當Sertaline治療停止後常見嚴重PMS再發


  May 19, 2009 — 一項發表在5月號一般精神學學誌的研究結果顯示,使用抗憂鬱藥物sertaline緩解嚴重經前症候群(PMS)症狀的女性,停藥後6至8個月再發的機率為40至60%。
  
  費城賓州大學的Ellen W. Freeman博士與其同事表示,經前症候群治療在達到滿意反應後的療程長度仍然未知,在提供藥物、不良反應及藥物費用的角度,需要這樣的資訊。
  
  這項研究的目的在於比較以sertaline hydrochloride於月經周期黃體期時投予,短期治療相較於長期治療再發率與再發所需時間。在這項為期18個月、於學術醫學物中心進行的存活研究中,174位罹患PMS或是經前煩躁異常(PMDD)的病患接受隨機分派雙盲研究,在sertaline治療4或12個月後轉換為安慰劑。這項研究的主要試驗終點為再發率,以每天評估直到症狀回到進入研究時的標準。
  
  在長期sertaline治療時,短期治療的再發率為41%比上60%(危險比值[HR]為0.58;95%信賴區間[CI]為0.34-0.98;P=0.04)。再發所需平均時間為8個月比上4個月。相較於症狀嚴重度較輕的病患,那些試驗前症狀較嚴重者比較可能再發(HR為2.02;95%信賴區間為1.18-3.41;P=0.01)且在短暫治療後也比較可能再發(P=0.03)。
  
  在症狀嚴重度較低的病患中,治療療程長短並不會影響再發(P=0.50)。體驗到症狀消退的受試者,比較不會再發(HR為0.22;95%信賴區間為0.10-0.45;P<0.001)。進一步比較每組在前6個月安慰劑治療時的再發率,結果相似。
  
  研究作者寫到,相較於長期治療,短期治療的再發率顯著較高;在延長藥物治療時再發率也較高。
  
  研究作者的結論是,試驗前症狀較嚴重的受試者比較可能再發,而再發並不會受到治療療程長短影響。這些發現顯示試驗前症狀嚴重度與治療後症狀消褪應該被用於決定治療時程長短。
  
  國家兒童健康與人類福祉機構贊助這項研究。Sertaline hydrochloride由輝瑞藥廠提供。部分研究作者表示與輝瑞藥廠、Berlex實驗室,LLC、Forest研究機構有限公司、Pherin製藥有限公司、禮來藥廠、Epix製造有限公司、Hoffman-LaRoche有限公司、Jazz製藥有限公司、Johnson & Johnson、諾華AG、賽諾菲安萬特研究、必治妥施貴寶、Genaissance製藥有限公司、格蘭素史克、默克有限公司、Pamlab,LLC以及/或是Somerset製藥有限公司有相關的資金往來。
  

Relapse of Severe PMS Common When Sertraline Treatment Stopped

By Laurie Barclay, MD
Medscape Medical News

May 19, 2009 — Relapse of severe premenstrual syndrome (PMS) in women whose symptoms are relieved by the antidepressant sertraline occurs in 40% to 60% of women within 6 to 8 months after stopping medication, according to the results of a study reported in the May issue of the Archives of General Psychiatry.

"The duration of treatment after achieving a satisfactory response is unknown in the treatment of premenstrual syndrome," write Ellen W. Freeman, PhD, from the University of Pennsylvania School of Medicine in Philadelphia, and colleagues. "This information is needed in view of the improvement provided by medication vs. the adverse effects and costs of drugs."

The goal of this study was to compare rates of relapse and time to relapse for short-term vs long-term treatment with sertraline hydrochloride given during the luteal phase of the menstrual cycle. In this 18-month survival study at an academic medical center, 174 patients with PMS or premenstrual dysphoric disorder (PMDD) underwent a randomized, double-blind switch to placebo after 4 or 12 months of sertraline treatment. The main endpoint of the study was relapse, defined as symptoms returning to the entry criterion level as evaluated with daily ratings.

During long-term sertraline treatment, the relapse rate was 41% vs 60% after short-term treatment (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.34 - 0.98; P = .04). Median time to relapse was 8 months vs 4 months, respectively. Compared with patients in the lower symptom severity group, those with severe symptoms at baseline were more likely to have a relapse (HR, 2.02; 95% CI, 1.18 - 3.41; P = .01) and were also more likely to experience relapse after short-term treatment (P = .03).

In the lower symptom severity group, duration of treatment did not affect relapse (P = .50). Participants who experienced remission were least likely to have a relapse (HR, 0.22; 95% CI, 0.10 - 0.45; P < .001). Findings were similar for additional analysis comparing relapse in each group during the first 6 months of placebo treatment.

"The relapse rate was significantly greater after short-term treatment compared with long-term treatment," the study authors write. "The relapse rate was also high during extended drug treatment."

"Subjects with severe symptoms at baseline were most likely to experience relapse, and relapse occurred more swiftly regardless of treatment duration," the study authors conclude. "These findings suggest that the severity of symptoms at baseline and symptom remission with treatment should be considered in determining the duration of treatment."

The National Institute of Child Health and Human Welfare supported this study. Sertraline hydrochloride was provided by Pfizer Inc. Some of the study authors have disclosed various financial relationships with Pfizer Inc; Berlex Laboratories, LLC; Forest Research Institute, Inc; Pherin Pharmaceuticals, Inc; Wyeth; Xanodyne Pharmaceuticals, Inc; Cephalon, Inc; DOV Pharmaceuticals Inc; Eli Lilly and Co; Epix Pharmaceuticals, Inc; Hoffman-LaRoche Inc; Jazz Pharmaceuticals, Inc; Johnson & Johnson; Novartis AG; Sanofi-Synthelabo Research; Bristol-Meyers Squibb Co; Genaissance Pharmaceuticals, Inc; GlaxoSmithKline; Merck & Co, Inc; Pamlab LLC; and/or Somerset Pharmaceuticals, Inc.

Arch Gen Psychiatry. 2009;66:537-544.

    
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2004/3/15 上午 09:23:00

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