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1、傳統中藥複方治療常見慢性疾病的系統評價傳統中藥複方治療常見慢性疾病的系統評價 Systematic Review of Traditional Herbal Formulae for the Treatment of Common Chronic Diseases 背景背景 Background RESEARCH PROJECT REPORT (HOC172-06) Principal Investigators Dr. XU Min, et al. (School of Chinese Medicine, HKBU) Advisors Prof. Vivian WONG, et al. (H
2、ospital Authority of Hong Kong) Participants: CHOI Ching-Mei, et al. (School of Chinese Medicine, HKBU) 2007- 2008 背景背景 Background 慢性疾病是導致人類死亡的主要原因；可占總死亡人數的慢性疾病是導致人類死亡的主要原因；可占總死亡人數的60以上以上。 The main causes of human death were common chronic diseases, and the mortality caused by chronic diseases occup
3、ied over 60% of all mortality in Chinese. 中醫藥治療各種慢性疾病已有數千年的歷史中醫藥治療各種慢性疾病已有數千年的歷史，積累了豐富的臨床經驗積累了豐富的臨床經驗。 Chinese medicines have been used to treat chronic diseases for thousands of years and there are plenty of practical experiences in clinics. 近年來中醫藥的臨床試驗研究近年來中醫藥的臨床試驗研究，為評價中醫藥治療各種慢性疾病的實用價為評價中醫藥治療各種慢性
4、疾病的實用價 值提供了寶貴數據值提供了寶貴數據。 During last decades clinical trials have provided valuable evidence for evaluating efficacy and safety of Chinese medicines in the treatment of chronic diseases. 背景背景 Background 中藥複方是中醫臨床用藥的主要形式和特色中藥複方是中醫臨床用藥的主要形式和特色，能能充分充分體現中醫理論體現中醫理論指導指導 下下臨床臨床辯證論治辯證論治的的規律規律和經驗和經驗。 Herbal
5、formula is the main style and feature of Chinese medicines in clinical application; and it might reflect essence of basic theory and clinical experience of traditional Chinese medicine. 傳統中藥複方歷經長期臨床應用傳統中藥複方歷經長期臨床應用，其組方與功效間的聯繫已被廣泛確認其組方與功效間的聯繫已被廣泛確認。 The relationship between ingredients and functions
6、had been recognized widely as TF had been clinically applied for a long history. 許多經典複方已製成中成藥收載於現代藥典許多經典複方已製成中成藥收載於現代藥典，其組成藥物其組成藥物、用量用量、劑型劑型 等固定等固定，並已有規範的生產工藝和質量控制標準並已有規範的生產工藝和質量控制標準。 Traditional herbal formula (TF) - their ingredients, dosages and forms were fixed basically; and some patent TF were
7、 recorded in the Chinese Pharmacopoeia, in which there were clear standards for their productions and quality controls. 對傳統中藥複方治療對傳統中藥複方治療1010種種常見慢性疾病包括高血壓常見慢性疾病包括高血壓、冠心病冠心病、中風中風、慢性阻慢性阻塞性肺病塞性肺病、肝癌肝癌、肝纖維化肝纖維化、糖尿病糖尿病、類風濕關節炎類風濕關節炎、抑鬱症抑鬱症、濕疹等的有濕疹等的有效性和安全性進行系統評價和薈萃分析效性和安全性進行系統評價和薈萃分析。 We performed system
8、atic reviews and meta-analyses on traditional herbal formulae (TF) in the treatment of ten chronic diseases including hypertension, coronary artery disease, stroke, chronic obstructive pulmonary disease, liver cancer, liver fibrosis, diabetes mellitus, rheumatoid arthritis, depression and eczema. 研究
9、目的研究目的 Project objective 主要研究包括主要研究包括: ( (1 1) ) 調查治療常見慢性疾病的傳統中藥複方調查治療常見慢性疾病的傳統中藥複方; ( (2 2) ) 統計在臨床試驗中最常用的中藥複方及組成中藥統計在臨床試驗中最常用的中藥複方及組成中藥; ( (3 3) ) 分析和對比傳統中藥複方的有效性和安全性分析和對比傳統中藥複方的有效性和安全性; ( (4 4) ) 評價臨床試驗的質量評價臨床試驗的質量; ( (5 5) ) 綜合常見慢性疾病辨證分型的現代診斷標準及臨床調查結果等綜合常見慢性疾病辨證分型的現代診斷標準及臨床調查結果等。 The project inc
10、luded: (1) investigating TF in the treatment of chronic diseases; (2) Identifying the most commonly used TF and their herbs in clinical trials; (3) evaluating the efficacy and safety of commonly used TF; (4) assessing the quality of design and data of clinical trials; (5) reviewing current diagnosti
11、c standards and survey results for types of syndrome-differentiation in the chronic diseases. 研究目的研究目的 Project objective 1. 1. 研究設計研究設計 Research strategy 2. 2. 資料收集資料收集 Data search (RCTs) 3. 資料整理資料整理 Data extraction 4. 4. 品質評價品質評價 Data quality assessment 5. 資料分析資料分析 Data analysis (Meta-analysis, etc
12、.) 研究研究方法方法 Procedure RevMan software was used to integrate and analyze the data in meta-analyses; Jadads scale was used to assess the quality of included RCTs. 研究研究方法方法 Procedure II = Selected RCTs by published Cochrane meta-analyses Review1-3; III = Paper-loss rate (%) = (II - III) / II 100%. Pape
13、r search Quality assessment Jadad scale (recommended by the Cochrane Collaboration) 1. Randomization and its description 2. Blinding and its description 3. Reporting dropout rate Low-quality (1-2 marks) High-quality (3-5 marks) 研究研究结果结果 Result 本研究本研究搜集整理和系统分析了大量临床搜集整理和系统分析了大量临床 RCTsRCTs 1. 1. 提示傳統中藥
14、複方已廣泛應用於防治提示傳統中藥複方已廣泛應用於防治多种多种慢性疾病的現代臨床慢性疾病的現代臨床 試驗試驗，並被證實是有效而安全的。並被證實是有效而安全的。 TF have been widely used in RCTs to treat chronic diseases, and has proven to be effective and safe in clinics. 2. 2. 但現有高質量的臨床試驗尚少仍需開展更多大樣本及長期追蹤但現有高質量的臨床試驗尚少仍需開展更多大樣本及長期追蹤 觀察等臨床研究加以驗證。觀察等臨床研究加以驗證。 More high-quality RCTs
15、with large sample size and long-term observations should be performed to further assess the TF. 研究研究结果结果 Result TF analysisTF analysis 高血压高血压 HypertensionHypertension ( (37 37 TF): TF): 天麻鉤藤飲天麻鉤藤飲 45 45 RCTsRCTs 六味地黃六味地黃丸丸 26 26 RCTsRCTs 半夏白朮天麻半夏白朮天麻湯湯 10 10 RCTsRCTs 冠心病冠心病 Coronary artery disease Coronary artery disease ( (74 74 TF):TF): 血府逐瘀血府逐瘀湯湯 7979 RCTsRCTs 補陽還五補陽還五湯湯 5252 RCTsRCTs 生脈生脈散散 4444 RCTsRCTs 中风中风 StrokeStroke ( (4141 TF):TF): 補陽還五湯補陽還五湯 7272 RCTsRCTs 溫膽湯溫膽湯 1010 RCTsRCTs 安宮牛黃丸安宮牛黃丸 9 9 RCTsRCTs 忧郁症忧郁症 Depression Depression ( (2626
