2004 4 6 377 / 1 2 1 2 3 4 5 6 7 8 9 1. ( 610041) ; 2. ( 610072) ; 3. ( 610041) ; 4. ( 646000) ; 5. ( 637000) ; 6. ( 637000) ; 7. ( 643000) ; 8. ( 621000) ; 9. ( 618000) / ( FESS), 340 170 170 ( 7 d), 10 ml, 3,20 d ; 20 d, ITT 9411 %, PP 9614 % ;, ITT 7513 %, PP 7910 %,, ( ITT : Z = 51635, P = 01018, Z = 41279, P = 01039),, ; / ; ; R311; R765.210.5 A 1672 2531(2004) 06 0377 06 Multi2Centre Randomized Controlled Trial of Bi Yuan Shu Liquid on Patients with Chronic Nasal Sinusitis or Nasal Polyp after Endosoopic Sinus Surgery LIAN G Chuan2 yu 1, WEN Pei 2, ZHEN Yan 1, HE Gang 2, FAN Ming 3, LI Wan2rong 4, TAN G Si2quan 5, PEN G Tao 6, LIAN G Guo2 qing 7, WAN G Jie 8, ZHAN G Yu2ping 9. 1. West China Hospital, Sichuan University, Chengdu 610041, China ; 2. People s Hospital of Sichuan, Chengdu 610072, China ; 3. The Seventh People s Hospital of Chengdu 610041, China ; 4. The Affiliated Hospital of Luzhou Medical College, Luzhou 646000, China ; 5. The Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, China ; 6. Central Hospital of Nanchong, Nanchong 643000, China ; 7. The Fouth People s Hospital of Zigong, Zigong 643000, China ; 8. Central Hospital of Mianyang, Mianyang 621000, China ; 9. Central Hospital of Deyang, Deyang 618000, China Abstract Objective To study the effect of Bi Yuan Shu Liquid on melioration of clinical symptoms and signs of chronic nasal sinusitis or nasal polyp patients after Functional Endosoopic Sinus Surgery (FESS), and discuss the effectiveness of Chinese composite medicine in the overall treatment after FESS. Methods A total of 340 patients were randomly allocated to treatment group ( n = 170) and control group ( n = 170) according to simple randomization procedure. Patients in treatment group were administrated with quinolone, steroid, and Bi Yuan Shu Liquid, which were compared with those in control group who were given quinolone and steroid. Results The apparent effect of treatment group and control group were 3016 % and 4214 % of 4214 % of ITT. Results by Wilcoxon signed rank test indicated that there was a statistically significant difference. Conclusion Bi Yuan Shu Liquid may improve the effectiveness of sinus surgery, reduce the time course of antibiotics and hor2 mones, and with out toxicity and side2effect. Key words Bi Yuan Shu Liquid ; Chronic nasal sinusitis/ nasal polyp ; Integrated west and Chinese medical treat2 ment ; Randomized controlled trial, 15 %,, : 2004 05 13 : 2004 06 02 :,(19432) 转载

378 Chinese J Evidence2Based Medicine, 2004, Vol. 4(6),,, FESS [1, ], FESS, 2003 10 2004 3 ; ;, 9, :, 1 111 11111 9,,, 3050 340,,20, 328, 1, 1 1,,, / ( FESS) 1 Table 1 Clinical centre & observed case Name of clinical centre No. of centre Intending case Case West China Medical Centre of Sichuan University 6 101 50 48 People s Hospital of Sichuan 6 102 50 49 The Seventh People s Hospital of Chengdu 6 103 30 29 The Affiliated Hospital of Luzhou Medical College 6 104 30 29 The Affiliated Hospital of North Sichuan Medical College 6 105 40 40 Central Hospital of Nachong 6 106 40 38 The Fourth People s Hospital of Zhigong 6 107 40 38 Central Hospital of Mianyang 6 108 30 30 Central Hospital of Deyang 6 109 30 27 Total (9) 340 328,, (1997 ) 11112 18 60 ; /, [2 ; /, ], 113 11113 ; 11311 03,, : : ; ; : ; 112 : ; : ;

2004 4 6 379 ; : CRF ; :, 80 %120 %,, 11312 03 2, : : : 211 :5 ml 21 ml 9 : 814 d 61 d 328, 166 162, : 7 d 30 d 18, 60, 114 FESS, ( ( 7 d) ) CT ( ),,, 10 ml, 3, 20 d ; ( 2),, 1 7 d 14 d 30 d 60 d 115 / (1997 ) 3, [4 ] = [ ( 2 ) / ] 100 % : > 90 % ; : 30 %90 % ; : < 30 %,, ( P < 0105) 213 4,, 116 SPSS 910, ( P < 0105) t, 214 1, 25 n = 166 I TT n = 170 PP n = 166 Case accord to criteria n = 328 : (intention2to2treat, ITT),, ( P < 0105), 1, ( P > 0105), 1, 215 n = 162 I TT n = 170 PP n = 162 Fig Flow diagram of the trial 212 3, 5,,, 165 1 (per2pro2, 14 tocol population, PP) :, 16 d 1 5 9

380 Chinese J Evidence2Based Medicine, 2004, Vol. 4(6) 2 ( PP,) Table 2 Comparison of characteristics of two groups ( PP, n) Program Statistic quantity P Num 166 162 Gender (M/ F) 93/ 73 89/ 73 2 = 01039 01912 Mean age ( x s, Yr) 38196 14102 38170 13189 t = 01146 01884 Type ( / / ) 49/ 85/ 32 52/ 78/ 31 2 = 0142 01809 Progress of disease (d) 63168 82119 t = 11877 01062 ( / / ) Doctor s evaluation of disease (Slight/ Moderate/ Severe) ( / / / ) Doctor s evaluation of life quality ( No/ Slight/ Big/ Severe) ( / / ) Patients s evaluation of disease (Slight/ Middle/ Severe) ( / / / ) Patients evaluation of life quality ( No effects/ Slight / Severe / Can not bear) CT ( / / / ) Screenage evaluation ( CT) ( Normal/ Slight/ Middle/ Severe) ( / ) Invaluation of the correlation of respiratory disease ( Possibly no correlation/ Possible correlation) 53/ 105/ 8 51/ 107/ 4 2 = 1134 01511 11/ 91/ 56/ 8 11/ 97/ 45/ 9 2 = 1140 01706 22/ 110/ 34 23/ 101/ 38 2 = 0158 01748 7/ 82/ 68/ 9 6/ 77/ 69/ 10 2 = 0125 01970 0/ 41/ 67/ 58 0/ 35/ 67/ 60 2 = 0146 01795 160/ 6 153/ 9 2 = 0171 01400 3 Table 3 Analysis of compositive effect of two groups Group ITT PP ITT PP n 170 166 170 162 Cure 108 108 56 56 6315 6511 3219 3416 Wilcoxon test : ITT : Z = 51635, P = 01018 ; PP : Z = 41279, P = 01039 Apparent effect 52 52 72 72 3016 3113 4214 4414 Invalid 10 6 42 34 519 316 2417 2110 Total apparent and apparent rate 160 160 128 128 9411 9614 7513 7910 Main Symptom 4 Table 4 Analysis of disappear rate of symptoms and signs of two groups Disappear Disappear 2 P ITT 103 92 8913 89 65 7310 81496 01004 Pain PP 99 92 9219 81 65 8012 61429 01011 ITT 168 154 9117 168 96 5711 521572 01000 Poor nasal ventilation PP 164 154 9319 160 96 6010 521820 01000 ITT 164 150 9115 148 90 6018 411177 01000 Purulent nasal discharge PP 160 150 9318 140 90 6413 401513 01000 ITT 107 57 5313 96 33 3414 71321 01007 Hyposmia PP 103 57 5513 88 33 3715 61061 01014 ITT 14 10 5516 16 8 3313 11429 01232 Fever PP 10 10 10010 8 8 10010 ITT 52 39 7510 52 34 6514 11149 01284 Chronic cough PP 48 39 8113 44 34 7713 01222 01638 ITT 62 52 8319 52 29 5518 101858 01001 Halitosis PP 58 52 8917 44 29 6519 81629 01003

2004 4 6 5 ( PP ) Table 5 Analysis of disappearing days of symptoms and signs of two groups ( PP) 381 Main Symptom Mean value of disappearing days Mean value of disappearing days t Pain 99 9137 8124 81 13132 10118 21879 01004 Poor nasal ventilation 164 12194 9161 160 16114 13121 21416 01033 Purulent nasal discharge 160 16183 9173 140 18196 10142 21640 01021 Hyposmia 103 11110 4177 88 14174 8148 31715 01000 Fever 10 4190 3107 8 5100 2151-01074 01942 Chronic cough 48 13165 10100 44 14186 9150-01598 01552 Halitosis 58 9141 7160 44 10175 4170-11092 01278 P 3 216 12,, 3153 %, (, 10 % ), 4, 8 6 6 ( ) Table 6 Lost of cases Side 2effect 1 3 Effect deficiency 0 1 Lose follow2up 3 4 3 /,,, ; ; ; ;, 2001 ; 12 (9 ) : 1012,,,,,,,,,,,, /,, / [1 ] Zhang N Z, Xia LJ. Observe after FESS for adult and children who suffer from chronic sinusitis by using Bi Yuan Shu Liquid [J ].. 2001 ( 416 ) Chi2 na J Otolaryngol Ingegrat Trad&West Medi ( special publication), 2001 ; 12 (9) : 10 12,. [J ]. [2 ] Multi2center, random,parallel and contrast Clinical research stadard for treating nose2antral inflammation with GG (glucocorticoid) and evaluating its effect and safty [ R ]. EN T department of CMA ( Chi2 na Medical Association). 2001 [ R ].

416 Chinese J Evidence2Based Medicine, 2004, Vol. 4 (6) their importance, the following questions must be ad2 dressed : How large was the effect of treatment? How precise was the estimate of the treatment effect? Will the results help my patient? This will only be true if the patients studied are similar to your patient. Clinical experience and acumen is nec2 essary to determine this. The outcomes measured in the study may not be those of relevance to your own pa2 tient. If they are, the following questions arise : What are the disadvantages of the treatment compared to the benefits (always recalling the degree of benefit which the study suggests might accrue to the pa2 tient)? Can the results be applied to my patient? Were all clinically important outcomes consid2 ered? Are the likely benefits worth the potential harms and costs? A similar framework can be used in appraising a pa2 per about the value of a diagnostic test. Since 1993, the Journal of the American Medical Association has published a series of 25 articles addressing many of the above issues under the general headingusersguides to the Medical Literature. In separate papers (which in 2002 were published both as a comprehensive, two2 volume textbook [3 ] and as a condensed, single vol2 ume [4 ] guidance is given on the use of articles concern2 ing therapy or prevention, diagnostic tests, harm, and prognosis. These papers are well worth reading as a starting point in acquiring critical appraisal skills. 3 3 3 For information and advice on planning and writing a systematic review, please contact the Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan Province, People s Re2 public of China. Tel : + 86 28 85422078/ 85422079 ; Fax : + 86 28 85582944. E - mail : cochrane @ mail. sc. cninfo. net ; Homepage : www. chinacochrane. org. The Cochrane Collaboration also provides free open learning material for reviewers, available at www. cochrane2net. org/ openlearning/. The website of the Cochrane EN T Disorders Group is at www. cochrane2ent. org. Reference [1 ] Result from running the Cochrane EN T Disorders Group s search strategy for otolaryngological diseases on MEDLINE (19662Septem2 ber 2003). Details of the group s search strategy can be found on The Cochrane Library. [2 ] Burton MJ, Towler B, Glasziou P. Tonsillectomy versus non2sur2 gical treatment for chronic/ recurrent acute tonsillitis ( Cochrane Re2 view). In : The Cochrane Library, Issue 3, 2003. Oxford : Update Software. [ 3 ] Guyatt G & Rennie D. UsersGuides to the Medical Literature : A Manual for Evidence2Based Clinical Practice, 2 vols [ R ]. ( with CD2ROM), Chicago, IL : American Medical Association, 2002 [4 ] Guyatt G & Rennie D. UsersGuides to the Medical Literature : Essentials of Evidence2Based Clinical Practice, [ R ]. Chicago, IL : American Medical Association, 2002 ( Edited by CAI Yu2jia) ( 381 ) [3 ] EN T department of CMA ( China Medical Association), Editorial Committee of China J Otolaryngol Medi. Clinical type and period of chronic sinusitis and nasal polyp &stadard of FESS (functional en2 doscopic sinus surgery ) evaluation [ J ]. China J Otolaryngol Medicine,1998 ; 33 (2) : 133,. ( : ) [J ]., 1998 ; 33 (2) : 133 [4 ] Chen LQ. Curative effectual observation of rhinitis and sinusits by using Bi Yuan Shu Liquid [ J ]. China J Otolaryngol Ingegrat Trad&West Medi ( special publication), 2001 ; 12 (9) : 23 24. [J ]., 2001 ; 12 (9 ) : 2324 ( : )