摘要
目的 比较不同生物制剂维持治疗中重度溃疡性结肠炎(UC)患者的疗效和安全性的网状meta分析。方法 检索中国知网、万方数据知识服务平台、维普资讯、中国生物医学文献数据库、PubMed、the Cochrane Library、Embase数据库中的RCTs,检索时间自数据库建库至2023年7月,收集不同生物制剂治疗中重度UC患者的相关研究。按照纳入和排除标准筛选文献、质量评价、提取数据资料后,采用RevMan 5.3和Stata16.0软件进行网状meta分析。结果 共检索到1374篇文献,最终纳入17篇,涉及18项RCTs,5939例中重度UC患者,包括安慰剂、英夫利西单抗静脉注射、阿达木单抗皮下注射、维多珠单抗静脉注射、维多珠单抗皮下注射、戈利木单抗皮下注射、乌司奴单抗皮下注射每8周1次、乌司奴单抗皮下注射每12周1次、依妥珠单抗皮下注射、米吉珠单抗皮下注射10种干预措施,7种药品。网状meta分析结果显示,每项有效性指标中,不同用药方案有不同的表现,综合内镜下黏膜愈合和总不良事件发生情况,发现维多珠单抗皮下注射既能保证较好的黏膜愈合疗效,又是不良事件发生率最低的干预措施,而维多珠单抗静脉注射和米吉珠单抗皮下注射次之。结论治疗UC的生物制剂主要有3种作用通路,其中整合素拮抗剂维多珠单抗的疗效和安全性表现较好,且有皮下注射和静脉注射两种剂型供临床选择,白细胞介素抑制剂米吉珠单抗可以作为次选。
Objective To employ a network meta-analysis comparing the effectiveness and safety of different biologic agents in patients with moderately to severely ulcerative colitis during the maintenance therapy period.Methods RCTs were searched in CNKI,Wanfang Data,VIP,China Biology Medicine disc,PubMed,the Cochrane Library,and Embase databases from their inception to July,2023.Relevant studies on biologics for the treatment of ulcerative colitis were collected.A network meta-analysis was performed using RevMan 5.3 and Stata 16.0 software after screening the literature according to the inclusion and exclusion criteria,evaluating the quality of the studies and extracting data.Results A total of 1374 articles were retrieved from various databases and 17 articles were included with 18 RCTs and totaled sample size of 5939 cases.There was a total of 10 intervention methods,including 7 medications.They were as follows:placebo,infliximab intravenous injection,adalimumab subcutaneous injection,vedolizumab intravenous injection,vedolizumab subcutaneous injection,golimumab subcutaneous injection,ustekinumab subcutaneous injection once every 8 weeks,ustekinumab subcutaneous injection once every 12 weeks,etrolizumab subcutaneous injection,mirikizumab subcutaneous injection.The meta results showed that different medication regimens had different performances in terms of efficacy indicators.Considering endoscopic mucosal healing and overall adverse events,it was found that vedolizumab subcutaneous injection not only provided good mucosal healing efficacy but also had the least incidence of adverse events followed by vedolizumab intravenous injection and mirikizumab subcutaneous injection.Conclusion There are three main pathways of biologics for the treatment of ulcerative colitis,of which the integrin antagonist vedolizumab excels in efficacy and safety and is available in both subcutaneous and intravenous dosage forms for clinical selection.The interleukin inhibitor mirikizumab can be used as a second choice.
作者
蔡钙强
梁耀文
李健荣
温咏平
陈萍娟
CAI Gai-qiang;LIANG Yao-wen;LI Jian-rong;WEN Yong-ping;CHEN Ping-juan(Department of Pharmacy,the Fifth People's Hospital of Zhongshan,Guangdong Zhongshan 528415,China)
出处
《临床药物治疗杂志》
2024年第2期46-54,共9页
Clinical Medication Journal
