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題 名 | Paroxetine in the Treatment of Chinese Patients with Depressive Episode: A Double-Blind Randomized Comparison with Imipramine=比較Paroxetine與Imipramine對華人憂鬱症患者療效與副作用之雙盲性研究 |
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作 者 | 邱獻章; 洪成志; 陳展航; | 書刊名 | 中華醫學雜誌 |
卷 期 | 57:6 1996.06[民85.06] |
頁 次 | 頁418-423 |
分類號 | 418.214 |
關鍵詞 | 抗憂鬱藥物; 憂鬱症; 色羥胺回收阻斷劑; Antidepressant; Depression; Paroxetine; Selective serotonin reuptake inhibitor; SSRI; |
語 文 | 英文(English) |
中文摘要 | 背景 Paroxetine是選擇性的色烴胺回收阻斷劑(SSRIs)。雖然西方國 家已普遍地用此藥來治療憂鬱症,這個藥對華人之憂鬱症的療效及副作用則未 有報告。 方法 在1994年間從台北榮民總醫院精神部之病房及門診選出40名合於 DSM-III-R診斷條件的重症憂鬱症患者以隨機分成二組,每組20名個案。以隨 機、雙盲方式進行研究。兩組分別使用paroxetine (20 mg - 30 mg/天)或imipramine (l00 mg - 125 mg/天)治療六週。並以Hamilton憂鬱量表(HAM-D)、臨床整體評估 量表(CGI)、副作用量表(TESS)及各種身體檢查來評估此兩種抗憂鬱藥物之療效 及副作用。 結果 五個人因為違反研究規定而被排除,有35人進入療效與副作用的比較。 其中67% (12/18)的paroxetine組患者與65% (11/17)的imipramine組患者在這個研 究中HAM-D分數下降超過50%;若以CGI來看,有66.7%的paroxetine組患者 恢復到正常或接近正常的狀態,而imipramine組的患者則只有35.3%,但這種差 異可能因為個案數不夠而沒有達到統計上的意義(p = 0.13)。在第六週結束時, paroxetine組與imipramine組HAM-D下降的分數分別是20.2 +/- 9.1與15.3 +/- 8.4, 也沒有達到統計上的意義(p > 0.1)。有3名paroxetine組與2名imipramine組的患 者因為副作用或沒有耐心而提前終止治療。Imipramine組的患者中發生抗膽鹼 素副作用的比率比paroxetine組高(p = 0.01)。 結論 Paroxetine對華人憂鬱症的療效與imipramine相當,但是抗膽鹼素副作用 卻比imipramine少。 |
英文摘要 | Background. Paroxetine is a potent inhibitor of serotonin re-uptake. Although it has been widely used as an antidepressant in western countries, its efficacy and side effects in the Chinese are unknown. Methods. Patients with major depressive episode were recruited from the outpatient clinic and the acute wards of the Department of Psychiatry, Veterans General Hospital-Taipei in 1994. Severity of depression was evaluated with Hamilton Rating Scale for Depression (HAM-D), Clinical Global Impression (CGI) and the adverse effects were evaluated with Treatment Emergent Symptom Scale (TESS). Forty Chinese patients with HAM-D scores >= 18 at the beginning of the first dose were randomized to receive paroxetine (20 to 30 mg/day) or imipramine (100 to 125 mg/day). The dosage was designed as a fixed-adjustable regimen for an active treatment period of six weeks. The patients and the clinical investigators -were both blind to the medication until the end of the trial. Results. Five patients violating the trial protocol were excluded from this study, leaving 35 patients for efficacy and adverse effect analyses. Sixty-seven percent (12/18) of paroxetine-treated patients and 65% (11/17) of imipramine-treated patients showed a 50% or more reduction in HAM-D scores. The rate of patients whose mood recovered to normal or near-normal (borderline) was higher in the paroxetine group (66.7%) than in the imipramine group (35.3%), but the difference was not statistically significant (p = 0.13). At the end of this trial, the mean reduction of HAM-D scores was similar between groups (20.2 +/- 9.1 vs 15.3 +/- 8.4, p > 0.1). Three patients in the paroxetine group and two patients in the imipramine group withdrew prematurely due to adverse effects or impatience. Adverse effects of anticholinergic effects were reported .more frequently in the imipramine group than in the paroxetine group (p = 0.01). Conclusions. In comparison with imipramine, paroxetine affords fewer anticholinergic adverse effects without the sacrifice of efficacy in the treatment of depressed Chinese patients. |
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