Song Huan, Lu DongHao, Navaratnam Kate, Shi Gang
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Box 281, Stockholm, Sweden, SE-17177.
Cochrane Database Syst Rev. 2013 Oct 23;2013(10):CD009505. doi: 10.1002/14651858.CD009505.pub2.
Uterine fibroids, also called uterine leiomyomas or myomas, are the most common benign tumours in women of reproductive age. Albeit generally benign, uterine fi broids can have a major impact on women's health and quality of life by contributing to abnormal uterine bleeding and causing pelvic pressure symptoms (such as increased urinary frequency, pelvic pain and constipation). Traditional treatments for symptomatic fi broids include a variety of surgical techniques. However, because of the high recurrence rate, as well as possible pain and infertility caused by the formation of postoperative adhesions, this approach may not be advisable. Safer and more effective medical therapy has long been awaited. Both in vitro studies and clinical trials have suggested that use of the aromatase inhibitors (AIs), a class of anti-oestrogens, might inhibit fi broid growth, thereby eliminating the need for surgery.
To evaluate the effectiveness and safety of aromatase Inhibitors (AIs) in women with uterine fibroids.
We searched the following databases (from inception to August 21, 2013): Cochrane Menstrual Disorders and Subfertility Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, CINAHL and PsycINFO. In addition, the reference lists of included trials were searched, and experts in the field were contacted.
Randomised controlled trials (RCTs) in women of reproductive age comparing the effects of any AI versus placebo, no treatment or any medical treatment/surgery were included.
Selection of eligible trials, assessment of trial quality and data extraction were performed independently by two review authors. If data were available, we planned to calculate odds ratios (ORs) for analysis of dichotomous data and mean differences for continuous data, with 95% confidence intervals (CIs).
Only one trial involving 70 participants was included. This trial did not report our primary review outcome (relief of symptoms of fibroids). The only secondary review outcomes reported by this trial were adverse effects (hot flushes) and reduction in fibroid size. Significantly fewer women reported hot flushes in the letrozole group than in the GnRHa group (0/33 vs 26/27, P < 0.05). Use of letrozole reduced fibroid volume by 46% and use of a gonadotrophin-releasing hormone (GnRH) agonist (GnRHa) by 32% after 12 weeks of treatment; these proportions were not significantly different. The included trial did not report data on fibroid volume in a form that permitted calcuation of an odds ratio. Morevoer it was unblinded and included only 60/70 women in analysis.
AUTHORS' CONCLUSIONS: Evidence is insufficient to support the use of AI drugs in the treatment of women with uterine fibroids.
子宫肌瘤，也称为子宫平滑肌瘤或肌瘤，是育龄女性最常见的良性肿瘤。尽管通常为良性，但子宫肌瘤可通过导致异常子宫出血和引起盆腔压迫症状（如尿频增加、盆腔疼痛和便秘），对女性健康和生活质量产生重大影响。有症状肌瘤的传统治疗方法包括多种手术技术。然而，由于复发率高，以及术后粘连形成可能导致的疼痛和不孕，这种方法可能不可取。人们长期以来一直期待更安全、更有效的药物治疗。体外研究和临床试验均表明，使用芳香化酶抑制剂（一类抗雌激素药物）可能抑制肌瘤生长，从而无需进行手术。
评估芳香化酶抑制剂（AIs）治疗子宫肌瘤女性的有效性和安全性。
我们检索了以下数据库（从建库至2013年8月21日）：Cochrane月经失调与生育力低下组专业注册库、Cochrane对照试验中央注册库（CENTRAL）（Cochrane图书馆）、MEDLINE、EMBASE、CINAHL和PsycINFO。此外，还检索了纳入试验的参考文献列表，并联系了该领域的专家。
纳入比较任何一种芳香化酶抑制剂与安慰剂、不治疗或任何药物治疗/手术效果的育龄女性随机对照试验（RCT）。
两名综述作者独立进行 eligible试验的选择、试验质量评估和数据提取。如果有数据，我们计划计算二分数据的比值比（OR）和连续数据的均值差，并给出95%置信区间（CI）。
仅纳入一项涉及70名参与者的试验。该试验未报告我们的主要综述结局（肌瘤症状缓解）。该试验报告的唯一次要综述结局是不良反应（潮热）和肌瘤大小缩小。来曲唑组报告潮热的女性明显少于促性腺激素释放激素激动剂（GnRHa）组（0/33 vs 26/27，P<0.05）。治疗12周后，来曲唑使肌瘤体积减少46%，促性腺激素释放激素（GnRH）激动剂（GnRHa）使肌瘤体积减少32%；这些比例无显著差异。纳入试验未以允许计算比值比的形式报告肌瘤体积数据。此外，该试验未设盲，分析中仅纳入了60/70名女性。
证据不足，无法支持使用芳香化酶抑制剂药物治疗子宫肌瘤女性。
