比较美沙拉嗪与柳氮磺吡啶治疗溃疡性结肠炎的疗效与安全性的meta分析
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摘要
目的比较美沙拉嗪与柳氮磺吡啶2种药物治疗溃疡性结肠炎(UC)的疗效与安全性。方法计算机检索PubMed、Cochrane Library、EMbase、CNKI、CBM和万方数据库,查找所有比较2种药物治疗UC的随机对照试验(RCT),检索时限均为建库至2014年2月12日。按照纳入与排除标准选择文献、评价质量并提取资料后,采用RevMan 5.2软件进行meta分析,并采用Jadad评价量表进行质量评价。结果共纳入13个RCT,其研究质量均为中等。合计1 104例UC患者。Meta分析结果显示,美沙拉嗪对比柳氮磺吡啶治疗UC总有效率差异有统计学意义[RR=1.21,95%CI(1.12,1.32),P<0.01],美沙拉嗪组总有效率高于柳氮磺吡啶组;共有3个RCT报道了复发率,结果显示,美沙拉嗪对比柳氮磺吡啶治疗UC,在复发率方面,差异有统计学意义[RR=0.60,95%CI(0.37,0.96),P=0.03],美沙拉嗪组复发率低于柳氮磺吡啶组。共有9个RCT报道了不良反应,采用随机效应模型,meta分析结果显示:两组差异有统计学意义[RR=0.45,95%CI(0.33,0.59),P<0.01],美沙拉嗪组不良反应发生率低于柳氮磺吡啶组。结论现有证据显示,美沙拉嗪治疗UC的疗效和安全性均优于柳氮磺吡啶。
[Objective]To assess the efficacy and safety of mesalazine versus sulphasalazine in the treatment of ulcerative colitis(UC).[Methods]Such database as PubMed,Cochrane Library,EMbase,CNKI,CBM and Wanfang were searched from their establishment to February 2014 for collecting the randomized controlled trials(RCTs) about Mesalazine versus sulphasalazine for the treatment of UC. After study selection and assessment by the inclusion standard,the meta-analysis was performed by using RevMan5. 2 software,and the quality of studies was evaluated by Jadad evaluation scale.[Results]13 RCTs involving 1 104 patients were included in this study. The results of meta-analysis showed that the total effective rate of the mesalazine group was significantly higher than that of the sulfasalazine group [RR = 1. 21,95% CI(1. 12,1. 32),P < 0. 01]. 3 RCTs reported the relapse rate,and the results presented that the relapse rate of the mesalazine group was significantly lower than that of the sulfasalazine group[RR =0.60,95% CI(0.37,0.96),P =0.03]. 9 RCTs reported adverse effects. By the random effect model,the meta-analysis revealed that the incidence of adverse effects in the mesalazine group was significantly lower than that in the sulfasalazine group[RR =0.45,95% CI(0.33,0.59),P <0. 01].[Conclusion]The analysis demonstrates that mesalazine is much more effective and safe than sulfasalazine in the management of UC.
[Objective]To assess the efficacy and safety of mesalazine versus sulphasalazine in the treatment of ulcerative colitis(UC).[Methods]Such database as PubMed,Cochrane Library,EMbase,CNKI,CBM and Wanfang were searched from their establishment to February 2014 for collecting the randomized controlled trials(RCTs) about Mesalazine versus sulphasalazine for the treatment of UC. After study selection and assessment by the inclusion standard,the meta-analysis was performed by using RevMan5. 2 software,and the quality of studies was evaluated by Jadad evaluation scale.[Results]13 RCTs involving 1 104 patients were included in this study. The results of meta-analysis showed that the total effective rate of the mesalazine group was significantly higher than that of the sulfasalazine group [RR = 1. 21,95% CI(1. 12,1. 32),P < 0. 01]. 3 RCTs reported the relapse rate,and the results presented that the relapse rate of the mesalazine group was significantly lower than that of the sulfasalazine group[RR =0.60,95% CI(0.37,0.96),P =0.03]. 9 RCTs reported adverse effects. By the random effect model,the meta-analysis revealed that the incidence of adverse effects in the mesalazine group was significantly lower than that in the sulfasalazine group[RR =0.45,95% CI(0.33,0.59),P <0. 01].[Conclusion]The analysis demonstrates that mesalazine is much more effective and safe than sulfasalazine in the management of UC.
引文
[1]Ordás I,Eckmann L,Talamini M,et al.Ulcerative colitis[J].Lancet,2012,380:1606-1619.
[2]Ito H,Iida M,Matsumoto T,et al.Direct comparison of two different mesalamine formulations for the induction of remission in patients with ulcerative colitis:a double-blind,randomized study[J].Inflamm Bowel Dis,2010,16:1567-1574.
[3]Feagan BG,MacDonald JK.Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis[J].Cochrane Database Syst Rev,2012:CD000544.
[4]Jadad AR,Moore RA,Carroll D,et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary[J]Control Clin Trials,1996,17:1-12.
[5]陈志辉,刘阳优,陈彩秀,等.美沙拉嗪颗粒和柳氮磺胺吡啶治疗溃疡性结肠炎的随机对照研究[J].临床和实验医学杂志,2009,8(7):73-74.
[6]沈学明.美沙拉嗪及SASP治疗溃疡性结肠炎的临床疗效比较[J].中国现代药物应用,2012,6(12):3-5.
[7]莫好红,美沙拉嗪肠溶片与水杨酸柳氮磺胺嘧啶肠溶片治疗溃疡性结肠炎的疗效观察[J].医学理论与实践,2013,26(13):1729-1731.
[8]黄明,吴雄健.比较美沙拉嗪与柳氮磺吡啶治疗溃疡性结肠炎的效果观察[J].医学信息,2013,26,(24):514-515.
[9]曾照秋.美沙拉嗪及柳氮磺砒啶在治疗溃疡性结肠炎中的疗效对比[J].中国现代药物应用,2013,7(10):99-100.
[10]甄春山,袁俏娴,美沙拉嗪与柳氮磺吡啶治疗溃疡性结肠炎的疗效对比研究[J].中外医学研究,2013(32):40-41.
[11]Rachmilewitz D.Coated mesalazine(5-aminosalicylic acid)versus sulphasalazine in the treatment of active ulcerative colitis:a randomised trial[J].BMJ,1989,298:82-86.
[12]Dew MJ.Maintenance of remission in ulcerative colitis with oral preparation of 5-aminosalicylic acid[J].Br Med J(Clin Res Ed),1982,285:10-12.
[13]Dew MJ,Harries AD,Evans N,et al.Maintenance of remission in ulcerative colitis with 5-amino salicylic acid in high doses by mouth[J].Br Med J(Clin Res Ed),1983,287:23-24.
[14]Riley SA,Mani V,Goodman MI,et al.Comparison of delayed release 5aminosalicylic acid(mesalazine)and sulphasalazine in the treatment of mild to moderate ulcerative colitis relapse[J].Gut,1988,29:669-674.
[15]Kam L,Cohen H,Dooky C,et al.A comparison of mesalamine suspension enema and oral sulfasalazine for treatment of active distal ulcerative colitis in adults[J].Am J Gastroenterol,1996,91:1338-1342.
[16]Munakata A,Yoshida Y,Muto T,et al.Double-blind comparative study of sulfasalazine and controlled-release mesalazine tablets in the treatment of active ulcerative colitis[J].J Gastroenterol,1995,30:108-111.
[17]Ardizzone S,Petrillo M,Imbest V,et al.Is maintenance therapy always necessary for patients with ulcerative colitis in remission[J].Aliment Pharmacol Ther,1999,13:373-379.
[2]Ito H,Iida M,Matsumoto T,et al.Direct comparison of two different mesalamine formulations for the induction of remission in patients with ulcerative colitis:a double-blind,randomized study[J].Inflamm Bowel Dis,2010,16:1567-1574.
[3]Feagan BG,MacDonald JK.Oral 5-aminosalicylic acid for maintenance of remission in ulcerative colitis[J].Cochrane Database Syst Rev,2012:CD000544.
[4]Jadad AR,Moore RA,Carroll D,et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary[J]Control Clin Trials,1996,17:1-12.
[5]陈志辉,刘阳优,陈彩秀,等.美沙拉嗪颗粒和柳氮磺胺吡啶治疗溃疡性结肠炎的随机对照研究[J].临床和实验医学杂志,2009,8(7):73-74.
[6]沈学明.美沙拉嗪及SASP治疗溃疡性结肠炎的临床疗效比较[J].中国现代药物应用,2012,6(12):3-5.
[7]莫好红,美沙拉嗪肠溶片与水杨酸柳氮磺胺嘧啶肠溶片治疗溃疡性结肠炎的疗效观察[J].医学理论与实践,2013,26(13):1729-1731.
[8]黄明,吴雄健.比较美沙拉嗪与柳氮磺吡啶治疗溃疡性结肠炎的效果观察[J].医学信息,2013,26,(24):514-515.
[9]曾照秋.美沙拉嗪及柳氮磺砒啶在治疗溃疡性结肠炎中的疗效对比[J].中国现代药物应用,2013,7(10):99-100.
[10]甄春山,袁俏娴,美沙拉嗪与柳氮磺吡啶治疗溃疡性结肠炎的疗效对比研究[J].中外医学研究,2013(32):40-41.
[11]Rachmilewitz D.Coated mesalazine(5-aminosalicylic acid)versus sulphasalazine in the treatment of active ulcerative colitis:a randomised trial[J].BMJ,1989,298:82-86.
[12]Dew MJ.Maintenance of remission in ulcerative colitis with oral preparation of 5-aminosalicylic acid[J].Br Med J(Clin Res Ed),1982,285:10-12.
[13]Dew MJ,Harries AD,Evans N,et al.Maintenance of remission in ulcerative colitis with 5-amino salicylic acid in high doses by mouth[J].Br Med J(Clin Res Ed),1983,287:23-24.
[14]Riley SA,Mani V,Goodman MI,et al.Comparison of delayed release 5aminosalicylic acid(mesalazine)and sulphasalazine in the treatment of mild to moderate ulcerative colitis relapse[J].Gut,1988,29:669-674.
[15]Kam L,Cohen H,Dooky C,et al.A comparison of mesalamine suspension enema and oral sulfasalazine for treatment of active distal ulcerative colitis in adults[J].Am J Gastroenterol,1996,91:1338-1342.
[16]Munakata A,Yoshida Y,Muto T,et al.Double-blind comparative study of sulfasalazine and controlled-release mesalazine tablets in the treatment of active ulcerative colitis[J].J Gastroenterol,1995,30:108-111.
[17]Ardizzone S,Petrillo M,Imbest V,et al.Is maintenance therapy always necessary for patients with ulcerative colitis in remission[J].Aliment Pharmacol Ther,1999,13:373-379.