| AimThis study is to evaluate the effect of Sha-Shen-Mai-Dong-Tang on the human urine trace elements (Cu/Zn and Cu/Se), TCM differentiation of syndrome, quality of patients' life as well as to see how the treatment of traditional Chinese medical systems effects on the cancer patients who receive the radiotherapy.MethodThere were80patients participated in our trial, all80subjects completed all the processes,33of them were male and47of them were female. They were grouped randomly;40of them in experimental group,40in control group. Patient's average age was55. Average duration of treatment with Sha-Shen-Mai-Dong-Tang lasted12weeks. Under radiotherapy, the average radiation-dose was55Gy, average treatment cycle of radiotherapy,5weeks. Observation factor before and after experiment includes:1. Differences on TCM clinical syndrome, weight, Karnofsky"s Performance Scale, Patient's quality of life:2. Patient's urine trace element (Cu/Zn and Cu/Se).Results1. In regard of TCM clinical syndrome, overall improvement of treatment group is highly significant (p<0.05) compared to control group.2. With improvement on TCM clinical syndrome, body weight of patients in treatment group effectively increased25%compared to5%increase rate on control group (p<0.05). Effective rate for treatment group and control group IV. Karnofsky's Performance Scale was37.5%and0%respectively (p<0.05). Result based on EORTC QLQ-30questionnaire showed that the treatment group was better than control group significantly (p=0.000) in the evaluation of quality of life. The items in EORTC QLQ-30included emotion, fatigue, nausea, vomiting, insomnia, and anorexia, social functions and recognition.3. The analysis of trace elements in treatment group indicate Cu decreased from34.95±52.24μg/L to9.34±6.89μg/L (p<0.001), Zn increased from214.00±284.01μg/L to89.56±839.89μg/L (p＜0.001), Se increased from36.42±34.62μg/L to108.73±802.05μg/L (p＜0.001), Zn/Cu ratio increased from14.26±11.28μg/L to128.56±159.29μg/L (p＜0.001), Se/Cu ratio increased from2.98±3.08μg/L to24.21±15.87μg/L (p＜0.001). On the other hand, trace element reading from control group indicates, Cu decreased from26.87±31.95μg/L to9.01±7.34μg/L (p＜0.001), Zn increased from55.21±36.02μg/L to169.30±94.39μg/L (p＜0.001), Se increased from30.04±25.78μg/L to70.47±32.78μg/L (p＜0.001), Zn/Cu ratio increased form5.59±8.02μg/L to32.50±22.88μg/L (p＜0.001), Se/Cu ratio increased form1.99±1.08μg/L to15.09±9.25μg/L (p＜0.001). ConclusionSha-Shen-Mai-Dong-Tang significantly improve TCM clinical syndrome, elevated the Cu/Zn&Cu/Se ratios of human trace elements and improved the quality of life in cancer patients during the treatment of radiotherapy (p<0.05). The corelationship among TCM syndrome provement, trace elements and quality of life in cancer patients showed positive relationship.
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