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- SMD-2合併手術後放射線及化學治療頭頸部癌病患對血中微量元素Cu/Zn 及Cu/Se之比值與生活品質與中醫體質之隨機取樣二期臨床試驗評估以及SMD-2對舌癌、口腔癌之細胞株及小鼠免疫之機轉探討
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題 名 | SMD-2合併手術後放射線及化學治療頭頸部癌病患對血中微量元素Cu/Zn 及Cu/Se之比值與生活品質與中醫體質之隨機取樣二期臨床試驗評估以及SMD-2對舌癌、口腔癌之細胞株及小鼠免疫之機轉探討=Phase II Randomized Clinical Trial: Evaluation of the Effect of SMD-2 on the Human Blood Trace Elements (Cu/Zn and Cu/Se), Quality of Life and Body Constitution in Head& Neck Cancer Patients receiving the Radiotherapy& Chemotherapy and In vitro/in Vivo Mechanisms of SMD-2 on SCC-4& Cal-27 Cell-line and Mice's Immune Modulation |
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作 者 | 蘇珊玉; | 書刊名 | 中醫藥年報 |
卷 期 | 光碟版1:3 2012.10[民101.10] |
頁 次 | 頁284-331 |
專 輯 | 中藥機轉及療效 |
分類號 | 413.3 |
關鍵詞 | 癌症患者; 生活品質; 血液; 微量元素; Cu/Zn及Cu/Se比值; Cancer patients; Quality of life; Blood; Trace element; Cu/Zn and Cu/Se ratios; |
語 文 | 中文(Chinese) |
中文摘要 | 研究目的: 本研究 SMD-2對放射線及化學治療頭頸部癌病患,以隨機分配方式,比較研究實驗組與對照組癌症病患兩年內之中醫體質特性變化,並比較介入前、後實驗組與對照組癌症病患血液中元素比值(Cu/Zn與 Cu/Se)與生活品質之差異;同時,也評估兩組在服藥後之其安全性與副作用。為了闡明 SMD-2在人體內的療效機轉,因此,本研究計畫將在第二年進一步探討 SMD-2對舌癌、口腔癌之細胞株及小鼠免疫之機轉。 研究方法: 自民國 99年 11月 18日至 100年 11月 20日止,頭頸部癌患者共收錄 70例,已完成全部療程並可分析者 42例,實驗組 22人及對照 20人組,年齡 30-86歲,平均年齡 53.75歲,中位年齡 52.75歲;服用 SMD-2平均週數為 20週,放射線照射平均劑量為 5440 Gy,化學治療平均週數為 8週。一、在整體生活品質方面,頭頸部癌對照組患者由 9.15±1.75增至 9.60±2.30 (p=0.476);實驗由 8.27±2.74增至 10.82±1.89(p=0.019)。進一步分析生活品質核心指標,發現頭頸部癌中實驗之身體功能、角色功能、情緒功能、社會功能以及疲勞、疼痛、噁心嘔吐、食慾不振、便秘、呼吸困難等症狀均有明顯的進步。 二、在血中微量元素方面,頭頸部癌實驗組患者之, Zn由 678.59±169.05提高至 748.41±142.11(p =0.001),Cu/Zn由 1.70±0.33減少至 1.39±0.21(p < 0.001), Cu/Se由 9.69±1.50減少至 9.12±1.67(p=0.011)。而對照組患者之 Cu由1008.5±264.73提高至 1081.90±295.57(p = 0.029),Zn由 797.70±206.03減少至 748.75±208.70(p = 0.003),Se由 116.10±18.13減少至 105.89±17.09(p<0.001),Cu/Zn由 1.33±0.43提高至 1.53±0.53(p<0.001),Cu/Se由 88±2.64提高至 10.45±3.18(p<0.001)。頭頸部癌患者血液中微量元素濃度前、中、後測之相關性:中測-前測比值 Cu/Zn p<0.001,Cu/Se p=0.003;後測-前測比值 Cu/Zn p < 0.001,Cu/Se p<0.001。 結果與討論: SMD-2對接受放射線及化學治療的頭頸部癌病人,可降低血液中 Cu/Zn及 Cu/Se之比值,明顯改善生活品質如身體功能、角色功能、情緒功能、社會功能以及疲勞、疼痛、噁心嘔吐、食慾不振、便秘、呼吸困難、食慾不振、整體生活品質。 |
英文摘要 | Aim: The present phase II RCT clinical study is to evaluate the effects of SMD-2 in the head & neck cancer patients receiving the radiotherapy and chemotherapy, especially exanimate their characteristic of TCM constitution, prosecute the TCM differentiation of syndrome, and analyze the distribution of TCM syndrome differentiation in cancer patients between SMD-2 group and control group for two years. Survival and mortality will also be evaluate at the same time. In addition, we are going to assess the clinical evaluation among the ratio of trace elements Cu/Zn and Cu/Se in blood during treatment, and to estimate the quality of life (EORTC: QLQ-C30) and body constitution (BCQ) during the period of radiotherapy and chemotherapy on the basis of Chinese Medicine Theory. To prove the efficacy of SMD-2 in human body, we have further in vitro/in vivo experiment to evaluate the mechanisms of SMD-2 on SCC-4 & Cal-27 cell-line and mice’s immune modulation during the second year. Method: From 18st November 2010 through 20st November 2011, there were 70 patients entered to our clinical trial. 42 cases have completed course and were analyzed included 22 cases of SMD-2 group and 20 cases of control group. The mean age was 53.75. The median age was 52.75. The average treatment-duration of SMD-2 was 20 weeks. The average radiation-dose was 5440 cGy. The average treatment-cycle of chemotherapy was 20 weeks. Results: The EORTC QLQ showed 9.15±1.79 increased to 9.60±2.30 (p =0.476) in control group, and 8.27±2.74 increased to 10.82±1.89 (p=0.019) in SMD-2 group, respectively. Further analysis, health function, emotion, social capability, fatigue , soreness, dyspnea, poor appetite , nausea, constipation and global outcome in SMD-2 group were much improved in quality of life. On the other hand, the analysis of trace elements in SMD-2 group, Zn showed 678.59±169.05 increased to 748.41±142.11 (p=0.001), Se showed 116.24±15.64 down to 114.05±14.28 (p =0.422), Cu/Zn showed 1.70±0.33 down to 1.39±0.21 (p<0.001), Cu/Se showed 9.69±1.50 down to 9.12±1.67 (p=0.011). Whereas in control group, Cu showed 1008.50±264.73 increased to 1081.90±295.57 (p = 0.029) Zn showed 797.70±206.03 down to 748.75±208.70 (p = 0.003), Se showed 116.10±18.13 down to 105.89±17.09 (p<0.001), Cu/Zn showed 1.33±0.43 increased to 1.53±0.53 (p<0.001), Cu/Se showed 8.88±2.64 increased to 10.45±3.18 (p<0.001). Discussion: The SMD-2 significantly degraded the Cu/Zn & Cu/Se ratios of human blood trace elements and improved the quality of life in cancer patients during the treatment of radiotherapy. The corelationship among trace elements, quality of life and changes of traditional Chinese medical systems in cancer patients showed positive relationship. |
本系統中英文摘要資訊取自各篇刊載內容。