二丙酸倍氯米松与美沙拉秦灌肠治疗活动性溃疡性结肠炎的疗效比较
|
摘要
目的:比较二丙酸倍氯米松(beclomethasone dipropionate,BDP)与美沙拉秦灌肠治疗活动性溃疡性结肠炎的疗效和安全性。方法:纳入2018年收治的轻至中度远端溃疡性结肠炎患者102例进行队列研究,根据随机数字表法分为BDP组(52例,采用BDP灌肠治疗)和美沙拉秦组(50例,采用美沙拉秦灌肠治疗)。治疗8周后,比较两组患者的疾病活动指数值(disease activity index,DAI)评分、临床疗效及安全性。结果:治疗后,两组患者的DAI评分较治疗前明显降低,差异均有统计学意义(P<0.05);BDP组患者的改善率为82.69%(95%CI=0.75～0.92),美沙拉秦组患者的改善率为80.00%(95%CI=0.72～0.90),两组的差异无统计学意义(P>0.05);BDP组患者的缓解率为34.00%(95%CI=0.25～0.54),美沙拉秦组患者的缓解率为32.00%(95%CI=0.34～0.60),两组的差异无统计学意义(P>0.05)。两种局部治疗方案的耐受性均良好;与基线相比,BDP组患者中未观察到早晨皮质醇水平变化情况。结论:BDP灌肠治疗活动性溃疡性结肠炎的疗效与美沙拉秦相当,且安全性较好,对于下丘脑-垂体-肾上腺轴的功能没有影响。
OBJECTIVE: To compare the efficacy and safety between beclomethasone dipropionate(BDP) and mesalazine in enema treatment of active ulcerative colitis. METHODS: Cohort study was conducted on 102 patients with mild or moderate active ulcerative colitis in 2018, which were divided into BDP group(52 cases, given BDP for enema) and mesalazine group(50 cases, given mesalazine for enema) via random number table. After 8-week treatment, differences in disease activity index(DAI) scores, clinical efficacy and safety between two groups were compared. RESULTS: After treatment, the DAI scores of both groups were significantly lower than those of before treatment, with statistically significant difference(P<0.05); the improvement rate of BDP group was 82.69%(95%CI=0.75-0.92), and that of mesalazine group was 80.00%(95%CI=0.72-0.90), the difference had no statistical significance(P>0.05); the remission rate of BDP group was 34.00%(95%CI=0.25-0.54), and that of mesalazine group was 32.00%(95%CI=0.34-0.60), the difference had no statistical significance(P>0.05). Both topical treatment regimens were well tolerated; compared with the baseline, no changes in cortisol levels in morning were observed in BDP group. CONCLUSIONS: The efficacy of BDP in enema treatment of active ulcerative colitis is comparable to that of mesalazine, with good safety, which has no effects on function of the hypothalamic-pituitary-adrenal axis.
OBJECTIVE: To compare the efficacy and safety between beclomethasone dipropionate(BDP) and mesalazine in enema treatment of active ulcerative colitis. METHODS: Cohort study was conducted on 102 patients with mild or moderate active ulcerative colitis in 2018, which were divided into BDP group(52 cases, given BDP for enema) and mesalazine group(50 cases, given mesalazine for enema) via random number table. After 8-week treatment, differences in disease activity index(DAI) scores, clinical efficacy and safety between two groups were compared. RESULTS: After treatment, the DAI scores of both groups were significantly lower than those of before treatment, with statistically significant difference(P<0.05); the improvement rate of BDP group was 82.69%(95%CI=0.75-0.92), and that of mesalazine group was 80.00%(95%CI=0.72-0.90), the difference had no statistical significance(P>0.05); the remission rate of BDP group was 34.00%(95%CI=0.25-0.54), and that of mesalazine group was 32.00%(95%CI=0.34-0.60), the difference had no statistical significance(P>0.05). Both topical treatment regimens were well tolerated; compared with the baseline, no changes in cortisol levels in morning were observed in BDP group. CONCLUSIONS: The efficacy of BDP in enema treatment of active ulcerative colitis is comparable to that of mesalazine, with good safety, which has no effects on function of the hypothalamic-pituitary-adrenal axis.
引文
[1] Ungaro R,Mehandru S,Allen PB,et al.Ulcerative colitis[J].Lancet,2017,389(10080):1756-1770.
[2] Morilla I,Uzzan M,Laharie D,et al.Colonic MicroRNA Profiles,Identified by a Deep Learning Algorithm,That Predict Responses to Therapy of Patients With Acute Severe Ulcerative Colitis[J].Clin Gastroenterol Hepatol,2019,17(5):905-913.
[3] Rizzello F,Mazza M,Salice M,et al.The safety of beclomethasone dipropionate in the treatment of ulcerative colitis[J].Expert Opin Drug Saf,2018,17(9):963-969.
[4] Kobayashi Y,Yasuba H,Asako M,et al.HFA-BDP Metered-Dose Inhaler Exhaled Through the Nose Improves Eosinophilic Chronic Rhino-sinusitis With Bronchial Asthma:A Blinded,Placebo Con-trolled Study[J].Front Immunol,2018,9:2192.
[5] Ostrom NK,Raphael G,Tillinghast J,et al.Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma[J].Allergy Asthma Proc,2018,39(2):117-126.
[6] Zhao X,Zhou C,Ma J,et al.Efficacy and safety of rectal 5-amin-osalicylic acid versus corticosteroids in active distal ulcerative colitis:a systematic review and network meta-analysis[J].Sci Rep,2017,7:46693.
[7] 王生锋.糖皮质激素在重度溃疡性结肠炎治疗中的应用效果分析[J].中国肛肠病杂志,2018,38(11):39-40.
[8] Biancone L,Gionchetti P,Blanco Gdel V,et al.Beclomethasone dipropionate versus mesalazine in distal ulcerative colitis:a multic-enter,randomized,double-blind study[J].Dig Liver Dis,2007,39(4):329-337.
[9] Jairath V,Jeyarajah J,Zou G,et al.A composite disease activity index for early drug development in ulcerative colitis:development and validation of the UC-100 score[J].Lancet Gastroenterol Hep-atol,2019,4(1):63-70.
[10] Mohammed Vashist N,Samaan M,Mosli MH,et al.Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis[J].Cochrane Database Syst Rev,2018,1:CD011450.
[11] Ahmad H,Kumar VL.Pharmacotherapy of ulcerative colitis—current status and emerging trends[J].J Basic Clin Physiol Pharmacol,2018,29(6):581-592.
[12] 王献春,张莉莉,郭振凯.丹参注射液联合美沙拉嗪治疗溃疡性结肠炎的疗效及对炎性因子、凝血指标的影响[J].中国医院用药评价与分析,2017,17(3):344-345,348.
[13] Lichtenstein GR,Gordon GL,Zakko S,et al.Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission[J].Dig Dis Sci,2016,61(1):221-229.
[14] 王锦,高青.二丙酸倍氯米松和传统糖皮质激素灌肠治疗溃疡性结肠炎:Meta分析[J].胃肠病学和肝病学杂志,2014,23(7):774-778.
[15] Gionchetti P,D'Arienzo A,Rizzello F,et al.Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine:a single-blind randomized controlled trial[J].J Clin Gastroenterol,2005,39(4):291-297.
[2] Morilla I,Uzzan M,Laharie D,et al.Colonic MicroRNA Profiles,Identified by a Deep Learning Algorithm,That Predict Responses to Therapy of Patients With Acute Severe Ulcerative Colitis[J].Clin Gastroenterol Hepatol,2019,17(5):905-913.
[3] Rizzello F,Mazza M,Salice M,et al.The safety of beclomethasone dipropionate in the treatment of ulcerative colitis[J].Expert Opin Drug Saf,2018,17(9):963-969.
[4] Kobayashi Y,Yasuba H,Asako M,et al.HFA-BDP Metered-Dose Inhaler Exhaled Through the Nose Improves Eosinophilic Chronic Rhino-sinusitis With Bronchial Asthma:A Blinded,Placebo Con-trolled Study[J].Front Immunol,2018,9:2192.
[5] Ostrom NK,Raphael G,Tillinghast J,et al.Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma[J].Allergy Asthma Proc,2018,39(2):117-126.
[6] Zhao X,Zhou C,Ma J,et al.Efficacy and safety of rectal 5-amin-osalicylic acid versus corticosteroids in active distal ulcerative colitis:a systematic review and network meta-analysis[J].Sci Rep,2017,7:46693.
[7] 王生锋.糖皮质激素在重度溃疡性结肠炎治疗中的应用效果分析[J].中国肛肠病杂志,2018,38(11):39-40.
[8] Biancone L,Gionchetti P,Blanco Gdel V,et al.Beclomethasone dipropionate versus mesalazine in distal ulcerative colitis:a multic-enter,randomized,double-blind study[J].Dig Liver Dis,2007,39(4):329-337.
[9] Jairath V,Jeyarajah J,Zou G,et al.A composite disease activity index for early drug development in ulcerative colitis:development and validation of the UC-100 score[J].Lancet Gastroenterol Hep-atol,2019,4(1):63-70.
[10] Mohammed Vashist N,Samaan M,Mosli MH,et al.Endoscopic scoring indices for evaluation of disease activity in ulcerative colitis[J].Cochrane Database Syst Rev,2018,1:CD011450.
[11] Ahmad H,Kumar VL.Pharmacotherapy of ulcerative colitis—current status and emerging trends[J].J Basic Clin Physiol Pharmacol,2018,29(6):581-592.
[12] 王献春,张莉莉,郭振凯.丹参注射液联合美沙拉嗪治疗溃疡性结肠炎的疗效及对炎性因子、凝血指标的影响[J].中国医院用药评价与分析,2017,17(3):344-345,348.
[13] Lichtenstein GR,Gordon GL,Zakko S,et al.Long-Term Benefit of Mesalamine Granules for Patients Who Achieved Corticosteroid-Induced Ulcerative Colitis Remission[J].Dig Dis Sci,2016,61(1):221-229.
[14] 王锦,高青.二丙酸倍氯米松和传统糖皮质激素灌肠治疗溃疡性结肠炎:Meta分析[J].胃肠病学和肝病学杂志,2014,23(7):774-778.
[15] Gionchetti P,D'Arienzo A,Rizzello F,et al.Topical treatment of distal active ulcerative colitis with beclomethasone dipropionate or mesalamine:a single-blind randomized controlled trial[J].J Clin Gastroenterol,2005,39(4):291-297.