7 + 0 weeks (p = 0.6), respectively. In case of 4 women treated with letrozole and in 2 treated with MTX (4/8, 50% vs 2/14, 14.3%, p = 0.07) the treatment was unsuccessful. There were no significant differences in blood parameters on days 0, 4 and 7 between both arms, except for the increasing urea concentration in the letrozole arm (p = 0.01).

CONCLUSIONS

Even though the results did not reach statistical significance, it is likely that a larger study sample would confirm the trend of letrozole being less effective. The results did not support the use of letrozole in the studied regimen as an alternative to MTX.

摘要

目的

来曲唑抑制雌二醇生成可能会干扰维持妊娠所需的孕酮的生理作用。用 来曲唑治疗输卵管妊娠(TP)可避免甲氨蝶呤(MTX)的缺点。本研究旨在比较来曲唑与 MTX 在 TP 治疗中的有效性。

材料与方法

对 TP 且β-人绒毛膜促性腺激素(β-hCG)浓度升高的女性进行一项前瞻性开放标签队列研究。MTX 静脉注射单剂量 100mg,而来曲唑口服剂量为 5mg,连用 10 天。在第 0、4 和 7 天检测血液参数(β-hCG、血红蛋白、肌酐、尿素、转氨酶、胆红素)。

结果

22 名符合条件的女性中,14 名接受 MTX,8 名接受来曲唑。MTX 组与来曲唑组的平均年龄、病灶直径、妊娠周数分别为:31 岁 vs 32 岁(p = 0.3),13.2mm vs 16.3mm(p = 0.1),7 + 1 周 vs 7 + 0 周(p = 0.6)。接受来曲唑治疗的 4 名女性和接受 MTX 治疗的 2 名女性(4/8,50% vs 2/14,14.3%,p = 0.07)治疗未成功。两组在第 0、4 和 7 天的血液参数无显著差异,但来曲唑组尿素浓度升高(p = 0.01)。

结论

尽管结果未达到统计学显著性,但更大的研究样本可能会证实来曲唑效果较差的趋势。结果不支持在所研究的方案中使用来曲唑替代 MTX。

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