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頁籤選單縮合
題名 | 教學醫院成立中藥臨床試驗中心=Clinical Trial Center for Traditional Chinese Medicine |
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作者 | 張智仁; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(101)1-(101)65 |
分類號 | 414.53 |
關鍵詞 | 臨床試驗; 加味逍遙散; 天麻鉤藤飲; 失眠症; 高血壓; Clinical trial; Jia-Wei-Xiao-Yao-San; Tian-Ma-Gou-Terng-Yiin; Insomnia; Hypertension; |
語文 | 中文(Chinese) |
中文摘要 | 加味逍遙散是中國古代的傳統方劑,主要用於治療肝鬱血虛、煩躁易怒,盜汗、頭痛目澀或月經不調。雖然加味逍遙散在中國大陸、香港及台灣皆普遍使用來治療失眠的方劑,可是缺乏證據醫學客觀的數據來證實其在臨床上的安眠療效及安全性。根據 2005~2009年中醫門診主診斷申報非器質性睡眠特殊障礙之處方中,加味逍遙散為最常開立的處方之一;而在文獻的回顧中,加味逍遙散中的一些成分在西方醫學的研究證實其有改善睡眠障礙之功能。為了證實加味逍遙散改善睡眠品質的功能,在本次臨床試驗研究中,我們擬以年滿 20~75歲之失眠症病患為研究對象,以雙盲、安慰劑對照性研究設計,每日給予加味逍遙散 10.8公克。研究目的是想了解給予加味逍遙散是否可以改善睡眠品質。經由隨機分派給予安慰劑或加味逍遙散治療,每日四次 (飯後服用 ),每次 2.7公克。在「加味逍遙散對單純性失眠症病人 -雙盲、對照性臨床試驗」的研究結果顯示加味逍遙散與安慰劑具有改善睡眠品質的療效,但兩者療效並無差異。安慰劑組在試驗前後的空腹血糖、胰島素、胰島素阻抗、身體質量指數、血脂質及血壓值並沒有統計上之差異。而加味逍遙散組在試驗後則發現有腰圍增加,但是其血中總膽固醇及低密度脂蛋白膽固醇則有顯著的下降。兩組在藥物不良反應事件方面之比較上,並沒有統計學上之差異。 天麻鉤藤飲是中醫門診治療高血壓患者的中藥製劑中,使用頻率很高的一帖方劑。雖然在文獻的回顧中,天麻鉤藤飲裡的多味藥材均具有降血壓之功效,但是臨床上的研究卻相當缺乏。因此,在本次臨床試驗研究中,我們以年滿 20~75歲之高血壓病患為研究對象,以隨機分派之對照性研究設計,每日給予天麻鉤藤飲 7.2公克,每日三次 (飯後服用 ),每次 2.4公克或捷賜瑞錠 10毫克,每日一次。研究目的是想了解給予天麻鉤藤飲及捷賜瑞錠是否可以改善高血壓。研究設計係隨機分派給予捷賜瑞錠或天麻鉤藤飲治療。研究結果顯示天麻鉤藤飲和捷賜瑞錠二組皆能有效減少收縮壓及舒張壓的數值 ,同時二組的降壓效果是相似的。此外,二組在空腹血糖、胰島素、胰島素阻抗、血脂質及藥物不良反應方面,皆沒有統計學上之差異。 |
英文摘要 | The ancient Chinese remedy Jia-Wei-Xiao-Yao-San was used for the patients with hepatic dysfunction, palpitation, dysmenorrhea, amnesia and insomia, etc. Jia-Wei-Xiao-Yao-San is a common sleep prescription in China, Hong Kong and Taiwan; however, there is a lack of enough evidence-based data to support its hypnotic efficacy and safety in clinical use. Based on Chinese medicine outpatient major diagnosis from 2005 to 2009, Jia-Wei-Xiao-Yao-San is the second highest proportion of prescriptions for patients with non-organic sleep disorder. Some of the ingredients in Jia-Wei-Xiao-Yao-San had been confirmed for the improvement of sleep disorders in the Western medical studies. In order to investigate the therapeutic effect of Jia-Wei-Xiao-Yao-San on sleep disorders, in the present study, we conducted a randomized, double-blind; placebo-controlled study of Jia-Wei-Xiao-Yao-San (10.8 g/day) in aged 20-75 year insomniac subjects. The aim of the study was to determine whether Jia-Wei-Xiao-Yao-San is effective in improving the rating of sleep quality. In this study, insomniac subjects were randomized to receive placebo or Jia-Wei-Xiao-Yao-San treatment four times (2.7 g, qid) a day. The clinical trial of “Jia-Wei-Xiao-Yao-San on sleep quality in primary insomniac subjects-double-blind placebo-controlled study” showed that both placebo group and Jia-Wei-Xiao-Yao-San group had a significant improvement of sleep quality, but no significant differences between the groups. The fasting plasma glucose, insulin, HOMA-IR, body mass index, lipid profile and blood pressure showed no significant changes in placebo group. However, increased waist circumference and decreased total cholesterol and low density-lipoprotein cholesterol levels were observed in subjects treated with Jia-Wei-Xiao-Yao-San. The adverse events showed no significant differences between the groups. Tian-Ma-Gou-Terng-Yiin is a traditional Chinese medicine prescription with high frequency used in the treatment of hypertension. Some of the ingredients in Tian-Ma-Gou-Terng-Yiin had been confirmed for the improvement of blood pressure in the animal studies, but clinical study was scarce. In order to investigate the therapeutic effect of Tian-Ma-Gou-Terng-Yiin on blood pressure, in the present study, we conducted a randomized, open-labled, active-controlled study of Tian-Ma-Gou-Terng-Yiin (7.2 g/day) in aged >20 year hypertensive patients and the aim of this study was to determine whether Tian-Ma-Gou-Terng-Yiin or Zestril is effective in improving blood pressure. Patients with hypertension were randomized to receive Zestril once a day (10 mg) or Tian-Ma-Gou-Terng-Yiin treatment 2.4 g three times (2.4 g.Tid) a day. The clinical trial of “A randomized study to evaluate the blood pressure-lowering effect between Tian-Ma-Gou-Terng-Yiin and anti-hypertension drugs” showed that both Tian-Ma-Gou-Terng-Yiin group and Zestril group significantly decreased systolic and diastolic blood pressure in hypertensive patients and the effect on blood pressure reduction was similar. However, there were no significant differences between Tian-Ma-Gou-Terng-Yiin group and Zestril group in fasting plasma glucose, insulin, HOMA-IR, body mass index, and lipid profile. The adverse events showed no significant differences between each groups. |
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