Efficacy and safety of Xileisan combined with mesalazine for ulcerative colitis:A meta-analysis and trial sequential analysis  

作　　者：Xin-Yu Yang Yun-Feng Yu Ke-Ke Tong Gang Hu Rong Yu Lian-Jun Su 

机构地区：[1]School of Traditional Chinese Medicine,Hunan University of Chinese Medicine,Changsha 410208,Hunan Province,China [2]The First Hospital of Hunan University of Chinese Medicine,Hunan University of Chinese Medicine,Changsha 410007,Hunan Province,China

出　　处：《World Journal of Clinical Cases》2024年第21期4703-4716,共14页世界临床病例杂志

基　　金：Discipline Construction Project of Hunan University of Chinese Medicine,No.22JBZ002.

摘　　要：BACKGROUND The benefits and risks of Xileisan(XLS)in the treatment of ulcerative colitis(UC)remain unclear.AIM The present study aimed to evaluate the efficacy and safety of the combination of XLS and mesalazine when treating UC.METHODS We searched eight databases for clinical trials evaluating the combination of XLS and mesalazine in the treatment of UC,up to January 2024.Meta-analysis and trial sequential analysis(TSA)were performed using Revman 5.3 and TSA 0.9.5.10 beta,respectively.RESULTS The present study included 13 clinical studies involving 990 patients,of which 501 patients received XLS combined with mesalazine while 489 patients received mesalazine alone.The meta-analysis showed that,in terms of efficacy,the combination of XLS and mesalazine significantly improved the clinical efficacy rate by 22%[risk ratio(RR)=1.22;95%CI:1.15–1.28;P<0.00001]and mucosal improvement rate by 25%(RR=1.25;95%CI:1.12–1.39;P=0.0001),while significantly reducing the duration of abdominal pain by 2.25 days[mean difference(MD)=-2.25;95%CI:-3.35 to-1.14;P<0.0001],diarrhea by 2.06 days(MD=-2.06;95%CI:-3.92 to-0.20;P=0.03),hematochezia by 2.32 days(MD=-2.32;95%CI:-4.02 to-0.62;P=0.008),tumor necrosis factor alpha by 16.25 ng/mL(MD=-16.25;95%CI:-20.48 to-12.01;P<0.00001),and interleukin-6 by 14.14 ng/mL(MD=-14.14;95%CI:-24.89 to-3.39;P=0.01).The TSA indicated conclusiveness in the meta-analysis of the efficacy endpoints.In terms of safety,the meta-analysis revealed that the combination of XLS and mesalazine did not increase the occurrence of total and gastrointestinal adverse events,abdominal distension,and erythema(P>0.05).The TSA showed non conclusive findings in the meta-analysis of the safety endpoints.Harbord’s test showed no publication bias(P=0.734).CONCLUSION Treatment with XLS alleviated the clinical symptoms,intestinal mucosal injury,and inflammatory response in patients with UC,while demonstrating good safety.

关 键 词：Xileisan MESALAZINE Ulcerative colitis META-ANALYSIS Trial sequential analysis 

分 类 号：R743.3[医药卫生—神经病学与精神病学]