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布地奈德泡沫剂治疗轻中度远端溃疡性结肠炎的Meta分析

发布时间:2018-10-19 16:14
【摘要】:目的:探讨布地奈德泡沫剂治疗远端溃疡性结肠炎的有效性及安全性。方法:按照Cochrane系统评价的方法,计算机检索The Cochrane Central Register of Controlled Trials、MEDLINE和EMBASE三大数据库,收集自建库至2016年6月所有关于布地奈德泡沫剂治疗远端溃疡性结肠炎(包括直肠炎、乙状结肠炎和直乙状结肠炎)的原始研究文献。按照本研究制定的纳入和排除标准选择合格的文献,使用Cochrane偏移风险评估标准和工具对原始研究文献的质量进行评价,提取拟纳入文献中的信息和数据。本研究所涉及的统计学运算均在STATA 12.0软件中进行。研究的主要观察结果为有效性和安全性相关的评价指标,采用相对危险度(RR)及95%可信区间(CI)来表示合并效应量。通过漏斗图、Begg和Egger检验来检测发表偏倚。结果:3项高质量的随机安慰剂对照试验被纳入,共包含711名轻中度的活动性远端溃疡性结肠炎患者。这些研究之间不存在明显的偏移和异质性。研究的主要结局指标均为临床缓解、内镜下改善、便血缓解和治疗相关的不良反应。合并分析表明,布地奈德泡沫剂较安慰剂可显著提高轻中度远端溃疡性结肠炎的临床缓解(RR=1.83,95%CI:1.41,2.37;P0.001)、内镜下改善(RR=1.44,95%CI:1.23,1.68;P0.001)和便血缓解,包括2周便血缓解(RR=2.00,95%CI:1.50,2.66;P0.001)、4周便血缓解(RR=1.73,95%CI:1.42,2.12;P0.001)和6周便血缓解(RR=1.76,95%CI:1.45,2.14;P0.001)。此外,布地奈德泡沫剂和安慰剂相关的不良反应没有显著的统计学差异。结论:对于轻中度远端溃疡性结肠炎,布地奈德泡沫剂可有效地诱导临床缓解、内镜下改善及缓解便血症状,且具有较好的安全性。由于本研究存在一定的局限性,结果仍需更多高质量、多中心、大样本的随机对照研究来加以验证。
[Abstract]:Objective: to investigate the efficacy and safety of budesonide foam in the treatment of distal ulcerative colitis. Methods: according to the method of Cochrane system evaluation, three databases of The Cochrane Central Register of Controlled Trials,MEDLINE and EMBASE were searched by computer, and all the data of budesonide foam therapy for distal ulcerative colitis (including proctitis) were collected until June 2016. The original literature on sigmoid colitis and straight sigmoid colitis. According to the inclusion and exclusion criteria of this study, the quality of the original research documents is evaluated by using Cochrane offset risk assessment criteria and tools, and the information and data to be included in the literature are extracted. The statistical operations involved in this study were carried out in STATA 12.0 software. The main results of the study are the effectiveness and safety related evaluation indexes. The relative risk (RR) and 95% confidence interval (CI) are used to express the combined effect quantity. Publication bias was detected by funnel graph, Begg and Egger tests. Results: three high quality randomized placebo controlled trials were conducted in 711 patients with mild to moderate active distal ulcerative colitis. There is no obvious deviation or heterogeneity between these studies. The main outcome indicators of the study were clinical remission, endoscopic improvement, hematochezia relief and treatment-related adverse reactions. 鍚堝苟鍒嗘瀽琛ㄦ槑,甯冨湴濂堝痉娉℃搏鍓傝緝瀹夋叞鍓傚彲鏄捐憲鎻愰珮杞讳腑搴﹁繙绔簝鐤℃,

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