Analysis of propacetamol-related hypotension based on database and data mining

JIA Xiaona; WANG Pan

doi:10.3969/j.issn.1002-266X.2025.06.006

Abstract：Objective To analyze the incidence of propacetamol-related hypotension based on database and data mining.Methods The related literatures about hypotension caused by propacetamol were searched in CNKI,Wanfang,Pubmed,Embase,Web of Science and Cochrane Library,the retrieval time was from the establishment of the databases to July 2024,and relevant literature materials were extracted.With"Propacetamol"as the search term,it was searched in Vi-giAccess( global open database of adverse drug reactions of the World Health Organiza-tion(WHO),and the search time was from the establishment of the database to December 8,2024.The preferred term(PT)and system organ class(SOC)in the 27th edition of Medical Dictionary for Regulatory Activities(MedDRA)were used to standardize and classify the adverse reactions of propacetamol retrieved by VigiAccess,and the number and fre-quency of adverse reactions reported at SOC and PT levels were calculated.Results A total of 211 articles were re-trieved,and 11 articles were finally included.Patients mainly originated from intensive care units,emergency depart-ments or perioperative patients;most of them were febrile patients applying propacetamol to reduce fever,and a few were pain patients needing analgesia,and in some articles the purpose of the drug was not reported.Propacetamol may cause hy-potension due to older age,fever/bacteremia,higher baseline blood pressure,combined medication,etc.The time to cause hypotension varied and was reported to be 15 min after dosing,30 to 60 min after dosing,or within 2 h of dosing,re-spectively.After patients developed hypotension,5.9%-33.0%of patients were intervened by intravenous fluids,vasopres-sors and positive inotropic drugs,and there were no reports of death due to hypotension.A total of 14 292 reports of adverse reactions related to propacetamol were retrieved from VigiAccess database,93.60%of which came from Asia and 6.33%from Europe.A total of 27 SOCs were involved in adverse reactions of propacetamol,among which vascular disorders ranked first in frequency with 4 566 cases(27.43%).The total frequency of adverse reactions of propacetamol at the PT lev-el was 18 658 cases,among which hypotension ranked first in frequency with 4 056 cases(21.74%).Conclusions The incidence of hypotension caused by propacetamol is high,which can occur within 15 min to 2 h after the administration of the drug.It is recommended that in clinical use,the risks and benefits of the drug should be assessed in the context of the in-dividual patient's situation,and the risk factors such as advanced age,severe infections,hemodynamic instability,and combined medication should be alert,and preventive measures should be taken in advance if necessary,in order to im-prove the safety of the drug.