抗肿瘤相关的中药注射液在静脉用药集中调配中心的分类调配与职业防护

目的:通过对抗肿瘤相关的中药注射液的调配进行合理分类，为静脉用药集中调配中心(PIVAS)人员的安全防护提供依据。方法:通过数据库和国家医保目录查找抗肿瘤相关的中药注射液品种，对药物活性成分、不良反应、药动学、特殊人群用药和毒理学研究等数据进行分析，作为分类调配的依据。结果:将通关藤注射液(消癌平注射液)、鸦胆子油乳注射液等13种抗肿瘤相关的中药注射液纳入本次研究。除黄芪多糖注射液外，多数抗肿瘤相关的中药注射液存在不同程度毒性，具有剂量和时间相关性。结合国内调配现状建议通关藤注射液、鸦胆子油乳注射液等7个品种按照抗肿瘤药物调配，其余6个品种按照普通危险药物和中药注射液调配，并根据药物的毒性和极性合理安排药物调配顺序。结论:目前国内尚无药品调配安全性分类及防护指南，PIVAS应进一步提高现有防护要求，以减少职业暴露。

Classification configuration and occupational protection of anti-tumor related traditional Chinese medicine injection in pharmacy intravenous admixture services

OBJECTIVE Rational distribution of anti tumor related Chinese medicine injections was carried out to provide basis for safety protection of PIVAS.METHODS The varieties of anti-tumor related traditional Chinese medicine injection were found through the database and national medical insurance catalogue,the data of drug active components,adverse reactions,pharmacokinetics,drug use in special population and toxicology were analyzed as the basis for classification and configuration.RESULTS 13 anti-tumor related traditional Chinese medicine injections such as Tongguanteng Injection(Xiaoaiping Injection)and Brucea javanica oil emulsion injection were included in this study.Except astragalus polysaccharide injection,most anti-tumor related traditional Chinese medicine injections had varying degrees of toxicity,with dose and time correlation.Combined with the current situation of domestic configuration,it is suggested that 7 varieties such as Tongguanteng Injection and Brucea javanica oil emulsion injection should be configured according to antitumor drugs,and the other 6 varieties can be configured according to common hazardous drugs and traditional Chinese medicine injection,and the drug configuration sequence should be reasonably arranged according to the toxicity and polarity of drugs.CONCLUSION At present,there is no safety classification and protection guide for drug configuration in China.PIVAS should further improve the existing protection requirements to reduce occupational exposure.