运用巢式病例对照设计研究医院集中监测下的丹红注射液不良反应影响因素

Analysis of adverse reactions’ factors to Danhong injection——nested case control study by using hospital centralized monitoring data

探讨真实世界下丹红注射液不良反应发生的影响因素。采用多中心、大样本、前瞻性医院集中监测方法,收集到全国37家综合性医院30 888例使用丹红注射液的病例,按巢式病例对照研究分为发生不良反应组、未发生不良反应组,应用单因素及多因素Logistic回归方法,探讨性别、过敏史、给药方式、合并用药与不良反应的相关性。共纳入30 888例病例,确定不良反应108例,发生率为0.35%,经分析有头孢类抗生素过敏史、中成药过敏史、丹红注射液合并用药（门冬氨酸钾镁、胸腺肽、塞来昔布、富马酸比索洛尔）的不良反应组不良反应发生多于对照组（P〈0.05,估计系数〉0）,提示此六者为引起丹红注射液不良反应显著的风险因素;丹红注射液合用阿司匹林的不良反应组不良反应发生少于对照组（P〈0.05,估计系数〈0）,提示其为引起丹红注射液不良反应的非风险因素。丹红注射液不良反应发生的影响因素为头孢类抗生素过敏史、中成药过敏史、丹红注射液合并用药（门冬氨酸钾镁、胸腺肽、塞来昔布、富马酸比索洛尔）,提示临床使用时应特别注意。

To study the adverse reactions＇ factors to Danhong injection in the real world. A multi-center,large sample and prospective hospital centralized monitoring method was adopted,and 30 888 cases of Danhong injection from 37 national 3 A hospitals were collected to carry out a nested case control design study. These cases were divided into adverse reaction group and non-adverse group.Single factor logistic regression and multiple factor logistic regression were used to analyze data,and investigate the correlation between adverse reaction and gender,allergy history,methods of administration,and combined drug use. One hundred and eight cases of adverse reactions in 30 888 patients were determined,with an incidence of 0. 35%. The results showed that Danhong injection combined with other medication（ potassium mendoxine magnesium,thymic peptide,celecoxib,fumarate bisoprolol） with history of adverse reactions including scephalosporin allergy and proprietary Chinese medicine allergies had more adverse reactions than the control group（ P〈0. 05,estimated coefficient〉 0）,indicating that these six factors were the risk factors for the adverse reaction of Danhong injection. The adverse reaction of Danhong injection combined with the aspirin was less than that in the control group（ P〈0. 05,estimated coefficient 〈0）,indicating that the aspirin was a non-risk factor for the adverse reaction of Danhong injection. All the above results indicate that the adverse factors to Danhong injection include scephalosporin allergy,patent Chinese medicine allergy,Danhong injection combined with medication（ potassium mendoxine magnesium,thymic peptide,celecoxib,fumarate bisoprolol）,suggesting special attention shall be paid in clinical application.