注射用甘氨双唑钠的药品临床综合评价  

Comprehensive Clinical Evaluation of Glycididazole Sodium for Injection

作　　者：赵紫楠[1] 赵飞 李婷[1] 薛薇[2] 金鹏飞[1] 张亚同[1] ZHAO Zinan;ZHAO Fei;LI Ting;XUE Wei;JIN Pengfei;ZHANG Yatong(Dept.of Pharmacy,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application(Beijing Hospital),Beijing 100730,China;Clinical Trial Center,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Science,Beijing 100730,China)

机构地区：[1]北京医院药学部,国家老年医学中心,中国医学科学院老年医学研究所,北京市药物临床风险与个体化应用评价重点实验室(北京医院),北京100730 [2]北京医院临床试验研究中心,国家老年医学中心,中国医学科学院老年医学研究所,北京100730

出　　处：《中国医院用药评价与分析》2022年第11期1357-1360,1364,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家重点研发计划项目(No.2020YFC2008305)。

摘　　要：目的:从有效性、安全性、经济性、创新性、适宜性和可及性6个维度对注射用甘氨双唑钠进行药品综合评价。方法:系统检索Embase、PubMed、the Cochrane Library、中国知网、中国生物医学文献数据库、万方数据库和NIHR等数据库,通过快速卫生技术评估的方法对注射用甘氨双唑钠的有效性、安全性和经济性进行分析。检索国家药品监督管理局、国家药品监督管理局药品审评中心等专业网站,以及各国药典、药品说明书,对药品的创新型、适宜性和可及性进行分析。结果:临床研究的研究方案为放射治疗联合注射用甘氨双唑钠与单独放疗相比或同步放化疗联合注射用甘氨双唑钠与同步放化疗相比。(1)有效性方面,6项研究结果显示,注射用甘氨双唑钠可显著提高食管癌放疗患者的近期疗效和1~3年生存率;4项研究结果显示,注射用甘氨双唑钠可提高鼻咽癌放疗患者的近期和远期生存率;1项研究结果显示,注射用甘氨双唑钠可提高食管癌同步放化疗患者的近期疗效;另1项研究结果显示,注射用甘氨双唑钠可提高鼻咽癌同步放化疗患者的近期疗效,并减少放疗剂量。(2)安全性方面,注射用甘氨双唑钠已被纳入2020年版国家医保目录。6项研究结果显示,注射用甘氨双唑钠不会增加食管癌放疗患者包括食管炎、白细胞减少、黏膜反应、骨髓移植在内的放疗相关不良反应;3项研究结果显示,注射用甘氨双唑钠不会增加鼻咽癌放疗患者的放疗不良反应;2项研究结果显示,注射用甘氨双唑钠均不会增加食管癌和鼻咽癌同步放化疗患者的不良反应。(3)经济学方面,与单纯放疗相比,加用注射用甘氨双唑钠在食管癌和鼻咽癌人群中均具有经济性。(4)创新性方面,注射用甘氨双唑钠的合成工艺和甘氨双唑钠组合物的制备方法均已获得专利。(5)适宜性方面,注射用甘氨双唑钠质量可控,静脉给药OBJECTIVE:To comprehensively evaluate the glycididazole sodium for injection from six dimensions:effectiveness,safety,economy,innovation,suitability and accessibility.METHODS:Embase,PubMed,the Cochrane Library,CNKI,CBM,Wanfang Data,NIHR and other databases were retrieved to analyze the effectiveness,safety and economy of glycididazole sodium for injection by rapid health technology assessment.The innovation,suitability and accessibility of drugs were analyzed by searching professional websites such as the National Medical Products Administration and the Drug Evaluation Center of the National Medical Products Administration,as well as pharmacopoeia and drug instructions of various countries.RESULTS:The study protocol was radiotherapy combined with glycididazole sodium for injection compared with radiotherapy alone or concurrent chemoradiotherapy combined with glycididazole sodium for injection compared with concurrent chemoradiotherapy.(1)In terms of effectiveness,6 studies showed that glycididazole sodium for injection could significantly improve the short-term efficacy and 1-year to 3-year survival rate of patients treated with radiotherapy for esophageal cancer.Four studies showed that glycididazole sodium for injection could improve the short-term and long-term survival rate in patients treated with radiotherapy for nasopharyngeal carcinoma.One study showed that glycididazole sodium for injection could improve the short-term efficacy in patients with concurrent chemoradiotherapy for esophageal cancer.Another study showed that glycididazole sodium for injection could improve the short-term efficacy and reduce the radiation dose in patients with concurrent chemoradiotherapy for nasopharyngeal carcinoma.(2)In terms of safety,glycididazole sodium for injection has been included in the 2020 edition of the National Health Insurance Directory.Six studies showed that glycididazole sodium for injection did not increase radiotherapy related adverse drug reactions including esophagitis,leukopenia,mucosal reactions,and bo

关 键 词：注射用甘氨双唑钠 放疗 药品临床综合评价 卫生技术评估 

分 类 号：R979.1[医药卫生—药品]