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研究生:黃品臻
研究生(外文):Pin-Chen Huang
論文名稱:半夏瀉心湯證之疊方配伍實證研究
論文名稱(外文):The Evidence-Based Medicine Study on Prescribed Types of Ban-Xia-Xie-Xin-Tang Pattern
指導教授:王靜瓊王靜瓊引用關係
指導教授(外文):Ching-Chiung Wang
口試委員:許中華戴承杰梁文俐
口試委員(外文):Chung-Hua HsuChen-Jei TaiWen-Li Liang
口試日期:2017-07-07
學位類別:碩士
校院名稱:臺北醫學大學
系所名稱:生藥學研究所
學門:醫藥衛生學門
學類:藥學學類
論文種類:學術論文
論文出版年:2017
畢業學年度:105
語文別:中文
論文頁數:105
中文關鍵詞:半夏瀉心湯疊方胃功能性障礙幽門螺旋桿菌發炎
外文關鍵詞:Ban-Xia-Xie-Xin-Tangprescription typesdisorders of function of stomachHelicobacter pyloriinflammation
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半夏瀉心湯是治療消化道疾病的常用處方,亦是調和腸胃的代表方劑。利用健保資料庫分析得知,半夏瀉心湯亦最常用於胃功能性障礙(ICD-9-536),且臨床上有五種常見疊方類型:類型一(T1):半夏瀉心湯,類型二(T2):半夏瀉心湯配伍平胃散,類型三(T3):半夏瀉心湯配伍香砂六君子湯,類型四(T4):半夏瀉心湯配伍保和丸、茯苓、延胡索,類型五(T5):半夏瀉心湯配伍安中散。T1春季用量最多,T3冬季用量最多,T4秋季用量最多。根據臨床研究文獻評讀結果,半夏瀉心湯與香砂六君子湯之實證強度較強,而藥理研究文獻亦顯示,半夏瀉心湯之實證強度最強。綜合上述質性分析顯示,半夏瀉心湯用於消化道疾病具有強的實證。繼而利用基礎實驗探討此五種處方類型對胃保護之作用。結果顯示:對於初代大鼠胃黏膜細胞,半夏瀉心湯、保和丸、茯苓可促進胃黏膜細胞生長。但各中藥及疊方配伍皆不具降低酒精誘導初代大鼠胃黏膜細胞損傷。抑制幽門螺旋桿菌之作用,除半夏瀉心湯外其餘皆有抑制作用,以茯苓之抑菌效果最高,其次為延胡索。而疊方配伍以T2與T4抑菌活性最佳。抗發炎活性,中藥及各疊方皆明顯抑制LPS誘導RAW 264.7細胞釋放NO與PGE2,但以半夏瀉心湯之作用最強。綜合質性分析與基礎實驗結果,推測半夏瀉心湯證為嘔吐、心下痞、腸鳴,與ICD-9診斷胃功能性障礙類似;嘔吐兼有噫氣呑酸、且心下痞更甚有脹滿時,配伍平胃散(T2);腸鳴兼有腹瀉、腹痛,配伍香砂六君子湯(T3);脹滿伴有宿食停積、腹痛者配伍保和丸、茯苓、延胡索(T4);嘔逆甚出現吐酸、脘腹痛者配伍安中散(T5)。各疊方用於胃功能性障礙是透過抗發炎作用。半夏瀉心湯不具抑制胃幽門螺旋桿菌作用故配伍其他中藥以增強作用。由於方劑及疊方的複雜性,半夏瀉心湯與之疊方的實證臨床療效與詳細藥理機制尚待進一步探索深入。
Ban-Xia-Xie-Xin-Tang (BXXXT), a representative herbal formula harmonizes the stomach and intestines, is widely used for gastrointestinal diseases. According to National Health Insurance Research Database, BXXXT is most commonly used in disorders of function of stomach, ICD (International Classification of Diseases)-9-536, and there are five common types of prescription: Type 1 【BXXXT】, Type 2 【BXXXT with Pin-Wei-San (PWS)】, Type 3 【BXXXT with Xiang-Sha-Liu-Jun-Zi-Tang (XSLJZT)】, Type 4 【BXXXT with Bal-He-Wan (BHW), Fu-Ling (FL), Yan-Hu-Suo (YHS)】, Type 5 【BXXXT with An-Zong-San (AZS)】. Type 1 used more in spring; Type 3 is mostly used in winter and Type 4 is mostly used in autumn. According to several clinical research review papers, BXXXT and XSLJZT were asscessed on their clinical efficacy and found both to have high evidence-based medicine (EBM) strength. Furthermore, pharmacological studies showed BXXXT to have the highest EBM strength. Moreover, the above qualitative research showed strong EBM score in the use of BXXXT for treating digestive tract diseases. Next, we evaluated gastric protection effects of these five types of prescription using primary culture rat gastric mucosal (PRGM) cells. Results showed that, BXXXT, BHW, FL enhance cell viability. However, prescription types and individual herbal formulations did not show protective effects on ethanol-induced PRGM cells damage. On the aspect of Helicobacter pylori(H. pylori) bacteriostatic effect, all individual formulations showed bacteriostatic effect except BXXXT, and FL exerted the highest effect followed by YHS. Type 2 and Type 4 showed best bacteriostatic effect on H. pylori. On the aspect of anti-inflammation, individual herbal formulations and prescription types significantly inhibited LPS induced release NO and PGE2 in RAW 264.7 cells with BXXXT having the highest effect. After integration of qualitative analysis and basic experimental results, we suggest that BXXXT (Type 1) syndrome nausea, vomiting, epigastric oppression, borborygmus is related with ICD-9-536; when belching, acid swallowing with inflation below the heart, prescribed with PWS (Type 2); when diarrhea and abdominal pain, added XSLJZT (Type 3); when diet indigestion and abdominal pain, prescribed with BHW, FL, YHS (Type 4); when stomach pain and acid vomiting, prescribed with AZS (Type 5). All these prescription types applies for ICD-9-536 through anti-inflammatory effects, which explains the importance of BXXXT in all prescription types. Due to the complexity of herbal formulas and co-prescriptions, clinical efficacy and detailed pharmacological mechanisms of BXXXT prescription types need further study.
目錄
圖目錄 V
表目錄 VI
縮寫表 VII
中文摘要 IX
Abstract X
緒論 1
一、中藥濃縮製劑與健保中藥給付 1
1. 中藥濃縮製劑 1
2. 中醫門診中藥之醫療給付 1
3. 中藥基準方 2
4. 中藥濃縮製劑疊方處方 2
二、半夏瀉心湯之介紹 3
1. 出典 3
2. 組成 3
3. 中醫應用與歷代論述 4
4. 瀉心湯之類方 10
5. 方義 13
6. 半夏瀉心湯之現代藥理作用 14
三、研究目的 15
四、研究設計 15
第一部分:半夏瀉心湯臨床應用之疾病診斷及疊方處方 16
一、前言 17
1. 半夏瀉心湯證與胃病 17
2. 中醫健保資料庫探勘與應用 18
3. 研究目的與研究設計 20
二、研究方法 21
1. 健保資料庫探勘 21
1-1. 健保資料庫內容 21
1-2. 資料處理流程 21
1-3. 統計分析方法 21
2. 方劑臨床療效之評價 22
2-1. 文獻來源 22
2-2. 證據等級分級 22
2-3. 文獻評讀方式與文獻評讀工具 23
2-3-1. 文獻評讀方式 23
2-3-2. 文獻評讀工具 24
三、結果 26
1. 半夏瀉心湯之常用疾病診斷 26
2. 半夏瀉心湯用於胃功能性障礙之疊方類型 28
2-1. 常用疊方類型 28
2-2. 依季節分析各處方之使用情形 29
3. 「胃功能性障礙」之常用中藥濃縮製劑 30
4. 方劑之文獻評讀 32
四、討論 40
1. 半夏瀉心湯方證與胃功能性障礙 40
2. 疊方類型之探討 41
五、結論 61
第二部分:半夏瀉心湯疊方配伍對胃之保護作用評估 63
一、前言 64
1. 胃功能性障礙 64
2. 胃的生理構造與功能 65
3. 實驗設計原理 66
3-1. 酒精對胃之影響 66
3-2. 幽門螺旋桿菌對胃之影響 67
3-3. 發炎反應 69
4. 研究目的與研究設計 70
二、實驗材料及方法 71
1. 實驗材料 71
1-1. 中藥藥材 71
1-2. 化學試劑 73
1-2-1. 一般化學試劑 73
1-2-2. 細胞培養 73
1-2-3. MTT反應試劑 73
1-2-4. Griess反應試劑 73
1-3. 試驗細菌株與細胞株 73
1-4. 抗菌實驗相關 74
1-5. 儀器設備 74
2. 實驗方法 75
2-1. 實驗樣品之製備 75
2-2. 初代大鼠胃黏膜細胞保護試驗 75
2-2-1. 胃黏膜細胞之分離及培養 75
2-2-2. 試液配製 76
2-2-3. 細胞毒性試驗:MTT assay 77
2-2-4. 中藥及疊方配伍對酒精誘導胃黏膜細胞死亡之作用評估 77
2-3. 體外抗幽門螺旋桿菌試驗 78
2-3-1. 試液配製 78
2-3-2. 幽門螺旋桿菌之培養 78
2-3-3. 瓊脂井化擴散試驗 78
2-4. 抗發炎活性試驗 79
2-4-1. RAW 264.7細胞株之培養 79
2-4-2. Griess反應測驗一氧化氮(NO)含量 79
2-4-3. 細胞毒性試驗:MTT assay 80
2-4-4. PGE2含量測定 81
3. 統計分析 81
三、實驗結果 82
1. 半夏瀉心湯及相關配伍對初代大鼠胃黏膜細胞保護作用 82
1-1. 處方及其中藥促進胃黏膜細胞生長作用 82
1-2. 酒精濃度對胃黏膜細胞之毒性 83
1-3. 處方及其中藥對酒精誘導初代大鼠胃黏膜細胞損傷之保護作用 83
1-4. 疊方配伍對酒精誘導初代大鼠胃黏膜細胞損傷之保護作用 84
2. 半夏瀉心湯及相關配伍之幽門螺旋桿菌抑菌作用 85
2-1. 處方及其中藥抑制幽門螺旋桿菌生長作用 85
2-2. 疊方配伍抑制幽門螺旋桿菌生長作用 85
3. 半夏瀉心湯及相關配伍之抗發炎作用 86
3-1. 處方及其中藥抑制LPS誘導RAW 264.7細胞發炎作用 86
3-2. 疊方配伍抑制LPS誘導RAW 264.7細胞發炎作用 87
3-3. 處方及其中藥單獨使用及合併使用抑制LPS誘導RAW 264.7細胞發炎作用 89
四、討論 91
五、結論 92
總結 93
參考文獻 94

圖目錄
圖 一、歷代方論與朝代順序 5
圖 二、瀉心湯類方之關係圖 12
圖 三、半夏瀉心湯證示意圖 13
圖 四、第一部分研究設計流程 20
圖 五、各疊方類型於不同季節之使用情形 29
圖 六、半夏瀉心湯疊方配伍適用之疾病體質 62
圖 七、胃之生理構造 65
圖 八、幽門螺旋桿菌之毒性因子及其作用 68
圖 九、第二部分研究設計 70
圖 十、瓊脂井化擴散法與樣品之抑菌圈外觀 78
圖 十一、中藥促進初代大鼠胃黏膜細胞生長作用 82
圖 十二、不同酒精濃度對初代大鼠胃黏膜細胞之毒性 83
圖 十三、中藥對酒精誘導初代大鼠胃黏膜細胞損傷之保護作用 83
圖 十四、疊方配伍對酒精誘導初代大鼠胃黏膜細胞損傷之保護作用 84
圖 十五、中藥對幽門螺旋桿菌之抑菌效果 85
圖 十六、疊方配伍對幽門螺旋桿菌之抑菌效果 85
圖 十七、中藥抑制LPS誘導RAW264.7細胞釋放NO之作用及細胞存活率 86
圖 十八、中藥抑制LPS誘導RAW264.7細胞釋放PGE2之作用 86
圖 十九、疊方配伍抑制LPS誘導RAW264.7細胞釋放NO之作用及細胞存活率 87
圖 二十、疊方配伍抑制LPS誘導RAW264.7細胞釋放PGE2之作用 88
圖 二十一、各疊方配伍之胃保護作用 92
圖 二十二、半夏瀉心湯疊方配伍原則與藥理作用 93

表目錄
表 一、半夏瀉心湯與其類方 12
表 二、半夏瀉心湯現代藥理活性整理 14
表 三、半夏瀉心湯證與其對應西醫病名 17
表 四、英國牛津大學實證醫學中心之證據等級分級 22
表 五、文獻評讀方法表格 23
表 六、AMSTAR checklist 24
表 七、Jadad Score 25
表 八、半夏瀉心湯於各日服劑量下,常用之疾病分類碼(ICD-9) 26
表 九、半夏瀉心湯應用於胃功能性障礙之常見處方疊方類型 28
表 十、、「胃功能性障礙」之常用中藥濃縮製劑,依劑量分組 30
表 十一、方劑之臨床療效文獻 33
表 十二、方劑之藥理研究 37
表 十三、處方疊方類型及其組成 45
表 十四、方劑之中醫應用 46
表 十五、疊方內組成中藥之中醫應用與其現代藥理 48
表 十六、半夏瀉心湯疊方配伍之藥性及作用 62
表 十七、半夏瀉心湯用於胃功能性障礙之疊方處方類型 71
表 十八、藥材與之對應方劑及處方一日量 72
表 十九、中藥抑制LPS誘導RAW264.7細胞釋放NO之作用 89
表 二十、疊方配伍抑制LPS誘導RAW264.7細胞釋放NO之作用 89
表 二十一、中藥抑制LPS誘導RAW264.7細胞釋放PGE2之作用 90
表 二十二、疊方配伍抑制LPS誘導RAW264.7細胞釋放PGE2之作用 90
表 二十三、疊方內中藥之藥理活性比較 92
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