某院紫杉醇注射剂用药情况与不良反应相关因素分析

Analysis of Related Factors and Adverse Reactions of Paclitaxel Injection in a Hospital

目的:分析紫杉醇注射剂用药情况及其不良反应相关因素,为临床合理用药提供参考。方法:回顾性分析某院2017年3月～2017年11月255例使用紫杉醇注射剂患者的用药情况如给药剂量、溶媒、紫杉醇剂型、化疗前是否进行预防用药和化疗方案等及其用药期间发生药品不良反应(ADR)的特点,并分析ADR的相关因素。结果:255例患者中男112例,女143例,平均年龄56.6岁,原发肿瘤主要为非小细胞肺癌、卵巢恶性肿瘤和头颈部癌,肿瘤TNM分期主要为Ⅳ期。紫杉醇单药化疗44例(17.25%),联合化疗211例(82.75%)。紫杉醇适应证、给药剂量和溶媒等方面超说明书用药比例分别为53.72%、20.54%和10.10%。ADR发生率为81.96%,严重ADR占20.70%(94/454)。主要ADR类型为血液和淋巴系统疾病及骨骼肌和结缔组织,最常见WBC降低(25.11%)。对紫杉醇ADR发生率有显著性影响的因素包括患者所在科室、生产厂家及是否进行预防用药。结论:某院紫杉醇注射剂存在超说明书用药情况,但超说明书用药与ADR发生无相关性。几种联合化疗方案的ADR发生率差异无统计学意义,使用紫杉醇脂质体可能会减少ADR的发生。

Objective:To analyze the drug use of paclitaxel injection and its related factors,and provide reference for clinical rational drug use.Methods:The medication status of 255 patients who took paclitaxel injection from March 2017 to November 2017 in a hospital were analyzed retrospectively,such as the dose,vehicle,paclitaxel dosage form,pre-chemotherapy,chemotherapy,and the characteristics of adverse drug reactions(ADR)during medication.Its ADR carries out related factor analysis.Results:Paclitaxel(112 males and 143 females)with an average age of 56.6 years was used in 255 patients.The primary tumors were mainly non-small cell lung cancer,ovarian malignant tumor and head and neck cancer.The tumor TNM stage was mainly stageⅣ.There were 44 cases(17.25%)of paclitaxel monotherapy and 211 cases(82.75%)of combination chemotherapy.The proportions of paclitaxel indications,dosages,and vehicles about off-label drug uses were 53.72%,20.54%,and 10.10%,respectively.The incidence of ADR was 81.96%,and severe ADR was 20.70%(94/454).The main ADR types were blood and lymphatic diseases and skeletal muscle and connective tissue,with the most common white blood cell count reduced(25.11%).Among them,gender,age,indications,vehicle,dose and chemotherapy regimen had no significant difference in the incidence of paclitaxel ADR.There were significant differences in the factors,including the department,the manufacturer and whether to take preventive medication.Conclusion:The paclitaxel injection in a hospital has off-label drug uses.The results suggest that there is no correlation between the over-instruction and ADR.The incidence of ADR in several combined chemotherapy regimens is not much different.The clinical selection of chemotherapy regimens may not require too much consideration for the difference in the incidence of ADR between the various chemotherapy regimens.The use of the liposome dosage form of paclitaxel may reduce the occurrence of ADR.