多剂量注射药物启用后安全使用期限的系统评价  

Safety period of multidose parenteral medication:A systematic review

作　　者：张丽君[1] 邱峰[1] 王红梅[1] 秦霞[1] 

机构地区：[1]重庆医科大学附属第一医院药学部,重庆400016

出　　处：《中国医院药学杂志》2015年第6期510-517,共8页Chinese Journal of Hospital Pharmacy

基　　金：重庆市医学科研计划重点项目(编号:2011-1-036)

摘　　要：目的:系统评价多剂量注射药物启用后的安全使用期限,为多剂量注射药物的安全、规范及合理使用提供参考。方法:计算机检索PubMed、Embase、CBM、CNKI、Wanfang、VIP数据库,检索时间为各库建库到2014年1月,纳入多剂量注射药物启用后的无菌性研究,并采用Rev Man 5.2软件进行Meta分析。结果:(1)纳入研究共61项,英文文献40项,中文文献21项;(2)纳入多剂量注射药物样本总数6 863瓶,污染样本数147瓶,污染率为2.14%,细菌为主要污染物;(3)Meta分析结果显示,与启用天数10~30 d比较,启用天数1~10 d能显著降低多剂量注射药物启用后的污染率(RD=-0.07,95%CI=-0.12^-0.01,P=0.02),提示启用天数越长,多剂量注射药物被污染的风险越高;而穿刺次数下的各组污染率差异无统计学意义(RD=-0.07,95%CI=-0.19~0.06,P=0.30),因此尚不能认定穿刺次数为无菌性影响因素;(4)启用后的无菌性影响因素包括无菌技术、启用天数、温度、抑菌剂特性、药物特性、储存容器特性、共用药物等。结论:在严格按照无菌技术的要求操作下,建议多剂量注射药物启用后的安全使用期限为1~10 d。OBJECTIVE To evaluate the safety period of multidose parenteral medication by a systematic review and provide basis for its safe,normative and rational use.METHODS PubMed,Embase,CBM,CNKI,Wanfang and VIP Database were retrieved since their foundation to the end of January,2014,to enroll literatures on study on sterility of multidose parenteral medication.Rev Man 5.2 was employed to conduct Meta analysis.RESULTS（1）Sixty one literatures were included,40 in English and 21 in Chinese.（2）A total of 6 863 vials were used for multidose parenteral medication,147 of them were contaminated（2.14%）.The major sources of contamination were bacteria.（3）Meta analysis results suggested that multidose parenteral medication for 1-10 days significantly reduced contamination rate compared with those for 10-30 days（RD=-0.07,95%CI=-0.12--0.01,P=0.02）,and more days for multidose parenteral medication,the risk of contamination was higher.No significant difference was found in contamination rate between different puncture times（RD=-0.07,95%CI=-0.19-0.06,P=0.30）,which was not considered as the influencing factor for sterility.（4）Aseptic techniques,injection days,temperature,nature of preservative,properties of drug,characteristics of storage containers,share drugs were the influencing factors of sterility after multidose parenteral medication.CONCLUSION Fllowing aseptic techniques strictly,the safety period is 1-10 d for multidose parenteral medication.

关 键 词：多剂量 注射药物 启用 无菌性 系统评价 

分 类 号：R969.3[医药卫生—药理学]