重组结核杆菌融合蛋白的临床综合评价  

Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein

作　　者：倪晓凤 刁莎 何思颐 焦雪峰 程晓 陈哲 刘峥 曾力楠[1] 康德英[2] 吴斌[3] 万朝敏[1,4] 应斌武 张慧[6] 赵荣生[7] 缪丽燕[8] 王卓[9] 李晓宇 刘茂柏 蔡本志[12] 邱峰[13] 孙峰[14] 初乃惠 林明贵[16] 沙巍 张伶俐[1] NI Xiaofeng;DIAO Sha;HE Siyi;JIAO Xuefeng;CHENG Xiao;CHEN Zhe;LIU Zheng;ZENG Linan;KANG Deying;WU Bin;WAN Chaomin;YING Binwu;ZHANG Hui;ZHAO Rongsheng;MIAO Liyan;WANG Zhuo;LI Xiaoyu;LIU Maobai;CAI Benzhi;QIU Feng;SUN Feng;CHU Naihui;LIN Minggui;SHA Wei;ZHANG Lingli(Dept.of Pharmacy/Evidence-Based Pharmacy Center/NMPA Key Laboratory for Technical Research on Drug Products in vitro and in vivo Correlation/Key Laboratory of Birth Defects and Related Diseases of Women and Children of Ministry of Education,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Evidence-based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,China;Dept.of Pharmacy,Renji Hospital,School of Medicine,Shanghai Jiaotong University,Shanghai 200127,China;Dept.of Pediatrics,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Dept.of Laboratory Medicine,West China Hospital,Sichuan University,Chengdu 610041,China;Dept.of Infection Management,West China Hospital,Sichuan University,Chengdu 610041,China;Dept.of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Dept.of Pharmacy,the First Affiliated Hospital of Soochow University,Suzhou 215006,China;Dept.of Pharmacy,Changhai Hospital,Naval Medical University,Shanghai 200433,China;Dept.of Pharmacy,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Dept.of Pharmacy,Fujian Medical University Union Hospital,Fuzhou 350001,China;Dept.of Pharmacy,the Second Affiliated Hospital,Harbin Medical University,Harbin 150086,China;Dept.of Pharmacy,the First Affiliated Hospital of Chongqing Medical University,Chongqing 400016,China;International Research Center for Medicinal Administration,Peking University,Beijing 100191,China;Dept.of Tuberculosis,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China;Dept.of Infection,Beijing Tsinghua Changgung Hospital,Tsinghua University,Beijing 102218,China;Dept.of Tuberculosis,Shanghai Pulmonary Hospital Affiliated to Tongji University,Shanghai 200433,China)

机构地区：[1]四川大学华西第二医院药学部/循证药学中心/国家药品监督管理局药物制剂体内外相关性技术研究重点实验室/出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [2]四川大学华西医院中国循证医学中心,成都610041 [3]上海交通大学医学院附属仁济医院药剂科,上海200127 [4]四川大学华西第二医院儿科,成都610041 [5]四川大学华西医院实验医学科,成都610041 [6]四川大学华西医院感染管理部,成都610041 [7]北京大学第三医院药剂科,北京100191 [8]苏州大学附属第一医院药学部,苏州215006 [9]海军军医大学长海医院药学部,上海200433 [10]复旦大学附属中山医院药剂科,上海200032 [11]福建医科大学附属协和医院药学部,福州350001 [12]哈尔滨医科大学附属第二医院药学部,哈尔滨150086 [13]重庆医科大学附属第一医院药学部,重庆400016 [14]北京大学医药管理国际研究中心,北京100191 [15]首都医科大学附属北京胸科医院结核科,北京101149 [16]清华大学附属北京清华长庚医院感染科,北京102218 [17]同济大学附属上海市肺科医院结核科,上海200433

出　　处：《中国药房》2023年第4期391-396,共6页China Pharmacy

基　　金：四川省科技计划项目(重点研发项目)(No.2020YFS0035)。

摘　　要：目的评价重组结核杆菌融合蛋白(EC)的有效性、安全性、经济性、创新性、适宜性和可及性,为遴选结核杆菌感染诊断和结核病辅助诊断的皮肤检测药品提供证据。方法采用系统评价法分析EC与结核菌素纯蛋白衍生物(TB-PPD)的有效性和安全性;以最小成本分析、成本-效果分析、成本-效用分析评价EC与TB-PPD的短期经济性,采用成本-效用分析评价两者的长期经济性;采用系统评价法、改良德尔菲专家咨询法确定创新性、适宜性和可及性评价的指标,通过各指标的权重计算EC和TB-PPD的各维度的综合评分。结果EC的有效性、安全性、经济性、创新性、适宜性评分均高于TB-PPD;两药的可负担性评分一致,EC的可获得性评分低于TB-PPD。考虑维度和指标权重后,EC的有效性、安全性、经济性、创新性、适宜性、可及性评分及其综合评分均高于TB-PPD。结论相较于TB-PPD,EC的有效性、安全性、经济性、创新性、适宜性和可及性均表现更优;但在可及性维度下,EC的可获得性应进一步改善。OBJECTIVE To evaluate the effectiveness,safety,economy,innovation,suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein(EC),and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis.METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin(TB-PPD)were analyzed by the method of systematic review.Cost minimization analysis,cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD,and cost-utility analysis was used to evaluate the long-term economy.The evaluation dimensions of innovation,suitability and accessibility were determined by systematic review and improved Delphi expert consultation,and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator.RESULTS The scores of effectiveness,safety,economy,innovation and suitability of EC were all higher than those of TB-PPD.The affordability scores of the two drugs were consistent,while the availability score of EC was lower than those of TB-PPD.After considering dimensions and index weight,the scores of effectiveness,safety,economy,innovation,suitability,accessibility and the comprehensive score of EC were all higher than those of TB-PPD.CONCLUSIONS Compared with TB-PPD,EC performs better in all dimensions of effectiveness,safety,economy,innovation,suitability and accessibility.However,it is worth noting that EC should further improve its availability in the dimension of accessibility.

关 键 词：重组结核杆菌融合蛋白 结核菌素纯蛋白衍生物 结核病 诊断药品 临床综合评价 

分 类 号：R981[医药卫生—药品]