地诺孕素治疗子宫内膜异位症的快速卫生技术评估  

A rapid health technology assessment of dienogest on endometriosis

作　　者：杜博冉[1] 史湘君 张雪艳[1] 王然[1] 阴赪宏[1] 冯欣[1] DU Boran;SHI Xiangjun;ZHANG Xueyan;WANG Ran;YIN Chenghong;FENG Xin(Department of Pharmacy,Beijing Obstetrics and Gynecology Hospital,Capital Medical University/Beijing Maternal and Child Health Care Hospital,Beijing 100026,China;Department of Rheumatology and Clinical Immunology,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China)

机构地区：[1]首都医科大学附属北京妇产医院/北京妇幼保健院药事部,北京100026 [2]首都医科大学附属北京天坛医院风湿免疫科,北京100070

出　　处：《世界临床药物》2024年第2期153-161,共9页World Clinical Drug

基　　金：国家自然科学基金青年项目(72204170);北京市属医院科研培育项目(PZ2021028);北京市医院管理中心临床医学专项经费资助(ZYLX202119);广东省药品不良反应监测中心委托业务(委31);中国药学会医院药学专业委员会医院药学科研专项资助项目(CPA-Z05-ZC-2022-002);北京药学会临床药学研究项目(LCYX-2022-06);首都医科大学附属北京妇产医院/北京妇幼保健院“优青人才”计划专项经费资助(YQRC201813);北京药理学会智慧药学专项(320.6750.2020-08-48);中华医学会临床药学分会2023年度临床药学青年项目(Z-2021-46-2101-2023);首都卫生发展专项(首发2024-2-2115)。

摘　　要：目的针对地诺孕素治疗子宫内膜异位症开展快速卫生技术评估,为临床评价及决策提供循证学基础。方法通过对Pubmed、Embase、中国知网及万方等数据库中涉及地诺孕素的研究进行检索。使用AMSTAR、OQAQ评价系统评价,CHEERS(2022)量表评估卫生经济学的相关方法学质量,对地诺孕素治疗子宫内膜异位症进行综合评价。结果综合评价结果显示,与期待治疗相比,地诺孕素在子宫内膜异位症术后维持治疗中,对预防复发、改善疼痛方面具有明显优势,与促性腺激素释放激素类似物(gonadotrophin releasing hormone analogue,Gn RH-a)效果相当。生育力保护方面较Gn RH-a无明显优势。安全性方面相较其他治疗药物,地诺孕素阴道出血风险相对较高,同时需注意头痛及体质量增加的风险,其对于潮热、阴道干燥、骨质疏松的风险相对较小。医保支付的角度上,卫生经济性较GnRH-a具有一定优势,但较复合雌孕激素(combined oral contraceptives,COC)无明显优势。结论地诺孕素可作为子宫内膜异位症术后长期维持治疗方案,但相较GnRH-a及COC等其他治疗手段,地诺孕素的有效性、安全性及经济性仍需进一步探讨。Objective To operate a rapid health technology assessment for treatment of endometriosis with dienogest,providing evidence for clinical evaluation and decision-making.Methods The researches of dienogest on endometriosis were searched in Pubmed,Embase,CNKI,Wanfang and other databases.AMSTAR,OQAQ and CHEERS(2022)were used to evaluate the methodological quality of health economics,and the treatment of endometriosis with dienogest was comprehensive evaluated.Results The comprehensive evaluation results showed that dienogest had obvious advantages in preventing recurrence rate and improving pain after endometriosis surgery compared with expectant treatment,and was comparable to gonadotrophin releasing hormone analogue(GnRH-a).On safety evaluation,compared with other therapeutic drugs,dienogest had a higher risk of vaginal bleeding,and the risk of headache and weight gain also should be noted,while the risk of hot flashes,vaginal dryness and osteoporosis was relatively small.From perspective of medical insurance payment,dienogest was more cost-effective compared with GnRH-a,but had no advantage compared with combined oral contraceptives(COC).Conclusion Dienogest could be used as a long-term maintenance treatment after endometriosis surgery.However,compared with other treatments such as GnRH-a and COC,the efficacy,safety,and pharmacoeconomics of dienogest should be further explored.

关 键 词：地诺孕素 子宫内膜异位症 快速卫生技术评估 卫生经济学评价 

分 类 号：R711.71[医药卫生—妇产科学]