頁籤選單縮合
題名 | 中西藥交互作用臨床監測與評估=Monitoring and Evaluation of between Traditional Chinese Medicine and Western Medicine Interactions |
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作者姓名(中文) | 楊榮季; | 書刊名 | 中醫藥年報 |
卷期 | 3 2014.12[民103.12] |
頁次 | 頁(8)1-(8)22 |
分類號 | 418.1 |
關鍵詞 | 中藥; 西藥; 交互作用; Chinese medicine; Western medicine; Drug interaction; |
語文 | 中文(Chinese) |
中文摘要 | 研究目的:中西藥併用是臨床用藥安全極需注重的焦點,其產生的交互作用可能影響療效,或產生不良反應 (Adverse Drug Reactions, ADR)。由於國內外相關文獻明顯不足,因此必須有系統分析病人中西藥併用在臨床上的相關資訊,本研究針對抗凝血藥物 Warfarin併用丹參、川芎、紅花及當歸以國際標準化凝血酶原時間比值 (International Normalized Ratio, INR)變化為先導性研究,進而建立中西藥併用集中監視系統,再依此建立中西藥併之藥物安全監視模型,達到早期發現、警告及預測中西藥交互作用之不良反應,提昇病人用藥安全。 研究方法:Warfarin併用中藥之病人為對象,包括病人的性別、年齡、看診科別、併用藥物名、劑量、頻率、主診斷、主訴及 INR值,回溯 2008~2010和即時監測 2011.1~9月 Warfarin併用中藥臨床使用之情形及 INR變化。 根據藥物安全監視 (Pharmacovigilance)的概念,依主動式監視 (active surveillance)的方法,將中西藥併用病人基本資料、中、西用藥診斷及生化檢驗值三資料表運用資訊技術建置中西藥併用集中監測系統 (Intensive Monitoring Syetem)。 Warfarin併用中藥先導性研究,將需臨床藥物治療監測 (Therapeutic Drug Monitoring)西藥併用中藥門診人數、併用藥物及血中濃度進行可行性評估,以期建立藥物安全監視模型。 結果與討論:2008~2010年 Warfarin併用中藥共計 305位病人, 2017張中藥處方,曾經使用 warfarin但沒有完整測量 INR值的病患共 51人,INR前後間隔>1人數及併用中 INR間隔>1人數共 24人均無不良反應發生;併用中 INR值>3.5人數共 15人僅 1人發生不良反應。其中併用中藥丹參(57人)、川芎(34人)、紅花( 7人)及當歸( 31人) INR前後間隔 >1或 INR值>3.5各 1人,無人發生不良反應。2011.1~9月 Warfarin併用中藥共計 128位病患, 596張中藥處方,曾經使用 warfarin但沒有測量 INR值的病患共 63人,INR前後間隔 >1人數共 14人,1人發生不良反應;併用中 INR值>3.5人數共 13人, 1人發生不良反應。其中併用中藥丹參( 32人)、川芎( 8人)、紅花( 4人)及當歸( 7人)前後間隔 >1有 4人,INR值>3.5則有 3人,僅 1人發生不良反應。 Warfarin併用丹參、川芎、紅花及當歸可能產生交互作用影響 INR值或延長凝血時間均於案例報告及動物試驗之結果,但實際上在臨床根據回溯和即時監測 2008~2011年 9月統計分析結果, Warfarin併用丹參、川芎、紅花或當歸 INR值前後上升 >1或 INR值>3.5異常值;數據顯示併用中藥後 INR值間變化並無明顯相關性,本研究之發現與文獻記載並無一致性。因此,急需建置監測系統追蹤確立其相關性,以提升民眾用藥安全。 中西藥併用集中監測系統其建置先從中、西醫病人中篩選出中西藥併用病人,除可長期持續追蹤、紀錄、分析病人的性別、年齡、看診科別、併用藥物名、時間、次數、劑量、頻率、主診斷及 INR值變化外;另一方面於系統中配合中西藥交互作用警示系統可提供醫師中西藥交互作用訊息外,藥師可以長期觀察病患用藥紀錄及生化檢驗值是否異常,監測並評估分析中西藥併用所產生不良反應案件及可能發生的交互作用。 除此之外,更能延伸為建立 (Therapeutic index)狹小西藥併用中藥之藥物安全監視模型,選取目前臨床需做臨床藥物治療監測 (Therapeutic Drug Monitoring)如 Digoxin(長葉毛地黃苷)、Theophylline(茶鹼)、Phenobarbital (苯巴比妥)、Phenytoin(二苯乙內醯脲)、Valproate及 Carbamazepine(卡巴氮平),其併用中藥初步分析研究可為後續研究範疇。 |
英文摘要 | OBJECTIVE: Concomitant administration of Western and Traditional Chinese Medicines (TCM) that may result in decreased efficacy or adverse reactions has long been of great clinical concern. Yet with few relevant literature available, systemic analyses of these concomitant uses is due and necessary. In our pilot study, patients concurrently taking warfarin with Radix Salviae Miltiorrhizae(丹參), Rhizoma Ligustici Chuanxiong(川芎), Flos Carthami(紅花) and Radix Angelicae Sinensis(當歸) are recruited and checked for their INR changes. Data are then used to set up a safeguard monitoring system to detect, warn and predict potential Western-Chinese medicine interactions for better drug safety. METHODS: 1. Data of gender, age, department visited, exact Chinese medicine ingested, dose, frequency, chief diagnosis, chief complaint and INR values from outpatients taking both warfarin and Chinese medicines were collected retrospectively from 2008 to 2010 and prospectively monitored and recorded from January to September, 2011. 2. Under the concept of pharmacovigilance and active surveillance, patient profiles, western and Chinese medicine diagnoses and biochemical data are used to set up the Intensive Western-Chinese Medicine Interaction Monitoring System. 3. According to the pilot study, we selected and recorded information about outpatients taking western medicines that requires therapeutic drug monitoring, their combined Chinese medicines and blood concentrations to assess the feasibility of a safeguard Western-Chinese medicine interaction monitoring system. RESULT and DISCUSSION: 1. In our retrospective review from 2008 to 2010, 305 outpatients were found to have combined warfarin and Chinese medicine using 2017 formulas. Fifty-one had used warfarin without complete INR checks; Twenty-four that found to had an INR increase of >1 before, during or after the combined use showed no signs of adverse events; only 1 out of the 15 found to have an INR increase of >3.5 during the combined use developed adverse reactions. Of the 57 people that combined Radix Salviae Miltiorrhizae (丹參), 34 that Rhizoma Ligustici Chuanxiong (川芎), 7 that Flos Carthami (紅花) and 31 that Radix Angelicae Sinensis (當歸), only 1 showed an INR increase of >1 or the other an INR value >3.5. No adverse reactions were noted in them. 2. In our study from January to September, 2011, 128 outpatients were found to combine western and Chinese medicines, in which 596 TCM formulas were used. Of the 128 patients, 63 had taken warfarin without INR checks, 14 had an INR increase >1, (in which 1 developed adverse reactions), 13 showed an INR over 3.5 during the combination (in which 1 developed adverse reactions). Radix Salviae Miltiorrhizae were combined by 32, Rhizoma Ligustici Chuanxiong by 8, Flos Carthami by 4 and Radix Angelicae Sinensis by 7 patients. 3. Although literature reported that combining warfarin with Radix Salviae Miltiorrhizae (丹參), Rhizoma Ligustici Chuanxiong (川芎), Flos Carthami(紅花) and Radix Angelicae Sinensis (當歸) could result in influence INR or prolonged Prothrombin Time (PT). According to our analysis of retrospective review and prospective monitoring from 2008 to September 2011, showed no correlation between INR increase and TCM combination in which only few possibly-related adverse reactions were noted. Our conclusion didn’t match the literature reviewed. It meant continuing monitoring along with a low starting dose is recommended. For high dose and low dose yet long-term ingestion, regular check-up for INR not only increases efficacy but promotes safety drug use. 4. Setting up the Intensive Western-Chinese Medicine Interaction Monitoring System involved selection of patients with combined use and long-term follow-up of patients’ profiles, visited departments, combined Chinese medicines, ingestion time, dose, frequency, chief diagnosis and INR changes. Moreover, an alarm system was incorporated to notify attending doctors of possible interaction events. Long-term observation of patients’ medication records and biochemical data is made possible and easy for pharmacists to detect potential adverse events and western-Chinese medicine interactions. 5. Since safe drug use models for narrow therapeutic index drugs are of greater importance, we have selected digoxin, theophylline, phenobarbital, phenytoin, valproate and carbamazepine to study their Chinese medicine combination events for our later western-Chinese medicine interaction researches. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。