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溃疡性肠炎 共识2010-2

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溃疡性肠炎 共识2010-2 ; accepted 23 November 2007 ava i l ab l e a t www.sc i enced i r ec t . com Journal of Crohn's and Colitis (2008) 2, 24–62 Azathioprine; Infliximab; Ileal pouch-anal anastomosis Contents 5. Medical management of active ulcerative colitis. . . . . . . . . . . ....
溃疡性肠炎 共识2010-2
; accepted 23 November 2007 ava i l ab l e a t www.sc i enced i r ec t . com Journal of Crohn's and Colitis (2008) 2, 24–62 Azathioprine; Infliximab; Ileal pouch-anal anastomosis Contents 5. Medical management of active ulcerative colitis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.1. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.1.1. Disease activity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.1.2. Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.2. Treatment according to site of disease and disease activity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.2.1. Proctitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 5.2.2. Left sided colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.2.3. Extensive ulcerative colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 5.2.4. Severe ulcerative colitis of any extent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 5.2.5. Intravenous-steroid resistant ulcerative colitis of any extent . . . . . . . . . . . . . . . . . . . . . . 29 5.2.6. Toxic dilatation and complications of severe ulcerative colitis . . . . . . . . . . . . . . . . . . . . . 31 5.2.7. Refractory proctitis and distal colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Received 23 November 2007 KEYWORDS Ulcerative colitis; Acute severe colitis; Mesalazine; SPECIAL ARTICLE European evidence-based Consensus on the management of ulcerative colitis: Current management S.P.L. Travis ⁎,1, E.F. Stange ⁎,1, M. Lémann, T. Øresland, W.A. Bemelman, Y. Chowers, J.F. Colombel, G. D'Haens, S. Ghosh, P. Marteau, W. Kruis, N.J.McC. Mortensen, F. Penninckx, M. Gassull for the European Crohn's and Colitis Organisation (ECCO) ⁎ Corresponding authors. Travis is to be contacted at John Radcliffe Hospital, Oxford, OX3 9DU, UK. Tel.: +44 1865 228753; fax: +44 1865 228763. Stange, Department of Internal Medicine 1, Robert Bosch Krankenhaus, PO Box 501120 Auerbachstr, 110, 70341 Stuttgart, Germany. Tel.: +49 711 81013404; fax: +49 711 81013793. E-mail addresses: simon.travis@ndm.ox.ac.uk (S.P.L. Travis), Eduard.Stange@rbk.de (E.F. Stange). 1 These authors acted as convenors of the Consensus and contributed equally to the work. 1873-9946/$ - see front matter © 2007 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.crohns.2007.11.002 25ECCO Consensus on UC: Current management 5.3. Treatment according to the course or behaviour of disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 5.3.1. Treatment of relapse compared to new cases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 5.3.2. Early relapse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 5.3.3. ‘Steroid-dependent’, active ulcerative colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 5.3.4. Oral steroid-refractory ulcerative colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 5.3.5. Immunomodulator-refractory ulcerative colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 5.4. Therapy-specific considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 5.4.1. Aminosalicylates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 5.4.2. Corticosteroids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 5.4.3. Infliximab (IFX) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 5.4.4. Other biological therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 5.4.5. Thiopurines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 5.4.6. Methotrexate (MTX) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 5.4.7. Calcineurin inhibitors (ciclosporin (CsA) and tacrolimus) . . . . . . . . . . . . . . . . . . . . . . . . . 38 5.4.8. Alternative therapies whose role remains to be established . . . . . . . . . . . . . . . . . . . . . . . 38 5.5. Preparation for the period after treatment of active disease . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 6. Maintenance of remission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 6.1. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 6.1.1. Maintenance therapy trial design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 6.1.2. Pattern of disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 6.1.3. Risk factors for relapse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 6.2. Medications for maintenance of remission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 6.2.1. Aminosalicylates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 6.2.2. Thiopurines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 6.2.3. Infliximab (IFX) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 6.2.4. Probiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 6.2.5. Other treatments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 6.3. Duration of maintenance therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 7. Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 7.1. General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 7.2. Technical considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 7.2.1. Surgery for acute severe colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 7.2.2. Managing the rectal remnant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 7.2.3. Site of anastomosis for restorative poctocolectomy . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 7.2.4. Anastomostic technique for restorative proctocolectomy . . . . . . . . . . . . . . . . . . . . . . . . 48 7.2.5. Site of anastomosis for neoplasia complicating colitis . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 7.2.6. Role of covering ileostomy for restorative proctocolectomy . . . . . . . . . . . . . . . . . . . . . . . . 49 7.2.7. Number of procedures to maintain competency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 7.2.8. Salvage surgery for pouches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 7.3. Follow-up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 7.3.1. General pouch follow up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 7.3.2. Pouch surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 7.4. Fertility and delivery in patients with a restorative proctocolectomy . . . . . . . . . . . . . . . . . . . . . . 50 7.4.1. Impact of pelvic surgery on fecundity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 7.4.2. Mode of delivery for patients with restorative proctocolectomy . . . . . . . . . . . . . . . . . . . . 50 7.5. Surgical choices in addition to restorative proctocolectomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 7.5.1. Age . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 7.5.2. Continent ileostomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 7.5.3. Ileorectal anastomosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 7.5.4. Cancer surveillance of the rectal remnant after colectomy . . . . . . . . . . . . . . . . . . . . . . . . . 51 7.5.5. Pouch excision after pouch failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 7.5.6. Laparoscopic pouch surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 7.5.7. Pouch surgery for indeterminate colitis, or IBD yet-to-be classified . . . . . . . . . . . . . . . . . . 51 7.6. Surgery and medication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 7.6.1. Perioperative prednisolone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51 7.6.2. Perioperative azathioprine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 7.6.3. Perioperative anti-TNF therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 7.7. Colectomy in practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 Acknowledgements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Active colitis limited to the rectum should first be treated topically. Suppositories are more appropriate than enemas, because suppositories target the site of inflam- mation; only 40% of foam enemas and 10% of liquid enemas can be detected in the rectum after 4 hr.10 Topical mesalazine (5-ASA) induced remission in active proctitis and distal colitis in 31–80% (median 67%) compared to 7– 11% given placebo in a meta-analysis of 11 trials in 778 patients.11 Topical mesalazine is at least twice as effective as topical steroids whether for symptoms (OR 2.42, 95%CI 1.72–3.41), endoscopy (OR 1.89, 95%CI 1.29–2.76), or histology (OR 2.03, 95%CI 1.28–3.20).12 Mesalazine suppo- sitories 1 g daily are highly effective.13 There is no dose response to topical therapy above a dose of 1 g mesalazine daily. Clinical (and endoscopic) remission can occur in up to 64% (52%) within 2 weeks.13 Topical steroids should be reserved 26 S.P.L. Travis et al. 5. Medical management of active ulcerative colitis 5.1. General The general principles for treating active ulcerative colitis are to consider the activity, distribution (proctitis, left-sided, extensive,1 and pattern of disease (relapse frequency, course of disease, response to previous medications, side-effect profile of medication, extra-intestinal manifestation), before treatment decisions are made in conjunction with the patient. 5.1.1. Disease activity The principal scoring systems used for clinical trials are covered in Section 5.1.2 and have been comprehensively reviewed.2 Some additional points are clinically relevant. In clinical practice it matters most to distinguish severe ulcerative colitis necessitating hospital admission from those with mild or moderate disease who can generally be treated as outpatients. The simplest, best validated and most widely used index for identifying acute severe UC remains that of Truelove & Wi_tts 3: any patient who has a bloody stool frequency ≥6/day and a tachycardia (N90 bpm), or temperature N37.8 °C, or anaemia (haemoglobin b10.5 g/dL), or an elevated ESR (N30 mm/ h) has severe ulcerative colitis (Table 1.3). This index has been used in 20/32 studies of intensive intravenous treatment for severe UC.4 Only one additional criterion in addition to the bloody stool frequency ≥6/day is needed to define a severe attack.5 While these criteria have the major limitation of being unresponsive and cannot track the course of disease, they do distinguish the severe from the moderate or mild and have value in everyday practice because they are easy to use, which no other index achieves. It should be standard practice to confirm active colitis by sigmoidoscopy or proctoscopy before starting treatment. Rectal mucosal biopsy helps exclude unexpected causes of symptoms similar to active disease (such as cytomegalovirus, amoebic, or other infection, rectal mucosal prolapse, Crohn's disease, or even irritable bowel syndrome and haemorrhoidal bleeding). 5.1.2. Approach Patients should be encouraged to participate actively in therapeutic decisions. In a systematic review of clinical trials, a mean 15% (95%CI 10–21%) of patients entered remission when receiving placebo.9 Prescribing no treat- ment, however, is rarely an option, because rectal bleeding and urgency are sufficiently concerning to the patient to justify topical therapy even if no systemic therapy is recommended. The appropriate choice of medication depends on many factors that are best tailored to the individual. Despite general agreement that treatment decisions for active UC should be based on the distribution, activity and pattern of disease, numbers in clinical trials often become too small for statistically valid conclusions to be drawn when patients are stratified according to the distribution and pattern of disease.7 Different galenic preparations are released at different sites and may have local activity as second line therapy for patientswho are intolerant of topical mesalazine.14 Topical mesalazine is more effective than oral mesalazine for proctitis,15 but the combination of oral and topical mesalazine may be better than either alone for colitis b50 cm from the anal verge.16 There have been no trials on combination therapy for proctitis alone. Combining topical mesalazine and steroids also helps: beclomethasone dipropio- nate (3mg) andmesalazine (2 g) enemas produced significantly better clinical, endoscopic and histological improvement than either agent alone.17 Patients who fail to improve on topical mesalazine and topical corticosteroids should be treated with additional oral mesalazine or, alternatively, oral prednisolone, as if the colitis was more extensive or severe (below). Treatment of refractory proctitis is discussed in Section 5.2.7. (such as mesalazine preparations, budesonide, or types of enema). The choice is influenced by the balance between drug potency and side-effects; previous response to treatment (especially when considering treatment of a relapse, treatment of steroid-dependent or -refractory disease, or immunomodulator-refractory disease, Section 5.3); and the presence of extraintestinal manifestations (indicating the need for systemic therapy). 5.2. Treatment according to site of disease and disease activity 5.2.1. Proctitis ECCO statement 5A Mesalazine 1 g suppository daily is the preferred initial treatment for mild or moderately active proctitis [EL1b, RG B]. Mesalazine foam enemas are an effective alternative [EL1b]. Suppositories may deliver drug more effectively to the rectum and are better tolerated than enemas [EL3, RG C]. Combining topical mesalazine with oral mesala- zine or topical steroid, may bemore effective than either alone and should be considered for escala- tion of treatment [EL1b, RG B]. Oral mesalazine alone is less effective [EL1b] zine.21 This is a modest benefit— (NNT to induce remission=10 (95% CI 7–21), and NNT=4 to induce response or remission (95% CI 3–6)22). A systematic review of 9 placebo controlled trials of oral aminosalicylates for active ulcerative colitis showed the overall remission rate to be only 20%.22 Two further placebo controlled trials of a multimatrix mesalazine formulation for mild-moderate UC have been published more recently,23,24 as well as a combined analysis.25 The first study randomized 280 patients to either MMx 4.8 g once daily, MMx 1.2 g twice daily, or placebo for 8 weeks. The primary endpoint was remission at 8 weeks. Once and twice daily dosing produced similar results, with remission rates of 29% and 34% respectively, compared to 13% on placebo (pb0.01)23 (see also Section 6.2.1). A further placebo-controlled study compared MMx mesalazine with Asacol® in 346 patients with active, mild-to-moderate UC.24 Clinical and endoscopic remission was achieved in 40.5% given MMxmesalazine 2.4 g/day once daily and 41.2% given 4.8 g/day once daily compared to 22.1% on placebo (p=0.01 and 0.007 respectively) and 32.6% given Asacol® (ns). determining the speed of response. If rectal bleeding persists beyond 10–14days, then the response canbe said to be slowand therapy augmented, which usually means decisive treatment with steroids. There is something of a transatlantic divide on the threshold for using steroids. The practice inmany European countries is to introduce oral steroids at an early stage, because aminosalicy- lates cannot match the speed of response for patients suffering miserable symptoms. The US concern about steroid-induced side-effects is shared by their patients, but may also be self- fulfilling. Late introduction of steroids selects a more refractory population. Steroids with a colonic release mechanism and low systemicbioavailabilty suchasbeclomethasonediproprionateor budesonide are becoming available. In the largest and most recent study of 177 patients with active left-sided or extensive colitis, beclomethasone diproprionate 5 mg/day had an effect 27ECCO Consensus on UC: Current management Meta-analysis of mesalazine for active UC shows a dose- response for improvement from b2.0 g, 2.0–2.9 g and N3.0 g 5.2.2. Left sided colitis Combined oral and topical mesalazine therapy is re- commended.14 There has been just one trial on 60 patients of combined therapy for distal colitis compared to oral or topical therapy alone, showing it toworkmore rapidly andeffectively.16 However, extrapolation from a trial of combination therapy for extensive colitis,18 evidence that topical therapy achieves higher rectal mucosal 5ASA concentrations than oral therapy19 and is associated with improved clinical outcome,19,20 are consistent with the recommendation. Most therapeutic trials of mild or moderate active colitis include patients with any disease distribution other than proctitis, but both oral and topical aminosalicylates (mesala- zine) are effective for left-sided colitis. In a meta-analysis of oral 5-ASA compounds for active colitis,21 mesalazine was more than twice as effective as placebo (OR 0.40, 95%CI 0.30–0.53), but not significantly better than sulphasalazine (OR 0.83, 95%CI 0.60–1.13) for the failure to induce global clinical improvement or remission. Therewas a trend formesalazine to be better than sulfasalazine for endoscopic improvement (OR 0.66, 95%CI 0.42–1.04) and mesalazine is better tolerated than sulfasala- ECCO statement 5B Left-sided active ulcerative colitis of mild-moderate severity should initially be treated with topical aminosalicylates [EL1b, RG B] combined with oral mesalazineN2 g/day [EL1a, RGA]. Topical steroids or mesalazine alone are also effective, but less effec- tive than combination therapy [EL1b, RG B]. Topical mesalazine is more effective than topical steroid [EL1a, RG A].
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