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題 名 | 酸棗仁湯治療更年期婦女睡眠障礙之追蹤觀察研究=Suan Zao Ren Tang as an Original Treatment for Sleep Difficulty in Climacteric Women: A Prospective Clinical Observation |
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作 者 | 葉家豪; 賴榮年; | 書刊名 | 中醫藥研究論叢 |
卷 期 | 13:2 2010.09[民99.09] |
頁 次 | 頁124-136 |
分類號 | 413.4 |
關鍵詞 | 酸棗仁湯; 更年期婦女; 匹茲堡睡眠評問卷; 睡眠障礙; Suan Zao Ren Tang; Climacteric; Pittsburg sleep quality index; Sleep difficulty; |
語 文 | 中文(Chinese) |
中文摘要 | 背景:本研究是以酸棗仁湯治療更年期婦女睡眠障礙,來評估酸棗仁湯治療的療效與安全性。研究材料與方法:以更年期婦女和病有失眠症狀服用酸棗仁湯治療,用追蹤觀察進行研究。目前於台北市立聯合醫院陽明院區中醫科門診共收案52名,運用更年期身心症狀評估量表(MRS)、中藥不良反應問卷及匹茲堡睡眠評問卷(PSQT)進行評估。並藉由全血球檢驗、肝、腎、血脂等生化檢驗於第0及28天評估,做為客觀的評估證據。結果:全部共收案52位,其中42位完成臨床試驗,有10位退出研究,其中因缺乏療效有3位及因不良事件退出有位5位、合併其它治療有2位。經過4星期的酸棗仁湯治療發現受試者的匹茲堡睡眠評問卷(PSQI)分數有顯著的進步,從13.5±2.2(Mean±SD)降為9.8±3.2(Mean±SD);52位受試者當中有7位的更年期身心症狀評估量表(MRS)分數有增加,只有1位表示治療前後睡眠品質一樣,其餘6位治療後睡眠品質較未治療前好。全部共有52位完成臨床試驗,其中有21位MRS<16和31位MRS>=160。MRS<16的族群其PSQI從13.5±2.6 (Mean±SD)降為9.6±3.1 (Mean±SD),MRS>=16的族群其PSQI,13.5±2.0 (Mean±SD)降為10.0±3.3 (Mean±SD)。有5位出現副作用:3位胃酸逆流、頭痛、胸痛、2位胃痛。結論:這是第一個針對酸棗仁湯的療效與安全所做的研究。經過四週的酸棗仁湯的治療,對於更年期婦女的睡眠品質是有顯著的改善。所以,除了有心痛及胃酸逆流的病史外,酸棗仁湯對於短期治療更年期婦女有睡眠障礙是相對的安全及有效。未來需要進一步針對酸棗仁湯的療效研究提出更強的實證醫學證據,建議可以朝向隨機雙盲的臨床試驗(Randomize control trail)來設計。 |
英文摘要 | Background Little scientific evidence supports the efficacy of herbal medicines in the treatment of women with sleep difficulty during the climacteric period. The purpose of this study is to evaluate both the efficacy and safety of a finished Chinese herbal preparation Suan Zao Ren Tang (SZRT) in reducing the impact of sleep disturbance on climacteric women. Methods A prospective follow-up study was carried out in Yang Ming branch of Taipei City Hospital between April 2008 and December 2009. Fifty-two climacteric women with sleep difficulity, received SZRT at a rate of 4.0 g, thrice daily for four weeks Baseline scores were measured on the Pittsburg Sleep Quality Index (PSQI), followed by further measures at the end of weeks 1, and 4. The Menopause Rating Scale (MRS) were undertaken as secondary outcomes. Regression models were constructed to explore the score differences between the baseline and at weeks 1 and 4 by various determinants including age, body mass index (BMI), and severity of baseline menopausal symptoms. Results Among 78 surveyed patients, 52 and 42 were screened for intention to treat (ITT) and per-protocol population set analysis, respectively. There were statistically significant reductions in the PSQI index scores on the fourth week. By week 4, the mean PSQI scores had fallen from 13.5(±2.2) to 9.8(±3.2) (95% confidence interval [CI] 2.57, 4.59) for total score, from 2.4(±0.5) to 1.6(±0.8) (95% CI 0.51, 0.99) for subjective sleep quality, from 2.4(±0.8) to 1.9(±0.9) (95 % CI 0.2 1,0.75) for sleep latency, and from 2.0(±1.1) to 1.1(±1.1) (95% CI 0.56, 1.17) for habitual sleep efficiency. There were no significant improvement in scores of subjective disturbance and daytime dysfunction at weeks 4 among intention-to-treat population. Further analyses showed that SZRT might not be as effective in treating poor sleepers with severe menopausal symptoms (MRS≧16), compared with those with mild and moderate symptoms. Five adverse drug reactions were detected: three events of acid regurgitation, headache, chest pain, and two events of stomach ache. Discussion Excluding women with past history of heartburn or acid regurgitation, four weeks of therapy with the Chinese herbal preparation SZRT appears to be a relatively safe and effective short-term therapeutic option for climacteric women with poor sleep quality, and may be considered to ease women's transition into menopause. |
本系統中英文摘要資訊取自各篇刊載內容。