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題 名 | 中藥治療乳癌患者化療副作用白血球減少之臨床療效評估計畫=Evaluation of the Effects of Chinese Medical Treatment on Leucopenia after Chemotherapy in Breast Cancer Patients |
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編 次 | (2-1) |
作 者 | 王惠暢; | 書刊名 | 中醫藥年報 |
卷 期 | 3 2014.12[民103.12] |
頁 次 | 頁(29)1-(29)27 |
分類號 | 413.3 |
關鍵詞 | 乳癌; 化學治療; 白血球減少; 中藥; 體質; 生活品質; Breast cancer; Chemotherapy; Leucopenia; Chinese medicine; Constitution; Quality of life; |
語 文 | 中文(Chinese) |
中文摘要 | 本研究目的在評估中藥之治療是否可改善乳癌患者化療後「白血球減少」之副作用。本研究於中國醫藥大學附設醫院乳房外科進行為期兩年期之臨床試驗研究,採雙盲、隨機、安慰劑對照之臨床試驗 (double blind, randomized, placebo controlled clinical trial)。受試者納入條件為經專科醫師首次確診之乳癌患者(年齡≧ 18歲,Stage I、II、IIIa、IIIb、IIIc);並排除以下研究樣本:(1)接受手術及化學治療前,病人已長期具有各種會引發影響判斷是否為「化療副作用」之相關症狀或疾病。(2)併有血液惡性腫瘤,或其他重大影響存活之疾病。(3)懷孕。(4)具嚴重之精神疾患。 受試者完成第一次化療即開始服用中藥。研究小組將在「手術前後、每次化療進行前」等時間點,記錄患者之血液及生化值;並同時分別以「 BCQ中醫體質量表」評估患者中醫體質狀態;以「癌症病患生活品質問卷表 (EORTC QLQ-C30)」、「乳癌病患特殊生活品質問卷表 (EORTC QLQ-BR23)」,及「Karnofsky身體功能狀況量表」評估患者生活品質;以美國國家癌症學會 (National Cancer Institute,NCI)所公佈之一般不良事件評量標準 (Common Terminology Criteria for Adverse Events,CTCAE Version 3.0)評估乳癌患者接受化療後出現頻率較高之副作用。 截至 102年 3月 31日止,共篩選出 130位可入案之乳癌患者,簽署同意書者共有 52人,其中因故中途退出 13人,目前服藥及追蹤中 4人,已完成全程服藥及追蹤 35人。將這 35位受試者資料解盲分析後,中藥組 16人,安慰劑組 19人。初步結果顯示當歸補血湯對於乳癌患者在接受化學治療時,對 WBC、RBC、 Hgb、Platelet有正面效益;另外,雖然未達統計上顯著差異,服用當歸補血湯受試者完成全程化療的天數較短,接受 GCSF的比例較低、接受 GCSF的總劑量亦較少;且中藥組無受試者因感染或血球降低而住院。 |
英文摘要 | This is a two-year double blind, placebo-controlled, and randomized clinical trial, which is aimed to evaluate the effects of Chinese medical treatment on leucopenia after chemotherapy in breast cancer patients. The study was conducted in the Department of General Surgery in China Medical University Hospital, Taichung. Fifty newly diagnosed breast cancer patient (age ≧18, Stage I, II, IIIa, IIIb, IIIc) were included. The exclusion criteria are: (1) Before receiving operation and chemotherapy, the patient already have other chronic diseases. (2) Already have hematological malignancy and other lethal disease. (3) Pregnant. (4) Have severe psychological diseases. The included subjects were interviewed and their blood was sampled before and after operation, 2 and 4 months after receiving chemotherapy. We will adopt the body constitution questionnaire (BCQ) to evaluate the Chinese medical constitutional status, the EORTC QLQ-C30, EORTC QLQ-BR23, and Karnofsky score to evaluate the quality of life, and to evaluate the adverse effects of the adjuvant chemotherapy with the NCI-CTCAE Version 3.0. At the end of the study, at least 35 subjects will complete the whole treatment protocol. This study will also investigate the influence of the operation and chemotherapy on the Chinese medical constitutional status, and in order to provide the basis for the complementary treatment for the breast cancer by adjusting and balancing the constitutional status of the patients. Till the end of March 2013, a total of 52 patients were included in our study, 13 of them dropped, 4 are still receiving the treatment, and 35 patients completed the whole prorocol. The results revealed that Chinese medical treatment has beneficial effects on the WBC, RBC, Hgb and Platelet. Though it didn’t achieve statistical significance, patients in the Chinese medical treatment group had shorter chemotherapy treatment length, received less GCSF administration, and no one was admitted because of infection. |
本系統中英文摘要資訊取自各篇刊載內容。