目的观察美沙拉秦栓1次/d与2次/d给药治疗轻中度活动期溃疡性直肠炎的疗效及安全性。方法本试验为随机、非劣效性研究。选取2013年10月—2015年6月济南军区总医院符合纳入与排除标准的轻中度活动期溃疡性直肠炎患者82例,采用随机数字表...目的观察美沙拉秦栓1次/d与2次/d给药治疗轻中度活动期溃疡性直肠炎的疗效及安全性。方法本试验为随机、非劣效性研究。选取2013年10月—2015年6月济南军区总医院符合纳入与排除标准的轻中度活动期溃疡性直肠炎患者82例,采用随机数字表将其分为A组(n=41)和B组(n=41)。A组给予美沙拉秦栓1.0g/次,晚睡前便后纳肛,1次/d;B组给予美沙拉秦栓0.5 g/次,便后纳肛,早、晚各1次。两组均给药8周。采用疾病活动指数(DAI)评价疾病活动程度。以治疗第8周时DAI评分作为主要疗效指标;以治疗第8周时DAI各分项评分(大便次数、大便带血、黏膜炎症、总体评价)及临床缓解率作为次要疗效指标,并记录两组不良反应发生情况。结果患者均完成8周治疗。两组治疗前后DAI评分比较,差异均有统计学意义(P<0.001);两组间治疗前及治疗第8周DAI评分比较,差异均无统计学意义(P>0.05)。A组治疗第8周时DAI评分-B组治疗第8周时DAI评分(U1-U2)双侧95%可信区间(-0.33,0.87)的下限>-1.00,拒绝无效假设,认为A组的疗效不差于B组。两组治疗8周后大便次数、大便带血、黏膜炎症、整体评价评分均低于治疗前,差异有统计学意义(P<0.05)。治疗前和治疗第8周,两组间大便次数、大便带血、黏膜炎症、整体评价评分比较,差异均无统计学意义(P>0.05)。经过8周治疗后,A、B两组临床缓解率分别为95.1%(39/41)、90.2%(37/41),差异无统计学意义(χ2=0.719,P=0.396)。A组不良反应发生率为48.8%(20/41),B组不良反应发生率为61.0%(25/41),差异无统计学意义(χ2=1.231,P=0.267)。结论在8周的临床试验中,美沙拉秦栓1.0 g 1次/d给药与0.5 g 2次/d给药治疗轻中度活动期溃疡性直肠炎疗效一致,且安全。展开更多
BACKGROUND Despite the advent of biological drugs, conventional therapy continues to be used in moderate to severe inflammatory bowel disease(MS-IBD). This study hypothesized that as a standard of treatment and the pr...BACKGROUND Despite the advent of biological drugs, conventional therapy continues to be used in moderate to severe inflammatory bowel disease(MS-IBD). This study hypothesized that as a standard of treatment and the primary alternative to biologics, conventional therapy should present robust effectiveness results in IBD outcomes.AIM To investigate the effectiveness of conventional therapy for MS-IBD.METHODS A systematic review with no time limit was conducted in July 2017 through the Cochrane Collaboration, MEDLINE, and LILACS databases. The inclusion criteria encompassed meta-analyses, systematic reviews, randomized clinical trials, observational and case-control studies concerning conventional therapy in adult patients with MS-IBD, including Crohn's disease(CD) and ulcerative colitis(UC). Corticosteroids(prednisone, hydrocortisone, budesonide, prednisolone,dexamethasone), 5-aminosalicylic acid(5-ASA) derivatives(mesalazine and sulfasalazine) and immunosuppressants [azathioprine(AZA), methotrexate(MTX), mycophenolate, cyclosporine, tacrolimus, 6-mercaptopurine(6-MP)] were considered conventional therapy. The exclusion criteria were sample size below50; narrative reviews; specific subpopulations(e.g., pregnant women,comorbidities); studies on postoperative IBD; and languages other than English,Spanish, French or Portuguese. The primary outcome measures were clinical remission(induction or maintenance), clinical response and mucosal healing. As secondary outcomes, fecal calprotectin, hospitalization, death, and surgeries were analyzed. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation criteria.RESULTS The search strategy identified 1995 citations, of which 27 were considered eligible(7 meta-analyses, 20 individual studies). For induction of clinical remission, four meta-analyses were selected(AZA and 6-MP showed no advantage over placebo,MTX or 5-ASA in CD; MTX showed no statistically significant difference versus placebo, 6-MP, or 5-ASA in UC; tacr展开更多
文摘目的观察美沙拉秦栓1次/d与2次/d给药治疗轻中度活动期溃疡性直肠炎的疗效及安全性。方法本试验为随机、非劣效性研究。选取2013年10月—2015年6月济南军区总医院符合纳入与排除标准的轻中度活动期溃疡性直肠炎患者82例,采用随机数字表将其分为A组(n=41)和B组(n=41)。A组给予美沙拉秦栓1.0g/次,晚睡前便后纳肛,1次/d;B组给予美沙拉秦栓0.5 g/次,便后纳肛,早、晚各1次。两组均给药8周。采用疾病活动指数(DAI)评价疾病活动程度。以治疗第8周时DAI评分作为主要疗效指标;以治疗第8周时DAI各分项评分(大便次数、大便带血、黏膜炎症、总体评价)及临床缓解率作为次要疗效指标,并记录两组不良反应发生情况。结果患者均完成8周治疗。两组治疗前后DAI评分比较,差异均有统计学意义(P<0.001);两组间治疗前及治疗第8周DAI评分比较,差异均无统计学意义(P>0.05)。A组治疗第8周时DAI评分-B组治疗第8周时DAI评分(U1-U2)双侧95%可信区间(-0.33,0.87)的下限>-1.00,拒绝无效假设,认为A组的疗效不差于B组。两组治疗8周后大便次数、大便带血、黏膜炎症、整体评价评分均低于治疗前,差异有统计学意义(P<0.05)。治疗前和治疗第8周,两组间大便次数、大便带血、黏膜炎症、整体评价评分比较,差异均无统计学意义(P>0.05)。经过8周治疗后,A、B两组临床缓解率分别为95.1%(39/41)、90.2%(37/41),差异无统计学意义(χ2=0.719,P=0.396)。A组不良反应发生率为48.8%(20/41),B组不良反应发生率为61.0%(25/41),差异无统计学意义(χ2=1.231,P=0.267)。结论在8周的临床试验中,美沙拉秦栓1.0 g 1次/d给药与0.5 g 2次/d给药治疗轻中度活动期溃疡性直肠炎疗效一致,且安全。
文摘BACKGROUND Despite the advent of biological drugs, conventional therapy continues to be used in moderate to severe inflammatory bowel disease(MS-IBD). This study hypothesized that as a standard of treatment and the primary alternative to biologics, conventional therapy should present robust effectiveness results in IBD outcomes.AIM To investigate the effectiveness of conventional therapy for MS-IBD.METHODS A systematic review with no time limit was conducted in July 2017 through the Cochrane Collaboration, MEDLINE, and LILACS databases. The inclusion criteria encompassed meta-analyses, systematic reviews, randomized clinical trials, observational and case-control studies concerning conventional therapy in adult patients with MS-IBD, including Crohn's disease(CD) and ulcerative colitis(UC). Corticosteroids(prednisone, hydrocortisone, budesonide, prednisolone,dexamethasone), 5-aminosalicylic acid(5-ASA) derivatives(mesalazine and sulfasalazine) and immunosuppressants [azathioprine(AZA), methotrexate(MTX), mycophenolate, cyclosporine, tacrolimus, 6-mercaptopurine(6-MP)] were considered conventional therapy. The exclusion criteria were sample size below50; narrative reviews; specific subpopulations(e.g., pregnant women,comorbidities); studies on postoperative IBD; and languages other than English,Spanish, French or Portuguese. The primary outcome measures were clinical remission(induction or maintenance), clinical response and mucosal healing. As secondary outcomes, fecal calprotectin, hospitalization, death, and surgeries were analyzed. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation criteria.RESULTS The search strategy identified 1995 citations, of which 27 were considered eligible(7 meta-analyses, 20 individual studies). For induction of clinical remission, four meta-analyses were selected(AZA and 6-MP showed no advantage over placebo,MTX or 5-ASA in CD; MTX showed no statistically significant difference versus placebo, 6-MP, or 5-ASA in UC; tacr
