AIM： To evaluate the efficacy of 5 compared to ：tO granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis. METHODS： In this pilot, prospective, multicenter randomized trial, 20 ...AIM： To evaluate the efficacy of 5 compared to ：tO granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis. METHODS： In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.RESULTS： Nine patients were randomized to 5 granulocyteaphaeresis sessions （group 1） and 11 patients to 10 granulocyteaphaeresis sessions （group 2）. At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported. CONCLUSION： Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.展开更多
Active ulcerative colitis （UC） is frequently associated with infiltration of a large number of leukocytes into the bowel mucosa. Leukocytapheresis is a novel nonphar- macologic approach for active UC, in which leuko...Active ulcerative colitis （UC） is frequently associated with infiltration of a large number of leukocytes into the bowel mucosa. Leukocytapheresis is a novel nonphar- macologic approach for active UC, in which leukocytes are mechanically removed from the circulatory system. Current data indicate that leukocytapheresis is effica- cious in improving response and remission rates with excellent tolerability and safety in patients with UC. Corticosteroid therapy remains a mainstay in the treat- ment of active UC, however, long-term, high doses of corticosteroids usually produce predictable and po- tentially serious side effects. If leukocytapheresis can spare patients from exposure to corticosteroids, the risk of steroid-induced adverse events should be mini- mized. This may be of great benefit to patients because severe side effects of steroids seriously impair health- related quality of life. In this article, we reviewed cur- rent evidence on whether leukocytapheresis can avoid or reduce the use of corticosteroids in the manage- ment of patients with UC. Several studies have shown that leukocytapheresis was effective for steroid-nafve patients with active UC. Furthermore, both short-term and long-term studies have demonstrated the steroid- sparing effects of leukocytapheresis therapy in patients with UC. Although the evidence level is not striking, theavailable data suggest that leukocytapheresis can avoid or reduce the use of corticosteroids in the management of UC. Large, well-designed clinical trials are necessary to more accurately evaluate the steroid-sparing effects of leukocytapheresis in the management of UC.展开更多
AIM:To investigate the therapeutic usefulness of leukocytapheresis (LCAP; Cellsoba) in steroid-naive patients with moderately active ulcerative colitis (UC). METHODS: Eighteen steroid-naive patients with moderately ac...AIM:To investigate the therapeutic usefulness of leukocytapheresis (LCAP; Cellsoba) in steroid-naive patients with moderately active ulcerative colitis (UC). METHODS: Eighteen steroid-naive patients with moderately active UC received one LCAP session every week for fi ve consecutive weeks. RESULTS: The remission rate 8 weeks after the last LCAP session was 61.1% (11/18). All three patients with deep ulcers showed worsening after LCAP. For the remaining 15 patients, who had erosions or geographic ulcers, the average clinical activity index (CAI) score dropped significantly from 9.4 to 3.8 eight weeks after the last LCAP session (t = 4.89, P = 0.001). The average C-reactive protein (CRP) levels before and after LCAP were 1.2 mg/dL and 1.0 mg/dL, respectively. Of the patients with erosions, geographic ulcers, and deep ulcers, 100% (9/9), 33.3% (2/6), and 0% (0/3) were in remission 8 weeks after the last LCAP session, respectively (χ2 = 7.65, P < 0.005). Forty- eight weeks after the last LCAP session, the remission rates for patients with erosions and geographic ulcers were 44.4% (4/9) and 16.7% (1/6), respectively. Only one patient suffered a mild adverse event after LCAP (nausea). CONCLUSION: LCAP is a useful and safe therapyfor steroid-naive UC patients with moderate disease activity. Moreover, the effi cacy of the treatment can be predicted on the basis of endoscopic fi ndings.展开更多
Although systemic steroids are highly efficacious in ulcerative colitis (UC), failure to respond to steroids still poses an important challenge to the surgeon and physician alike. Even if the life time risk of a fulmi...Although systemic steroids are highly efficacious in ulcerative colitis (UC), failure to respond to steroids still poses an important challenge to the surgeon and physician alike. Even if the life time risk of a fulminant UC flare is only 20%, this condition is potentially life threatening and should be managed in hospital. If patients fail 3 to 5 d of intravenous corticosteroids and optimal supportive care, they should be considered for any of three options: intravenous cyclosporine (2 mg/kg for 7 d, and serum level controlled), infliximab (5 mg/kg Ⅳ, 0-2-6 wk) or total colectomy. The choice between these three options is a medical- surgical decision based on clinical signs, radiological and endoscopic findings and blood analysis (CRP, serum albumin). Between 65 and 85% of patients will initially respond to cyclosporine and avoid colectomy on the short term. Over 5 years only 50% of initial responders avoid colectomy and outcomes are better in patients naive to azathioprine (bridging strategy). The data on infliximab as a medical rescue in fulminant colitis are more limited although the efficacy of this anti tumor necrosis factor (TNF) monoclonal antibody has been demonstrated in a controlled trial. Controlled data on the comparative efficacy of cyclosporine and infliximab are not available at this moment. Both drugs are immunosuppressants and are used in combination with steroids and azathioprine, which infers a risk of serious, even fatal, opportunistic infections. Therefore, patients not responding to these agents within 5-7 d should be considered for colectomy and responders should be closely monitored for infections.展开更多
文摘AIM： To evaluate the efficacy of 5 compared to ：tO granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis. METHODS： In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.RESULTS： Nine patients were randomized to 5 granulocyteaphaeresis sessions （group 1） and 11 patients to 10 granulocyteaphaeresis sessions （group 2）. At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported. CONCLUSION： Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.
文摘Active ulcerative colitis （UC） is frequently associated with infiltration of a large number of leukocytes into the bowel mucosa. Leukocytapheresis is a novel nonphar- macologic approach for active UC, in which leukocytes are mechanically removed from the circulatory system. Current data indicate that leukocytapheresis is effica- cious in improving response and remission rates with excellent tolerability and safety in patients with UC. Corticosteroid therapy remains a mainstay in the treat- ment of active UC, however, long-term, high doses of corticosteroids usually produce predictable and po- tentially serious side effects. If leukocytapheresis can spare patients from exposure to corticosteroids, the risk of steroid-induced adverse events should be mini- mized. This may be of great benefit to patients because severe side effects of steroids seriously impair health- related quality of life. In this article, we reviewed cur- rent evidence on whether leukocytapheresis can avoid or reduce the use of corticosteroids in the manage- ment of patients with UC. Several studies have shown that leukocytapheresis was effective for steroid-nafve patients with active UC. Furthermore, both short-term and long-term studies have demonstrated the steroid- sparing effects of leukocytapheresis therapy in patients with UC. Although the evidence level is not striking, theavailable data suggest that leukocytapheresis can avoid or reduce the use of corticosteroids in the management of UC. Large, well-designed clinical trials are necessary to more accurately evaluate the steroid-sparing effects of leukocytapheresis in the management of UC.
文摘AIM:To investigate the therapeutic usefulness of leukocytapheresis (LCAP; Cellsoba) in steroid-naive patients with moderately active ulcerative colitis (UC). METHODS: Eighteen steroid-naive patients with moderately active UC received one LCAP session every week for fi ve consecutive weeks. RESULTS: The remission rate 8 weeks after the last LCAP session was 61.1% (11/18). All three patients with deep ulcers showed worsening after LCAP. For the remaining 15 patients, who had erosions or geographic ulcers, the average clinical activity index (CAI) score dropped significantly from 9.4 to 3.8 eight weeks after the last LCAP session (t = 4.89, P = 0.001). The average C-reactive protein (CRP) levels before and after LCAP were 1.2 mg/dL and 1.0 mg/dL, respectively. Of the patients with erosions, geographic ulcers, and deep ulcers, 100% (9/9), 33.3% (2/6), and 0% (0/3) were in remission 8 weeks after the last LCAP session, respectively (χ2 = 7.65, P < 0.005). Forty- eight weeks after the last LCAP session, the remission rates for patients with erosions and geographic ulcers were 44.4% (4/9) and 16.7% (1/6), respectively. Only one patient suffered a mild adverse event after LCAP (nausea). CONCLUSION: LCAP is a useful and safe therapyfor steroid-naive UC patients with moderate disease activity. Moreover, the effi cacy of the treatment can be predicted on the basis of endoscopic fi ndings.
文摘Although systemic steroids are highly efficacious in ulcerative colitis (UC), failure to respond to steroids still poses an important challenge to the surgeon and physician alike. Even if the life time risk of a fulminant UC flare is only 20%, this condition is potentially life threatening and should be managed in hospital. If patients fail 3 to 5 d of intravenous corticosteroids and optimal supportive care, they should be considered for any of three options: intravenous cyclosporine (2 mg/kg for 7 d, and serum level controlled), infliximab (5 mg/kg Ⅳ, 0-2-6 wk) or total colectomy. The choice between these three options is a medical- surgical decision based on clinical signs, radiological and endoscopic findings and blood analysis (CRP, serum albumin). Between 65 and 85% of patients will initially respond to cyclosporine and avoid colectomy on the short term. Over 5 years only 50% of initial responders avoid colectomy and outcomes are better in patients naive to azathioprine (bridging strategy). The data on infliximab as a medical rescue in fulminant colitis are more limited although the efficacy of this anti tumor necrosis factor (TNF) monoclonal antibody has been demonstrated in a controlled trial. Controlled data on the comparative efficacy of cyclosporine and infliximab are not available at this moment. Both drugs are immunosuppressants and are used in combination with steroids and azathioprine, which infers a risk of serious, even fatal, opportunistic infections. Therefore, patients not responding to these agents within 5-7 d should be considered for colectomy and responders should be closely monitored for infections.
