Normative Application of Xiyanping Injection: A Systematic Review of Adverse Case Reports

Abstract EN

Purpose.

To summarize the characteristics and the relevant factors and to give references for preventing adverse drug reactions (ADRs) associated with xiyanping (XYP), we provide a systematic review of adverse case reports about XYP.

Methods.

Seven medical databases were searched from inception to January 2018.

Case reports detailing ADRs associated with XYP were included.

Data were extracted independently by two reviewers.

After the assessment of causality and severity, we carried out a descriptive analysis for the relevant ADRs.

Results.

Forty-three articles involving a total number of 55 cases were included.

Eight cases were off-label drug use.

In the remaining 47 cases, 26 (55.3%) had probable causality and 23 (48.9%) were serious cases.

XYP used in children (≤14 years old) accounted for 66.0%.

Respiratory diseases (83.0%) were major primary diseases.

No allergic history mentioned (55.3%) and unspecific drug combination (59.6%) were common in these reports.

As for ADR types, anaphylaxis and anaphylactic shock were up to 97.9%.

ADRs happened mostly when applying XYP within 30 minutes (70.2%) and the majority (95.7%) were cured when treated in time.

Conclusions.

Clinicians and patients are supposed to obey the package insert of XYP in clinical application.

Through the results of XYP, normalization of ADR reports is also worthy of attention.

High-quality researches are required to improve the drug instruction and evaluate the safety of XYP in effective diseases and different age groups.

Mechanism of ADRs aiming at the hypersensitivity and the drug combination should still be further identified.