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1 / ( ) ; 2. ( ) ; 3. ( ) ; 4. ( ) ; 5. ( ) ; 6. ( ) ; 7. ( ) ; 8. ( ) ; 9. ( ) / ( FESS), ( 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; R A (2004) 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 West China Hospital, Sichuan University, Chengdu , China ; 2. People s Hospital of Sichuan, Chengdu , China ; 3. The Seventh People s Hospital of Chengdu , China ; 4. The Affiliated Hospital of Luzhou Medical College, Luzhou , China ; 5. The Affiliated Hospital of North Sichuan Medical College, Nanchong , China ; 6. Central Hospital of Nanchong, Nanchong , China ; 7. The Fouth People s Hospital of Zigong, Zigong , China ; 8. Central Hospital of Mianyang, Mianyang , China ; 9. Central Hospital of Deyang, Deyang , 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 %,, : : :,(19432) 转载
2 378 Chinese J Evidence2Based Medicine, 2004, Vol. 4(6),,, FESS [1, ], FESS, ; ;, 9, :, ,,, ,,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 People s Hospital of Sichuan The Seventh People s Hospital of Chengdu The Affiliated Hospital of Luzhou Medical College The Affiliated Hospital of North Sichuan Medical College Central Hospital of Nachong The Fourth People s Hospital of Zhigong Central Hospital of Mianyang Central Hospital of Deyang Total (9) ,, (1997 ) ; /, [2 ; /, ], ; ,, : : ; ; : ; 112 : ; : ;
3 ; : CRF ; :, 80 %120 %,, , : : : 211 :5 ml 21 ml 9 : 814 d 61 d 328, , : 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,,, (per2pro2, 14 tocol population, PP) :, 16 d 1 5 9
4 380 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 Gender (M/ F) 93/ 73 89/ 73 2 = Mean age ( x s, Yr) t = Type ( / / ) 49/ 85/ 32 52/ 78/ 31 2 = Progress of disease (d) t = ( / / ) 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 = / 91/ 56/ 8 11/ 97/ 45/ 9 2 = / 110/ 34 23/ 101/ 38 2 = / 82/ 68/ 9 6/ 77/ 69/ 10 2 = / 41/ 67/ 58 0/ 35/ 67/ 60 2 = / 6 153/ 9 2 = Table 3 Analysis of compositive effect of two groups Group ITT PP ITT PP n Cure Wilcoxon test : ITT : Z = 51635, P = ; PP : Z = 41279, P = Apparent effect Invalid Total apparent and apparent rate Main Symptom 4 Table 4 Analysis of disappear rate of symptoms and signs of two groups Disappear Disappear 2 P ITT Pain PP ITT Poor nasal ventilation PP ITT Purulent nasal discharge PP ITT Hyposmia PP ITT Fever PP ITT Chronic cough PP ITT Halitosis PP
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 Poor nasal ventilation Purulent nasal discharge Hyposmia Fever Chronic cough Halitosis P ,, 3153 %, (, 10 % ), 4, ( ) Table 6 Lost of cases Side 2effect 1 3 Effect deficiency 0 1 Lose follow2up /,,, ; ; ; ;, 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 ] ( 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) [ R ].
6 416 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 For information and advice on planning and writing a systematic review, please contact the Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, , Sichuan Province, People s Re2 public of China. Tel : / ; Fax : E - mail : 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, 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) : [J ]., 2001 ; 12 (9 ) : 2324 ( : )
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