摘要
目的:采用循证医学的方法评价美沙拉嗪治疗溃疡性结肠炎的有效性和安全性。方法:计算机检索PubMed、Cochrane图书馆和Embase、CNKI、VIP、CBM数据库。按Cochrane系统评价的方法评价纳入研究质量,并进行Meta分析。结果:共纳入9个随机对照试验(RCT),共1541例溃疡性结肠炎患者。Meta分析结果显示,美沙拉嗪治疗溃疡性结肠炎在有效率、缓解率方面均优于安慰剂组(P<0.05);在复发率方面,虽然二者比较差异无统计学意义(P>0.05),但美沙拉嗪有降低复发率的趋势;9项研究均报道了不良反应,Meta分析的结果提示,二者比较差异无统计学意义(P>0.05)。结论:美沙拉嗪在疗效方面优于安慰剂,在不良反应发生率方面差异无统计学意义(P>0.05)。但由于纳入的9个RCT中有4个RCT的质量较低,使得这一结论受到影响,有必要开展更多设计严谨,大样本、多中心的RCT来确证这种趋势。
OBJECTIVE:To evalute the effectiveness and safety of mesalazine vs.placebo in the treatment of ulcerative colitis(UC)by evidence-based medicine.METHODS:Literatures were retrieved from PubMed,Cochrane library,CNKI,Embase,VIP,CBM.The qualities of enrolled studies were evaluated by Cochrane systematic evaluation method,and meta-analysis was performed.RESULTS:9 RCTs were included in this study with a total of 1 541 patients.Meta-analysis showed that the effective rate and remission rate of UC in mesalazine group were better than in placebo group(P〈0.05).There was no statistical difference in the remission rate between 2 groups(P〈0.05),but mesalazine tend to reduce the remission rate.9 RCTs compared the ADRs,meta-analysis showed there was no significant difference between 2 groups(P〈0.05).CONCLUSION:The analysis shows that mesalazine is better than placebo in respect of clinical efficacy,and there was no significant difference(P〈0.05).However,among the included 9 RCTs there are 4 RCTs are of poor quality and multi-center large-scale randomized controlled trials of higher quality are needed to confirm this.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第44期4201-4204,共4页
China Pharmacy