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1 CJ ITWM, January 2006, Vol. 26, No , (61 ), (41 ), EORTC QLQ2C43 FACT2L,,, ( P < 0105) ; ECO G KPS ; ( P < 0105) ; ( P > 0105),, ; ; Evaluation on Effect of Feiji Recipe on Quality of Life of Patients with Non2small Cell Lung Cancer by Adopt2 ing International Questionna ire of QOL YOU Jie, SHI Zhi2ming, HAN Bao2hui, et al Center of Cli nical O n2 cology, L onghua Hospital, S hanghai U niversity of TCM, S hanghai ( ) Abstract Objective To evaluate the effect of Feiji Recipe ( FJ R) on quality of life (QOL) of patients with non2small cell lung cancer (NSCLC). Methods One hundred and two patients with NSCLC were ran2 domly assigned into 2 groups. The 61 patients in the combined treated group were given FJ R and chemotherapy and the 41 patients in the control group were treated with chemotherapy alone. They were observed for two treatment courses with QOL estimated by EORTC QLQ2C43 questionnaire and FACT2L questionnaire, the two international questionnaires as t he tools for measurement, and referred to t he t raditional evaluating indexes of clinical efficiency. Results QOL in the combined treated group was improved after treatment with the improve2 ment of scores in all domains, including functional and symptom sub2domain, while it in the control group de2 prived significantly, showing significant difference between t he two groups ( P < 0105). Similar result s were al2 so shown in t he evaluation of p hysical performance by Eastern Cooperative Oncology Group ( ECO G) and Karnovf sky performance scoring. The gast rointestinal reaction and myelo2suppression were slighter in t he com2 bined treated group than those in the control group ( P < 0105), and no significant difference was shown be2 tween the response rate of the two groups ( P > 0105). Conclusion FJ R can improve QOL of patients with NSCLC, reduce the adverse reaction of chemotherapy, and improve patientsphysical performance. Key words Feiji Recipe ; non2small2cell lung cancer ; quality of life ; international questionnaire of QOL ; e2 valuation Treat ment of Cancer Quality of Life Questionnaire L C2 :11 ( ) ; com 1,, ( European Organization for Research and :, Tel : , E2mail 43, EORTC QLQ2C43) ( Functional Assessment of Cancer Therapy General and Lung, FACT2L),

2 CJ ITWM, January 2006, Vol. 26, No g 30 g 12 g (1) : b 5, a 14, b 17, 25 ; : 24, 37 ; : 26, 35 29,12, ; 1, 40 ; : 18, 23 ; : b 5, a, ( P > 0105) 3, : WHO ; 1 1, ;, 1, ( [( %) ] G2 CSF) ;, NP : 25 mg/ m 2 d1,d8 80 mg/ m 2,28 2 1, EORTC QLQ2C43 30 g 15 g 15 g 30 g 15 g 3, ; (2) : WHO ; (3) 1875 ; (4) ; 4, ( CR) ( PR) (5) > 70 ; (6) ; (7) (NC) ( PD) 5 ; (8) (1) ; (2) ; (3) EORTC QLQ2C43 ; (4) ; (5) FACT2L : (1) 1 1, ; (2) () 2 ; (3) ( Karnovfsky per , formance status, KPS) ( East cooperative oncology group performance stat us,,102 (7415 %) ECO G),, , ,16, ; 5,, :0,:1,:2,:3 56 ; : 19, 42 ; 4. 4 WHO 7, 1 5 SPSS t,, 2, Wilcoxon 10, b 12, 14 ; : 21, EORTC QLQ2C43 LC13 20 ; : 16, 25, n PR NC PD n NC PD 35 6 (1711) 26 (7413) 3 (816) (9612) 1 (318) 25 2 (810) 20 (8010) 3 (1210) (7510) 4 (2510) 2

3 CJ ITWM, January 2006, Vol. 26, No EORTC QLQ2C43 (, gx s) :, 3 P < 0105 ;, P < FACT2L (, gx s) :, 3 P < 0105 ;, P < 0105 ( P < 0105), 3 KPS ECO G, 4 KPS ECO G,, (wilcoxon ( P < 0105), ), (P < 0101) 4 KPS ECO G (), ( P < 0105),, KPS() ( P < 41 ECO G() ), ( P < 0105) 4, [ ( ) ] ( P < 0105), [ ( ) ] ( P < 0101) ; 2. 2 FACT2L 3 [ ( ) ] [ ( ) ], ( P < 0101) ( P < 0101) ( P < 0105) 5 5 ( P < 0105),, ( P < 0105)

4 CJ ITWM, January 2006, Vol. 26, No. 1 5 () 0 < 1W 12W > 2W ; Morita 16,, 8,,,,,, ;,, ( KPS ECO G) 9, 24,10, 1,,, ;2 11 Mary ,,,, 6 Osoba 13 QLQ2 C30 160,,,,, 2, 14 ;,, (end point) 15 1 Beitz J, Gnecco C, J ustice R. Quality of life end points in cancer clinical trials : the US Food and Drug Administration perspective. J Natl Cancer Inst Monogr 1996 ; , ( 2. ( ). ) :, , Edited by Chinese Anti2cancer Association. New criterion of diagnosis and treatment of malignant tumor. 9th vol. Beijing :, Chinese Academy of Medical Science and Peking Union Medi2, cal College Press, ,, 3 AJ CC/ U ICC (97 ). :.. : ( ), , American Joint Committee on Cancer ( AJ CC) / International, Union Against Cancer (U ICC) staging system for lung cancer (1997). In : Zhou J C, editor. Practical oncology. Beijing : People s Medical Publishing House, :, 2001

5 CJ ITWM, January 2006, Vol. 26, No Sun Y, editor. Oncology. Beijing : People s Medical Publishing House, :, Wan CH. The methods of measurement and evaluation of qual2 ity of life. Kunming : Yunnan University Press, :tress, and change over time in patients receiving treatment for, Zheng XY, editor. Guiding principles of clinical research on new drugs of TCM. Beijing : China Medico2Pharmaceutical Sciences and Technology Publishing House, : Life Res 1994 ; 3(5) , Tang ZY, editor. Mordern oncology. 2nd ed. Shanghai : Shanghai Medical University Publishing House, Frost MH, Bonomi AE, Ferrans CE,et al. Patient,clinician, and population perspectives on determination of the clinical significance of quality2of2life scores. Mayo Clin Proc 2002 ;77 (5) Breathnach OS, Freidlin B, Conley B, et al. Twenty2two years of phase trials for patients with advanced non2small cell lung cancer : sobering results. J Clin Oncol ;19(6) 10 Cella D. Impact of ZD1839 on non small2cell lung cancer2relat2 ed symptoms as measured by the functional assessment of can2 cer therapy2lung scale. Semin Oncol 2003 ; 30 ( Suppl 1 ) 11 Natale RB, Zaretsky SL. ZD1839 ( Iressa) : What s in it for the patient? Oncologist 2002 ; 7 (Suppl 4) Mary E, Short TH, Moriarty HJ. Symptom prevalence, dis2 lung cancer. Psycooncology 2003 ; 12 (7) Osoba D,Zee B,Pater J,et al. Psychometric properties and re2 sponsiveness of the EORTC quality of life questionnair (QLQ2 C30) in patients with breast, ovarian and lung cancer. Qual 14 Montazeri A, Milroy R, Hole D,et al. Quality of life in lung cancer patients. As an important prognostic factor. Lung Can2 cer 2001 ;31 (2 3) Paris K. Quality of life as a new end point. Chest 1996 ;109 (5) Morita S, Kobayashi K, Eguchi K, et al. Influence of clinical parameters on quality of life during chemotherapy in patients with advanced non2small cell lung cancer : application of a gen2 eral linear model. Jpn J Clin Oncol 2003 ; 33(9) ( : : ),, 20, 40, (973) ; 4, ,! ( )

( KPS) ( ECO G ) , ; ( European organization for re2 search and treatment of cancer quality of life question2 naire LC243, EORTC QLQ2LC43) 1

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