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目的以1%磺胺嘧啶银乳膏为对照,观察复方多黏菌素B软膏治疗烧伤残余创面的疗效。方法采用随机、自身对照的方法,将30例受试者共计60处创面随机分为试验组(n=30)和对照组(n=30)。试验组予以复方多黏菌素B软膏(FDA称三抗软膏)治疗,对照组予以1%磺胺嘧啶银乳膏(SSD)治疗,均每日换药,周期21d。观察用药后7、14、21d创面细菌培养阳性率、创面菌株清除率、创面愈合率、患者疼痛程度及不良反应。结果本试验共入组30例,无病例脱落,所有数据均纳入统计分析。(1)用药后7、14、21d试验组细菌培养阳性率分别为60.0%、26.7%、23.3%,均明显低于对照组(83.3%、60.0%、50.0%,P<0.05)。(2)用药后7、14、21d试验组菌株清除率分别为39.6%、72.9%、79.2%,均明显高于对照组(18.2%、34.1%、47.7%,P<0.05)。(3)用药后7、14、21d试验组中革兰阴性杆菌清除率分别为48.1%、85.2%、92.6%,革兰阳性球菌清除率为28.6%、57.1%、61.9%;第14、21天两组数据间比较差异具有统计学意义(P<0.05)。(4)用药后7、14、21d试验组创面愈合率分别为(36.6±31.9)%、(66.7±33.6)%、(78.5±27.4)%,对照组为(25.9±26.9)%、(53.6±33.0)%、(66.0±29.7)%;第14、21天两组数据间比较差异具有统计学意义(P<0.05);(5)试验组患者疼痛评分(3.4±1.5)分,对照组为(4.6±1.7)分,P<0.001;所有病例均未出现药物不良反应,心肝肾功能及听力未见明显损伤。结论复方多黏菌素B乳膏对烧伤后残余创面的治疗效果优于磺胺嘧啶银乳膏,局部使用时具有相当的安全性,且革兰阴性杆菌清除效果优于革兰阳性球菌。
Objective To compare the efficacy of compound polymyxin B ointment in the treatment of residual burn wounds with 1% sulfadiazine silver cream as control. Methods A total of 60 wounds of 30 subjects were randomly divided into experimental group (n = 30) and control group (n = 30) using a randomized, self-controlled method. The experimental group was treated with compound polymyxin B ointment (FDA said three anti-ointment), the control group was treated with 1% sulfadiazine silver cream (SSD), were daily dressing, cycle 21d. The positive rate of bacterial culture, wound strain clearance rate, wound healing rate, patient’s pain degree and adverse reactions were observed on the 7th, 14th and 21st day after treatment. Results A total of 30 patients were enrolled in this study. All cases were included in the statistical analysis. (1) The positive rates of bacterial culture in experimental group were 60.0%, 26.7% and 23.3% at 7, 14 and 21 days after treatment, respectively, which were significantly lower than those in control group (83.3%, 60.0% and 50.0%, P <0.05). (2) The clearance rate of the test group was 39.6%, 72.9% and 79.2% on the 7th, 14th and 21st day after treatment, respectively, which were significantly higher than that of the control group (18.2%, 34.1%, 47.7%, P <0.05). (3) The rates of Gram-negative bacilli in the experimental group were 48.1%, 85.2% and 92.6% at 7, 14 and 21 days after treatment, respectively. The clearance rates of Gram-positive cocci were 28.6%, 57.1% and 61.9% The difference between the two groups of days was statistically significant (P <0.05). (4) The wound healing rates of the experimental group were (36.6 ± 31.9)%, (66.7 ± 33.6)% and (78.5 ± 27.4)% on the 7th, 14th and 21st day after treatment, respectively, while those in the control group were (25.9 ± 26.9)% and (33.0)% and (66.0 ± 29.7)%, respectively; (5) The pain score of the test group was 3.4 ± 1.5, and the difference between the two groups on the 14th and 21st days was statistically significant (P <0.05) (4.6 ± 1.7) points, P <0.001. No adverse drug reactions were found in all cases, and no obvious injury was found in heart, liver, kidney and hearing. Conclusions The compound polymyxin B cream is superior to silver sulfadiazine cream in the treatment of post-burn residual wounds. It has considerable safety when applied locally, and Gram-negative bacilli are superior to Gram-positive cocci.