中國醫藥大學機構典藏 China Medical University Repository, Taiwan:Item 310903500/46111

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(1)GICMS-384. Effects of Sha-Sheng-Mai-Dong-Tang on Quality of Life, Serum Cooper, Zinc, and Selenium, and Body Constitution in Head and Neck Cancer Patients Receiving the Radiotherapy and Chemotherapy.

(2) ................................................................................................ 1 ........................................................................................ 4 2.1 ................................................................. 4 2.2 .......................................... 6 2.3 ................................................................. 8 2.3.1 ....................................................... 8 ....................................................... 8 2.3.2 2.3.3 ....................................................... 8 2.3.4 ....................................................... 8 2.3.5 ............................................ 9 .................................................................................. 10 3.1 ...................................................................................... 10 3.2 ...................................................................................... 10 ...................................................................................... 10 3.3 3.4 ............................................................................... 11 3.5 ...................................................................................... 11 ...................................................................................... 12 3.6 3.7 ...................................................................................... 12 .............................................................................................. 15 4.1 ...................................................................................... 15 4.2 ............................................................................... 17 4.3 ................................................... 23 4.4 ............................................................... 28 4.5 ........................................................... 32 .............................................................................................. 33 5.1 ................................................................... 33 5.2 ................................................... 33 ........................................................................... 34 5.3 5.4 ...................................................................................... 35 5.5 ...................................................................................... 36 .............................................................................................. 38 .................................................................................................... 39 …….. .................................................................................................. 45. iv.

(3) 4-1 4-2 4-3 4-4 4-5 4-6 4-7 4-8 4-9 4-10 4-11. ...................... 22 .......................... 25 .......................... 26 .......................... 26 ...................... 27 ...................... 27 ...................... 27 .......................... 29 .......................... 30 .................... 30 ............................ 31. v.

(4) 2-1 3-1 3-2 3-3 4-1 4-2 4-3 4-4 4-5 4-6 4-7 4-8 4-9 4-10 4-11 4-12 4-13 4-14 4-15 4-16 4-17. ....................................................... 7 EORTC QLQ-C30 ................. 13 .................................................................... 13 .......................... 14 ........................................................................ 15 ............................................................................ 15 ............................................................................ 16 .......................... 16 ............................................. 18 ..................................................... 19 ..................................................... 20 ............................................. 21 ............................................. 22 24 ............ 24 24 ................................................... 25 .................... 28 ........................................................... 29 ........................................................... 29 ................ 32. vi.

(5) 0.026 0.019. 0.011. 0.021. 0.016. <0.001 <0.001 0.004 0.013. 0.047. 1. 0.005.

(6) 71 28. 98. 39,917. (. 142,240. )28.06%. 3.5. 98 400 98. ( ) 3. 4. (. 70%). 57.0 1. 5. 60-90% 2. 2, 3. 4. 1.

(7) 5. 6. 7. (. ). (. ). amine oxidases, ferroxidases, cytochrome c oxidase, dopamine β-hydroxylase, superoxide dismutase, and tyrosinase (Menkes disease) (Wilson disease)8. 2.

(8) 8. 8. 9. 10 11 12. 13. 14 15. 87.5% 16. 3.

(9) 2.1 3500. 17 18-20. 21. …22 23 24. …… 25. 26. 22. …… 27 28. 4.

(10) …… …… 26. ……. …… 21. ……. …… …26 29. 23 30 31. 26. 5.

(11) 2.2 2-1. 32. 33. 3. 34 35 36 37. 38. 39. 6.

(12) 32. 2-1. (. ). ( (. ) ) (. ). (. ) ). ( (. ). ALT (. ). ECG. (. ) Bun. Cr. (. ) (. ). 7.

(13) 2.3 2.3.1 6. 7. 2.3.2 (1). II A. 18β-. (2) (3) (4). 5,6,7,8-tetrahydro-2,4-dimethylquinoline. 5,6,7,8-tetrahydro-2,4-methylquinoline (5) ,. 40. ,. 2.3.3 (1) (2). PD. (3). 40. 2.3.4 (1) 41. (8) 47. (13). (2). (3). (9). (4). (10) 48. (5) (11) 49-50. (14). 8. 42-45 46. (6). (12). (7).

(14) 2.3.5 (1) 51. (2) 52. (3) 53. CD 4 / CD 8. 9.

(15) 3.1 (. IRB. DMR98-IRB-241-1. 1). 3.2 1. 2. 3.. ECOG. 4.. GOT. 5.. BUN. 6.. Hb. 7.. 2. GPT. 3 40 mg/dl. Bilirubin Cr. 3 mg/dl. 8 mg/dl 75000/mm3. Platelet count. 8. 9. 3.3 1. 2. 3.. GOT. 4.. BUN. 5.. Hb. 6.. GPT 40mg/dl. 3. Bilirubin>3mg/dl. Cr. 3mg/dl. 8mg/dl Platelet count. 75000/mm³. 7. 8. 9. 10.. 10. 3 mg/dl.

(16) 3.4 1. 2. 3. 4. 3.5 1. 3 gm. (. ) 3. 1/10 2.. 3. (1). EORTC QLQ-C30. (. 2). 30 (5. ) (2. (2. ). (4. ). ). (2. (2 (3. (1. ). ). (1. ). (2 ). (1. ). ). (2 ). ). (1. ). ). (1. 5-1 54-55. (2) (3). (Body Constitution Questionnaire, BCQ)( 3 11. 3) (19.

(17) ). (19. ). (16 ). 56-57. 3.6 1.. GMP 3.1. 2. 3.2 3.7 1.. ANOVA t-test. 2.. ANOVA t-test. 3.. t-test. 12. ). 44. (.

(18) 3-1. EORTC QLQ-C30. 50-51. Q1-Q5 (5. ). (2. ). Q6-Q7. (4. ). Q21-Q24. (2. ). Q20 Q25. (2. ). Q26-Q27. (3. ). Q10 Q12. (2. ). Q9. (1. Q19. (1. ). Q14-Q15. (1. ). Q8. ) (1. Q11 ). Q13. (1. ). Q16. (1. ). Q17. (1. Q18. ) (2. Q28 ). Q29-Q30. 3-2 1. Glehniae Radix. 2. Ophiopogonis Radix. Glehnia littoralis Fr. Schmidt ex Miq.. 4. Polygonati Odorati Rhizoma Mori Folium. 5. Trichosanthis Radix. 6. Lablab Album Semen. 7. Glycyrrhizae Radix et Rhizoma. 3. 13. Ophiopogon japonicus (Thunb.) Ker-Gawl Polygonatum odoratum (Mill.) Druce Morus alba L. Trichosanthes kirilowii Maxim. Leguminosae Dolichos lablab L. Glycyrrhiza uralensis Fisch..

(19) 3-3 μg/g Ag Al As B Ba Be Bi Ca Cd Co Cr Cu Fe Ga Ge Hg. μg/g. ppm. 0.112  0.053 380.600  2.200 0.467  0.065 0.792  0.056 12.706  0.112 N.D N.D 12591.10  23.800 0.074  0.008 6.906  0.112 10.826  0.119 27.615  0.223 116.150  0.380 0.427  0.023 0.121  0.034 N.D. 1. N.D 2.. K Li Mg Mn Mo Na Ni Pb Sb Se Sr Te Ti Tl V Zn. 100 ppm. 14. ppm. 25265.90  43.800 0.413  0.056 47440.30  26.800 779.020  2.120 2.858  0.221 803.60  36.700 28.666  0.223 0.556  0.078 0.037  0.011 0.379  0.064 141.250  2.120 0.177  0.045 716.20  26.500 0.021  0.007 0.823  0.066 85.651  1.223.

(20) 4.1 99. 11. 18. 100. 11. 20. 42 30-84. 70. 22. 54.45. 20. 52.75. 5440 Gy. 8. 42. 4-1. 20 5. 6. 15. 16. 4-3 Total Dropout 40.0 Dropout 40.5. (15. ). Total Dropout. (28 39.3. 4-2 ) (13. Total ). 4-4 (Hemoglobin (BUN. WBC count Creatinine. ). K. (GOT GPT). ). 4-1 2. 2. 10. 2. 1. ,. 1. 2. 1. 3. 1. 7. 1. 4. 1. 1. 1. 1. 1. 4-2. 42. 5. 6. 15. 15. 16.

(21) 4-3 Total Dropout Total Dropout 40.5 (15 ). 2. 40. (28. ). Total Dropout 39.3 (13 ). 2. 3. 11. 9. 0. 0. 2. 1. 4-4 P value Hb. 13.55 ± 2.04. 12.38 ± 2.43. 0.580. WBC. 7.72 ± 2.85. 8.90 ± 6.21. 0.563. N.Segment. 71.32±11.36. 74.64±11.11. 0.642. Lymphocyte. 15.67 ± 9.58. 12.95 ± 9.41. 0.546. Monocyte. 7.17 ± 2.47. 8.21 ± 4.26. 0.376. Basophil. 0.62 ± 1.05. 0.26 ± 0.28. 0.217. Eosinophil. 1.18 ± 1.21. 0.95 ± 1.28. 0.603. GOT. 28.00±12.23. 31.00±21.42. 0.681. GPT. 31.14±20.74. 37.67±20.89. 0.434. Creatinine. 1.00 ± 0.49. 0.97 ± 0.36. 0.850. BUN. 13.24 ± 4.24. 14.09 ± 4.35. 0.610. K. 4.07 ± 0.52. 3.81 ± 0.51. 0.226. Body Weight. 64.90±10.15. 62.23±13.67. 0.469. 16.

(22) 4.2 4-5. EORTC QLQ-C30 p. 0.05. 4-6. ANOVA. Scheffe. 4-7. ANOVA. 4-8 p 4-9. 0.05 3. 17.

(23) 4-5 (n=22) 6.77±1.95 4.36±1.99. (n=20) p v a l u e 7.15±1.78 0.518 4.15±1.76 0.715. 7.64±2.34. 7.10±2.31. 0.460. 3.32±1.21. 3.40±1.31. 0.835. 4.00±1.92 5.91±2.02 2.82±0.91. 4.10±1.89 6.20±2.17 2.85±0.93. 0.866 0.655 0.911. 2.55±1.14. 2.30±0.80. 0.430. 1.55±0.67. 1.55±0.61. 0.982. 1.64±0.95 1.73±1.03 1.59±0.85 1.27±0.70 1.73±0.94. 1.75±0.97 1.50±0.83 1.50±0.51 1.25±0.64 1.70±0.87. 0.704 0.439 0.682 0.913 0.923. 8.27±2.75. 8.40±1.54. 0.856. 18.

(24) 4-6. (N=22) ANOVA. *. p. Scheffe. 6.77±1.95 4.36±1.99 7.64±2.34. 9.00±2.66 4.36±1.52 6.95±2.87. p va l ue 6.27±1.27 <0.001* 2.91±0.86 0.002* 7.18±2.34 0.663. 3.32±1.21 4.00±1.92 5.91±2.02 2.82±0.91 2.55±1.14 1.55±0.67 1.64±0.95 1.73±1.03. 3.23±0.92 4.14±1.49 6.64±2.28 3.64±1.05 3.00±1.02 1.45±0.51 1.82±1.01 2.09±0.81. 3.05±0.79 3.32±1.04 4.36±1.18 2.73±0.77 2.05±0.21 1.14±0.35 1.41±0.59 1.23±0.43. 0.650 0.173 0.001* 0.003* 0.003* 0.032* 0.302 0.003*. 0.955 0.957 0.439 0.016* 0.249 0.849 0.787 0.325. 0.831 0.341 0.001* 0.007* 0.003* 0.143 0.689 0.003*. 0.660 0.215 0.029* 0.947 0.188 0.043* 0.303 0.123. 1.59±0.85 1.27±0.70 1.73±0.94 8.27±2.75. 1.50±0.67 1.36±0.58 1.73±0.55 8.86±2.25. 1.09±0.29 1.13±0.35 1.50±0.51 11.09±1.48. 0.030* 0.410 0.495 <0.001*. 0.898 0.867 1.000 0.679. 0.122 0.415 0.556 0.006*. 0.045* 0.726 0.556 <0.001*. < 0.05. 19. 0.003* 1.000 0.672. <0.001* 0.010* 0.957. 0.720 0.010* 0.838.

(25) 4-7. (N=20) ANOVA. Scheffe p va l ue. 7.15±1.78. 8.55±2.46. 7.90±3.02. 0.210. 0.211. 0.710. 0.634. 4.15±1.76 7.10±2.31 3.40±1.31 4.10±1.89. 3.85±1.57 6.70±2.08 3.30±1.26 3.85±1.39. 3.15±1.30 6.65±2.43 3.30±1.03 3.70±1.75. 0.122 0.763 0.955 0.752. 0.830 0.836 0.966 0.896. 0.369 0.997 1.000 0.756. 0.136 0.798 0.966 0.961. 6.20±2.17 2.85±0.93 2.30±0.80. 6.00±2.34 3.50±1.54 2.95±0.89. 5.65±2.13 3.05±1.23 2.70±1.13. 0.730 0.241 0.084. 0.960 0.257 0.088. 0.883 0.517 0.688. 0.736 0.877 0.388. 1.55±0.61 1.75±0.97 1.50±0.83 1.50±0.51 1.25±0.64 1.70±0.87 8.40±1.54. 1.55±0.76 1.80±1.01 1.90±0.57 1.25±0.55 1.15±0.37 1.85±0.88 9.25±1.99. 1.50±0.61 1.80±0.83 1.50±0.69 1.20±0.41 1.30±0.57 1.90±0.97 9.60±2.30. 0.963 0.981 0.192 0.130 0.670 0.768 0.150. 1.000 0.986 0.288 0.287 0.842 0.872 0.400. 0.972 1.000 1.000 0.950 0.680 0.985 0.854. 0.972 0.986 0.288 0.168 0.958 0.784 0.166. 20.

(26) 4-8 (n=22). (n=20) p v a l u e. 9.00±2.66. 8.55±2.46. 0.573. 4.36±1.52 6.95±2.87 3.23±0.92. 3.85±1.57 6.70±2.08 3.30±1.26. 0.289 0.746 0.831. 4.14±1.49 6.64±2.28 3.64±1.05 3.00±1.02 1.45±0.51. 3.85±1.39 6.00±2.34 3.50±1.54 2.95±0.89 1.55±0.76. 0.524 0.373 0.729 0.859 0.632. 1.82±1.01 2.09±0.81 1.50±0.67 1.36±0.58 1.73±0.55. 1.80±1.01 1.90±0.57 1.25±0.55 1.15±0.37 1.85±0.88. 0.954 0.461 0.198 0.167 0.586. 8.86±2.25. 9.25±1.99. 0.561. 21.

(27) 4-9 (n=22) 6.27±1.27 2.91±0.86 7.18±2.34 3.05±0.79 3.32±1.04 4.36±1.18 2.73±0.77 2.05±0.21 1.14±0.35 1.41±0.59 1.23±0.43 1.09±0.29 1.13±0.35 1.50±0.51 11.09±1.48 *. p. < 0.05. 4-1. 22. (n=20) p v a l u e 7.90±3.02 0.026* 3.15±1.30 0.482 6.65±2.43 0.429 3.30±1.03 0.371 3.70±1.75 0.390 5.65±2.13 0.019* 3.05±1.23 0.310 2.70±1.13 0.011* 1.50±0.61 0.021* 1.80±0.83 0.085 1.50±0.69 0.127 1.20±0.41 0.325 1.30±0.57 0.265 1.90±0.97 0.098 9.60±2.30 0.016*.

(28) 4.3. 4-10. 4-11 (difference) -. -. 4-12 (referent). 4-13 23.

(29) 4-10 (μg/L). (n=22). (n=20). p. Cu Zn Se. 1125.04±227.30 678.59±169.05 116.24 ± 15.63. 1008.50±264.73 797.70±206.03 116.10 ± 18.13. 0.188 0.188 0.734. Cu Zn Se. 1092.64±224.29 740.68±171.61 116.18 ± 16.12. 1060.45±301.30 763.75±212.68 112.91 ± 16.49. 0.450 0.880 0.597. Cu Zn Se. 1034.41±207.00 748.41±142.11 114.05 ± 14.28. 1081.90±295.57 748.75±208.70 105.89 ± 17.09. 0.497 0.546 0.110. 4-11 (μg/L). p. (n=22) Cu Zn Se. 1125.04±227.30 678.59±169.05 116.24 ± 15.63. 1092.64±224.29 740.68±171.61 116.18 ± 16.12. 1034.41±207.00 748.41±142.11 114.05 ± 14.28. <0.001* 0.001* 0.422. (n=20) Cu Zn Se. 1008.50±264.73 797.70±206.03 116.10 ± 18.13. 1060.45±301.30 763.75±212.68 112.91 ± 16.49. 1081.90±295.57 748.75±208.70 105.89 ± 17.09. 0.029* 0.003* <0.001*. 4-12 (μg/L) Cu Zn Se Cu Zn Se Cu Zn Se. (n=22). (n=20). p. -32.41±88.80 62.09±70.38 -0.06 ± 7.06. 51.95±113.68 -33.95 ± 57.93 -3.190 ± 7.26. 0.015* <0.001* 0.102. -90.64±59.95 69.82±84.80 -2.20 ± 5.33. 73.40±119.22 -48.95 ± 69.36 -10.220 ± 9.45. <0.001* <0.001* 0.001*. -58.23±81.44 7.73±48.59 -2.13 ± 5.17. 21.45±124.89 -15.00 ± 47.47 -7.020 ± 6.63. 0.009* 0.110 0.012*. 24.

(30) 4-13 (μg/L). a. a. p. B(SE) Referent Referent Referent. -80.82(32.10) 85.75(20.04) 2.810(2.08). 0.012* <0.001* 0.177. Cu Zn Se. Referent Referent Referent. -155.32(29.15) 98.81(23.42) 7.920(2.15). <0.001* <0.001* <0.001*. (ug/L). Cu Zn Se. 4-2. 25.

(31) 1200. (ug/L). 1000 800 600 400 200 0. 4-3. 4-4. 26.

(32) 1150. ug/L. 1100. 1050 1000 950. 4-5. ug/L. 4-6. 118 116 114 112 110 108 106 104 102 100. 4-7 27.

(33) 4.4 (. ). 3 4-14. 4-15 4-16. 4-14 ( N = 2 2 ) ( N = 2 0 ) 29.36 ± 6.60 30.62 ± 6.09 34.00 ± 7.82 32.71 ± 5.07 23.64 ± 4.71 28.38 ± 5.33 30.41 ± 5.87 32.14 ± 7.07 34.67 ± 6.99 32.38 ± 5.78 26.14 ± 3.38 30.05 ± 6.13 26.00 ± 4.67 26.48 ± 6.52 29.64 ± 5.83 29.48 ± 4.92 22.50 ± 2.99 25.24 ± 5.32 85.77±14.10 89.24±17.22 98.27±17.92 91.52±14.32 72.27 ± 8.88 83.67±15.48. 28. P value 0.521 0.525 0.004* 0.386 0.257 0.013* 0.786 0.923 0.047* 0.474 0.454 0.005*.

(34) 4-15 ANOVA. Scheffe P value. 29.36 ± 6.60. 34.00 ± 7.82. 23.64±4.71. <0.001*. 0.069. <0.001*. 0.018*. 30.41 ± 5.87. 34.67 ± 6.99. 26.14±3.38. <0.001*. 0.051. <0.001*. 0.048*. 26.00 ± 4.67. 29.64 ± 5.83. 22.50±2.99. <0.001*. 0.041*. <0.001*. 0.051. 85.77±14.10. 98.27±17.92. 72.27±8.88. <0.001*. 0.018*. <0.001*. 0.009*. 4-16 ANOVA. Scheffe P va l ue. 30.62 ± 6.09 32.14 ± 7.07 26.48 ± 6.52 89.24±17.22. 32.71 ± 5.07 32.38 ± 5.78 29.48 ± 4.92 91.52±14.32. 28.38 ± 5.33 30.05 ± 6.13 25.24 ± 5.32 83.67±15.48. 4-8. 29. 0.047* 0.329 0.071 0.093. 0.654 0.975 0.347 0.752. 0.050* 0.505 0.075 0.100. 0.291 0.381 0.693 0.364.

(35) 4-9. 4-10. 30.

(36) 4-11. 31.

(37) (Hemoglobin WBC count ). (GOT. GPT). (BUN. Creatinine. K. K 4-17. 4-17 P value Hb. 12.37 ± 1.44. 11.32 ± 1.81. 0.127. WBC. 5.65 ± 2.18. 6.43 ± 3.01. 0.480. N.Segment. 70.04±10.03. 74.94 ± 9.17. 0.250. Lymphocyte. 19.00±10.95. 14.08 ± 5.79. 0.230. Monocyte. 8.81 ± 2.45. 9.10 ± 3.56. 0.821. Basophil. 0.42 ± 0.22. 0.96 ± 1.98. 0.444. Eosinophil. 2.61 ± 1.92. 1.59 ± 1.52. 0.194. GOT. 24.67±10.26. 48.57±34.07. 0.464. GPT. 27.38±31.47. 27.71±16.42. 0.980. Creatinine. 0.97 ± 0.33. 0.97 ± 0.25. 0.984. BUN. 14.77±11.39. 10.11 ± 3.53. 0.286. K. 9.87±15.05. 4.16 ± 0.84. 0.354. Body Weight. 62.19 ± 9.37. 59.50±11.12. 0.400. 32. ).

(38) 5.1. 3. 32. 5.2. 58 59-61. ( 33.

(39) (H2O2). glutathione peroxidase) 62 63-65. DNA 66-67. 68. 5.3. 3500. 17. 18-20. 26. 69. 34.

(40) 23. 31. 70-72. 73. --. 5.4. 74. 35.

(41) 26. 5.5. 70 28. 42 20. 60% 5. 3. 36.

(42) 37.

(43) 1.. 2.. 3.. 38.

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(52) 2. EORTC QLQ-C30. TNM. Ⅰ. Ⅱ. 47. Ⅲ. Ⅳ.

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(54) Pre-Treatment. Hospital Code. Patient No.. Series No.. Patient Initials. Page 3 of 4. ：□□/□□/□□□□ （MM/DD/YYYY）. EORCT. QLQ-C30. version 3. Coding. Coding. 49.

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(63) Clinical Evaluation of the Effect of Sha-Sheng-Mai-Dong-Tang on Quality of Life, Serum Cooper, Zinc, and Selenium, and Body Constitution in Head and Neck Cancer Patient Receiving the Radiotherapy and Chemotherapy Ching-Feng Su Major Professor: Tung-Yuan Lai Graduate Institute of Chinese Medicine Aim The present RCT clinical study is to evaluate the effects of Sha-Sheng-Mai-Dong-Tang in the head & neck cancer patients receiving the radiotherapy and chemotherapy. We are going to assess the clinical evaluation among the serum cooper, zinc, and selenium 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. Method There were 70 patients entered to our clinical trial. 42 cases have completed course and were analyzed included 22 cases of experimental group and 20 cases of control group. Experimental group were treated with Sha-Sheng-Mai-Dong-Tang where control group were treated with 1/10 Sha-Sheng-Mai-Dong-Tang. Result 1. In the respect of quality of life, experimental group had significantly better quality of life in health function(p=0.026), fatigue(p=0.019), nausea and vomiting(p=0.011), dyspnea(p=0.021), and whole quality of life(p=0.016) compared with control group. 2. The analysis of Serum Cu, Zn, and Se in experimental group, compared with control group, experimental group was on the 58.

(64) downside in serum cooper (p<0.001)and had a trend of escalation in serum zinc and selenium(both p<0.001). 3. In the respect of body constitution, experimental group gave better score than control in Yang-Xu(p=0.004), Ying-Xu(p=0.013), phlegm stagnates(p=0.047), and whole body constitution(p=0.005) in post-test. Key word: cancer patients, quality of life, blood, trace element, body constitution. 59.

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