纳米银用于Ⅱ度烧伤创面的疗效及安全性评价
Curative effect and safety evaluation of nanometer silver in treatment of Ⅱ degree burn wound
摘要目的 观察纳米银应用于Ⅱ度烧伤创面的感染防治、创面愈合作用及安全性.方法 将6%~10%Ⅱ度(深、浅)烧伤创面患者按随机表方法分为试验组(纳米银敷料组)和对照组(质量分数为1%磺胺嘧啶银霜组),每组35例,按分组在5%TBSA上进行相应处理,创面敷料及用药每天更换1次,连续使用7 d后,同其他剩余创面一样,采用10 g/L碘伏纱布常规换药处理.两组分别在创面换药前后进行创面细菌培养,观察创面愈合时间;换药前和换药后的1,7,14 d采集血和24 h尿标本,采用电感耦合等离子体质谱测定血清银离子和24 h尿平均银离子水平;测定息者第7,14天的肝、肾功能.结果 试验组治疗后细菌培养阳性率(3%)与对照组(3%)相近,均较治疗前(12%、19%)下降,但差异无统计学意义.试验组的浅Ⅱ度创面愈合时间(9.18±1.9)d比对照组(12.9±1.3)d提前3 d多,差异有统计学意义(P<0.01).两组患者创面使用银制剂前血银离子水平为(1.55±1.26)μg/L和(1.54±1.28)μg/L,24 h尿排银量为(1.67±1.05)μg和(1.87±1.37)μg,两组间差异无统计学意义(P>0.05);使用银制剂均能造成血中银离子水平蓄积性升高(P<0.01),但试验组血清离子水平明显低于对照组(P<0.01);24 h尿的平均银离子水平及24 h尿银排出量跟血清中银离子水平呈相同规律的变化.两组少数患者的血清ALT出现无明显规律的异常变化,肾功能正常.结论 对烧伤Ⅱ度创面来讲,纳米银较磺胺嘧啶银更能提前其愈合时间;从银代谢安全性角度来看也有较大的提高,是一种比较理想的烧伤创面用药.
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abstractsObjective To observe the infection prevention, wound healing effect and safety of nanometer silver in treatment of Ⅱ degree burn wound. Methods The patients with 6%-10% TBSA Ⅱ degree burn wound ( deep or superficial) were randomly divided into test group ( treated with nanome-ter silver, n =35) and control group (treated with 1% sulfadiazine silver, n =35). Each group was reg-ulated to change dressing and medication one time a day for seven days on 5% superficial Ⅱ degree burn wound. Then, 1% iodophors and gauze were used for change dressing. Before and after change dressing, bacterial culture was done in two groups to observe the time for wound healing. The blood collected before change dressing and at days 1,7 and 14 after change dressing and urine within 24 hours were employed for detecting serum silver level and mean silver level in urine by using inductively coupled plasma mass-spec-trum ( thermoelectricity of American Ⅹ Series Ⅱ ). In the meantime, the liver and renal function was e-valuated at days 7 and 14. Results Positive rate of bacterial culture in test group and control group was 3% and 3.1% respectively after treatment, which showed a decrease compared with the levels before treatment (12. 1% and 15.6% respectively), with no statistical difference. The wound healing time of test group was (9. 18 ± 1.9) days, which was shorter than ( 12.9 ± 1.3 ) days in control group, with sta-tistical difference (P<0.01). Before treatment, the silver level of blood was ( 1.55 ± 1.26) μL and ( 1.54 ± 1.28 ) μg/L respectively in test group and control group, and silver level of urine within 24 hours was ( 1.67 ± 1.05 ) μg and ( 1.87 ± 1.37) μg respectively test group and control group, with no statistical difference (P > 0. 05 ). Silver medication could elevate the serum silver level ( P < 0.01 ), with lower level in test group than control group (P <0. 01 ). Average silver level of urine within 24 hours showed similar change with that in the serum. The patients showed normal renal function, with no abnormal change of ALT. Conclusions For Ⅱ degree burn wound, nanometer silver can more significantly short-en wound healing time compared with sulfadiazine silver. Moreover, nanometer silver has higher degree of safety on silve metabolism and is an ideal medcation for burn wound.
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