沙参麦冬汤合并放化疗治疗头颈部癌疗效观察及微量元素锌、硒、铜关系研究
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摘要
研究背景
头颈部癌症常用放射线治疗，或配合化疗。在放、化疗过程中易损伤人体正气，常有副作用发生。依据辨证，多表现气阴两虚证候。沙参麦冬汤为滋养肺胃之阴的代表方，此方既能滋阴清热，又能养胃益气，是防止和减轻放、化疗副作用的理想方剂。
微量元素与人类生理功能与疾病发生关系密切，其中铜、锌、硒是人体酵素、激素和维生素的重要部份，维持正常的生理功能，彼此有协同、拮抗和相互抑制等作用。铜锌硒微量元素失衡引起体内多种酵素系统代谢障碍，其与癌症的发生、发展亦具有密切关系。
因此用沙参麦冬汤配合放、化疗治疗头颈部癌症，观察其治疗效果并探讨其与微量元素变化之关系具有重要的学术意义。
研究目的
研究沙参麦冬汤配合放射线及化学治疗头颈部癌与肺癌患者的症状改善，提高生活质量及观察尿中微量元素铜/锌及铜/硒比值，研究微量元素锌、硒、铜与癌症发病的关系。
研究方法
选择头颈部恶性肿瘤病人42例,同时选择肺癌病人10例，均接受放射治疗每天180cGY，每周五天，连续6~8周。或化学治疗，化学治疗平均周数为4周。同时给予沙参麦冬汤每次3克，每日三次，每周七天，连续6-8周。
结果
在生活品质方面，头颈部癌患者由1.73±0.39减少至1.48±0.32（p <0.001）；肺癌患者则由1.76±0.29减少至1.39±0.23（p <0.001）。进一步分析生活品质核心指针，发现头颈部癌之身体功能、角色功能、情绪功能、认知功能、社会功能以及疲劳、疼痛、呼吸困难、食欲不振等症状均有明显的进步。另发现肺癌之角色功能、认知功能、疲倦、呼吸困难、食欲不振等症状均有明显的进步。
在尿中微量元素方面，头颈部癌患者之铜由33.95±52.00减少至8.33±6.81（p <0.001），锌由212.21±274.1提高至790.78±862.99（p <0.001），硒由37.44±35.74提高至115.83±862.99（p <0.001），锌/铜由11.01±15.30提高至122.14±114.37（p <0.001），硒/铜由2.08±2.20提高至20.80±16.46（p <0.001）。而肺癌患者之铜由25.93±30.64减少至8.55±7.44（p=0.003），锌由50.90±38.23提高至164.73±96.65（p=0.003），硒由29.45±24.58提高至69.75±31.88（p=0.003），锌/铜由4.89±7.90提高至30.82±21.78（p=0.003），硒/铜由1.80±1.20提高至13.97±8.99（p=0.003）。头颈部癌与肺癌患者尿液中微量元素浓度前、中、后测之相关性：前-中比值锌/铜p=0.001，硒/铜无统计意义；前-后比值锌/铜p <0.001，硒/铜无统计意义。
头颈部癌与肺癌患者治疗前、中、后中医证型之百分比变化：「气阴两虚」由57.7%减少至15.4%，「气血两虚」由5.8%减少至0%，「气虚」由13.4%提高至40.4%，「阴虚」由17.3%提高至42.3%。头颈部癌患者治疗前、中、后中医证型之百分比变化：「气阴两虚」由64.2%减少至16.7%，「气血两虚」由4.8%减少至0%，「气虚」由14.2%提高至42.8%，「阴虚」由12%提高至40.5%。肺癌患者治疗前、中、后中医证型之百分比变化：「气阴两虚」由30%减少至10%，「气虚」由10%提高至30%，「阴虚」由40%提高至50%。
结论
沙参麦门冬汤对接受放射线及化学治疗的头颈部癌病人，可提高尿中锌/铜及硒/铜之比值，明显改善生活品质如身体功能、角色功能、情绪功能、认知功能、社会功能以及疲劳、疼痛、呼吸困难、食欲不振、整体生活品质，并与中医证型变化的转归呈正相关性（p <0.05）。
Aim
This study assessed the effectiveness of SMD-2on the human urine trace elements（Cu/Zn and Cu/Se）, quality of life and TCM differentiation of syndrome in cancerpatients（head&neck cancer and lung cancer）receiving the radiotherapy and/orchemotherapy.
Method
From21stJanuary2009through31stDecember2009, there were eighty patientsentered to our clinical trial. Fivty-two cases have completed course and were analyzedincluded forty-two cases of head&neck cancer and ten cases of lung cancer. The male tofemale ratio was35:17. The mean age was55.2. The median age was54. The averagetreatment-duration of SMD-2was8weeks. The average radiation-dose was5440cGy. Theaverage treatment-cycle of chemotherapy was4weeks.
Results
The EORTC QLQ showed1.73±0.39fell to1.48±0.32(p <0.001) in head&neckcancer patients, and1.76±±0.29down to1.39±0.23(p <0.001) in lung cancer patients,respectively. Further analysis, health function, emotion, recognition, social capability,fatigue, soreness, dyspnea, poor appetite and global outcome in head&neck cancerpatients were much improved in quality of life. While in lung cancer patients, recognition,fatigue, dyspnea, poor appetite and global outcome were also much improved.
On the other hand, the analysis of trace elements in head&neck cancer patients, Cushowed33.95±52.00fell to8.33±6.81(p <0.001), Zn showed212.21±274.1increased to790.78±862.99(p <0.001), Se showed37.44±35.74increased to115.83±862.99(p <0.001), Zn/Cu showed11.01±15.30increased to122.14±114.37(p <0.001), Se/Cu showed2.08±2.20increased to20.80±16.46(p <0.001). Whereas in lung cancer patients, Cushowed25.93±30.64down to8.55±7.44(p=0.003) Zn showed50.90±38.23elevated to164.73±96.65(p=0.003), Se showed29.45±24.58elevated to69.75±31.88(p=0.003),Zn/Cu showed4.89±7.90elevated to30.82±21.78(p=0.003), Se/Cu showed1.80±1.20elevated to13.97±8.99(p=0.003).
In changes of traditional Chinese medical systems in both head&neck cancer and lung cancer patients,「deficiency of Qi and Yin」showed57.7%fell to15.4%,「deficiencyof Qi and Blood」 showed5.8%fell to0%,「Qi deficiency」 showed13.4%increased to40.4%,「Yin deficiency」 showed17.3%increased to42.3%.
Discussion
The SMD-2significantly elevated the Cu/Zn&Cu/Se ratios of human urine traceelements and improved the quality of life in cancer patients during the treatment ofradiotherapy and/or chemotherapy (p <0.05). The corelationship among trace elements,quality of life and changes of traditional Chinese medical systems in cancer patientsshowed positive relationship.
头颈部癌症常用放射线治疗，或配合化疗。在放、化疗过程中易损伤人体正气，常有副作用发生。依据辨证，多表现气阴两虚证候。沙参麦冬汤为滋养肺胃之阴的代表方，此方既能滋阴清热，又能养胃益气，是防止和减轻放、化疗副作用的理想方剂。
微量元素与人类生理功能与疾病发生关系密切，其中铜、锌、硒是人体酵素、激素和维生素的重要部份，维持正常的生理功能，彼此有协同、拮抗和相互抑制等作用。铜锌硒微量元素失衡引起体内多种酵素系统代谢障碍，其与癌症的发生、发展亦具有密切关系。
因此用沙参麦冬汤配合放、化疗治疗头颈部癌症，观察其治疗效果并探讨其与微量元素变化之关系具有重要的学术意义。
研究目的
研究沙参麦冬汤配合放射线及化学治疗头颈部癌与肺癌患者的症状改善，提高生活质量及观察尿中微量元素铜/锌及铜/硒比值，研究微量元素锌、硒、铜与癌症发病的关系。
研究方法
选择头颈部恶性肿瘤病人42例,同时选择肺癌病人10例，均接受放射治疗每天180cGY，每周五天，连续6~8周。或化学治疗，化学治疗平均周数为4周。同时给予沙参麦冬汤每次3克，每日三次，每周七天，连续6-8周。
结果
在生活品质方面，头颈部癌患者由1.73±0.39减少至1.48±0.32（p <0.001）；肺癌患者则由1.76±0.29减少至1.39±0.23（p <0.001）。进一步分析生活品质核心指针，发现头颈部癌之身体功能、角色功能、情绪功能、认知功能、社会功能以及疲劳、疼痛、呼吸困难、食欲不振等症状均有明显的进步。另发现肺癌之角色功能、认知功能、疲倦、呼吸困难、食欲不振等症状均有明显的进步。
在尿中微量元素方面，头颈部癌患者之铜由33.95±52.00减少至8.33±6.81（p <0.001），锌由212.21±274.1提高至790.78±862.99（p <0.001），硒由37.44±35.74提高至115.83±862.99（p <0.001），锌/铜由11.01±15.30提高至122.14±114.37（p <0.001），硒/铜由2.08±2.20提高至20.80±16.46（p <0.001）。而肺癌患者之铜由25.93±30.64减少至8.55±7.44（p=0.003），锌由50.90±38.23提高至164.73±96.65（p=0.003），硒由29.45±24.58提高至69.75±31.88（p=0.003），锌/铜由4.89±7.90提高至30.82±21.78（p=0.003），硒/铜由1.80±1.20提高至13.97±8.99（p=0.003）。头颈部癌与肺癌患者尿液中微量元素浓度前、中、后测之相关性：前-中比值锌/铜p=0.001，硒/铜无统计意义；前-后比值锌/铜p <0.001，硒/铜无统计意义。
头颈部癌与肺癌患者治疗前、中、后中医证型之百分比变化：「气阴两虚」由57.7%减少至15.4%，「气血两虚」由5.8%减少至0%，「气虚」由13.4%提高至40.4%，「阴虚」由17.3%提高至42.3%。头颈部癌患者治疗前、中、后中医证型之百分比变化：「气阴两虚」由64.2%减少至16.7%，「气血两虚」由4.8%减少至0%，「气虚」由14.2%提高至42.8%，「阴虚」由12%提高至40.5%。肺癌患者治疗前、中、后中医证型之百分比变化：「气阴两虚」由30%减少至10%，「气虚」由10%提高至30%，「阴虚」由40%提高至50%。
结论
沙参麦门冬汤对接受放射线及化学治疗的头颈部癌病人，可提高尿中锌/铜及硒/铜之比值，明显改善生活品质如身体功能、角色功能、情绪功能、认知功能、社会功能以及疲劳、疼痛、呼吸困难、食欲不振、整体生活品质，并与中医证型变化的转归呈正相关性（p <0.05）。
Aim
This study assessed the effectiveness of SMD-2on the human urine trace elements（Cu/Zn and Cu/Se）, quality of life and TCM differentiation of syndrome in cancerpatients（head&neck cancer and lung cancer）receiving the radiotherapy and/orchemotherapy.
Method
From21stJanuary2009through31stDecember2009, there were eighty patientsentered to our clinical trial. Fivty-two cases have completed course and were analyzedincluded forty-two cases of head&neck cancer and ten cases of lung cancer. The male tofemale ratio was35:17. The mean age was55.2. The median age was54. The averagetreatment-duration of SMD-2was8weeks. The average radiation-dose was5440cGy. Theaverage treatment-cycle of chemotherapy was4weeks.
Results
The EORTC QLQ showed1.73±0.39fell to1.48±0.32(p <0.001) in head&neckcancer patients, and1.76±±0.29down to1.39±0.23(p <0.001) in lung cancer patients,respectively. Further analysis, health function, emotion, recognition, social capability,fatigue, soreness, dyspnea, poor appetite and global outcome in head&neck cancerpatients were much improved in quality of life. While in lung cancer patients, recognition,fatigue, dyspnea, poor appetite and global outcome were also much improved.
On the other hand, the analysis of trace elements in head&neck cancer patients, Cushowed33.95±52.00fell to8.33±6.81(p <0.001), Zn showed212.21±274.1increased to790.78±862.99(p <0.001), Se showed37.44±35.74increased to115.83±862.99(p <0.001), Zn/Cu showed11.01±15.30increased to122.14±114.37(p <0.001), Se/Cu showed2.08±2.20increased to20.80±16.46(p <0.001). Whereas in lung cancer patients, Cushowed25.93±30.64down to8.55±7.44(p=0.003) Zn showed50.90±38.23elevated to164.73±96.65(p=0.003), Se showed29.45±24.58elevated to69.75±31.88(p=0.003),Zn/Cu showed4.89±7.90elevated to30.82±21.78(p=0.003), Se/Cu showed1.80±1.20elevated to13.97±8.99(p=0.003).
In changes of traditional Chinese medical systems in both head&neck cancer and lung cancer patients,「deficiency of Qi and Yin」showed57.7%fell to15.4%,「deficiencyof Qi and Blood」 showed5.8%fell to0%,「Qi deficiency」 showed13.4%increased to40.4%,「Yin deficiency」 showed17.3%increased to42.3%.
Discussion
The SMD-2significantly elevated the Cu/Zn&Cu/Se ratios of human urine traceelements and improved the quality of life in cancer patients during the treatment ofradiotherapy and/or chemotherapy (p <0.05). The corelationship among trace elements,quality of life and changes of traditional Chinese medical systems in cancer patientsshowed positive relationship.
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