• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2023, Vol. 40 ›› Issue (3): 271-276.

• 药物经济学 • 上一篇    下一篇

维得利珠单抗治疗炎症性肠病的快速卫生技术评估

董艳珍1, 宋沧桑1,2*, 李兴德1,2, 毛盼盼2, 张函舒2, 王国徽2   

  1. 1.大理大学药学院,云南 大理 671000;
    2.昆明市第一人民医院药学部, 云南 昆明 650000
  • 收稿日期:2023-02-13 修回日期:2023-05-23 出版日期:2023-06-28 发布日期:2023-07-24
  • 基金资助:
    云南省卫生健康委员会医学领军人才培养计划项目(No. L-2018012);昆明市卫生科技人才培养项目 [No. 2018-SW(省)-05]

Rapid Health Technology Assessment of Vedolizumab in the Treatment of Inflammatory Bowel Disease

  1. 1.College of pharmacy, Dali University,Yunnan Dali 671000, China;
    2.Department of pharmacy, The First People′s Hospital of Kunming, Yunnan Kunming 650000, China
  • Received:2023-02-13 Revised:2023-05-23 Online:2023-06-28 Published:2023-07-24
  • Contact: Sang CangSONG E-mail:songcs163@163.com

摘要: 目的:评价维得利珠单抗(VDZ)治疗炎症性肠病(IBD)的有效性、安全性和经济性,为临床用药决策提供循证医学证据。方法: 系统检索PubMed、the Cochrane Library、Embase、中国知网、万方等数据库和卫生技术评估(HTA)网站。根据纳排标准筛选文献、提取资料,并对文献进行质量评价与定性合成分析。结果: 共纳入文献31 篇,其中HTA报告2 篇,系统评价/Meta分析17 篇,经济学研究12 篇。在有效性方面,VDZ有效提高IBD患者的临床应答率、临床缓解率、无类固醇缓解率、黏膜愈合率。安全性方面,VDZ的一般不良事件、严重不良事件、因不良事件停药、严重感染、输注反应发生率与安慰剂相当,优于其他IBD生物制剂,发生率低且为轻中度,其中鼻咽炎发生率较高。经济性方面,基于中国医疗保健体系,对于既往未接受过抗TNF-α 治疗或抗TNF-α 治疗失败的克罗恩病患者,VDZ比传统药物经济;对于既往未接受过抗TNF-α 治疗的中重度活动性溃疡性结肠炎患者,VDZ比英夫利昔单抗经济。结论: VDZ治疗IBD具有良好的安全性、有效性、经济性。

关键词: font-size:medium, ">维得利珠单抗;炎症性肠病;有效性;安全性;经济性;快速卫生技术评估

Abstract: Objective:To evaluate the efficacy, safety and economy of vedolizumab (VDZ) in the treatment of inflammatory bowel disease (IBD),and provide evidence-based medical evidence for clinical drug decision. Methods: PubMed, the Cochrane Library, Embase, CNKI, Wanfang databases and Health Technology Assessment (HTA) websites were systematically searched. According to the inclusion and exclusion criteria,the researchers screened the literature, extracted data, and conducted quality evaluation and qualitative synthesis of the literature. Results: A total of 31 articles were included, including 2 HTA reports, 17 systematic reviews/meta-analyses, and 12 economic studies. In terms of effectiveness, VDZ effectively improved the clinical response rate, clinical remission rate, steroid-free remission rate, and mucosal healing rate in IBD patients. In terms of safety, the incidence of general adverse events, serious adverse events, discontinuation due to adverse events, serious infection, and infusion reactions of VDZ was comparable to placebo, and superior to other IBD biologics. The incidence of adverse reactions of vedolizumab was low and mild to moderate, among which the incidence of rhinitis and pharynx was higher. In terms of economy, based on the Chinese healthcare system, VDZ was more economical than traditional drugs for Crohn′s disease patients who have never received anti-TNF-α therapy or failed anti-TNF-α therapy. VDZ was more economical than infliximab for patients with moderate-to-severe active ulcerative colitis who have not previously received anti-TNF-α therapy. Conclusion: VDZ is safe, effective and economical in the treatment of IBD.

Key words: font-size:medium, ">Vedolizumab; Inflammatory bowel disease; Effectiveness; Security; Economy; Rapid health technology assessment

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