多西他赛与紫杉醇药品不良反应真实世界数据及危险因素比较

Comparison of Real-World Data of Adverse Drug Reactions Induced by Docetaxel or Paclitaxel and Their Risk Factors

目的为临床合理使用多西他赛与紫杉醇提供参考。方法统计山西省某三级甲等肿瘤专科医院2020年胃癌患者使用多西他赛或紫杉醇出现的药品不良反应(ADR)累及器官/系统及其临床表现,并将ADR发生率与患者年龄、性别、体表面积、卡氏生活质量(KPS)评分、给药剂量、治疗线数等进行单因素分析并进行Logistic多因素回归分析。结果接受多西他赛或紫杉醇治疗患者ADR发生率分别为32.23%(1081/3354),39.09%(518/1325),2种药品的ADR累及器官/系统相似,主要表现在血液及淋巴系统、皮肤及其附件、神经系统、消化系统、全身性、肝脏系统、心血管系统等损害,但多西他赛的骨髓抑制发生率显著高于紫杉醇(44.69%比13.62%),过敏反应发生率显著低于紫杉醇(3.13%比6.14%)。Logistic回归分析结果显示,两者发生ADR的独立影响因素也不尽相同,多西他赛为给药剂量[OR=0.579,95%CI(0.523,0.641),P<0.05]、患者性别[OR=0.591,95%CI(0.504,0.693),P<0.05]及KPS评分[OR=2.712,95%CI(2.307,3.189),P<0.05],紫杉醇为患者是否有吸烟史[OR=1.278,95%CI(1.017,1.606),P=0.035]及KPS评分[OR=1.870,95%CI(1.494,2.341),P<0.05]。结论真实世界中多西他赛与紫杉醇引起的ADR较多且各自特征明显。临床应预测、预防ADR的发生,并采取措施及时干预,降低用药风险,提升药品疗效及安全性。

Objective To provide a reference for clinical rational use of docetaxel and paclitaxel.Methods The organs/systems involved in adverse drug reactions(ADRs)and their clinical manifestations in patients with gastric cancer treated with docetaxel or paclitaxel in a GradeⅢClass A cancer hospital in Shanxi Province in 2020 were counted.Univariate analysis and Logistic multivariate regression analysis were conducted on the correlation between the incidence of ADRs and patients′age,gender,body surface area,Karnofsky Performance Scale(KPS)score,dosage and the types of treatment lines.Results The incidence of ADRs in patients treated with docetaxel and paclitaxel was 32.23%(1081/3354)and 39.09%(518/1325),respectively.The organs/systems involved in ADRs in the two drugs were similar,mainly in the blood and lymphatic system,skin and its accessories,nervous system,digestive system,systemic diseases,liver system and cardiovascular system,but the incidence of bone marrow suppression induced by docetaxel was significantly higher than that induced by paclitaxel(44.69%vs.13.62%),while the incidence of allergic reaction induced by docetaxel was significantly lower than that induced by paclitaxel(3.13%vs.6.14%).Logistic regression analysis showed that the independent influencing factors of ADRs induced by the two drugs were not exactly the same,those of docetaxel were dosage[OR=0.579,95%CI(0.523,0.641),P<0.05],patients′gender[OR=0.591,95%CI(0.504,0.693),P<0.05],KPS score[OR=2.712,95%CI(2.307,3.189),P<0.05],and those of paclitaxel were the patients′smoking history[OR=1.278,95%CI(1.017,1.606),P=0.035]and KPS score[OR=1.870,95%CI(1.494,2.341),P<0.05].Conclusion In the real world,there are many ADRs induced by docetaxel and paclitaxel,and their characteristics are obvious.Clinically,we should predict and prevent the occurrence of ADRs,take measures to intervene in time,reduce the risk of medication and improve the efficacy and safety of drugs.