复方谷氨酰胺肠溶胶囊辅助治疗溃疡性结肠炎有效性及安全性Meta分析

Meta-analysis on efficacy and safety of Compound Glutamine Enteric Capsules for the adjuvant treatment of ulcerative colitis

目的:运用Meta分析的方法评价复方谷氨酰胺肠溶胶囊(CGEC)辅助治疗溃疡性结肠炎(UC)的有效性和安全性,为CGEC的临床运用提供循证学依据。方法:本研究通过计算机检索中国知网、维普、万方、中国生物医学文献数据库、Cochrane Library、EMBASE及Pubmed数据库中CGEC治疗UC的所有临床文献,检索时间均为数据库建库时间至2020年1月30日。分析软件采用Review Manager 5.3和Stata 13.0。结果:本研究最终纳入12项临床随机对照试验,共计905名患者。Meta分析结果显示,治疗后CGEC联合常规药物组临床总有效率(RR=1.25,95%CI[1.17,1.34]P<0.00001)和肠镜下黏膜总有效率(RR=1.24,95%CI[1.11,1.38]P=0.0002)显著高于常规药物组;患者血清TNF-α和IL-6的改善情况显著优于常规药物组(MDTNF-α=-9.96,95%CI[-12.81,-7.12]P<0.00001;MDIL-6=-15.00,95%CI[-18.79,-11.20]P<0.00001)。在安全性方面,试验组的不良反应发生率(RR=0.39,95%CI[0.27,0.57]P<0.00001)显著低于对照组。结论:CGEC辅助治疗UC能显著改善患者腹痛、腹泻等临床症状,临床总有效率显著提高,肠镜下黏膜总有效率显著提高,且可显著降低患者血清炎症因子水平,安全性较好,能使患者明显获益,值得临床推广使用。

Objective:To evaluate efficacy and safety of Compound Glutamine Enteric Capsules(CGEC)in adjuvant treatment of ulcerative colitis(UC)by Meta-analysis,and provid evidence-based basis for the clinical application of CGEC.Method:This study retrieved all the clinical literature on the treatment of UC by CGEC in CNKI,VIP,Wanfang,SinoMed,Cochrane Library,EMBASE and Pubmed data base and the retrieval time ranged from the time of database construction to January 30,2020.The analysis software used Review Manager 5.3 and Stata 13.0.Result:A total of 12 clinical randomized controlled trials were included with the total number of 905 patients.Meta-analysis showed that in CGEC combined with conventional drug group after treatment,the clinical total effective rate(RR=1.25,95%CI[1.17,1.34]P<0.00001)and total efficiency of colonoscopy(RR=1.24,95%CI[1.11,1.38]P=0.0002)were significantly higher than that of conventional drug group.The serum inflammatory factor levels TNF-α(WD=-9.96,95%CI[-12.81,-7.12]P<0.00001)and IL-6(WD=-15.00,95%CI[-18.79,-11.20]P<0.00001)were significantly lower than that of conventional drug group.In terms of safety,the incidence of adverse reactions(RR=0.39,95%CI[0.27,0.57]P<0.00001)in the experimental group was significantly lower than that in the control group.Conclusion:CGEC adjuvant treatment of UC can significantly improve the clinical symptoms of patients such as abdominal pain and diarrhea.The clinical total effective rate is significantly improved.The total effective rate of the mucosa under colonoscopy is significantly improved,and the level of serum inflammatory factors in patients can be significantly reduced with better safety,which bring obvious benefits to patients,and is worthy of clinical popularization.