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中国临床药理学与治疗学 ›› 2024, Vol. 29 ›› Issue (5): 512-519.doi: 10.12092/j.issn.1009-2501.2024.05.005

• 子宫内膜异位症药物治疗最新研究进展 • 上一篇    下一篇

地诺孕素治疗子宫内膜异位症的快速卫生技术评估

郭华,刘兰兰,黄春芝,孙楠,任艳丽   

  1. 郑州大学第三附属医院,药学部,郑州  450052,河南
  • 收稿日期:2023-11-02 修回日期:2023-12-28 出版日期:2024-05-26 发布日期:2024-04-16
  • 通讯作者: 任艳丽,女,主任药师,研究方向:药事管理。 E-mail: yanli535@163.com
  • 作者简介:郭华,女,硕士研究生,研究方向:临床药学、循证药学。 E-mail: guohuahua0421@163.com
  • 基金资助:
    河南省医学科技攻关计划(联合共建)项目(LHGJ20200463)

Rapid health technology assessment of dienogest in the treatment of endometriosis

GUO Hua, LIU Lanlan, HUANG Chunzhi, SUN Nan, REN Yanli   

  1. Department of Pharmacy, the Third Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, Henan, China
  • Received:2023-11-02 Revised:2023-12-28 Online:2024-05-26 Published:2024-04-16

摘要:

目的:快速评价地诺孕素治疗子宫内膜异位症的有效性、安全性和经济性,旨在为临床药物选择和决策提供循证依据。方法:计算机检索PubMed、Embase、Cochrane Library、中国知网、SinoMed、万方数据、国内外卫生技术评估(HTA)机构官方网站及相关数据库,收集地诺孕素治疗子宫内膜异位症的HTA报告、系统评价/Meta分析和药物经济学研究,检索时限均为建库起至2023年9月。资料提取和质量评价后,对纳入研究的结果进行描述性分析。结果:共纳入9篇系统评价(Meta分析)、2篇药物经济学研究。Meta分析文献质量偏低,经济学研究质量较好。有效性方面,与无治疗相比,地诺孕素可以显著降低术后复发率、盆腔疼痛(VAS)评分,提高妊娠率及有效率;地诺孕素与促性腺激素释放激素激动剂(GnRHa)、复方口服避孕药(COC)在复发率方面疗效相当;在复发率、妊娠率方面,地诺孕素优于达那唑,孕三烯酮以及米非司酮。安全性方面,与安慰剂对比,地诺孕素阴道出血、头痛的发生率显著增高,骨质丢失情况无差异;地诺孕素阴道出血发生率显著高于GnRHa,但潮热、骨质丢失的发生率低于GnRHa。经济性方面,与GnRHa比较,地诺孕素更具有成本-效益优势;而与COC比较,地诺孕素不具有经济性。结论:地诺孕素治疗子宫内膜异位症具有良好的有效性和安全性;经济性优于GnRHa,但劣于COC。

关键词: 地诺孕素, 子宫内膜异位症, 有效性, 安全性, 经济性, 快速卫生技术评估

Abstract:

AIM: To rapidly evaluate the effectiveness, safety and economy of dienogest in the treatment of endometriosis so as to provide evidence-based reference for clinical drug selection and decision. METHODS: Retrieved from PubMed, Embase, Cochrane Library, CNKI, SinoMed, Wanfang and health technology assessment (HTA) organization websites, HTA report, systematic review/Meta-analysis and pharmacoeconomic study were included during the inception to Sep 2023. Data extraction and quality evaluation were carried out for the literature that met the inclusion and exclusion criteria, and the research results were summarized and analyzed qualitatively. RESULTS: Nine systematic review/Meta-analyses, and 2 pharmacoeconomic studies were included. The quality of Meta-analysis literatures was low, and the quality of economic research was good. In terms of effectiveness, compared with no treatment, dienogest can significantly reduce postoperative recurrence rate, VAS score, and improve pregnancy rate and effective rate; Dienogest has similar therapeutic effects in terms of recurrence rate as GnRHa and COC; With regard to recurrence rate and pregnancy rate, dienogest is superior to danazol, gestrinone, and mifepristone. In terms of safety, compared with placebo, the incidence of vaginal bleeding and headache was significantly increased with dienogest, and there was no difference in bone loss; The incidence of vaginal bleeding caused by dienogest was significantly higher than that of GnRHa, but the incidence of hot flashes and bone loss was lower. In terms of economy, dienogest has a more cost-effective advantage comparing with GnRHa, but does not have economic benefits comparing with COC. CONCLUSION: Dienogest has good effectiveness and safety in the treatment of endometriosis, and economically superior to GnRHa, but inferior to COC.

Key words: dienogest, endometriosis, effectiveness, safety, economy, rapid health technology assessment

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