Study on the characteristics and risk factors of adverse reactions of niacin for injection
注射用烟酸不良反应特征及风险因素研究

摘要

目的 系统分析注射用烟酸的不良反应发生特征及相关风险因素。方法 提取国家药品不良反应监测中心收录的注射用烟酸不良反应报告 23875 份，采用描述性统计方法分析患者人口学特征、用药相关情况、不良反应表现及转归，通过 logistic 回归模型识别不良反应发生的独立危险因素。结果 女性不良反应占比更高，中老年人是高发群体；不良反应多发生在用药当日，严重不良反应主要累及免疫系统、全身及皮肤及其附件；超说明书用药、联合用药、溶媒使用不规范均为重要风险因素，女性是心悸发生的独立危险因素。结论 注射用烟酸不良反应与患者年龄、性别、用药时间、用药规范程度及联合用药密切相关，临床需加强特殊人群监测，严格遵说明书用药，规范操作以降低风险。

Abstract

Objective To systematically analyze the characteristics of adverse reactions and related risk factors of niacin for injection.
Methods A total of 23,875 adverse reaction reports of nicotinic acid for injection included in the National Center for Adverse Drug Reaction Monitoring were extracted. Descriptive statistical methods were used to analyze the demographic characteristics of patients, drug-related situations, manifestations and outcomes of adverse reactions, and the independent risk factors for adverse reactions were identified through the logistic regression model.
Results The results showed that the proportion of adverse reactions was higher in women, and middle-aged and elderly people were the high-risk groups. Adverse reactions mostly occur on the day of medication. Severe adverse reactions mainly involve the immune system, the whole body, the skin and its appendages. Off-label drug use, combined drug use, and non-standard solvent use are all important risk factors. Women are an independent risk factor for palpitations.
Conclusion   The adverse reactions of nicotinic acid for injection are closely related to the patient's age, gender, timing of medication, degree of medication standardization and combined medication. In clinical practice, it is necessary to strengthen the monitoring of special populations, strictly follow the instructions for medication, and standardize the operation to reduce risks.