对帕罗西汀治疗血管舒缩症状的批判性评价。
Critical appraisal of paroxetine for the treatment of vasomotor symptoms.
作者信息
Carroll Dana G, Lisenby Katelin M, Carter Tracy L
机构信息
Department of Pharmacy Practice, Harrison School of Pharmacy, Auburn University, Auburn, AL, USA ; Department of Family Medicine, College of Community Health Sciences, University of Alabama, University Medical Center, Tuscaloosa, AL, USA.
Department of Pharmacy, DCH Regional Medical Center, Tuscaloosa, AL, USA.
出版信息
Int J Womens Health. 2015 Jun 18;7:615-24. doi: 10.2147/IJWH.S50804. eCollection 2015.
BACKGROUND
Vasomotor symptoms (VMS), characterized by hot flashes and night sweats, are the most commonly reported symptoms associated with estrogen deficiency during menopause and occur in up to 70% of women. The goal of treatment is to reduce the frequency and severity of symptoms. Although hormone therapy (HT) is generally recommended as first-line treatment, it is not appropriate for all patients. Antidepressants, specifically selective serotonin reuptake inhibitors, have been evaluated and utilized internationally for alternative treatment for VMS. In 2013, paroxetine mesylate (Brisdelle(®)) received a US Food and Drug Administration-labeled indication for moderate-to-severe hot flashes, making it the first nonhormonal treatment for VMS associated with menopause. The objective of this review is to critically evaluate available clinical data regarding the efficacy and safety of paroxetine for the treatment of VMS in menopausal women.
METHODS
MEDLINE, PubMed, and Google Scholar were searched using the keywords paroxetine, vasomotor symptoms, hot flashes, and menopause. Searches were limited to humans, English language, and clinical trial design with a primary outcome of hot flash/vasomotor changes.
RESULTS
Paroxetine (hydrochloride and mesylate) has been associated with a 33%-67% reduction in hot flash frequency with 6-12 weeks of treatment compared to 13.7%-37.8% reductions with placebo in patients both with and without a history of breast cancer. It was also associated with significant reductions in hot flash severity. Benefits of treatment persisted through 24 weeks in the study of the longest duration. Most adverse effects reported were of mild-to-moderate severity, with improved tolerability associated with lower doses (7.5-12.5 mg/day).
CONCLUSION
Paroxetine is a safe and effective therapy for the treatment of VMS during menopause. Paroxetine (7.5-12.5 mg/day) should be considered a first-line therapy option for VMS in patients when HT is either inappropriate or intolerable.
背景
血管舒缩症状（VMS），以潮热和盗汗为特征，是绝经期间与雌激素缺乏相关的最常见报告症状，多达70%的女性会出现。治疗目标是减少症状的频率和严重程度。虽然激素疗法（HT）通常被推荐为一线治疗，但并非适用于所有患者。抗抑郁药，特别是选择性5-羟色胺再摄取抑制剂，已在国际上进行评估并用于VMS的替代治疗。2013年，甲磺酸帕罗西汀（Brisdelle®）获得美国食品药品监督管理局批准用于治疗中重度潮热，成为首个用于治疗绝经相关VMS的非激素疗法。本综述的目的是严格评估有关帕罗西汀治疗绝经后女性VMS的疗效和安全性的现有临床数据。
方法
使用关键词“帕罗西汀”“血管舒缩症状”“潮热”和“绝经”在MEDLINE、PubMed和谷歌学术上进行检索。检索仅限于人类、英语语言以及以潮热/血管舒缩变化为主要结局的临床试验设计。
结果
与安慰剂相比，接受6 - 12周治疗的患者中，无论有无乳腺癌病史，帕罗西汀（盐酸盐和甲磺酸盐）均可使潮热频率降低33% - 67%，而安慰剂组降低幅度为13.7% - 37.8%。它还能显著降低潮热严重程度。在最长为期24周的研究中，治疗益处持续存在。报告的大多数不良反应为轻至中度，较低剂量（7.5 - 12.5毫克/天）的耐受性更好。
结论
帕罗西汀是治疗绝经期间VMS的安全有效疗法。当HT不适用或无法耐受时，帕罗西汀（7.5 - 12.5毫克/天）应被视为VMS患者的一线治疗选择。
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