某院妇科病房紫杉醇引起严重药物不良反应的危险因素分析及持续质量改进

Analysis of risks factors and application of continuous quality improvement projects about paclitaxel injection induced serious adverse reactions in gynecological wards

目的:探讨妇科肿瘤患者使用紫杉醇注射液化疗发生严重不良反应的相关危险因素,并通过持续质量改进措施促进临床安全用药。方法:回顾性分析2016年上半年某院输注紫杉醇注射液出现严重不良反应的病历,随机抽取使用紫杉醇注射液未出现严重不良反应的病历作为对照,通过单因素分析法排除紫杉醇注射液输液器材,配制溶媒、浓度、滴速,化疗前预处理方法,患者药物过敏史,化疗前评分一系列因素的影响,明确患者术后体温平稳至化疗开始的时间间隔长短是导致患者使用紫杉醇注射液出现严重不良反应的主要原因。临床药师通过加大不良反应频发病区药学查房力度,重点关注患者开始化疗和体温平稳的间隔时间;每月对使用紫杉醇注射液发生严重不良反应的病史进行专项点评;加强与临床医务人员的沟通,后续追踪随访;定期在院内信息平台上公示紫杉醇注射液引起的严重不良反应相关信息等措施进行整改。结果:临床药师通过一系列整改措施,使得2016年下半年该频发病区在使用紫杉醇注射液化疗时患者术后体温平稳的天数显著延长,严重不良反应发生例数和发生率均明显降低,由上半年的6例下降为2例,发生率由5.5%下降为2.3%。结论:临床药师通过对紫杉醇注射液引起严重不良反应的相关危险因素进行分析并进行持续质量改进,减少严重不良反应的发生,降低了本药在临床使用中的风险,保障了患者临床用药安全。

OBJECTIVE To use PDCA cycle to promote the safety and reasonability of rational drug use by investigating risk factors of paclitaxel related serious hypersensitivity in gynecological wards.METHODS Six cases were collected as control group from a random sample of no serious adverse reactions during paclitaxel chemotherapy by retrospective analysis in the first half of 2016.Factors of infusion apparatus of paclitaxel,solvent,compound concentration,dripping speed,pre-processing method,history of drug allergy were analyzed by single variable analysis,and it was found the duration from stable temperature of patient after operation to chemotherapy was the main reason to paclitaxel related serious hypersensitivity.Clinical pharmacist reduced the incidence rate by strengthening intensity of pharmaceutical care in ward,focusing on checking of prescriptions,enhancing communication with medical staff,paying attentions to following-up and declarations of related information.RESULTS In this research,the duration between stable temperature of patient after operation to chemotherapy was prolonged after taking PDCA interferential measures in the latter half of the 2016,and the incidence rate of paclitaxel related serious hypersensitivity was declined significantly.Patients were reduced from6 to 2,and the incidence rate was declined from5.5%to2.3%.CONCLUSION The application of continuous quality improvement projects in declining incident rate of paclitaxel related serious hypersensitivity is successful,which provides assurance for rational clinical drug usage and drug safety in patients.