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巴曲酶相关严重低纤维蛋白原血症的危险因素分析及风险预测

模型构建
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蔡 乐 ，赵雨晴 ，崔佳珠 ，文 笑 ，郭代红 ，朱 曼 （1.解放军总医院医疗保障中心药剂科，北京 100853；
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2.蚌埠医科大学药学院，安徽 蚌埠 233030；3.沈阳药科大学生命科学与生物制药学院，沈阳 110016）
中图分类号 R969.3 文献标志码 A 文章编号 1001-0408（2026）04-0462-06
DOI 10.6039/j.issn.1001-0408.2026.04.09

摘 要 目的 探讨巴曲酶相关严重低纤维蛋白原血症（HFIB）的临床特征及危险因素，并构建其风险预测模型。方法 回顾性收
集2020年1月1日至2024年12月31日某三甲医院第一医学中心使用巴曲酶的住院患者资料，并根据发生HFIB的严重程度分为
非严重HFIB组和严重HFIB组。采用单因素和多因素Logistic回归分析筛选巴曲酶相关严重HFIB的独立影响因素。采用R 4.5
软件“rms”程序包绘制列线图；采用受试者工作特征曲线检验模型的预测性能；采用Bootstrap自助抽样法评估模型的校准度；采
用Hosmer-Lemeshow检验评价模型的拟合优度。结果 共纳入1 472例患者，其中1 445例发生HFIB，发生率为98.17%；895例为
严重HFIB，发生率为60.80%。多因素Logistic回归分析结果显示，年龄增长、较高的首剂量/10 kg体重、使用维持剂量、合并使用
糖皮质激素是巴曲酶相关严重HFIB的独立危险因素，较高的纤维蛋白原（FIB）基线值为其独立保护因素（P＜0.05）。模型的受试
者工作特征曲线下面积为 0.760[95% 置信区间为（0.735，0.785）]；校准曲线的平均绝对误差为 0.006；Hosmer-Lemeshow 检验的 P
值为0.609。结论 巴曲酶可快速、显著降低FIB，易引起严重HFIB；年龄增长、使用较高首剂量/10 kg体重、使用维持剂量以及合并
使用糖皮质激素患者的巴曲酶相关严重HFIB的发生风险较高，而FIB基线值较高患者的巴曲酶相关严重HFIB的发生风险较低；
基于上述因素建立的风险预测模型可用于预测巴曲酶相关严重HFIB的发生风险。
关键词 巴曲酶；低纤维蛋白原血症；风险预测模型；列线图；危险因素

Analysis of risk factors and construction of risk prediction model for batroxobin-related severe
hypofibrinogenemia
CAI Le ，ZHAO Yuqing ，CUI Jiazhu ，WEN Xiao ，GUO Daihong ，ZHU Man（1. Dept. of Pharmacy， Medical
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Supplies Center of Chinese PLA General Hospital， Beijing 100853， China；2. School of Pharmacy， Bengbu
Medical University， Anhui Bengbu 233030， China；3. School of Life Sciences and Biopharmaceuticals，
Shenyang Pharmaceutical University， Shenyang 110016， China）
ABSTRACT OBJECTIVE To investigate the clinical characteristics and risk factors for batroxobin-related severe
hypofibrinogenemia （HFIB） and construct a risk prediction model. METHODS A retrospective analysis was conducted on
inpatients treated with batroxobin in the First Medical Center of a tertiary hospital from January 1， 2020， to December 31， 2024.
Patients were categorized into non-severe HFIB group and severe HFIB group based on the severity of HFIB. Univariate and
multivariate Logistic regression analyses were performed to identify the independent influencing factors for batroxobin-related severe
HFIB. A nomogram was developed using the “rms” package in R 4.5 software. The predictive performance of the model was
evaluated using the receiver operating characteristic curve. Calibration was assessed via the Bootstrap resampling method， and
goodness-of-fit was evaluated with the Hosmer-Lemeshow test. RESULTS A total of 1 472 patients were included in this study. Of
these， 1 445 developed HFIB， yielding an incidence of 98.17%. Furthermore， 895 were classified as severe HFIB， accounting for
60.80% of the cohort. Multivariate Logistic regression analysis showed that increased age， high initial dose per 10 kg body weight，
use of maintenance dose， and concomitant glucocorticoid use were independent risk factors for batroxobin-related severe HFIB，
while high baseline fibrinogen （FIB） level was identified as a
Δ 基金项目 首都卫生发展科研专项（No.首发2024-2-5012）；临床
protective factor. The model demonstrated an area under the
重点药品的使用监测和评价研究专项（No.Y2023FH-YWPJ03-101）
＊第一作者 副主任药师，硕士。研究方向：临床药学。E-mail： curve of 0.760 （95% CI： 0.735-0.785）. The mean absolute
caile15009@163.com error of the calibration curve was 0.006. The P value of the
# 通信作者 副主任药师，硕士。研究方向：临床药学。E-mail： Hosmer-Lemeshow test was 0.609. CONCLUSIONS
zhucindy301@189.cn Batroxobin can rapidly and significantly reduce FIB levels and

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