頓服與分次口服美沙拉嗪對治療輕-中度潰瘍性結(jié)腸炎療效、安全性及依從性的Meta分析

鄭州大學第五附屬醫(yī)院消化內(nèi)科，河南 鄭州 450000

【Abstract】ObjectiveTo evaluate the efficacy, safety, and adherence of once daily versus multiple daily Mesalazine therapy for mild to moderate ulcerative colitis.MethodsThe databases of PubMed, Embase, Web of Science, Cochrane Library, CNKI, VIP, CBM and WanFang were searched (by Mar. 2018) to identity relevantly published studies about once daily versus multiple daily Mesalazine therapy for mild to moderate ulcerative colitis. According to inclusion and exclusion criteria, two reviewers independently screened the literature, extracted data and quality evaluation. Statistical analysis was performed by RevMan 5.2 software.ResultsA total of 14 studies including 4 126 patients were enrolled. Meta-analysis results showed that there was no significant difference in the remission rate of once daily versus multiple daily Mesalazine therapy for mild to moderate ulcerative colitis in induction trials (RR=1.06, 95%CI: 0.98-1.14,P=0.17); there was no statistical difference in the incidence of adverse reactions (RR=0.89, 95%CI: 0.74-1.07,P=0.23). There was no significant difference in the remission rate of once daily versus multiple daily Mesalazine therapy for mild to moderate ulcerative colitis in maintenance trials (RR=1.01, 95%CI: 0.97-1.06,P=0.53); there was no statistical difference in the incidence of adverse reactions (RR=1.02, 95%CI: 0.95-1.09,P=0.83). In induction trials, once daily Mesalazine was superior to multiple daily Mesalazine in the treatment of mild to moderate ulcerative colitis (RR=1.17, 95%CI: 1.07-1.27,P=0.0003). Funnel plot showed that the symmetry of the graph was good, and the possibility of publication bias was small.ConclusionThere are no differences in efficacy and safety between once daily and multiple daily Mesalazine therapy for mild to moderate ulcerative colitis. But once daily Mesalazine is better than multiple daily Mesalazine in adherence. Due to limited quantity and quality of included studies, the above conclusions are needed to be validated by more high quality studies.

【Keywords】 Mesalazine; Mild to moderate ulcerative colitis; Once daily; Multiple daily; Meta-analysis

潰瘍性結(jié)腸炎是一種慢性炎癥性腸病，可引起結(jié)腸炎癥和潰瘍，可發(fā)生在任何年齡，多見于20～40歲，也見于兒童或老年人，其特征為復發(fā)性的疾病發(fā)作(活動期)和緩解(緩解期)。其主要的臨床癥狀為反復發(fā)作的腹瀉、黏液膿血便及腹痛，還可有缺鐵性貧血及腸外癥狀和體征，所有這些都可導致生活質(zhì)量下降。潰瘍性結(jié)腸炎是一種全球性疾病，發(fā)達國家及發(fā)展中國家潰瘍性結(jié)腸炎發(fā)病率正在隨時間不斷增加，1950-2010年，潰瘍性結(jié)腸炎的發(fā)病率在10萬居民中，歐洲由4.9人增至505人，亞洲和中東由4.9人增至168.3人[2-3]。對于輕-中度潰瘍性結(jié)腸炎，5-氨基水楊酸(5-ASA)頓服或分次口服是臨床最常用的治療方案。一項多中心觀察研究發(fā)現(xiàn)，約21.2%的患者未能合理及時服用藥物，患者服用藥物依從性影響治療效果。但由于潰瘍性結(jié)腸炎呈反復性，活動期與緩解期交替發(fā)生，患者需長時間服用5-ASA，因此，如何提高患者依從性，是一個重要的問題。

為了進一步明確頓服與分次口服美沙拉嗪治療輕-中度潰瘍性結(jié)腸炎的臨床療效、安全性及依從性差異，本研究利用Cochrane系統(tǒng)評價的方法對所納入的隨機對照試驗進行系統(tǒng)評價，以期得到一個客觀準確的結(jié)果，為臨床實踐提供最佳證據(jù)。

1 資料與方法

1.1文獻篩選及質(zhì)量評價檢索Web of Science、PubMed、Cochrane Library、Embase、中國知網(wǎng)、CBM、維普、萬方等數(shù)據(jù)庫中有關(guān)頓服與分次口服治療輕-中度潰瘍性結(jié)腸炎效果的對比研究，檢索時間從建庫到2018年3月，并追查納入文獻的參考文獻。……