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中国防痨杂志 ›› 2022, Vol. 44 ›› Issue (9): 917-926.doi: 10.19982/j.issn.1000-6621.20220253

• 论著 • 上一篇    下一篇

重组结核杆菌融合蛋白(EC)用于诊断结核分枝杆菌感染的有效性和安全性系统评价

程晓1,2,3,4, 陈哲1,2,3,4, 焦雪峰1,2,3,4, 杨楠1,2,3,4,5, 刁莎1,2,3,4, 倪晓凤1,2,3,4, 刘峥1,2,3,4,6, 何思颐1,2,3,4,5, 曾力楠1,2,3,4, 万朝敏4,7, 康德英8, 吴斌9, 应斌武10, 张慧11, 赵荣生12, 张伶俐1,2,3,4()   

  1. 1四川大学华西第二医院药学部,成都 610041
    2四川大学华西第二医院循证药学中心,成都 610041
    3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,成都 610041
    4出生缺陷与相关妇儿疾病教育部重点实验室,成都 610041
    5四川大学华西药学院,成都 610041
    6四川大学华西临床医学院,成都 610041
    7四川大学华西第二医院儿科,成都 610041
    8四川大学华西医院中国循证医学中心,成都 610041
    9上海交通大学医学院附属仁济医院药剂科,上海 200127
    10四川大学华西医院实验医学科,成都 610041
    11四川大学华西医院感染管理部,成都 610041
    12北京大学第三医院药剂科,北京 100191
  • 收稿日期:2022-07-10 出版日期:2022-09-10 发布日期:2022-09-05
  • 通信作者: 张伶俐 E-mail:zhanglingli@scu.edu.cn

Efficacy and safety of recombinant Mycobacterium tuberculosis fusion proteins (EC) for the diagnosis of Mycobacterium tuberculosis infection: A system review

Cheng Xiao1,2,3,4, Chen Zhe1,2,3,4, Jiao Xuefeng1,2,3,4, Yang Nan1,2,3,4,5, Diao Sha1,2,3,4, Ni Xiaofeng1,2,3,4, Liu Zheng1,2,3,4,6, He Siyi1,2,3,4,5, Zeng Linan1,2,3,4, Wan Chaomin4,7, Kang Deying8, Wu Bin9, Ying Binwu10, Zhang Hui11, Zhao Rongsheng12, Zhang Lingli1,2,3,4()   

  1. 1Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu 610041, China
    2Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu 610041, China
    3NMPA Key Laboratory for Technical Research on Drug Products In Vitro and In Vivo Correlation, National Medical Products Administration, Chengdu 610041, China
    4Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, Chengdu 610041, China
    5West China School of Pharmacy, Sichuan University, Chengdu 610041, China
    6West China School of Medicine, Sichuan University, Chengdu 610041, China
    7Department of Pediatrics, West China Second University Hospital, Sichuan University, Chengdu 610041, China
    8Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China
    9Department of Pharmacy, Ren Ji Hospital, Shanghai Jiaotong University, Shanghai 200127, China
    10Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu 610041, China
    11Department of Infection Management, West China Hospital, Sichuan University, Chengdu 610041, China
    12Department of Pharmacy, Peking University Third Hospital, Beijing 100191, China
  • Received:2022-07-10 Online:2022-09-10 Published:2022-09-05
  • Contact: Zhang Lingli E-mail:zhanglingli@scu.edu.cn

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摘要：

目的: 系统评价重组结核杆菌融合蛋白(EC)相较于结核菌素纯蛋白衍生物(TB-PPD)用于诊断结核分枝杆菌(Mycobacterium tuberculosis,MTB)感染的有效性和安全性。方法: 检索临床指南数据库、生物医学文献数据库、卫生行政部门和行业协会官方网站及不良反应监测官方网站,检索时间均自建库截止到2022年2月。英文检索词:Recombinant Mycobacterium tuberculosis fusion protein、CFP10/ESAT6;中文检索词:重组结核分枝杆菌融合蛋白、重组结核杆菌融合蛋白、宜卡、CFP10/ESAT6。收集重组结核杆菌融合蛋白(EC)和结核菌素纯蛋白衍生物(TB-PPD)诊断MTB感染有效性和安全性的指南、共识、团体标准、系统评价和原始研究等。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险,根据异质性大小采用Meta分析或描述性分析。结果: 纳入指南2部、专家共识3篇、团体标准2部,均指出重组结核杆菌融合蛋白(EC)和结核菌素纯蛋白衍生物(TB-PPD)可用于诊断MTB感染和结核病辅助诊断。纳入系统评价1篇,结果显示,重组结核杆菌融合蛋白(EC)皮肤试验共招募参与者887名,其敏感度为86.06%(95%CI:82.39%~89.07%)。纳入原始研究4篇,均为随机对照试验,有效性Meta分析结果显示,不区分人群,重组结核杆菌融合蛋白(EC)和结核菌素纯蛋白衍生物(TB-PPD)的敏感度(89.3% vs. 90.4%)和阴性似然比(0.177 vs. 0.220)的差异无统计学意义,重组结核杆菌融合蛋白(EC)的特异度(85.5% vs. 47.3%)、诊断比值比(42.238 vs. 8.040)、阳性似然比(6.048 vs. 1.710)、阳性预测值(66.0% vs. 35.1%)、阴性预测值(96.2% vs. 94.0%)优于结核菌素纯蛋白衍生物(TB-PPD),差异有统计学意义。安全性结果显示,重组结核杆菌融合蛋白(EC)和结核菌素纯蛋白衍生物(TB-PPD)不良事件均为局部瘙痒和疼痛,均未发生严重不良事件。结论: 重组结核杆菌融合蛋白(EC)可用于MTB感染诊断、辅助结核病诊断,相较于结核菌素纯蛋白衍生物(TB-PPD),其有效性表现更优。

关键词: 重组结核杆菌融合蛋白(EC), 结核菌素试验, 皮肤试验, 分枝杆菌,结核, Meta分析(主题)

Abstract:

Objective: Compared with purified protein derivative of tuberculin (TB-PPD), to systematically evaluate the efficacy and safety of recombinant Mycobacterium tuberculosis fusion protein (EC) in the diagnosis of Mycobacterium tuberculosis (MTB) infection. Methods: Data were searched from the clinical guideline database, biomedical literature database, official websites of health administrative departments and industry associations, and official websites of adverse reaction monitoring. The retrieval time is from the time of building the database to February 2022. English search terms were recombinant Mycobacterium tuberculosis fusion protein and CFP10/ESAT6; Chinese search terms were recombinant Mycobacterium tuberculosis fusion protein, Yika, and CFP10/ESAT6. Guidelines, consensuses, group standards, systematic reviews, and original studies on the efficacy and safety of recombinant Mycobacterium tuberculosis fusion protein (EC) and TB-PPD in diagnosing MTB infection were collected. Two investigators independently screened literature, extracted data, and assessed the risk of bias of included studies. Meta-analysis or descriptive analysis were used according to the size of heterogeneity. Results: Two guidelines, three expert consensus papers, and two group standards were included, and all presented that both recombinant Mycobacterium tuberculosis fusion protein (EC) and TB-PPD could be used for the detection of MTB infection and tuberculosis. One systematic review was included, and the results showed that the recombinant Mycobacterium tuberculosis fusion protein (EC) skin test recruited a total of 887 participants, with the sensitivity of 86.06% (95%CI: 82.39%-89.07%). The four original studies included were randomized controlled trials. The effectiveness meta-analysis showed that, regardless of the population, the sensitivity (89.3% vs. 90.4%) and negative likelihood ratio (0.177 vs. 0.220) of recombinant Mycobacterium tuberculosis fusion protein (EC) and TB-PPD were not significantly different. The specificity (85.5% vs. 47.3%), diagnostic odds ratio (42.238 vs. 8.040), positive likelihood ratio (6.048 vs. 1.710), positive predictive value (66.0% vs. 35.1%) and negative predictive value (96.2% vs. 94.0%) of recombinant Mycobacterium tuberculosis fusion protein (EC) were significantly better than those of TB-PPD. The safety results showed that the adverse events of recombinant Mycobacterium tuberculosis fusion protein (EC) and TB-PPD were just local itching and pain, and no serious adverse events occurred. Conclusion: Recombinant Mycobacterium tuberculosis fusion protein (EC) can be used for the diagnosis of MTB infection and auxiliary diagnosis of tuberculosis, and has better efficacy when compared with TB-PPD.

Key words: Recombinant Mycobacterium tuberculosis fusion protein (EC), Tuberculin test, Skin tests, Mycobacterium tuberculosis, Meta-analysis as topic

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