住院患者奥沙利铂超适应证用药调查分析

Evaluation of Off-label Use of Oxaliplatin in Hospitalized Patients

目的:分析奥沙利铂的超适应证用药,为临床合理用药提供参考。方法:从医院信息系统调取2018年1月1日~2019年6月30日住院病历中使用奥沙利铂的所有医嘱数据。用Excel软件录入患者情况、科室及诊断等信息,并进行统计分析,将病例诊断与美国及日本奥沙利铂说明书、NCCN指南以及国内指南及诊疗规范收载的适应证进行比对。结果:共收集到临床应用注射用奥沙利铂的患者90例,符合说明书适应证患者68例(75.6%),其中转移性/晚期结直肠癌及肝癌分别为52例及16例;奥沙利铂超适应证用药患者22例(24.4%),分别用于胃癌、非小细胞肺癌、肾癌、膀胱癌、宫颈癌、B细胞淋巴瘤、T细胞淋巴瘤、小细胞肺癌及胆管癌。奥沙利铂超适应证用药中,用于胃癌临床证据较为充足,可推荐使用;用于B细胞淋巴瘤及T细胞淋巴瘤可推荐二线治疗;非小细胞肺癌患者不能耐受卡铂或顺铂时,可考虑使用;以目前的临床证据,奥沙利铂可推荐用于胆管癌;用于治疗小细胞肺癌、肾癌、膀胱癌及宫颈癌,循证医学证据尚不充分,不推荐使用。结论:需进一步对奥沙利铂超适应证用药进行规范和管理,以提高用药的合理性和安全性。

Objective:To analyze evaluation of off-label use of oxaliplatin and provide reference for clinical medicination.Methods:The information of inpatient oxaliplatin prescriptions from January 1,2018 to June 30,2019 were collected from the information system in one hospital,then the software of Excel was employed to statistically analyze the data including patient status,department and diagnosis.The diagnoses were compared with foreign drug specifications,NCCN guidelines,and domestic guidelines and medical treatment norms.Results:A total of 90 patients of oxaliplatin were enrolled.68 patients(75.6%)were in compliance with indications of oxaliplatin.Of them,52 patients were metastatic/advanced colorectal cancer and 16 patients were metastatic/advanced liver cancer.22 patients(24.4%)were off-label use of oxaliplatin and involved 9 tumor diseases,including gastric cancer,non-small cell lung cancer,kidney cancer,bladder cancer,cervical cancer,B-cell lymphomas,T-cell lymphomas,small cell lung cancer and cholangiocarcinoma.The evidences of off-label use for the therapy of gastric cancer were high quality and could be recommended.Oxaliplatin could recommend second-line treatment of B-cell lymphoma and T-cell lymphoma.Oxaliplatin could be considered for use as alternative chemotherapy in patients who could not tolerate conventional platinum-based regimens.Oxaliplatin could be recommended for cholangiocarcinoma based on current clinical evidence,due to the lack of standard chemotherapy for cholangiocarcinoma.The evidences of off-label use for the therapy of small cell lung cancer,kidney cancer,bladder cancer and cervical cancer were not sufficient and could not be recommended.Conclusion:The management of off-label use should be further strengthened to promote the safe and rational use of oxaliplatin.