Pharmacovigilance of cutaneous adverse drug reactions in associations with drugs and medical conditions: a retrospective study of hospitalized patients
- PMID: 35948985
- PMCID: PMC9364295
- DOI: 10.1186/s40360-022-00603-4
Pharmacovigilance of cutaneous adverse drug reactions in associations with drugs and medical conditions: a retrospective study of hospitalized patients
Abstract
Background: Cutaneous adverse drug reaction (CADR) is a common problem in clinical medication. This study aimed to investigate the correlation between clinical drug application and CADR occurrence as evidence for preventive strategies and rational clinical drug use.
Methods: We analyzed the characteristics of CADRs of 858 patients admitted to Shandong Provincial Third Hospital from March 2007 to December 2018. The most significant drugs concerning the common skin symptoms and their significance to CADR were investigated by case-non-case and multiple logistic regression analyses.
Results: A total of 266 drugs were involved in 858 cases of CADR. Among the ten most relevant medications, primarily antibiotics and herbal injections, and nutritional support drugs, potassium sodium dehydroandrographolide succinate injection, and cefoperazone sodium and sulbactam sodium injection were found to be 2.1 and 1.45 times statistically more prone to CADRs than to other adverse drug reactions (ADRs), respectively. The main route of administration was intravenous (63.16%), with oral administration accounting for 25.19%. There were 747 cases of ADR, 71 of severe ADR, 2 of new and severe ADRs, and 38 cases of new ADR. Overall, 100 cases of CADR exhibited abnormal alanine aminotransferase, aspartate aminotransferase, and serum creatinine levels. The predictive factors for severe CADR occurrence included allergy and smoking histories, cefoperazone sodium, sulbactam sodium injection, levofloxacin lactate and sodium chloride injection.
Conclusions: Drug-induced CADR symptoms are commonly associated with other ARDs, predominantly rashes and pruritus, and are often accompanied by some medical conditions, especially liver and kidney damage. Detailed attention to a patient's primary diseases, allergy history, and drug safety profile could help prevent or reverse CADR in most patients.
Keywords: Abnormal liver and kidney function; Adverse drug reaction; Case-non-case study; Cutaneous reactions.
© 2022. The Author(s).
Conflict of interest statement
The authors declare that they have no competing interests.
References
-
- Yang F, Chen Z, Chen SA, Zhu Q, Wang L, Xiong H, et al. Clinical profile of cutaneous adverse drug reactions: a retrospective study of 1883 hospitalized patients from 2007 to 2016 in Shanghai. China Eur J Dermatol. 2020;30:24–31. - PubMed
-
- Former Ministry of Health . Adverse drug reaction reporting and monitoring management measures. Order No. 81 of the Ministry of Health of the People’s Republic of China. 2011.
-
- Wang DY. Research on the definition and scope of adverse drug reaction monitoring. Chin J Pharmacovigil. 2014;11:732–738.
-
- Liu X, Fan X. Analysis of 100 cases of adverse drug reaction reports in our hospital in 2018. Dig World Latest Med Inf. 2019;19:11–12.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical
Research Materials
