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Pharmacy， Peking University Third Hospital， Beijing 100191， China；8. Dept. of Pharmacy， the First Affiliated
Hospital of Soochow University， Suzhou 215006， China；9. Dept. of Pharmacy， Changhai Hospital， Naval Medical
University， Shanghai 200433， China；10. Dept. of Pharmacy， Zhongshan Hospital， Fudan University， Shanghai
200032， China；11. Dept. of Pharmacy， Fujian Medical University Union Hospital， Fuzhou 350001， China；12. Dept.
of Pharmacy， the Second Affiliated Hospital， Harbin Medical University， Harbin 150086， China；13. Dept. of
Pharmacy， the First Affiliated Hospital of Chongqing Medical University， Chongqing 400016， China；14. International
Research Center for Medicinal Administration， Peking University， Beijing 100191， China；15. Dept. of Tuberculosis，
Beijing Chest Hospital， Capital Medical University， Beijing 101149， China；16. Dept. of Infection， Beijing Tsinghua
Changgung Hospital， Tsinghua University， Beijing 102218， China；17. Dept. of Tuberculosis， Shanghai Pulmonary
Hospital Affiliated to Tongji University， Shanghai 200433， China）

ABSTRACT 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.
KEYWORDS recombinant Mycobacterium tuberculosis fusion protein； purified protein derivative of tuberculin； tuberculosis；
diagnostic drugs； clinical comprehensive evaluation

结核病是由结核分枝杆菌（Mycobacterium tubercu‐ 强LTBI者的主动发现、筛查结核病患者密切接触者，是
[7]
losis，MTB）感染引起的慢性传染病，是严重危害人民健 降低LTBI者发病率的重要措施 。
康的全球性公共卫生问题。据 WHO 统计，2020 年结核 目前 LTBI 的诊断缺乏金标准，只能通过免疫学方
病已成为全球第13位死因，且在单一传染病中位列第2 法辅助诊断。结核菌素纯蛋白衍生物（purified protein
位 [1―2] 。我国结核病负担高居全球第 2 位，据 2021 年全 derivative of tuberculin，TB-PPD）是一种将结核菌素作
球结核病报告统计，MTB感染人数约3.5亿，新发结核病 为抗原来诱发机体发生迟发型变态反应的诊断药品，具
患者84.2万，其中病死率为3.80% [2―4] 。 有成本低、检测方法简单、无需复杂的设备仪器及专门
人体感染 MTB 后是否发病，取决于 MTB 数量、毒 的实验室等特点，是临床判断 LTBI 常用和传统的皮肤
性大小及人体免疫力。感染后约5%的感染者会在短时 检测药品。重组结核杆菌融合蛋白（recombinant Myco‐
间内发展为活动性结核病（active tuberculosis，ATB），而 bacterium tuberculosis fusion protein，EC）为一种新型结
约 95% 的感染者体内的 MTB 会进入长期潜伏状态，这 核皮肤检测药品，由高效表达结核杆菌ESAT6-CFP10基
又称为潜伏性结核感染（latent tuberculosis infection， 因的大肠埃希菌，经发酵、分离和纯化后制成。EC的检
[5]
LTBI） 。LTBI 人群庞大，已成为新发结核病的巨大源 测是否较TB-PPD更具优势，目前尚缺乏其有效性、安全
头，因此有效识别 LTBI 对控制结核病具有重要意义。 性、经济性、创新性、适宜性和可及性 6 个维度的研究。
2015年，WHO提出将开展LTBI系统筛查和干预作为终 因此，本研究以 TB-PPD 为对照，对 EC 进行临床综合评
止结核病的重要策略之一 。我国《高危人群结核分枝 价，旨在为遴选 MTB 感染诊断和结核病辅助诊断的皮
[6]
杆菌潜伏感染检测及预防性治疗专家共识》亦指出，加 肤检测药品提供证据。

· 392 · China Pharmacy 2023 Vol. 34 No. 4 中国药房 2023年第34卷第4期