查詢結果分析
來源資料
頁籤選單縮合
題名 | 臺灣外科手術病人服用中草藥對外科麻醉相關藥物交互作用之調查與臨床實證醫學探討=Survey and Study on Drug Interactions between Chinese-Herb Medicines and Surgery-Anesthesia Related Drugs in Taiwan Surgical Patients |
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編 次 | (2-2) |
作者姓名(中文) | 何善台; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(37)1-(37)58 |
各篇題名 | 子計畫一: 外科手術病人服用中草藥之流行病學調查研究、子計畫二: 中西藥併用之交互作用臨床研究 |
內容 | 子計畫一: 外科手術病人服用中草藥之流行病學調查研究、子計畫二: 中西藥併用之交互作用臨床研究 |
分類號 | 414.5 |
關鍵詞 | 中草藥醫學; 輔助及替代醫學; 草藥與藥物交互作用; 中西藥交互作用; 龍膽瀉肝湯; Nalbuphine; Traditional Chinese herbal medicine; TCHM; Complementary and alternative medicine; CAM; Herbal-Drug interaction; CYP450; UGT; Herb-drug interaction; Nalbuphine; |
語文 | 中文(Chinese) |
中文摘要 | 子計畫一:外科手術病人服用中草藥之流行病學調查研究 研究背景:國人廣泛使用中草藥用以調理體質來達到保健養身的效果或治療特定的疾病,目前雖有許多研究指出外科手術病人服用中草藥會造成不利之影響,但其服用中草藥之盛行率及對於手術麻醉中及手術後相關影響之研究,在國外雖有少數的研究探討,但國內並沒有相關研究結果。 研究目的:本研究目的是探討外科手術病人服用中草藥與保健食品之盛行率、調查常見之中草藥與保健食品之使用情形、瞭解外科手術病人服用中草藥與保健食品之相關影響因子及經由手術中、後相關臨床數據與文獻探討其服用中草藥與保健食品於手術期間可能產生之不良反應。 研究方法:本研究設計為橫斷研究法,在一家醫學中心採自擬半結構式問卷,調查外科手術病人服用中草藥與保健食品之情形。以 SPSS 18.0進行統計分析,利用 t檢定、卡方檢定及羅吉斯分析來探討服用中草藥與保健食品與變項之相關性等。 結果:研究結果顯示在 1,428位外科手術病人其服用中草藥與保健食品之比率分別為 52.1%及 68.8%。年齡、性別、宗教信仰及家庭所得等相關因子會影響到外科手術病人服用中草藥之情形;性別、教育程度、宗教信仰、家庭所得等相關因子會影響到外科手術病人服用保健食品之情形。最常使用之中藥複方為四神湯 (經常使用 1.0%;偶而使用 23.9%),其它依序為四物湯、咳嗽散等;中藥單方為枸杞子(經常使用 4.1%;偶而使用 28.9%),其它依序為山藥、大棗等;保健食品為維他命類(經常使用 20.4%;偶而使用 22.5%),其它依序為綠茶、維骨力等。 結論:外科手術病人服用中草藥與保健食品是一很普遍之現象,在眾多相關因子中以性別與家庭所得變項較具影響力。而本研究歸納出之 15種最常使用之中草藥與保健食品,也經由文獻探討了對外科手術中、術後或與麻醉藥物交互影響的情形,以期能進一步成為國家未來衛生政策之參考。 子計畫二:中西藥併用之交互作用臨床研究 研究目的:口服 Nalbuphine 併用龍膽瀉肝湯後, nalbuphine在健康受試者體內的藥動學變化,以確認 Nalbuphine 併用龍膽瀉肝湯的中西藥交互作用 研究方法:受試者分三階段進行實驗,第一階段給予受試者單一劑量之 Nalbuphine (66mg),經過至少一星期的 washout period後繼續進行第二階段試驗,第二階段再同時給予單一劑量 Nalbuphine (66mg)及單一劑量龍膽瀉肝湯 (3g);後再經過至少一星期的 washout period後進行第三階段試驗,第三階段則先給予多劑量之龍膽瀉肝湯,每天三次,每次 3克,連續給予七天,在第七天最後一次給予龍膽瀉肝湯後再立刻給予單一劑量之 Nalbuphine (66mg)。參與試驗者共 28人次,受試者在篩選體檢時,除一般項目外,另給予半乳糖並抽血以檢測肝剩餘功能。試驗開始時受試者在給藥前先抽一次血,之後服藥,受試者固定時間間隔抽血 (0.25、0.5、1、1.25、1.5、2、2.5、3、4、6、8、12及 24小時),血液檢體以高效液相層析質譜儀 (LC/MS/MS)分析其中 nalbuphine之濃度,並以獲得數據計算相對生體可用率、濃度時間曲線下面積、最高血中濃度、達到最高濃度的時間以及排除半衰期等藥動學參數。 結果與討論:單一劑量組之臨床藥動學試驗,結果發現當受試者給予龍膽瀉肝湯 (3g/人)併服 Nalbuphine(66mg/人)後,受試者體內血漿之 Nalbuphine濃度會在吸收相顯著升高,而由 Nalbuphine動力學參數來看, Nalbuphine體內最高濃度 (Cmax)由控制組的 28.59 ± 10.69 ng/mL,升高至 44.96 ± 16.55 (p < 0.05)。代表體內吸收藥物的總量的 AUCt,則由控制組的 122.21 ± 60.90 hr*ng/mL,升高至 151.99 ± 50.2 hr*ng/mL (p < 0.05),增加吸收達 1.24倍;而代表藥物清除速率的 Cl/F,由控制組的 622.45 ± 356.20 L/hr,減緩至 467.99 ± 214.53 (p < 0.05)。多劑量組 (龍膽瀉肝湯 3克, TID, 7days) 併服單一劑量 (66mg)西藥與單服 (66mg)西藥的控制組之臨床藥動學試驗,結果發現當受試者給予龍膽瀉肝湯 (3克, TID, 7days )併服 Nalbuphine(66mg/人)後,受試者體內血漿之 Nalbuphine濃度會在吸收相顯著升高,而由 Nalbuphine動力學參數來看, Nalbuphine體內最高濃度 (Cmax)由控制組的 25.49 ± 9.97 ng/mL,升高至 43.74 ± 12.26 (p < 0.01)。代表體內吸收藥物的總量的 AUCt,則由控制組的 112 ± 54 hr*ng/mL,升高至 179 ± 22 hr*ng/mL (p < 0.001),增加吸收達 1.6倍;而代表藥物清除速率的 Cl/F,由控制組的 654 ± 313 L/hr,減緩至 323 ± 37 (p < 0.01);由此可知,龍膽瀉肝湯與 Nalbuphine併服會造成藥物交互作用。 依據目前試驗資料有以下之結論:(一)服用多劑量龍膽瀉肝湯後併服 nalbuphine結果發現 nalbuphine最高血中濃度及吸收量顯著高於單獨口服 nalbuphine者,與前年度服用單劑量龍膽瀉肝湯後併服 nalbuphine結果相似,多劑量組的影響高於單劑量組。(二)本子計畫依據前五年計畫成果,由體外試驗中會顯著抑制代謝酵素活性的中藥來進行大鼠體內藥動試驗,再從中挑選與西藥併服後會產生顯著的交互作用的中藥來進行本計畫的人體試驗,結果顯示體內體外試驗之相關性甚高,未來,使用體外試驗快速且大量篩檢中西藥交互作用是值得參考的工具。 |
英文摘要 | PART I: BACKGROUND: Traditional Chinese Herbal Medicines (TCHM) are widely used to strengthen physique, to recuperate health after sickness and to treat a variety of diseases. Currently, there are many studies which have pointed out that TCHM would cause adverse effects on surgical patients. Nevertheless, little information is available about the TCHM epidemiology and impact on surgical patients. OBJECTIVES: To investigate the most popular TCHM inclusive of Chinese herbal formulae and single Chinese herbals and the supplements used among surgical patients, to analyze the sociodemographic and health-related medical conditions influencing the choice of the TCHM and supplements, and to do the literature researching about potential risk of taking TCHM and supplements. METHODS: This study was a cross-sectional in design. A semi-structured questionnaire survey was conducted at a tertiary hospital in a space of 2 years. Data collected from the questionnaires were subjected to statistic analysis with SPSS 18.0. Chi-Square test and multivariate logistic regression were used to identify important associated factors which influenced the usage of the TCHM and supplements. RESULTS: Of the 1428 surgical patients under survey, 744 (52.1%) reported the use of TCHM, and 983 (68.8%) the use of supplements. Multivariate logistic regression analysis revealed that the factors associated with TCHM usage included age, gender, religion, and household income; as to supplements the associated factors were gender, education level, religion, and household income. As to TCHM formulae, Szu-Shen-Tang (a soup made of Chinese yam, Lotus seed, Euryales semen, Indian bread, and small intestine and stomach of swine) was the most favorite one in use (regular use: 1.0%; casual use: 23.9%) followed in sequence by Szu-Wu-Tang (a soup made of Rehmannia root, Chinese angelica root, Peony root and Ligusticum chuanxiong Hortorum) and Hai-Sou-San (cough powder). In single Chinese herbals, gou-qi-zi (Wolfberry fruit) was the choicest one in use (regular use: 4.1%; casual use: 28.9%) followed in sequence by shan-yao (Chinese yam) and da-zao (Jujube). The supplements most regularly used were vitamins (regular ues: 20.4%; casual use: 22.5%) followed in order by green tea and glucosamine. CONCLUSIONS: TCHM and supplements are commonly used in the surgical patients of Taiwan. Among these associated factors, the most influential ones are gender and household income. Our study has enumerated 15 most popular TCHM and supplements. In the near future we will continue our studies with prior attention to the potential risks and harmful events during perioperative period. PART II: AIMS: To evaluate the drug-drug interaction between Chinese medicine, Long-dan-xie-gan-tang (LDXGT) and marketed drug, nalbuphine. METHODS: Healthy volunteers were included in this study for three stages treatments. For the first stage, subjects were orally administered with single dose of nalbuphine (66mg) only. For the second stage, subjects were orally co-administered with single dose of nalbuphine (66mg) and single dose of LDXGT (3g). For the third stage, subjects were administered with multiple doses of LDXGT (3g, tid) for seven days, then, after the last dose of LDXGT, subjects were orally administered with single dose nalbuphine (66mg). Subjects were taken blood samples from the forearm veins at 0, 0.25, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours after the dosing of nalbuphine. The plasma samples were analyzed for nalbuphine concentration with LC/MS/MS. The pharmacokinetic parameters, Cmax, AUC, and half-life were calculated and compared for the three stages to evaluate the herb-drug interaction between LDXGT and nalbuphine. RESULTS: For the first year of this projetcs, when subjects were co-administered with single dose of LDXGT and nalbuphine, their plasma levels of nalbuphine were significantly higher than the ones of subjects administered with nalbuphine only. The Cmaxs of nalbuphine of subjects administered with or without LDXGT were 44.96 ± 16.55 and 28.59 ± 10.69 ng/mL, respectively. The extent of absorption (AUCt ) of nalbuphine of subjects co-administered with LDXGT and nalbuphine were also significantly increased to 124% compared to the ones of subjects administered with nalbuphine only (152.0 ± 50.2 vs. 122.2 ± 60.9 hr*ng/mL, p < 0.05).The clearance (CL/F) of nalbuphine were also significantly decreased (468.0 ± 214.5 vs. 622.5 ± 356.2 L/hr, p<0.01). For the second year of this project, when subjects were co-administered with multiple dose of LDXGT and nalbuphine, their plasma levels of nalbuphine were significantly higher than the ones of subjects administered with nalbuphine only. The Cmaxs of nalbuphine of subjects administered with or without LDXGT were 43.74 ± 12.26 and 25.49 ± 9.97 ng/mL, respectively (p<0.01). The extent of absorption (AUCt ) of nalbuphine of subjects co-administered with LDXGT and nalbuphine were also significantly increased to 160% compared to the ones of subjects administered with nalbuphine only (179 ± 22 vs. 112 ± 54 hr*ng/mL, p < 0.005). The clearance (CL/F) of nalbuphine of subjects co-administered with LDXGT were also significantly decreased from the ones without LDXGT (323 ± 37 vs. 654 ± 313 L/hr, p<0.01). CONCLUSIONS: Herb-drug interactions were found between Chinese medicine, Long-dan-xie-gan-tang and Western medicines, nalbuphine. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。