【摘要】：目的:探討布地奈德泡沫劑治療遠(yuǎn)端潰瘍性結(jié)腸炎的有效性及安全性。方法:按照Cochrane系統(tǒng)評(píng)價(jià)的方法,計(jì)算機(jī)檢索The Cochrane Central Register of Controlled Trials、MEDLINE和EMBASE三大數(shù)據(jù)庫,收集自建庫至2016年6月所有關(guān)于布地奈德泡沫劑治療遠(yuǎn)端潰瘍性結(jié)腸炎(包括直腸炎、乙狀結(jié)腸炎和直乙狀結(jié)腸炎)的原始研究文獻(xiàn)。按照本研究制定的納入和排除標(biāo)準(zhǔn)選擇合格的文獻(xiàn),使用Cochrane偏移風(fēng)險(xiǎn)評(píng)估標(biāo)準(zhǔn)和工具對(duì)原始研究文獻(xiàn)的質(zhì)量進(jìn)行評(píng)價(jià),提取擬納入文獻(xiàn)中的信息和數(shù)據(jù)。本研究所涉及的統(tǒng)計(jì)學(xué)運(yùn)算均在STATA 12.0軟件中進(jìn)行。研究的主要觀察結(jié)果為有效性和安全性相關(guān)的評(píng)價(jià)指標(biāo),采用相對(duì)危險(xiǎn)度(RR)及95%可信區(qū)間(CI)來表示合并效應(yīng)量。通過漏斗圖、Begg和Egger檢驗(yàn)來檢測發(fā)表偏倚。結(jié)果:3項(xiàng)高質(zhì)量的隨機(jī)安慰劑對(duì)照試驗(yàn)被納入,共包含711名輕中度的活動(dòng)性遠(yuǎn)端潰瘍性結(jié)腸炎患者。這些研究之間不存在明顯的偏移和異質(zhì)性。研究的主要結(jié)局指標(biāo)均為臨床緩解、內(nèi)鏡下改善、便血緩解和治療相關(guān)的不良反應(yīng)。合并分析表明,布地奈德泡沫劑較安慰劑可顯著提高輕中度遠(yuǎn)端潰瘍性結(jié)腸炎的臨床緩解(RR=1.83,95%CI:1.41,2.37;P0.001)、內(nèi)鏡下改善(RR=1.44,95%CI:1.23,1.68;P0.001)和便血緩解,包括2周便血緩解(RR=2.00,95%CI:1.50,2.66;P0.001)、4周便血緩解(RR=1.73,95%CI:1.42,2.12;P0.001)和6周便血緩解(RR=1.76,95%CI:1.45,2.14;P0.001)。此外,布地奈德泡沫劑和安慰劑相關(guān)的不良反應(yīng)沒有顯著的統(tǒng)計(jì)學(xué)差異。結(jié)論:對(duì)于輕中度遠(yuǎn)端潰瘍性結(jié)腸炎,布地奈德泡沫劑可有效地誘導(dǎo)臨床緩解、內(nèi)鏡下改善及緩解便血癥狀,且具有較好的安全性。由于本研究存在一定的局限性,結(jié)果仍需更多高質(zhì)量、多中心、大樣本的隨機(jī)對(duì)照研究來加以驗(yàn)證。
[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. 鍚堝茍鍒嗘瀽琛ㄦ槑,甯冨湴濂堝痙娉℃搏鍓傝緝瀹夋叞鍓傚彲鏄捐憲鎻愰珮杞諱腑搴﹁繙绔簝鐤℃，

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