关于一次性使用无菌导尿管润滑剂的研究
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摘要
目的研究不同润滑剂的刺激性及不同润滑剂对不同材质导尿管的影响,并对临床上导尿管润滑剂的使用提出建议。方法采用鸡胚绒毛尿囊膜试验法、拉力测定法和恒温浸泡法,对液体石蜡、丙三醇、甲基硅油、利多卡因凝胶的刺激性及四种润滑剂对国产乳胶导尿管、进口乳胶导尿管、轻度硅化乳胶导尿管、重度硅化乳胶导尿管、橡胶导尿管、硅胶导尿管的影响进行探究。结果四种润滑剂均无刺激性。液体石蜡对各种材质导尿管影响较大,显著降低了导尿管球囊的承受力;甲基硅油对硅胶材质导尿管影响较大,降低了硅胶导尿管球囊的承受力,对其他材质导尿管几乎没有影响;丙三醇、利多卡因凝胶对各种材质导尿管几乎没有影响。结论规范临床上导尿管润滑剂的选择,避免使用液体石蜡等石油基质润滑剂,硅胶材质导尿管避免使用硅酮类润滑剂;建议使用利多卡因凝胶、丙三醇等水溶性润滑剂,同时建议导尿管生产厂家应根据导尿管材质明确标出润滑剂可用类型。
Objective To investigate the irritancy of different lubricants and the effect of different lubricants on different materials of catheters, and make recommendations for the use of catheter lubricants in clinic. Methods The irritancy of liquid paraffin, glycerol, methyl silicone oil and lidocaine gel and the effects of these lubricants on various materials of catheters(domestic latex cathetes, imported latex catheter, severe silicone latex catheter, mild silicone latex catheter, rubber catheter and silicone catheter) were studied by chicken chorioallantoic membrane test method, tensile force test and constant temperature immersion method. Results All four kinds of lubricants were not irritating. Liquid paraffin had a great influence on various materials of catheters, which significantly reduced the tolerance of catheter balloon. Methyl silicone oil had an influence on the silicone catheter, which reduced the tolerance of the silicone catheter balloon, but had little effect on other catheter. Glycerol and lidocaine gel had almost no effect on all six materials of catheters. Conclusion It is important for standardizing the choice of catheter lubricants in clinical use. Petroleum matrix lubricants, such as liquid paraffin, should be banned. Silicone catheters should avoid the use of silicone lubricants. It is recommended to use water-soluble lubricants, such as lidocaine gel and glycerol. It is recommended that the catheter manufacturers should clearly indicate the available lubricants according to the material of the catheter.
Objective To investigate the irritancy of different lubricants and the effect of different lubricants on different materials of catheters, and make recommendations for the use of catheter lubricants in clinic. Methods The irritancy of liquid paraffin, glycerol, methyl silicone oil and lidocaine gel and the effects of these lubricants on various materials of catheters(domestic latex cathetes, imported latex catheter, severe silicone latex catheter, mild silicone latex catheter, rubber catheter and silicone catheter) were studied by chicken chorioallantoic membrane test method, tensile force test and constant temperature immersion method. Results All four kinds of lubricants were not irritating. Liquid paraffin had a great influence on various materials of catheters, which significantly reduced the tolerance of catheter balloon. Methyl silicone oil had an influence on the silicone catheter, which reduced the tolerance of the silicone catheter balloon, but had little effect on other catheter. Glycerol and lidocaine gel had almost no effect on all six materials of catheters. Conclusion It is important for standardizing the choice of catheter lubricants in clinical use. Petroleum matrix lubricants, such as liquid paraffin, should be banned. Silicone catheters should avoid the use of silicone lubricants. It is recommended to use water-soluble lubricants, such as lidocaine gel and glycerol. It is recommended that the catheter manufacturers should clearly indicate the available lubricants according to the material of the catheter.
引文
[1]YY0325-2016,一次性使用无菌导尿管标准[S].
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[6]王宁,洪新宇,帅怡.鸡胚绒毛尿囊膜血管试验在化妆品安全性评价中的应用研究[J].现代预防医学,2016,43(22):4163-4165.
[7]刘彩云,吴培诚,梁高卫,等.鸡胚绒毛尿囊膜试验研究不同香波对眼的刺激强度[J].香料香精化妆品,2016,(5):47-49.
[8]刘琰.导尿管气囊破裂常见原因与处理方法[J].齐鲁护理杂志,2010,16(20):45-46.
[9]张志广,谢竞慧,陈彦北,等.硅油的种类及用量对硅橡胶阻尼性能的影响[J].合成橡胶工业,2016,39(5):386-390.
[10]王小华,陈宏志.舒芬太尼联合利多卡因乳膏对全麻前置尿管舒适度的影响[J].实用药物与临床,2016,19(10):1269-1272.
[11]杨世喜.利多卡因在高龄前列腺增生患者术前导尿的应用[J].护理学杂志,2018,33(8):26-27.
[12]石少将,殷志春.盐酸利多卡因胶浆导尿降低全麻苏醒期躁动的临床观察[J].社区医学杂志,2017,15(18):72-73.
[13]姚建华.利多卡因凝胶在老年男性急性尿潴留患者导尿术中的应用[J].基层医学论坛,2016,20(S1):89-90.
[14]邱洪波,成小燕,张琳娟,等.复方利多卡因乳膏在男性患者留置导尿中的应用[J].当代护士(上旬刊),2016,(9):98-100.
[15]童玲红,黄淳茂.利多卡因胶浆在男性患者术前留置导尿中的应用效果[J].解放军护理杂志,2013,30(3):75-76.
[16]杨斌,陈琪,江继宏,等.利多卡因和丁卡因胶浆尿道表麻对男性胸腔镜术后躁动的比较[J].实用医学杂志,2017,33(12):2019-2022.
[17]李洪芬,钱海涛,庄丽芳.盐酸利多卡因胶浆减少留置尿管男性患者麻醉苏醒期躁动的效果[J].江苏医药,2016,42(12):1409-1411.
[18]Mu L,Geng LC,Xu H,et al.Lidocaine-prilocaine cream reduces catheter related bladder discomfort in male patients during the general anesthesia recovery period[J].Medicine,2017,96(14):e6494.
[19]崔福德,龙晓英.药剂学[M].北京:人民卫生出版社,2011:298-299.
[2]李志锋.乳胶气囊导尿管国内生产概况[J].特种橡胶制品,2013,34(1):75-80.
[3]国家食品药品监督管理总局.医疗器械不良事件信息通报(2014年第3期)关注导尿管风险[EB/OL].(2014-11-25)[2018-05-12]http://samr.cfda.gov.cn/WS01/CL1993/109740.html.
[4]健康必读杂志.2017年国家医疗器械不良事件年度监测报告详解[EB/OL].(2018-05-25)[2018-07-28].https://www.jkbdgw.com/h-nd-149.
[5]尹建兵,王越,张兰,等.导尿管在临床使用中的不良事件分析[J].中国医疗器械杂志,2016,40(5):369-372.
[6]王宁,洪新宇,帅怡.鸡胚绒毛尿囊膜血管试验在化妆品安全性评价中的应用研究[J].现代预防医学,2016,43(22):4163-4165.
[7]刘彩云,吴培诚,梁高卫,等.鸡胚绒毛尿囊膜试验研究不同香波对眼的刺激强度[J].香料香精化妆品,2016,(5):47-49.
[8]刘琰.导尿管气囊破裂常见原因与处理方法[J].齐鲁护理杂志,2010,16(20):45-46.
[9]张志广,谢竞慧,陈彦北,等.硅油的种类及用量对硅橡胶阻尼性能的影响[J].合成橡胶工业,2016,39(5):386-390.
[10]王小华,陈宏志.舒芬太尼联合利多卡因乳膏对全麻前置尿管舒适度的影响[J].实用药物与临床,2016,19(10):1269-1272.
[11]杨世喜.利多卡因在高龄前列腺增生患者术前导尿的应用[J].护理学杂志,2018,33(8):26-27.
[12]石少将,殷志春.盐酸利多卡因胶浆导尿降低全麻苏醒期躁动的临床观察[J].社区医学杂志,2017,15(18):72-73.
[13]姚建华.利多卡因凝胶在老年男性急性尿潴留患者导尿术中的应用[J].基层医学论坛,2016,20(S1):89-90.
[14]邱洪波,成小燕,张琳娟,等.复方利多卡因乳膏在男性患者留置导尿中的应用[J].当代护士(上旬刊),2016,(9):98-100.
[15]童玲红,黄淳茂.利多卡因胶浆在男性患者术前留置导尿中的应用效果[J].解放军护理杂志,2013,30(3):75-76.
[16]杨斌,陈琪,江继宏,等.利多卡因和丁卡因胶浆尿道表麻对男性胸腔镜术后躁动的比较[J].实用医学杂志,2017,33(12):2019-2022.
[17]李洪芬,钱海涛,庄丽芳.盐酸利多卡因胶浆减少留置尿管男性患者麻醉苏醒期躁动的效果[J].江苏医药,2016,42(12):1409-1411.
[18]Mu L,Geng LC,Xu H,et al.Lidocaine-prilocaine cream reduces catheter related bladder discomfort in male patients during the general anesthesia recovery period[J].Medicine,2017,96(14):e6494.
[19]崔福德,龙晓英.药剂学[M].北京:人民卫生出版社,2011:298-299.