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来曲唑和醋酸炔诺酮与来曲唑和曲普瑞林治疗子宫内膜异位症相关疼痛症状的疗效比较:一项随机对照试验。

Letrozole and norethisterone acetate versus letrozole and triptorelin in the treatment of endometriosis related pain symptoms: a randomized controlled trial.

机构信息

Department of Obstetrics and Gynaecology, San Martino Hospital and University of Genoa, Italy.

出版信息

Reprod Biol Endocrinol. 2011 Jun 21;9:88. doi: 10.1186/1477-7827-9-88.

DOI:10.1186/1477-7827-9-88
PMID:21693037
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3141645/
Abstract

BACKGROUND

When aromatase inhibitors are used to treat premenopausal women with endometriosis, additional drugs should be used to effectively down-regulate gonadal estrogen biosynthesis. This randomized prospective open-label study compared the efficacy in treating pain symptoms and the tolerability of letrozole combined with either norethisterone acetate or triptorelin.

METHODS

Women with pain symptoms caused by rectovaginal endometriosis were treated with letrozole (2.5 mg/day) and were randomized to also receive either oral norethisterone acetate (2.5 mg/day; group N) or intramuscular injection of triptorelin (11.25 mg every 3 months; group T). The scheduled length of treatment was 6 months. A visual analogue scale and a multidimensional categorical rating scale were used to assess the severity of pain symptoms. The volume of the endometriotic nodules was estimated by ultrasonography using virtual organ computer-aided analysis. Adverse effects of treatment were recorded.

RESULTS

A total of 35 women were randomized between the two treatment protocols. Significantly more patients in group N rated their treatment as satisfactory or very satisfactory (64.7%) as compared to group T (22.2%; p=0.028). The intensity of both non-menstrual pelvic pain and deep dyspareunia significantly decreased during treatment in both study groups, though no statistically meaningful difference between the two groups was apparent. Reduction in the volume of endometriotic nodules was significantly greater in group T than in group N. Interruption of treatment due to adverse effects significantly differed between the groups, with 8 women in group T (44.4%) and 1 woman in group N (5.9%) interrupting treatment (p=0.018). Similarly, 14 women included in group T (77.8%) and 6 women included in group N (35.3%) experienced adverse effects of treatment (p=0.018). During treatment, mineral bone density significantly decreased in group T but not in group N.

CONCLUSIONS

Aromatase inhibitors reduce the intensity of endometriosis-related pain symptoms. Combining letrozole with oral norethisterone acetate was associated with a lower incidence of adverse effects and a lower discontinuation rate than combining letrozole with triptorelin.

摘要

背景

当芳香化酶抑制剂被用于治疗绝经前的子宫内膜异位症患者时,需要使用其他药物来有效下调性腺雌激素的生物合成。本随机前瞻性开放标签研究比较了来曲唑联合醋酸甲地孕酮或曲普瑞林治疗疼痛症状的疗效和耐受性。

方法

患有直肠阴道子宫内膜异位症引起疼痛症状的女性接受来曲唑(2.5mg/天)治疗,并随机分为同时接受口服醋酸甲地孕酮(2.5mg/天;N 组)或肌肉注射曲普瑞林(每 3 个月 11.25mg;T 组)治疗。治疗计划为 6 个月。采用视觉模拟评分法和多维分类评分量表评估疼痛症状的严重程度。使用虚拟器官计算机辅助分析通过超声评估子宫内膜异位结节的体积。记录治疗的不良反应。

结果

共有 35 名女性被随机分配到两种治疗方案中。N 组中更满意或非常满意治疗效果的患者比例(64.7%)明显高于 T 组(22.2%;p=0.028)。两组患者非经期盆腔痛和深部性交痛的强度在治疗期间均显著降低,但两组之间无统计学意义上的差异。T 组的子宫内膜异位结节体积减少显著大于 N 组。由于不良反应而中断治疗的情况在两组之间有显著差异,T 组有 8 名女性(44.4%)和 N 组有 1 名女性(5.9%)中断治疗(p=0.018)。同样,T 组有 14 名女性(77.8%)和 N 组有 6 名女性(35.3%)经历了治疗的不良反应(p=0.018)。治疗期间,T 组的骨矿物质密度显著下降,但 N 组没有。

结论

芳香化酶抑制剂可减轻子宫内膜异位症相关疼痛症状的强度。与来曲唑联合曲普瑞林相比,来曲唑联合醋酸甲地孕酮治疗的不良反应发生率较低,停药率较低。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/885e/3141645/a4a2bb1d1a3c/1477-7827-9-88-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/885e/3141645/a4a2bb1d1a3c/1477-7827-9-88-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/885e/3141645/a4a2bb1d1a3c/1477-7827-9-88-1.jpg

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