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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 systematically evaluate the safety period after multi-dose injection is started and provide reference for the safety, standardization and rational use of multi-dose injection. Methods: The databases of PubMed, Embase, CBM, CNKI, Wanfang and VIP were searched by computer, and the retrieval time was from the establishment of each library to January 2014, and the sterility study after the multi-dose injection was started was implemented and Rev Man 5.2 software was used Meta analysis. Results: (1) A total of 61 studies, 40 English studies and 21 Chinese studies were included in the study. (2) A total of 6,863 bottles of multi-dose injections were enrolled. The number of contaminated samples was 147, with a contamination rate of 2.14% (3) The results of Meta-analysis showed that the number of days one to ten days after the start of administration was significantly lower than that of the control (RD = -0.07,95% CI -0.12 ~ -0.01, P = 0.02), suggesting that the longer the number of days of activation, the higher the risk of multi-dose injection was contaminated; and the difference in the rate of contamination among the groups with the number of punctures was not statistically significant (RD = -0.07,95% CI = -0.19 ~ 0.06, P = 0.30). Therefore, the number of punctures was not considered to be a factor influencing the sterility. (4) The aseptic factors after the start of treatment included sterility technique, days of activation, temperature, bacteriostatic agent, Characteristics, storage container characteristics, shared drugs and more. CONCLUSIONS: In strict accordance with the requirements of aseptic technique, it is recommended that the safe period of use of multi-dose injections be 1 to 10 days.