2012～2014年我院抗肿瘤药物超说明书用药调查分析与合理性评价

Analysis and evaluation of the off-label medication of antitumor agents in our hospital from 2012 to 2014

目的了解新疆医科大学附属肿瘤医院（以下简称“我院”）抗肿瘤药超说明书用药情况，探讨抗肿瘤药物应用合理性评价方法。方法随机抽取我院2012-2014年应用抗肿瘤药物医嘱的成年人出院病历，根据药品说明书，分析超说明书用药情况。结合美国国立综合癌症网络（NCCN）相关恶性肿瘤临床实践指南，对超说明书用药进行合理性评价。结果共抽取3600份病历，含8895条抗肿瘤药医嘱。其中，超说明书用药医嘱2868条，占32．24％。超说明书用药发生率较高的抗肿瘤药依次为抗肿瘤抗生素（48．72％）、其他抗肿瘤药物（36．33％）及烷化剂（30．99％）；超说明书用药类型前3位的是超适应证（44．98％）、超溶媒用量（38．91％）及溶媒品种（7．53％）。参照NCCN指南进行合理性评价，其中65．48％超说明书用药不合理，不合理的情况主要为溶媒用量、溶媒品种、给药途径。结论我院抗肿瘤药超说明书使用普遍存在，部分超说明书使用有一定的合理性。医院应完善医嘱系统，规范护理操作，临床药师积极参与并干预抗肿瘤药物的应用，以确保化疗患者用药的安全有效，优化治疗方案。

Objective To investigate the off-label use of antitumor agents in the Affiliated Cancer Hospital of Xinjiang Medical University （＂our hospital＂ for short）, in order to discuss the evaluation method for rationality use of antitumor agents application. Methods The adults medical records which used antitumor agents in our hospital from 2012 to 2014 were sampled at random, according to drug instruction, the situation of off-label use was analyzed. Then combination of National Comprehensive Cancer Network （NCCN） clinical practice guideline, the rationality of off-label use was evalu- ated. Results A total of 3600 medical records were sampled, including 8895 orders of antitumor agents, 2868 （32.24%） orders had off-label. The high incidence of off-label of the antitumor agents were antitumor antibiotics （48.72%）, other antitumor agents （36.33%） and alkylating agents （30.99%）. The problems such as over-indication （44.98%）, over-sol- vent volume （38.91%） and over-solvent varieties （7.53%） were the main medication type of off-label. Reference to the NCCN guide for reasonable evaluation, 65.48% off-label uses were unreasonable, mainly including the solvent volume, solvent type, route of administration. Conclusion The off-label medication of antitumor agents in our hospital is widespread, and some of the use is reasonable. The hospital should improve the doctor＇s order system, regulate the op- eration of nursing, clinical pharmacists actively participate in and interfere with the application of antitumor agents, in order to ensure the safety and effectiveness of drug treatment in patients with chemotherapy, and optimize the treatment plan.