运用流行率-窗口期模型对烟台地区2018—2022年经输血传播的乙型肝炎、丙型肝炎和人类免疫缺陷病毒残余风险的评估

doi:10.3969/j.issn.1006-7795.2025.05.020

首都医科大学学报 ›› 2025, Vol. 46 ›› Issue (5): 898-906.doi: 10.3969/j.issn.1006-7795.2025.05.020

运用流行率-窗口期模型对烟台地区2018—2022年经输血传播的乙型肝炎、丙型肝炎和人类免疫缺陷病毒残余风险的评估

沈欣堂¹ , 宋和蔚¹ , 曲家黎¹ , 周敏² , 吴晓黎¹ , 王晓华^3*

1.山东省烟台市中心血站检验科，山东烟台 264003；2.罗氏诊断(上海)有限公司客户服务部，上海 201106；3.山东省烟台市烟台山医院检验科，山东烟台 264000

收稿日期:2025-01-23 修回日期:2025-08-30 出版日期:2025-10-21 发布日期:2025-10-22
通讯作者: 王晓华 E-mail:ytymg@sina.com

Residual risk estimates of transfusion transmissible hepatitis B,hepatitis C and human immunodeficiency virus using P-WP model in Yantai,China,2018 through 2022

Shen Xintang ¹，Song Hewei ¹，Qu Jiali ¹,Zhou Min ²，Wu Xiaoli ¹，Wang Xiaohua ^3*

1.Department of Clinical Laboratory, Yantai Central Blood Station, Yantai 264003, Shandong Province, China; 2.Roche Diagnostics China, Shanghai 201106, China;3.Department of Clinical Laboratory, Yantaishan Hospital, Yantai 264000, Shandong Province, China

Received:2025-01-23 Revised:2025-08-30 Online:2025-10-21 Published:2025-10-22

摘要/Abstract

摘要： 目的估算山东省烟台市无偿献血人群中输血传播疾病乙型肝炎病毒(hepatitis B virus ，HBV)、丙型肝炎病毒(hepatitis C virus, HCV)和人类免疫缺陷病毒(human immunodeficiency virus, HIV)的残余风险(residual risk, RR)，并分析5年期间的演变趋势。方法收集并分析山东省烟台市中心血站2018～2022年酶联免疫吸附试验(enzyme-linked immunosorbent assay, ELISA)及核酸检测(nucleic acid testing, NAT)筛查数据，比较首次献血者(first-time donors, FTDs)和重复献血者(repeat donors, RDs)的流行率(prevalence rate, P)，计算3种病毒的P，使用流行率-窗口期(prevalence-window period, P-WP)模型估算RR。结果 5年期间共计320 016人次献血，输血传播疾病的总反应率为0. 165%，其中HBV(0. 129%)最常见；P(FTDs)为0. 310%远高于P(RDs) 的0. 054%(χ²=312. 783,P<0. 05)。HBV、HCV和HIV的血清学RR分别为1∶188 090、1∶1 042 805和1∶392 995。5年期间分别由1∶129 495降至1∶390 011、1∶697 002降至1∶1 145 826、1∶684 109降至1∶1 067 317。NAT后HCV和HIV RR分别为1∶22 369 329 和1∶6 639 965，降低了21. 5倍和16. 9倍。HBV-DNA(+)献血者中RDs占比为61. 8%(68/110),RR为1∶65 350。结论本研究结果提示引入NAT在降低HBV、HCV和HIV的RR方面具有一定成效，特别是对HCV和HIV。由于隐匿性HBV感染(occult HBV infections, OBI)的发现，HBV的RR相较于HCV和HIV较高。因此，进一步降低RR的关键在于使用更敏感的试剂和检测平台。此外，制定有效的长期激励机制和战略规划，以增加RDs的比例，对于提高输血安全至关重要。

关键词: 无偿献血者, 残余风险, 输血传播疾病, 乙型肝炎病毒, 丙型肝炎病毒, 人类免疫缺陷病毒

Abstract: Objective Estimating the residual risk of transfusion-transmitted diseases in voluntary blood donors is crucial for monitoring blood safety. and to analyze the evolution trend over a five-year period in Yantai, Shandong Province. Methods This study retrospectively reviewed screening data from Yantai Central Blood Station between 2018 and 2022.We compared the positivity rates between first-time and repeat donors, calculated the prevalence of each virus, and estimated the residual risk using the prevalence-window period model. Meanwhile, the age characteristics of all positive donors were analyzed. Results Over the five-year period, a total of 320 016 individuals donated blood. The overall reaction rate of transfusion-transmitted diseases was 0. 165%, with HBV (0. 129%) being the most common. The positivity rate among first-time donors ［P(FTDs)］ (0. 310%) was significantly higher than that among repeat donors ［P(RDs)］ (0. 054%)(χ²=312. 783,P<0. 05). The serological residual risks for HBV, HCV, and HIV were 1∶188 090, 1∶1 042 805, and 1∶392 995, respectively. During the five-year period, they decreased from 1∶129 495 to 1∶390 011, from 1∶697 002 to 1∶1 145 826, and from 1∶684 109 to 1∶1 067 317, respectively.The residual risks of HCV and HIV after NAT were 1∶22 369 329 and 1∶6 639 965, respectively, which were significantly reduced by 21. 5-fold and 16. 9-fold, and decreased steadily during the study period. Among the HBV-DNA (+) donors, 61. 8% (68/110) were RDs, and the residual risk was 1∶65 350. Conclusion This study demonstrates the remarkable effectiveness of introducing nucleic acid amplification technology (NAT) in reducing the residual risk of HBV, HCV, and HIV, particularly for HCV and HIV. The residual risk for HBV remains higher compared to HCV and HIV due to the discovery of occult HBV infections (OBI). Therefore, a crucial step toward further reducing this residual risk is the use of more sensitive reagents and detection platforms. Furthermore, implementing effective long-term incentive mechanisms and strategic planning to increase the proportion of repeat donors (RDs) is critical for enhancing transfusion safety.

Key words: voluntary blood donors, residual risk, transfusion-transmitted infectious diseases, hepatitis B virus, hepatitis C virus, human immunodeficiency virus

中图分类号:

R446.
6

沈欣堂, 宋和蔚, 曲家黎, 周敏, 吴晓黎, 王晓华. 运用流行率-窗口期模型对烟台地区2018—2022年经输血传播的乙型肝炎、丙型肝炎和人类免疫缺陷病毒残余风险的评估[J]. 首都医科大学学报, 2025, 46(5): 898-906.

Shen Xintang , Song Hewei , Qu Jiali , Zhou Min , Wu Xiaoli , Wang Xiaohua . Residual risk estimates of transfusion transmissible hepatitis B,hepatitis C and human immunodeficiency virus using P-WP model in Yantai,China,2018 through 2022[J]. Journal of Capital Medical University, 2025, 46(5): 898-906.

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运用流行率-窗口期模型对烟台地区2018—2022年经输血传播的乙型肝炎、丙型肝炎和人类免疫缺陷病毒残余风险的评估

Residual risk estimates of transfusion transmissible hepatitis B,hepatitis C and human immunodeficiency virus using P-WP model in Yantai,China,2018 through 2022

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