Combined budesonide and antibiotic therapy for active Crohn's disease: a randomized controlled trial

被引:159
作者
Steinhart, AH [1 ]
Feagan, BG
Wong, CJ
Vandervoort, M
Mikolainis, S
Croitoru, K
Seidman, E
Leddin, DJ
Bitton, A
Drouin, E
Cohen, A
Greenberg, GR
机构
[1] Mt Sinai Hosp, Dept Med, Toronto, ON, Canada
[2] John P Robarts Res Inst, London Clin Trials Res Grp, London, ON, Canada
[3] McMaster Univ, Dept Med, Hamilton, ON, Canada
[4] St Justine Hosp, Gastroenterol Div, Montreal, PQ, Canada
[5] Dalhousie Univ, Dept Med, Halifax, NS, Canada
[6] Royal Victoria Hosp, Montreal, PQ H3A 1A1, Canada
[7] Jewish General Hosp, Montreal, PQ, Canada
关键词
D O I
10.1053/gast.2002.34225
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Background & Aims: Although antibiotics are frequently used to treat Crohn's disease, this practice is not supported by strong evidence from randomized trials. Methods: We conducted a double-blind. multicenter study of patients with active Crohn's disease of the ileum, right colon, or both. Patients were randomized to receive oral ciprofloxacin and metronidazole, both 500 mg twice daily, or placebo for 8 weeks. All patients received oral budesonide 9 mg once daily. The primary efficacy measure was the proportion of patients in remission at week 8. Results: Of the 134 patients who were randomized, 130 were evaluated for efficacy; 66 received placebo, and 64 received antibiotics. At week 8, 21 patients (33%) assigned to antibiotics were in remission as compared with 25 patients (38%) in the placebo group (P = 0.55; absolute difference, -5%; 95% confidence interval, -21% to 11%). An interaction (P = 0.025) between treatment allocation and disease location on treatment response was identified. Among patients with disease of the colon, 9 of 17 (53%) were in remission after treatment with antibiotics, compared with 4 of 16 (25%) of those who received placebo (P = 0.10). Discontinuation of therapy because of adverse events occurred in 13 of 66 (20%) patients treated with antibiotics, compared with 0 of 68 in the group who received placebo (P < 0.001). Conclusions: In patients with active Crohn's disease of the ileum, the addition of ciprofloxacin and metronidazole to budesonide is an ineffective intervention, but this antibiotic combination may improve outcome when there is involvement of the colon.
引用
收藏
页码:33 / 40
页数:8
相关论文
共 33 条
[1]   ANTIBIOTIC-THERAPY FOR TREATMENT IN RELAPSE OF INTESTINAL CROHNS-DISEASE - A PROSPECTIVE RANDOMIZED STUDY [J].
AMBROSE, NS ;
ALLAN, RN ;
KEIGHLEY, MRB ;
BURDON, DW ;
YOUNGS, D ;
BARNES, P ;
LENNARDJONES, JE .
DISEASES OF THE COLON & RECTUM, 1985, 28 (02) :81-85
[2]   Blockade of interleukin 6 trans signaling suppresses T-cell resistance against apoptosis in chronic intestinal inflammation:: Evidence in Crohn disease and experimental colitis in vivo [J].
Atreya, R ;
Mudter, J ;
Finotto, S ;
Müllberg, J ;
Jostock, T ;
Wirtz, S ;
Schütz, M ;
Bartsch, B ;
Holtmann, M ;
Becker, C ;
Strand, D ;
Czaja, J ;
Schlaak, JF ;
Lehr, HA ;
Autschbach, F ;
Schürmann, G ;
Nishimoto, N ;
Yoshizaki, K ;
Ito, H ;
Kishimoto, T ;
Galle, PR ;
Rose-John, S ;
Neurath, MF .
NATURE MEDICINE, 2000, 6 (05) :583-588
[3]   The indigenous gastrointestinal microflora [J].
Berg, RD .
TRENDS IN MICROBIOLOGY, 1996, 4 (11) :430-435
[4]  
BEST WR, 1976, GASTROENTEROLOGY, V70, P439
[5]  
BITTON A, 1995, GASTROENTEROL CLIN N, V24, P541
[6]   BUDESONIDE - AN UPDATED REVIEW OF ITS PHARMACOLOGICAL PROPERTIES, AND THERAPEUTIC EFFICACY IN ASTHMA AND RHINITIS [J].
BROGDEN, RN ;
MCTAVISH, D .
DRUGS, 1992, 44 (03) :375-407
[7]   Oral budesonide is as effective as oral prednisolone in active Crohn's disease [J].
Campieri, M ;
Ferguson, A ;
Doe, W ;
Persson, T ;
Nilsson, LG ;
Malchow, H ;
Prantera, C ;
Mani, V ;
OMorain, C ;
Selby, W ;
Pallone, F ;
diPietralata, MM ;
Sjodahl, R ;
Florin, T ;
Smith, P ;
Bianchi, P ;
Lofberg, R ;
Rutgeerts, P ;
Smallwood, R ;
Lamers, HW ;
TasmanJones, C ;
Hunter, JO ;
Hodgson, H ;
Danielsson, A ;
Lee, FI ;
Piacitelli, G ;
Giovanni, S ;
Ellis, A ;
Weir, DG .
GUT, 1997, 41 (02) :209-214
[8]   A CONTROLLED DOUBLE-BLIND-STUDY OF AZATHIOPRINE IN THE MANAGEMENT OF CROHNS-DISEASE [J].
CANDY, S ;
WRIGHT, J ;
GERBER, M ;
ADAMS, G ;
GERIG, M ;
GOODMAN, R .
GUT, 1995, 37 (05) :674-678
[9]   Drug-induced diarrhoea [J].
Chassany, O ;
Michaux, A ;
Bergmann, JF .
DRUG SAFETY, 2000, 22 (01) :53-72
[10]   T cell specificity and cross reactivity towards enterobacteria, Bacteroides, Bifidobacterium, and antigens from resident intestinal flora in humans [J].
Duchmann, R ;
May, E ;
Heike, M ;
Knolle, P ;
Neurath, M ;
zum Büschenfelde, KHM .
GUT, 1999, 44 (06) :812-818