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加巴喷丁与低剂量透皮雌二醇治疗绝经后中重度潮热妇女的比较。

Gabapentin vs. low-dose transdermal estradiol for treating post-menopausal women with moderate to very severe hot flushes.

机构信息

Postmenopausal Health and Female Endocrinology Unit, Quito, Ecuador.

出版信息

Gynecol Endocrinol. 2010 May;26(5):333-7. doi: 10.3109/09513590903511539.

Abstract

BACKGROUND

Gabapentin (GPT), a widely used drug in neurology, has been proposed as a non-hormonal option for the management of hot flushes in menopausal women with contraindications for estrogen therapy.

OBJECTIVE

To compare GPT versus low-dose transdermal estradiol (E(2)) for treating post-menopausal women with moderate to very severe hot flushes.

METHODS

A total of 45 post-menopausal women with moderate to very severe hot flushes were prospectively and single-blinded randomised to receive oral GPT 600 mg/night or transdermal 25 microg/day E(2) per week. Hot flush intensity and frequency were assessed with the Menopause Rating Scale and a numeric scale respectively at baseline and at 1, 4 and 8 weeks. Side effects were also assessed.

RESULTS

Hot flush intensity and frequency significantly decreased for both groups at 1, 4 and 8 weeks of treatment as compared to baseline; however, this decrease was statistically more evident for the E(2) group. Although the percentage of hot flush intensity and frequency reduction at the end of the treatment was higher for E2, this was not statistically significant (68.2% vs. 60.6% for intensity and 70.1% vs. 58.9% for frequency, respectively, p > 0.05, NS). Encountered side effects included: drowsiness, dizziness, fatigue (GPT group) and mastodynia, vaginal spotting and a local allergic reaction (E(2) group). Compliance to treatment was 95.6% (GPT group) as compared to 90.9% for the E(2) group.

CONCLUSION

Despite statistical significant differences, from a clinical point of view oral GPT 600 mg was as effective as low-dose transdermal E(2) in controlling moderate to severe hot flushes in post-menopausal women, and should be recommended as an alternative option in those with contraindications to estrogen therapy. More research is warranted in this regard.

摘要

背景

加巴喷丁(GPT)是一种广泛应用于神经病学的药物,被提议作为一种非激素选择,用于治疗有雌激素治疗禁忌的绝经后妇女的热潮红。

目的

比较 GPT 与低剂量经皮雌二醇(E(2))治疗绝经后中重度热潮红妇女。

方法

共 45 例绝经后中重度热潮红妇女前瞻性、单盲随机分为口服 GPT 600mg/晚或每周经皮 25μg/天 E(2)。在基线和 1、4、8 周时,使用绝经评分量表和数字量表分别评估热潮红强度和频率。还评估了副作用。

结果

与基线相比,两组在治疗 1、4 和 8 周时热潮红强度和频率均显著降低;然而,E(2)组的这种降低更为明显。尽管 E2 组治疗结束时热潮红强度和频率的降低百分比更高,但差异无统计学意义(强度分别为 68.2%和 60.6%,频率分别为 70.1%和 58.9%,p>0.05,NS)。出现的副作用包括:嗜睡、头晕、疲劳(GPT 组)和乳房触痛、阴道出血和局部过敏反应(E(2)组)。治疗依从性为 95.6%(GPT 组),E(2)组为 90.9%。

结论

尽管存在统计学差异,但从临床角度来看,口服 GPT 600mg 与低剂量经皮 E(2)在控制绝经后妇女中重度热潮红方面同样有效,应作为雌激素治疗禁忌妇女的替代选择。这方面需要进一步研究。

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