New and Severe Adverse Drug Reaction Reports of Guilong Kechuanning Preparations:A Analysis of 293 Cases
Objective To provide a reference for the clinical rational and safe use of Guilong Kechuanning preparations.Methods A total of 293 new and severe adverse drug reaction(ADR)reports related to Guilong Kechuangning preparations from May 1,2008 to April 30,2023 were collected from the Shandong Province ADR database.The reporting institutions,annual trends,drug dosage forms,administration routes,usage and dosage,patients'demographic characteristics,past and family history,medication reasons,ADR occurrence time,and clinical manifestations of ADR reports were retrospectively analyzed.The drug instructions of various Guilong Kechuanning preparations were compared and analyzed,and the risk factors for ADR occurrence were analyzed.Results Among 293 ADR reports,293 patients were involved and 399 ADRs occurred.Among them,there were 285 new ADR reports(97.27％),of which 268 cases were obtained from medical institutions;eight severe ADR reports(2.73％)were obtained from medical institutions.Among the ADRs reported from 2009 to 2022,the highest number(47 cases)was in 2014,which gradually decreased and began to show an increasing trend in 2019;the dosage forms included tablets(240 cases),capsules(51 cases),and granules(2 cases);the administration route was oral administration,and 253 cases(86.35％)met the recommended dosage in the drug instructions;the patients'average age was 55.26 years old,mainly occurring in middle-aged and elderly patients aged ≥60 years old(71.68％);the male to female ratio was 1.11∶1;203 cases(69.28％)had no history of adverse drug reactions(ADRs)or adverse drug events(ADEs),while 90 cases(30.72％)had an unknown history of ADRs or ADEs;the family ADR/ADE history of all patients was unknown;a total of 38 cases(12.97％)had a history of smoking.ADRs induced by Guilong Kechuanning preparations were reported in 123 cases(41.98％)for bronchitis,75 cases(25.60％)for cough,19 cases(6.48％)for anti-inflammatory and asthma relief,17 cases(5.80％)for upper respiratory tract infections,and 59 cases(20.14％)for other conditions.ADRs mostly occurred within 1 d after medication(79.18％).Among 399 cases of ADRs,16 cases were combined medication,involving 10 system/organ classifications,mainly including gastrointestinal system damage,skin and accessory damage,central and peripheral nervous system damage,heart rate and arrhythmia,etc.The main clinical manifestations were nausea,rash,diarrhea,itching,dizziness,abdominal pain,vomiting,headache,etc.Most patients had a good overall prognosis.In the drug instructions,only Guilong Kechuanning Honey Refining Cream was briefly labeled as ADR,while others were"not yet clear".Conclusion There are many new and severe ADRs in the clinical use of Guilong Kechuanning preparations,but the warning content in the drug instructions is not sufficient,and there is a lack of medication guidance for special populations.The indications and principles of medication should be strictly controlled,and ADRs should be closely monitored during medication.The marketing authorization holder(MAH)should actively improve the drug instructions to ensure drug safety.
Guilong Kechuanningadverse drug reactionssafe medicationchest tightnessheart palpitations
万方数据
维普
