The effect of ribavirin on the severity of adverse reactions of xiyanping injection: A propensity score-matched analysis.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE\nXiyanping injection (XYP), a Chinese patent medicine, was approved to treat bronchitis in China and obtained the drug batch number of the National Medical Products Administration in 2002. It is the extraction of herb named Andrographis paniculate (Andrographis paniculata (Burm. f.) Nees, chuan xin lian). XYP is extraordinary widely used in China. In 2017, there have been a mass XYP safety incident throughout the country. However, the risk factors of severity of adverse reactions are frequently called in question.\n\n\nAIM OF THE STUDY\nTo determine whether the XYP-Ribavirin combination treatment is associated with the severity of adverse drug reactions (ADRs).\n\n\nMATERIALS AND METHODS\nWe investigated 26317 ADRs cases reported in National Adverse Drug Reaction Monitoring Information System with a history of using XYP from 2004 to 2017. The baseline characteristics included sex, age, ethnicity, weight and route of administration. Data were analyzed with respect to age, sex, ethnicity, previous ADRs, family ADRs, dosage specification, medication frequency specification, weight, route of administration, drug interactions (Ribavirin, Cefatriaxone, Penicillin sodium, Ambroxol hydrochloride, Clindamycin, Cefoxitin Sodium, Azithromycin, Ceftazidime, Amoxicillin sodium and clavulanate potassium, Levofloxacin, Cefazolin sodium pentahydrate, Acyclovir) by univariate analysis and multivariate analysis. Propensity score matching (PSM) was used to compare groups of patients with general or serious ADRs.\n\n\nRESULTS\nThe study included 24911 general ADRs and 1406 serious ADRs. Univariate analysis identified age (p\xa0<\xa00.001), weight (p\xa0<\xa00.001), route of administration (p\xa0=\xa00.008), XYP\xa0+\xa0Ribavirin combination (p\xa0=\xa00.031) as risk factors. Multivariate analysis identified XYP\xa0+\xa0Ribavirin combination (p\xa0=\xa00.048) and age (p\xa0<\xa00.001) as the independent risk factors. After PSM, the related factors were nearly balanced in two groups, and the severity of ADRs in patients with XYP\xa0+\xa0Ribavirin combination increased (p\xa0=\xa00.020).\n\n\nCONCLUSIONS\nThe results indicated that age and XYP\xa0+\xa0Ribavirin combination are risk factors for the severity of ADRs. Avoiding the interaction of XYP and Ribavirin might be helpful to clinical practitioners in lowing the incidence rate of serious ADRs. This information may provide suggestions in the prevention of ADRs and revision of instruction in the future.