滴眼液开启后污染状况及危险因素研究

Study on pollution and risk factors of eye drops after opening in the real environment of hospital

目的探讨真实世界条件下,滴眼液开启后在医院病区污染状况及其相关危险因素。方法随机选取眼科常用抗生素类左氧氟沙星滴眼液320瓶与非抗生素类马来酸噻吗洛尔滴眼液320瓶,按照医院病区不同区域、不同气候季节分期、不同使用放置时间等条件试验观测,根据滴眼液开启使用0~20 d留取样本的细菌和真菌培养结果,以是否阳性结果分为污染组与未污染组,采取单因素和二元Logistic回归分析,分析不同条件下滴眼液启用后的污染情况,确定污染的危险因素。结果(1)污染率640瓶滴眼液启用后20 d观察到周期内出现污染11瓶(供暖期9例、春温期0例、夏暑期1例、秋凉期1例),污染率为1.72%,时间范围0~17 d(第0、1、9、12、17 d),且均为真菌,未培养出细菌。滴眼液启用时(第0 d)培养结果阳性的滴眼液,在观察结束时取样培养结果均是阴性。(2)单因素分析两组(污染组和非污染组)在病房区域(Х^(2)=4.532,P=0.033)、气候季节(Х^(2)=19.517,P=0.000)方面差异均有统计学意义(P<0.05),而在药品类别、放置时间方面差异无统计学意义(P>0.05);(3)二元Logistic回归分析病区区域因素的回归系数值为1.551,Z=1.963,P=0.049;气候季节因素的回归系数值为-1.121,Z=-2.721,P=0.007,而药品类别因素的回归系数值为0.192,放置时间因素的回归系数值为0.019,均无统计学意义(P>0.05)。结论滴眼液开启后在医院病区出现污染与病区区域因素有正向影响关系;气候季节因素尤其供暖期对滴眼液污染有负向影响关系;而药品类别、放置时间因素并不会对污染结果产生影响关系。

OBJECTIVE To explore the pollution status and related risk factors of eye drops after opening in the ward of hospital under real world conditions.METHODS A total of 320 bottles of levofloxacin eye drops commonly used in ophthalmology and 320 bottles of non-antibiotic timolol maleate eye drops were randomly selected.They were divided into pollution group and non-pollution group based on the positive results according to different areas of the hospital ward,different seasons,different storage time and other conditions for test and observations.According to the results of bacterial and fungal culture of the eye drops open and used from day 0 to day 20,the samples were divided into contaminated and uncontaminated groups according to whether the results were positive.Single factor and binary logistic regression analysis were used to analyze the pollution situation of eye drops under different conditions and thereby the risk factors of pollution were clarified.RESULTS(1)Pollution rate:640 bottles of eye drops were contaminated during the 20-days observation period(9 cases in the heating period,none in the spring,1 case in the summer,and 1 case in the autumn).The pollution rate was 1.72%and the time range was 0-17 d(Day 0,1,9,12,and 17),and they were all fungi other than bacteria.When the eye drops were open(day 0),these eye drops with positive culture results all got negative result at the end of the observation.(2)Univariate analysis:It showed that the two groups(contaminated group and non-contaminated group)had statistically significant differences in ward area(Х^(2)=4.532,P=0.033)and seasonal condition(Х^(2)=19.517,P=0.000),but there was no statistically significant difference in drug category and placement time(P>0.05).(3)Binary Logistic regression analysis:the results showed that the regression coefficient value of the ward area factor was 1.551,Z=1.963,P=0.049,and the regression coefficient value of the seasonal four-phase factor was-1.121,Z=-2.721,P=0.007,while the regression coefficient of the drug category factor was 0.192,and the regression coefficient value of the storage time factors was 0.019,both of which were not statistically significant(P>0.05).CONCLUSIONS After opening the eye drops,the contamination of them in the hospital ward had a positive relationship with the area of the ward.The factors of the season,especially the heating period had a negative influence on the contamination of the eye drops.While the type of medicine and the storage time were not related to the contamination results.