生肌玉红膏抑制下肢慢性溃疡创面微生物生长而促进愈合的临床多中心随机双盲对照研究

The distribution of microorganism of the wound on the treatment of chronic lower leg ulcer patients with Traditional Chinese Medicine of Shengji Yuhong Gao:A 257 cases of multicenter, double-blinded RCT

目的:通过双盲、随机、对照研究,观察生肌玉红膏干预下肢慢性溃疡创面的微生物分布与促进愈合的作用。方法:将257例下肢慢性溃疡患者随机分为试验组与对照组,记录患者临床观察的各项量化数据。结果:共257例患者完成研究,揭盲后显示试验组与对照组患者在性别构成比、病程、病因、发病部位及创面面积大小等分布均衡一致;组内治疗前后比较,试验组铜绿假单胞菌、金黄色葡萄球菌、变形杆菌及其他未分类细菌种类均明显减少,而对照组未见明显变化,两组比较,试验组创面铜绿假单胞菌与其他未分类细菌感染率显著降低(P<0.05);创面炎症反应变化显示,试验组创面渗出液以色泽鲜明、无气味或气味呈淡腥味血清样为主,14 d时试验组显著优于对照组(P<0.05),21 d时差异亦有统计学意义(P<0.001);试验组创面平均愈合了80%左右,对照组平均愈合了30%(P<0.001)。结论:生肌玉红膏能抑制创面铜绿假单胞菌及其他未分类细菌的生长,改善炎性渗出,促进下肢慢性溃疡创面愈合。

Objective： A multicenter, double-blinded RCT study was designed to provide the clinical evidence of Traditional Chinese Medicine of Shengji Yuhong Gao on the treatment of chronic lower leg ulcer with the effects of antibiotic mechanism. Methods： 257 cases of chronic lower leg ulcer patients were applied randomly on the experimental and controlled groups, followed by the standardized clinical pathway of treatment with ShengJi Yuhong Gao or petrolatum oil gauze and filled out all the records on each designed clinical report case. All results were analyzed by the third institute of data management. Re- suits： There were accordant distributions on the gender composition, etiology, the course, wound part and the area of wound. The infectious rates of pseudomonas aeruginosa, staphylococcus aureus and proteus on the wound decreased significantly after treatment in experimental group than those of the control group. The infectious rates of pseudomonas aeruginosa and other un-identified microorganisms are significant less in the experimental group than those of control group. The wound appearance evaluated by lower leg measure tool scores system showed that there were clear color with little or without odor serosan- guineous exudate on the wound of experimental group. The healing rates of experimental group were up to 28.46% as well as the positive effective rates of 46.34%, comparing to the control group which only reached to one-third percentage of experi- mental group with P value of less than 0.0001. Conclusions： One of the mechanisms for the effects of improving wound healing of chronic lower leg ulcer of Shengji Yuhong Gao may inosa and other un-identified microorganisms on the wound.