硝酸银软膏对Ⅱ度烧伤创面治疗作用的多中心临床研究

目的观察硝酸银(AgNO3)软膏对浅Ⅱ、深Ⅱ度烧伤创面的治疗效果,并评价其药物不良反应。方法选择80例浅Ⅱ度和40例深Ⅱ度烧伤患者,进行多中心、随机、阳性药物平行对照和同体试验研究(共4个中心,每个中心30例)。将患者创面按用药不同分为AgNO3组和磺胺嘧啶银(SD-Ag)组,观察各组创面完全愈合时间、指定时相点下创面愈合率、创面细菌培养情况、药物疗效和安全性、药物对创面的刺激性等。结果浅Ⅱ度创面:AgNO3组完全愈合时间为(9．5±2．7)d, SD-Ag组为(10．8±3．4)d,用药后7 d创面愈合率分别为(77．9±20．5)％及(67．3±22．6)％;深Ⅱ度创面:AgNO3组完全愈合时间为(21．5±4．8)d,SD-Ag组为(23．3±6,4)d,用药后20 d创面愈合率分别为(86．6±15．9)％及(78．5±17．7)％。同等深度烧伤创面上述各项数据两组间比较,差异均有统计学意义(P<0．01)。同等深度烧伤创面AgNO3组与SD-Ag组比较,具有同样明显的杀菌作用,但前者对创面的刺激性更小。结论AgNO3软膏是一种可用于浅Ⅱ、深Ⅱ度烧伤创面的有效、安全的外用药。

Multi-center clinical study of the effect of silver nitrate ointment on the partial-thickness burn wounds

OBJECTIVE: To evaluate the therapeutic effect of silver nitrate ointment on partial-thickness burn wounds, and observe its side-effects. METHODS: Multi-center, randomized, positive drug paralleled self-controlled trial was carried out. Eighty patients with superficial partial-thickness burns, and 40 with deep-partial thickness burns were randomized into AgNO3 group and SD-Ag group according to drug topically applied to the wounds. The wound healing time, wound healing rate and bacterial culture of the wound, the effect and safety of the drug, as well as drug irritation to the wounds were studied in these two groups. RESULTS: For the patients with superficial partial-thickness burn wounds, the wound healing time in silver nitrate group was (9.5 +/- 2.7) days, which was obviously shorter than that in SD-Ag group (10.8 +/- 3.4) days, P <0.01]. The wound healing rate in silver nitrate group on 7 post-burn day ( PBD) was (77.9 +/- 20.5)%, which was obviously higher than that in SD-Ag group (67.3 +/- 22.6) %, P < 0.01]. For those with deep-partial thickness burn wounds, the wound healing time in silver nitrate group was (21.5 +/- 4.8) days, which was evidently shorter than that in SD-Ag group (23.3 +/- 6.4) days, P <0.01]. The wound healing rate in silver nitrate group on 20 PBD was (86.6 +/- 15.9)%, which was evidently higher than that in SD-Ag group (78.5 +/- 17.7)%, P < 0.01]. Silver nitrate ointment has the same antibacterial effect as 1% SD-Ag cream, but it was less painful when applied to the open wounds. CONCLUSION: Silver nitrate ointment is an effective and safe medicament for the clinical management of partial-thickness burn wounds.