维得利珠单抗治疗溃疡性结肠炎的快速卫生技术评估

Rapid health technology assessment of vedolizumab in the treatment of ulcerative colitis

目的:评价维得利珠单抗治疗溃疡性结肠炎的有效性、安全性和经济性,为临床决策和合理用药提供循证依据。方法:计算机检索PubMed、Embase、Cochrane Library、CNKI、Sinomed、万方、维普数据库和国内外卫生技术评估相关官方网站,收集维得利珠单抗治疗溃疡性结肠炎的卫生技术评估报告、系统评价/Meta分析和药物经济学研究,检索时限自建库/建站起至2022年8月。对结果进行描述性分析。结果:共纳入8篇Meta分析和9篇药物经济学研究。维得利珠单抗与安慰剂相比,可显著提高溃疡性结肠炎患者的临床反应率、临床缓解率、内镜缓解率和无类固醇缓解率(所有P<0.05);与阿达木单抗、戈利木单抗和乌司奴单抗相比具有更高的临床反应率和临床缓解率(所有P<0.05);与英夫利西单抗和托法替布相比疗效相当。在安全性方面,维得利珠单抗与安慰剂或其他治疗溃疡性结肠炎药物比较未见显著差异。经济学研究结果显示,维得利珠单抗在中国、英国和美国等多个国家具备经济学优势。结论:维得利珠单抗治疗溃疡性结肠炎有良好的有效性、安全性和经济性。

OBJECTIVE To evaluate the effectiveness,safety and economy of vedolizumab in the treatment of ulcerative colitis,so as to provide evidence-based reference for clinical decision and rational drug use.METHODS PubMed,the Cochrane Library,CNKI,Sinomed,Wanfang and VIP databases were retrieved,and the related HTA websites were searched.HTA reports,systematic reviews/Meta-analysis and pharmacoeconomic research of vedolizumab in the treatment of ulcerative colitis were collected.The retrieval time ranged from the establishment of the database/station to August 2022.The results were analyzed by descriptive summary.RESULTS Totally 8 Meta-analysis and 9 pharmacoeconomic researches were included.The results showed vedolizumab could significantly improve the clinical response rate,clinical remission rate,endoscopic remission rate and steroid free remission rate of patients with ulcerative colitis when compared with those of placebo(all P<0.05).Compared with adalimumab,golimumab and ustekinumab,vedolizumab had higher clinical response rate and clinical remission rate(all P<0.05).Vedolizumab had the same therapeutic effect as infliximab and tofacitinib.Safety analysis showed that there was no significant difference between vidrizumab and placebo or other drugs for ulcerative colitis.The results of pharmacoeconomic researches showed that vedolizumab was more cost-effective than other drugs in China and many other countries.CONCLUSION Vedolizumab has promising effectiveness,safety and economic advantages in the treatment of ulcerative colitis.