基于真实世界数据的疏血通注射液上市后临床安全性研究

Post-marketing Clinical Safety Study of Shuxuetong Injection Based on Real World Data

目的基于真实世界数据获取疏血通注射液不良反应的发生率、发生类型及影响因素,为临床用药提供风险预警。方法收集2014年1月至2019年4月期间河南省两家三甲医院使用疏血通注射液的住院患者病例,以使用疏血通注射液治疗发生不良反应的患者为病例组,描述性统计分析疏血通注射液不良反应的发生情况、特点及转归,以年龄和性别1:4在未发生不良反应的队列中匹配对照组,logistic回归分析个人药物/食物过敏史、家族过敏史、单次用药剂量、合并用药种类等对疏血通注射液发生不良反应的影响。结果疏血通注射液不良反应的发生率为4.23‰。皮肤及其附件损害(24.42%)和中枢及外周神经系统损害(24.42%)最为常见,主要临床表现为皮疹(20.93%)、头晕(17.44%)。所有不良反应均为轻度或中度,停药或对症治疗后不良反应均为好转或痊愈转归。发生不良反应的独立危险因素为个人药物/食物过敏史(OR=3.997,P=0.000)。结论疏血通注射液在一般人群中具有良好的耐受性。有个人药物/食物过敏史的患者使用疏血通注射液需谨慎。基于真实世界数据开展药品上市后临床安全性研究是获取临床安全性证据的一种可靠的研究方法。

Objective To evaluate the incidence,types and predictive factors of adverse reactions of Shuxuetong injection in clinical application.Methods This study adopted a retrospective,nested case-control study design.We collected the medical records who used Shuxuetong injection in the First Affiliated Hospital of Henan University of CM and Zhengzhou TCM Hospital from January 2014 to April 2019.The inpatients who had adverse reactions during the course of the disease were recorded as the case group.We performed descriptive statistical analysis of the occurrence,characteristics and outcomes of the adverse reactions of Shuxuetong injection.The cases in the control group were matched with 1:4 by age and gender using the propensity score matching method.The demographic characteristics of the study subjects were collected,including gender,age,personal drug food allergy history and family allergy history.Logistic regression was used to analyze the influencing factors of adverse reactions.Results The incidence of adverse reactions of Shuxuetong injection was 4.23‰.Skin and appendage damage(24.42%),central and peripheral nervous system damage(24.42%)were common adverse reactions;the main clinical manifestations were rash(20.93%)and dizziness(17.44%).All adverse reactions were mild or moderate.The adverse reactions of the patients after stopping the drug or receiving symptomatic treatment were improved or healed.The influencing factors for the occurrence of adverse reactions include a history of personal food and drug allergy(OR=3.997,95%CI[2.089,7.648]),combined use of gastrodin injection(OR=2.116,95%CI[1.058,4.233]),Xueshuantong Injection(OR=2.811,95%CI[1.270,6.223]),Bailing capsule(OR=4.480,95%CI[1.790,11.211]),Danhong injection(OR=4.793,95%CI[1.728,13.290]).Conclusion Shuxuetong injection is well tolerated in the general population.Patients with a history of personal food and drug allergies should be cautious in taking medications and strictly control the types of combined medications.Postmarketing clinical safety research methods based on case review can be used as a powerful supplement to the postmarketing safety evidence.