关键词: 骨疾病, 骨肽注射液, 过敏反应, 处方序列分析, 病例对照研究, 倾向评分匹配, 影响因素分析

Abstract: Background　 The monitoring data of the National Drug Adverse Reaction Monitoring Center showed that the application of ossotide injection can cause severe allergic reaction，and the occurrence of drug allergic reaction in hospital can prolong the time of hospitalizati，increase the financial burden of patients，and even threaten patients' lives.However，there are few studies on the affecting factors of allergic reaction to ossotide injection.Objective　To investigate the influencing factors of suspected allergic reactions to ossotide injection，and to provide a reference for clinical rational drug use.Methods　The 9 351 cases of inpatient medical records with ossotide injection which were covered by seven 3A general hospitals from January 2010 to January 2020 were collected.The patients with suspected allergic reaction and non-allergic patients were analysised and screened by prescription sequence analysis，and the patients with suspected allergic reaction were included into the group of suspected allergic reaction（n=68）.Propensity score matching was used to match the control group from non-allergic patients in a ratio of 1∶4（n=272）.The age，sex，hospital department，allergy history and medication use of the two groups were collected〔including single dose of ossotide injection，menstruum and combination medication use（the first 20 drugs of ossotide injection combined drug use frequency were selected for analysis due to the limitation of sample size，and only one drug use was recorded for the same patient）〕.Univariate Logistic regression analysis and multivariate Logistic regression analysis were used to analyze the affecting factors of suspected allergic reaction of ossotide injection.Results　Univariate Logistic regression analysis showed that potassium chloride，omeprazole，ambroxol and calcium acetate in the combination of drugs might be the affecting factors of the suspected allergic reaction （P<0.05）.Multiple Logistic regression analysis showed that potassium chloride（OR=3.515，P=0.003），omeprazole（OR=2.901，P=0.005），cervus and cucumis polypeptide（OR=2.693，P=0.014） were the influencing factors of suspected allergic reaction to ossotide injection.Conclusion　The combination with omeprazole，potassium chloride，and cervus and cucumis polypeptide may increase the risk of allergic reactions in ossotide injection.However，the analysis results need to be verified by further prospective studies.

Key words: Bone diseases, Ossotide injection, Anaphylaxis, Prescription sequence analysis, Case-control studies, Propensity value matching, Root cause analysis