메뉴 건너뛰기




Volumn 7, Issue 3, 2013, Pages 239-247

Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: A multicentre, double-blind, randomized, parallel-group Phase II study

Author keywords

Budesonide; Crohn's disease; Japanese patients

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BUDESONIDE; MESALAZINE; PLACEBO; SALAZOSULFAPYRIDINE; SERUM ALBUMIN;

EID: 84873709770     PISSN: 18739946     EISSN: 18764479     Source Type: Journal    
DOI: 10.1016/j.crohns.2012.06.006     Document Type: Article
Times cited : (38)

References (32)
  • 1
    • 34248136340 scopus 로고    scopus 로고
    • Inflammatory bowel disease: clinical aspects and established and evolving therapies
    • Baumgart D.C., Sandborn W.J. Inflammatory bowel disease: clinical aspects and established and evolving therapies. Lancet 2007, 369(9573):1641-1657.
    • (2007) Lancet , vol.369 , Issue.9573 , pp. 1641-1657
    • Baumgart, D.C.1    Sandborn, W.J.2
  • 2
    • 0033785374 scopus 로고    scopus 로고
    • Crohn's disease in Japan: diagnostic criteria and epidemiology
    • Yao T., Matsui T., Hiwatashi N. Crohn's disease in Japan: diagnostic criteria and epidemiology. Dis Colon Rectum 2000, 43(10 Suppl.):S85-S93.
    • (2000) Dis Colon Rectum , vol.43 , Issue.10 SUPPL.
    • Yao, T.1    Matsui, T.2    Hiwatashi, N.3
  • 3
    • 34248136828 scopus 로고    scopus 로고
    • Inflammatory bowel disease: cause and immunobiology
    • Baumgart D.C., Carding S.R. Inflammatory bowel disease: cause and immunobiology. Lancet 2007, 369(9573):1627-1640.
    • (2007) Lancet , vol.369 , Issue.9573 , pp. 1627-1640
    • Baumgart, D.C.1    Carding, S.R.2
  • 5
    • 0028838411 scopus 로고
    • Long-term follow-up study of Crohn's disease in Japan. The Research Committee of Inflammatory Bowel Disease in Japan
    • Iida M., Yao T., Okada M. Long-term follow-up study of Crohn's disease in Japan. The Research Committee of Inflammatory Bowel Disease in Japan. J Gastroenterol 1995, 30(Suppl. 8):17-19.
    • (1995) J Gastroenterol , vol.30 , Issue.SUPPL. 8 , pp. 17-19
    • Iida, M.1    Yao, T.2    Okada, M.3
  • 6
    • 0344825279 scopus 로고    scopus 로고
    • Clinical course and longterm prognosis of Japanese patients with Crohn's disease: predictive factors, rates of operation, and mortality
    • Oriuchi T., Hiwatashi N., Kinouchi Y., Takahashi S., Takagi S., Negoro K., et al. Clinical course and longterm prognosis of Japanese patients with Crohn's disease: predictive factors, rates of operation, and mortality. J Gastroenterol 2003, 38(10):942-953.
    • (2003) J Gastroenterol , vol.38 , Issue.10 , pp. 942-953
    • Oriuchi, T.1    Hiwatashi, N.2    Kinouchi, Y.3    Takahashi, S.4    Takagi, S.5    Negoro, K.6
  • 7
    • 0142090735 scopus 로고    scopus 로고
    • Mortality and cause of death in Japanese patients with Crohn's disease
    • Uno H., Yao T., Matsui T., Sakurai T., Iida M., Matsumoto T., et al. Mortality and cause of death in Japanese patients with Crohn's disease. Dis Colon Rectum 2003, 46(10 Suppl.):S15-S21.
    • (2003) Dis Colon Rectum , vol.46 , Issue.10 SUPPL.
    • Uno, H.1    Yao, T.2    Matsui, T.3    Sakurai, T.4    Iida, M.5    Matsumoto, T.6
  • 8
    • 21844466250 scopus 로고    scopus 로고
    • Nutritional therapy for Crohn's disease in Japan
    • Matsui T., Sakurai T., Yao T. Nutritional therapy for Crohn's disease in Japan. J Gastroenterol 2005, 40(Suppl. 16):25-31.
    • (2005) J Gastroenterol , vol.40 , Issue.SUPPL. 16 , pp. 25-31
    • Matsui, T.1    Sakurai, T.2    Yao, T.3
  • 9
    • 0027997229 scopus 로고
    • A comparison of budesonide with prednisolone for active Crohn's disease
    • Rutgeerts P., Lofberg R., Malchow H., Lamers C., Olaison G., Jewell D., et al. A comparison of budesonide with prednisolone for active Crohn's disease. N Engl J Med 1994, 331(13):842-845.
    • (1994) N Engl J Med , vol.331 , Issue.13 , pp. 842-845
    • Rutgeerts, P.1    Lofberg, R.2    Malchow, H.3    Lamers, C.4    Olaison, G.5    Jewell, D.6
  • 10
    • 0030870541 scopus 로고    scopus 로고
    • Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group
    • Campieri M., Ferguson A., Doe W., Persson T., Nilsson L.G. Oral budesonide is as effective as oral prednisolone in active Crohn's disease. The Global Budesonide Study Group. Gut 1997, 41(2):209-214.
    • (1997) Gut , vol.41 , Issue.2 , pp. 209-214
    • Campieri, M.1    Ferguson, A.2    Doe, W.3    Persson, T.4    Nilsson, L.G.5
  • 11
    • 0032491040 scopus 로고    scopus 로고
    • A comparison of budesonide and mesalamine for active Crohn's disease. International Budesonide-Mesalamine Study Group
    • Thomsen O.O., Cortot A., Jewell D., Wright J.P., Winter T., Veloso F.T., et al. A comparison of budesonide and mesalamine for active Crohn's disease. International Budesonide-Mesalamine Study Group. N Engl J Med 1998, 339(6):370-374.
    • (1998) N Engl J Med , vol.339 , Issue.6 , pp. 370-374
    • Thomsen, O.O.1    Cortot, A.2    Jewell, D.3    Wright, J.P.4    Winter, T.5    Veloso, F.T.6
  • 12
    • 0035981630 scopus 로고    scopus 로고
    • Budesonide (Entocort EC capsules): a review of its therapeutic use in the management of active Crohn's disease in adults
    • McKeage K., Goa K.L. Budesonide (Entocort EC capsules): a review of its therapeutic use in the management of active Crohn's disease in adults. Drugs 2002, 62(15):2263-2282.
    • (2002) Drugs , vol.62 , Issue.15 , pp. 2263-2282
    • McKeage, K.1    Goa, K.L.2
  • 13
    • 0141557900 scopus 로고    scopus 로고
    • Oral budesonide in the management of Crohn's disease
    • Hofer K.N. Oral budesonide in the management of Crohn's disease. Ann Pharmacother 2003, 37(10):1457-1464.
    • (2003) Ann Pharmacother , vol.37 , Issue.10 , pp. 1457-1464
    • Hofer, K.N.1
  • 14
    • 79251534064 scopus 로고    scopus 로고
    • Budesonide 9mg is at least as effective as mesalamine 4.5g in patients with mildly to moderately active Crohn's disease
    • Tromm A., Bunganic I., Tomsova E., Tulassay Z., Lukas M., Kykal J., et al. Budesonide 9mg is at least as effective as mesalamine 4.5g in patients with mildly to moderately active Crohn's disease. Gastroenterology 2011, 140(2):425-434.
    • (2011) Gastroenterology , vol.140 , Issue.2 , pp. 425-434
    • Tromm, A.1    Bunganic, I.2    Tomsova, E.3    Tulassay, Z.4    Lukas, M.5    Kykal, J.6
  • 16
    • 0017227303 scopus 로고
    • Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study
    • Best W.R., Becktel J.M., Singleton J.W., Kern F. Development of a Crohn's disease activity index. National Cooperative Crohn's Disease Study. Gastroenterology 1976, 70(3):439-444.
    • (1976) Gastroenterology , vol.70 , Issue.3 , pp. 439-444
    • Best, W.R.1    Becktel, J.M.2    Singleton, J.W.3    Kern, F.4
  • 17
    • 1642503859 scopus 로고    scopus 로고
    • Reliability, validity, and responsiveness of the Japanese version of the Inflammatory Bowel Disease Questionnaire
    • Hashimoto H., Green J., Iwao Y., Sakurai T., Hibi T., Fukuhara S. Reliability, validity, and responsiveness of the Japanese version of the Inflammatory Bowel Disease Questionnaire. J Gastroenterol 2003, 38(12):1138-1143.
    • (2003) J Gastroenterol , vol.38 , Issue.12 , pp. 1138-1143
    • Hashimoto, H.1    Green, J.2    Iwao, Y.3    Sakurai, T.4    Hibi, T.5    Fukuhara, S.6
  • 18
    • 0032580377 scopus 로고    scopus 로고
    • Interval estimation for the difference between independent proportions: comparison of eleven methods
    • Newcombe R.G. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998, 17(8):873-890.
    • (1998) Stat Med , vol.17 , Issue.8 , pp. 873-890
    • Newcombe, R.G.1
  • 19
    • 0028071632 scopus 로고
    • Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group
    • Greenberg G.R., Feagan B.G., Martin F., Sutherland L.R., Thomson A.B., Williams C.N., et al. Oral budesonide for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. N Engl J Med 1994, 331(13):836-841.
    • (1994) N Engl J Med , vol.331 , Issue.13 , pp. 836-841
    • Greenberg, G.R.1    Feagan, B.G.2    Martin, F.3    Sutherland, L.R.4    Thomson, A.B.5    Williams, C.N.6
  • 20
    • 0036311105 scopus 로고    scopus 로고
    • Budesonide CIR capsules (once or twice daily divided-dose) in active Crohn's disease: a randomized placebo-controlled study in the United States
    • Tremaine W.J., Hanauer S.B., Katz S., Winston B.D., Levine J.G., Persson T., et al. Budesonide CIR capsules (once or twice daily divided-dose) in active Crohn's disease: a randomized placebo-controlled study in the United States. Am J Gastroenterol 2002, 97(7):1748-1754.
    • (2002) Am J Gastroenterol , vol.97 , Issue.7 , pp. 1748-1754
    • Tremaine, W.J.1    Hanauer, S.B.2    Katz, S.3    Winston, B.D.4    Levine, J.G.5    Persson, T.6
  • 21
    • 84873726213 scopus 로고    scopus 로고
    • AstraZeneca Entocort EC (budesonide) capsules: prescribing information
    • Available from
    • AstraZeneca Entocort EC (budesonide) capsules: prescribing information Available from. http://www.entocortec.com/PDF/ENTOCORT_PI.pdf.
  • 22
    • 18144450891 scopus 로고    scopus 로고
    • Efficacy of treatment with chimeric monoclonal antibody (infliximab) to tumor necrosis factor-alpha for Crohn's disease in Japan: evaluation by rapid turnover proteins, and radiologic and endoscopic findings
    • Asakura H., Yao T., Matsui T., Koganei K., Fukushima T., Takazoe M., et al. Efficacy of treatment with chimeric monoclonal antibody (infliximab) to tumor necrosis factor-alpha for Crohn's disease in Japan: evaluation by rapid turnover proteins, and radiologic and endoscopic findings. J Gastroenterol Hepatol 2001, 16(7):763-769.
    • (2001) J Gastroenterol Hepatol , vol.16 , Issue.7 , pp. 763-769
    • Asakura, H.1    Yao, T.2    Matsui, T.3    Koganei, K.4    Fukushima, T.5    Takazoe, M.6
  • 23
    • 44749089544 scopus 로고    scopus 로고
    • Therapeutic efficacy of infliximab on patients with short duration of Crohn's disease: a Japanese multicenter survey
    • Matsumoto T., Iida M., Motoya S., Haruma K., Suzuki Y., Kobayashi K., et al. Therapeutic efficacy of infliximab on patients with short duration of Crohn's disease: a Japanese multicenter survey. Dis Colon Rectum 2008, 51(6):916-923.
    • (2008) Dis Colon Rectum , vol.51 , Issue.6 , pp. 916-923
    • Matsumoto, T.1    Iida, M.2    Motoya, S.3    Haruma, K.4    Suzuki, Y.5    Kobayashi, K.6
  • 24
    • 34347387623 scopus 로고    scopus 로고
    • Open label trial of clarithromycin therapy in Japanese patients with Crohn's disease
    • Inoue S., Nakase H., Matsuura M., Ueno S., Uza N., Kitamura H., et al. Open label trial of clarithromycin therapy in Japanese patients with Crohn's disease. J Gastroenterol Hepatol 2007, 22(7):984-988.
    • (2007) J Gastroenterol Hepatol , vol.22 , Issue.7 , pp. 984-988
    • Inoue, S.1    Nakase, H.2    Matsuura, M.3    Ueno, S.4    Uza, N.5    Kitamura, H.6
  • 25
    • 0037986771 scopus 로고    scopus 로고
    • Metronidazole plus ciprofloxacin therapy for active Crohn's disease
    • Ishikawa T., Okamura S., Oshimoto H., Kobayashi R., Mori M. Metronidazole plus ciprofloxacin therapy for active Crohn's disease. Intern Med 2003, 42(4):318-321.
    • (2003) Intern Med , vol.42 , Issue.4 , pp. 318-321
    • Ishikawa, T.1    Okamura, S.2    Oshimoto, H.3    Kobayashi, R.4    Mori, M.5
  • 26
    • 57249089077 scopus 로고    scopus 로고
    • Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin
    • Feagan B.G., Greenberg G.R., Wild G., Fedorak R.N., Pare P., McDonald J.W., et al. Treatment of active Crohn's disease with MLN0002, a humanized antibody to the alpha4beta7 integrin. Clin Gastroenterol Hepatol 2008, 6(12):1370-1377.
    • (2008) Clin Gastroenterol Hepatol , vol.6 , Issue.12 , pp. 1370-1377
    • Feagan, B.G.1    Greenberg, G.R.2    Wild, G.3    Fedorak, R.N.4    Pare, P.5    McDonald, J.W.6
  • 27
    • 33846242958 scopus 로고    scopus 로고
    • Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial
    • Colombel J.F., Sandborn W.J., Rutgeerts P., Enns R., Hanauer S.B., Panaccione R., et al. Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial. Gastroenterology 2007, 132(1):52-65.
    • (2007) Gastroenterology , vol.132 , Issue.1 , pp. 52-65
    • Colombel, J.F.1    Sandborn, W.J.2    Rutgeerts, P.3    Enns, R.4    Hanauer, S.B.5    Panaccione, R.6
  • 28
    • 0034242597 scopus 로고    scopus 로고
    • Quality of life rapidly improves with budesonide therapy for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group
    • Irvine E.J., Greenberg G.R., Feagan B.G., Martin F., Sutherland L.R., Thomson A.B., et al. Quality of life rapidly improves with budesonide therapy for active Crohn's disease. Canadian Inflammatory Bowel Disease Study Group. Inflamm Bowel Dis 2000, 6(3):181-187.
    • (2000) Inflamm Bowel Dis , vol.6 , Issue.3 , pp. 181-187
    • Irvine, E.J.1    Greenberg, G.R.2    Feagan, B.G.3    Martin, F.4    Sutherland, L.R.5    Thomson, A.B.6
  • 29
    • 33744964650 scopus 로고    scopus 로고
    • Beclomethasone dipropionate for the treatment of mild-to-moderate Crohn's disease: an open-label, budesonide-controlled, randomized study
    • Tursi A., Giorgetti G.M., Brandimarte G., Elisei W., Aiello F. Beclomethasone dipropionate for the treatment of mild-to-moderate Crohn's disease: an open-label, budesonide-controlled, randomized study. Med Sci Monit 2006, 12(6):PI29-PI32.
    • (2006) Med Sci Monit , vol.12 , Issue.6
    • Tursi, A.1    Giorgetti, G.M.2    Brandimarte, G.3    Elisei, W.4    Aiello, F.5
  • 30
    • 0036131469 scopus 로고    scopus 로고
    • Budesonide and mesalazine in active Crohn's disease: a comparison of the effects on quality of life
    • Thomsen O.O., Cortot A., Jewell D., Wright J.P., Winter T., Veloso F.T., et al. Budesonide and mesalazine in active Crohn's disease: a comparison of the effects on quality of life. Am J Gastroenterol 2002, 97(3):649-653.
    • (2002) Am J Gastroenterol , vol.97 , Issue.3 , pp. 649-653
    • Thomsen, O.O.1    Cortot, A.2    Jewell, D.3    Wright, J.P.4    Winter, T.5    Veloso, F.T.6
  • 32
    • 6044261115 scopus 로고    scopus 로고
    • Pharmacokinetics of budesonide (Entocort EC) capsules for Crohn's disease
    • Edsbacker S., Andersson T. Pharmacokinetics of budesonide (Entocort EC) capsules for Crohn's disease. Clin Pharmacokinet 2004, 43(12):803-821.
    • (2004) Clin Pharmacokinet , vol.43 , Issue.12 , pp. 803-821
    • Edsbacker, S.1    Andersson, T.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.