两种不同配液环境对配液质量影响

目的 观察两种不同环境对配液质量的影响。方法 回顾性分析我院配制肠外营养液的情况。1990－1995年为A组，接受配制营养液的病例数10900例，接受肠外营养的时间平均为6天，共配制65400袋营养液。配液环境：单独房间（7平方米）内放有100级洁净台（JJT－2型由中国北京半导体设备二厂生产），属垂直送风，用传统手工配液法进行配制。1995－2000年为B组，接受配制营养液的病例数23700例，接受肠外营养液的时间平均为10天，共配制237000袋营养液。配液环境：外套间为10000级层流房间，内套间为1000级层流房间（共14平方米），放有100级洁净台（SW－CJ－1C型由中国苏州空气技术有限公司生产），属水平送风。手工及用电脑混合配液机两种形式进行配液。有配制规范（SOP），观察两组液体的污染情况。结果 （1）不同环境配液室内空气细菌培养结果：A组空气培养260次，15％的细菌培养结果为阳性，其中1／3有1至5个菌落，2／3有6至12个菌落为霉菌、葡萄球菌、大肠杆菌等；B组空气培养260次，0．77％的培养结果为阳性，只有1至3个菌落，以酶菌、葡萄球菌多见。（2）洁净台内空气培养结果：A组1．92％的空气细菌培养结果为阳性，有1至3个菌落，以酶菌、葡萄球菌多见。（2）洁净台内空气培养结果：A组1．92％的空气细菌培养结果为阳性，有1至3个菌落，以酶菌、葡萄球菌多见；B组细菌培养结果均为阳性。（3）营养液用终端0．22μ的滤器，富集3000亳升液体，通过滤器后，在无菌条件下取滤膜电镜检验结果：A组抽样滤膜检验80次，有52次验出杂质为阳性，阳性率为65％；B组抽样滤膜检验46次，有12次验出杂质为阳性，阳性率为26．1％。（4）营养液用终端0．22μ的滤器滤膜培养结果：A组抽样滤膜培养80次，有13个滤器的滤膜霉菌培养阳生；酵母菌阳性4个；占30．8％，硝酸盐阴性杆菌阳性6个，占46．2％，黑曲霉菌阳性3个，占23％。B组抽样滤膜培养46次均无细菌生长。（5）临床输液感染及输液反应：A组B组均无直接输液感染及输液反应。（6）配液方式的改变：A组为手工配液，配液中从未使用过滤器；B组使用电脑配液机，通过直径为1．2μ的滤器进行配制，所以，没有超过1．2μ的大颗粒，增加肠外营养的安全性。结论 A组有微生物及杂质存在，有潜在的感染和输液反应的可能性；B组配制营养液，潜在感染的可能性几乎消失，配液质量得到提高，但仍须密切监测，以免问题偶然发生。

The impact of the twodifferent preparing environment on the quality of the mixed parenteral nutrition fluids

Objective To investigate the impact of the two differentpreparing environment on the quality of the mixed parenteral nutrition fluids. Method The condition of the parenteralnutrition fluids mixed in our hospital was respectively analysed.10,900 patients from 1990-1995 requiring an average of 6 day parenteral nutrition support by a total of 65,400 bags of fluids were assigned to Group A,who had their fluids manually mixed on a vertical laminar flow super clean bench of grade 100(Model JJT-2,product of the Second Beijing Semiconductor Factory of China)in a 7 m２ room.23,700 patients from 1995-2000 requesting an average of 10 day parenteral nutrition support by a total of 237 000 bags of fluids were assigned to Group B,who had their fluids miexed under SOP manually or by computer assisted mixing machine on a horizontal laminar flow super clean bech of grade 100(Model SW-CJ-lC,product of the Suzhou Air Technology Company Ltd.of China)in a 14 m２ laminar flow room with the outer cell of grade 10,000 and the inner of 1 000.The possible contamination status of the mixed fluids was investigated. Results (1)Different room air bacterial cultivation results:in Group A,15% of the 260 time cultivation turned out to be positive,1/3 of which had 1-5 bacterial colony,2/3 had 6-12 consisting of mould,staphylococcus,Escherichia coli,etc;while in Group B,only 0.7% of the 260 time cultivation turned out to be positive,each of which only had 1-3 bacterial colony dominated by mould and staphylococcus.(2)Bacterial cultivation of the air upon the super clean bench:2.1% in Group A were postitive while all negative in Group B.(3)Electronic microscopic examination under sterile condition of the 0.22 end line filter membranes passed through by 3 000 ml mixed fluid for each:in Group A,52 out of the 80 sampled filter membranes were particle positive (65%),while only 12 out of the 46(26.1%) in Group B were positive.(4)Bacterial cultivation of the 0.22μ end line filter membranes:in Group A,13 out of the 80 sampled filter membranes bacterial positive,4(30%)of which was of yeast fungus,6(50%) of nitrate Gram negative bacilli,3(20%) of black aspergillus;while none positive in Group B.(5)Clinical infusion induced infection and infusion reaction:no direct infusion induced infection or infusion reaction in both the groups.(6)Change of the preparation method:the fluids were only mixed manually and filters were never applied during mixing in Group A;while in Group B,the computerassisted mixing machine equipped with a 1.2μ filter was employed to assure there were no particles larger than 1.2μ existing in the mixed fluid,which enhanced the safety of the parenteral nutrition support. Conclusions The existence of microorganisms and particles in PN fluids of Group A could have the potential possibility leading to infusion induced infection or infusion reaction;while in Group B,the potential possibility leading to infusion induced infection almost disappeared.which improved the quality of the mixed fluids,but close monitoring was still needed to prevent the occasional occurrence.