头孢哌酮/他唑巴坦不良反应风险因素分析

Risk Factors Analysis of the Adverse Drug Reaction of Cefoperazone / Tazobactam

目的：研究头孢哌酮/他唑巴坦不良反应的风险因素。方法：收集2006-2014年某省各单位上报该省药品不良反应监测中心的所有头孢哌酮/他唑巴坦相关不良反应（ADR）报告64例作为病例组,同时随机抽取我院2014年11月-2015年8月使用过头孢哌酮/他唑巴坦且未出现ADR的128例患者作为对照组。用χ-2检验对患者性别、年龄、用药时间、既往ADR史和原患疾病5个疑似风险因素进行单因素分析;用条件Logistic回归对上述几项疑似风险因素进行多因素分析,从中发现头孢哌酮/他唑巴坦ADR的风险因素。结果：通过单因素分析发现,头孢哌酮/他唑巴坦ADR的发生与患者的年龄、性别、用药时间、既往ADR史和原患疾病5个因素有关。而条件Logistic回归的多因素分析表明年龄、既往ADR史、原患疾病和用药时间是头孢哌酮/他唑巴坦ADR的风险因素。在分析用药时间时发现,病例组头孢哌酮/他唑巴坦用药≤72 h出现ADR占70.8%,〉72 h出现的ADR占29.2%。对头孢哌酮/他唑巴坦ADR的用药时间分析发现,使用头孢哌酮/他唑巴坦〉72 h的患者在性别、既往有无ADR史和原患疾病等方面与用药时间≤72 h的患者比较,差异无统计学意义（P〉0.05）,仅在年龄方面差异有统计学意义（P〈0.05）。结论：头孢哌酮/他唑巴坦ADR的风险因素为年龄、既往ADR史、原患疾病和用药时间。

Objective： To study the risk factors of adverse drug reaction （ADR） of cefoperazone/tazobatam. Methods ：64 cases report of cefoperazone/tazobatam ADR were collected （2006-2014） from one province center for adverse drug reaction monitoring. 128 patients who received cefoperazone/tazobatam treatment and has not appeared ADR during the course of hospitalization （2014.11-2015.8） were selected for control. Suspected ADR risk factors were statistical analysis by chi-square test and conditional logistic regression, such as gender, age, medication time, past medical history and original disease. Results：Univariate analysis indicated that the occurrence of adverse reactions relate to the patient＇ s gender, age, the length of medication use, the original disease and past medical history. The result of conditional logistic regression muhivariable analysis indicated that age, personal history, medication time, and original disease are the ADR risk factors of cefoperazone/tazobatam. Medication time was analyzed by univariate analysis, ADR of cefoperazone/ tazobatam was 70.8% appear within 72 hours. Analyse the time of ADR of cefoperazone/tazobatam, find ADR of cefoperazone/tazobatam appear within 72 h and after 72h did not have statistical differences in gender, administration route, past medical history and the original disease （ P 〉 0.05 ）, only have statistical different in age （ P 〈 0.05 ）. Conclusion： ADR risk factors of cefoperazone/tazobatam were medication time, dosage of administration and past medical history.