| Objective:In this study,loratadine was used as a control,and the safety of cetirizine in children was evaluated through systematic reviews,real-world studies and questionnaires.Methods:The comprehensive evaluation of safety is carried out by means of literature evaluation,government website information,real-world data research and survey questionnaires.It is planned to confirm the main evaluation indicators of the incidence of adverse effects of cetirizine through RCT literature research.The supplementary evaluation of the degree and classification of cetirizine adverse reactions is through the methods of government website information,real-world data research and questionnaire research.1.Safety System Evaluation Based on Secondary Research of Literature Cetirizine screened for literature research.First,the research determined the inclusion and exclusion criteria.Then,after setting the subject and free words.The research systematically searched CNKI,VIP,Wanfang Data,Cochrane Library,Pubmed,including references to literature.Based on the loratadine of the same level of evidence literature in the RCT study.The main evaluation indicators of the incidence of adverse effects of cetirizine were studied by literature induction and systematic review.2.Security evaluation information of government websites The safety information of cetirizine was obtained in this study by searching for the government departments such as CFDA,Center for Drug Reevaluation,NMPA(National Center for ADR Monitoring,China),and the FDA,AHRQ,ISPOR,INATHA and other websites.3.Security monitoring based on real-world research Adverse drug reactions were collected and confirmed from 124 children who were reported by Shandong Provincial Center for ADR monitoring from 2015 to 2018 due to the use of anti-allergic drug.4.Real world questionnaires This study design questionnaires for the use of cetirizine in the real world.The questionnaires are divided into three versions,physician version,pharmacist version,and parent version.The questionnaires were used to obtain the safety evaluation of the drug users.Results:1.Safety System Evaluation Based on Secondary Research of Literature A total of 238 articles were retrieved according to the search terms from the establishment of each database to December 31,2019.According to the inclusion and exclusion criteria,23 articles were included in the literature study.There are 22 RCT studies.After a summary analysis of literature cases,cetirizine was included in 1609 cases.And the common adverse reaction rate of children taking cetirizine is 15.10%.Loratadine was included in 17 RCT research literatures.A total of 886 cases were included.And the common adverse reaction rate of children taking loratadine is 15.10%.There was one case report of acute dystonia,which was not included in the instruction manual.2.Security evaluation information for government websites A total of 5 reports on the safety of cetirizine were found.Adverse drug reactions include headache,pharyngitis,drowsiness,sensitivity to sunlight,acute systemic rash pustulosis,rebound gastroenteritis,drug eruption,exacerbation of existing urticaria and hepatitis.Among them,the photosensitivity of cetirizine,acute systemic rash pustulosis,rebound gastroenteritis,urticaria exacerbation,and hepatitis are not mentioned in the existing drug instructions.3.Security monitoring based on real-world research314 children were reported ADR due to the use of anti-allergic drugs.Antiallergic drugs with the most ADRs were loratadine.There were 77 cases(24.52%)of ADRs due to taking loratadine and 47 cases(14.97%)of ADRs due to taking cetirizine.Cetirizine and loratadine showed no serious adverse reactions.The involved organs and symptoms of cetirizine and loratadine adverse drug reactions are basically consistent with the drug instructions.4.Real world questionnaires A total of 712 valid questionnaires were collected.The questionnaire was used to evaluate subjective acceptability and acceptance of common anti-histamine drugs such as cetirizine and loratadine from three groups: physicians,pharmacists,and parents.The results show that physicians believe that cetirizine has better safety than loratadine.Physicians,pharmacists,and parents all believe that drops,oral liquids,and syrups have more safety advantages in precise dosage administration than dispersion tablets,dry suspensions,effervescent tablets,granules,capsules,and tablets.Conclusion:1.The incidence of common adverse reactions in cetirizine children was 15.10%,which was slightly higher than 12.65% of loratadine.Serious adverse drug reactions are rare. 2.The acute dystonia of cetirizine,photosensitivity,acute systemic rash pustulosis,rebound gastroenteritis,urticaria exacerbation,and hepatitis are not mentioned in the existing drug product instructions.3.Real-world studies have shown that neither cetirizine nor loratadine have reported serious adverse reactions.The organs and symptoms of adverse drug reactions are basically consistent with the drug instructions.4.The results of the survey showed that physicians believe that cetirizine has better safety than loratadine.Physicians,pharmacists,and parents all believe that drops,oral liquids,and syrups have the safety advantages of precise dosage administration over dispersion tablets,dry suspensions,effervescent tablets,granules,capsules,tablets,etc.5.Recommendations: A.It is recommended to further carry out prospective active monitoring research on the real world of cetirizine to verify the incidence of adverse drug reactions;B.Based on the existing evidence-based evidence,on the basis of comprehensive evaluation of its effectiveness,economy,suitability,etc,from the perspective of safety,it is recommended to include cetirizine in the national essential medicine list;C.It is recommended to increase the performance of acute dystonia,photosensitive,acute systemic rash pustulosis,rebound gastroenteritis,urticaria exacerbation and hepatitis in the drug package insert;D.Appropriately increase the marketed medicines of drops,oral liquids and syrups on the industrial demand. |
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