基于BCPNN法对培门冬酶和左旋门冬酰胺酶上市后安全警戒信号的挖掘与评价 点击下载
论文标题： 基于BCPNN法对培门冬酶和左旋门冬酰胺酶上市后安全警戒信号的挖掘与评价
英文标题：
中文摘要： 目的：挖掘和评价培门冬酶（PEG-ASP）和左旋门冬酰胺酶（L-ASP）上市后的安全警戒信号，比较二者的安全性差异，为临床安全合理用药提供参考。方法：调取美国FDA不良事件报告系统2004年1月1日至2020年6月30日发布的PEG-ASP和L-ASP的药品不良事件（ADE）报告，采用贝叶斯置信区间递进神经网络法（BCPNN），以信息成分（IC）下限（IC－2SD）＞0且事件数≥3为条件，挖掘这两种药品的安全信号，重点评价和比较两药在胃肠系统、肝胆系统、血液及淋巴系统、血管及淋巴管类、各类神经系统、免疫系统、代谢及营养类和各类检查等8个系统器官分类中IC－2SD≥1.5的中强及强信号，并对特定ADE信号的IC值及其95％置信区间进行时间扫描图谱分析。结果与结论：以PEG-ASP、L-ASP为怀疑药物的报告分别有2324、3824份，纳入中强及强信号分别为67、68个。其中，胃肠系统疾病中，筛选出两药的共同强信号为坏死性胰腺炎；肝胆系统疾病中，两药均有静脉闭塞性肝病的强信号且该ADE未在二者的药品说明书中出现；血液及淋巴系统疾病中，筛选出两药的共同强信号为发热性中性粒细胞减少症、凝血障碍、中性粒细胞减少症、发热性骨髓再生障碍；血管及淋巴管类疾病中，除血流动力学不稳定外，L-ASP其余信号的IC值均高于PEG-ASP；各类神经系统疾病中，除颅内出血外，L-ASP其余信号的IC值均高于PEG-ASP；免疫系统疾病中，L-ASP的速发过敏反应为中强信号，而PEG-ASP的这一ADE为强信号；代谢及营养类疾病中，除肿瘤溶解综合征外，L-ASP其余信号的IC值均高于PEG-ASP。时间扫描图谱结果显示，PEG-ASP的坏死性胰腺炎和凝血障碍2个信号为稳定信号，而静脉闭塞性肝病和超敏反应2个信号为不稳定信号，需继续观察；L-ASP的上述4个信号均为稳定信号。临床使用PEG-ASP或L-ASP时，应密切关注超敏反应、凝血障碍、血栓、坏死性胰腺炎、静脉闭塞性肝病和低蛋白血症等安全问题。
英文摘要： OBJECTIVE： To mine and evaluate the post-marketing safety alert signals of pegaspargase （PEG-ASP） and L-asparaginase （L-ASP），and compare the safety differences between them ，so as to provide reference for clinical safe and rational drug use. METHODS ： The adverse drug event （ADE） reports of PEG-ASP and L-ASP issued by FDA adverse event reporting system from Jan. 1st，2004-Jun. 30th，2020 were retrieved. BCPNN method was used to mine the safety signals of these two drugs under the condition that the lower limit of information component （IC－2SD）＞0 and the number of events ≥3. The medium and strong signals of two drugs with IC －2SD≥1.5 were evaluated and compared in 8 system organ class，such as gastrointestinal system ，hepatobiliary system ，blood and lymphatic system ，blood vessels and lymphatic vessels ， nervous system ，immune system ，metabolism and nutrition ，various examinations. IC value of specific ADE signal and its 95％ confidence interval were analyzed by time scanning spectrum. RESULTS & CONCLUSIONS ：The reports of PEG-ASP and L-ASP as suspected drugs were 2 324 and 3 824；67 and 68 medium and strong signals were included ，respectively. In gastrointestinal system，the common strong signal of PEG-ASP and L-ASP was necrotic pancreatitis. In hepatobiliary system ，both of them showed strong signal in venoocclusive liver disease ，and this ADE was not included in the drug instruction. In blood and lymphatic system ， common strong signals of the two drugs were febrile neutropenia ，coagulation disorder ，neutropenia and febrile bone marrow regeneration disorder ；in blood vessels and lymphatic vessels ，in addition to haemodynamic instability ，IC values of other signals of L-ASP were higher than those of PEG-ASP. In nervous system ，IC values of other signals of L-ASP were higher than those of PEG-ASP except for intracranial haemorrhage. In immune system ，anaphylactic reaction was a medium signal for L-ASP but was a strong signal for PEG-ASP. In metabolism and nutritional diseases ，except for tumor lysis syndrome ，IC values of other signals of L-ASP were higher than those of PEG-ASP. The results of time scanning spectrum showed that the signals of necrotic pancreatitis and coagulation disorder of PEG-ASP were stable ，while the signals of veno occlusive liver disease and hypersensitivity were unstable and needed to be observed ；above four signals of L-ASP were stable signals. When using PEG-ASP or L-ASP clinically ， close attention should be paid to the safety problems such as hypersensitivity ，coagulation disorder ，thrombosis，necrotic pancreatitis，venoocclusive liver disease and hypoproteinemia.
期刊： 2021年第32卷第16期
作者： 张妮，王红力，钟贵遵，龚军，蒙龙，王惠来，肖剑文，贾运涛
英文作者： ZHANG Ni， WANG Hongli，ZHONG Guizun，GONG Jun，MENG Long，WANG Huilai，XIAO Jianwen，JIA Yuntao
关键字： 培门冬酶；左旋门冬酰胺酶；不良事件；药物安全；挖掘；美国FDA不良反应事件报告系统
KEYWORDS： Pegaspargase；L-asparaginase；Adverse event；Drug safety ；Mining；FDA adverse event reporting system
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