Introduction
Anaphylaxis is a severe, potentially fatal, systemic allergic reaction
that occurs suddenly after contact with an allergy-causing
substance[1], and it can lead to serious consequences if there
exists delayed diagnosis and inappropriate treatments, drugs are
generally considered to be the main cause of anaphylaxis[2].
Although anaphylaxis is a rare adverse drug reaction(ADR), drug induced
anaphylaxis remains the leading cause of allergic death in adults [3;
4]. In addition, with the introduction of new medications such as
biologics, small molecule drugs, and new chemotherapeutic drugs, the
incidence of hospitalization caused by drug induced anaphylaxis
continues to increase [5; 6]. During the past decade, there has been
an advanced understanding of the diagnosis, pathogenesis, and treatment
management of anaphylaxis [7; 8], but significant data and knowledge
gaps remain in key clinical care and research domains, such as
population science, validated clinical or biomarker-based models that
predict disease outcome, acute management, etc. [7; 9], especially
in China[10]. There were few active surveillance studies and
epidemiological data on anaphylaxis in China, and studies showed gaps in
the initial treatment of anaphylaxis between China and international
guidelines[11].
China Hospital Pharmacovigilance System (CHPS) was developed and
popularized by the China National Center for ADR Monitoring since 2016.
The system can automatically collect and analyze information (such as
diagnoses, medical orders, progress notes, test and examination results,
and other information) extracted from the electronic hospital
information systems (HIS) in sentinel hospitals (Figure 1)[12]. The
connection to HIS makes it possible to simply, actively, and
comprehensively obtain real-world drug safety data. At present, CHPS has
covered more than 400 hospitals in China and can be used to carry out
drug safety research with high operability and accessibility[12;
13].
This study aims to develop anaphylaxis triggers by the Delphi method and
construct active surveillance programs based on CHPS. The programs were
then ran on 238,194 discharged patients to evaluate their performances
and analyze the characteristics, allergens, and management of
anaphylaxis in the Chinese population.