SMD-2合併放射線及化學治療頭頸部癌病患對尿中微量元素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(2-1)

賴東淵
中國醫藥大學
放射治療是癌症治療中佔有重要的角色，許多早期癌症接受根除性放射線照射，5年存活率高達90%；許多晚期癌症接受姑息性放射線照射，仍可緩解症狀，延長生命。然而，放射線治療也會導致副作用。由前導研究（91年度），使用三黃瀉心湯也對癌症病人尿中微量元素（Cu/Zn與Cu/Se）比值與生活品質呈現反比，其原因可能三黃瀉心湯會降低人體氧化性傷害(oxidative stress)，增加其免疫能力。
此外，98年度進行之研究（pilot study）得知，放射治療癌症患者接受SMD-2輔助性治療，初步顯示癌症患者食慾、口乾、體力與精神等4個症狀均有改善。因此，也啟發我們進一步探討其作用機轉。
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。
根據我們前導研究(pilot study)得知，在人體試驗發現SMD-2及三黃瀉心湯具有改善頭頸部癌病患接受放射線及化學治療的副作用，以及提高其生活品質的作用。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。
關鍵字：癌症患者、生活品質、Cu/Zn及Cu/Se比值、中醫體質、存活率、死亡率、細胞株

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 (2-1)

Radiotherapy plays an important role in cancer therapy. Most of the early stages of cancer with curative radiotherapy can achieve up to 90% of a 5-year survival rate. Even for patients at late stage, their symptoms also can be relieved. Every radiotherapy and chemotherapy has the potential to cause harm and produce toxicity such as weakness, tired, anorexia nervosa, dry mouth. With the early research, we find that SMD-2 can relieve the symptoms of weakness, tired, anorexia nervosa, dry mouth. Furthermore, we have also found out that the cancer patients who are receiving the therapy of San-Huang-Hsien-Hsin Tang (Year 2002) and SMD-2 (Year 2009), shows an inverse ratios between the quality of life and trace elements Cu/Zn and Cu/Se in urine. So we are interested to probe into the mechanism of SMD-2 on this research.
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 examinate 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.
關鍵字：cancer patients, quality of life, Cu/Zn and Cu/Se ratio, body constitution, survival, mortality, cell-line