生肌玉红膏治疗下肢慢性溃疡祛腐生肌疗效的临床研究
Clinical Research on the Removing the Necrotic Tissue Effect of Shengji Yuhong Plaster treating on Chronic Ulcer of leg
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摘要: 目地 通过双盲、随机、对照研究，评价生肌玉红膏对下肢慢性溃疡创面脓腐坏死分泌物的作用。方法 257例下肢慢性溃疡患者通过非中心随机双盲入实验组与对照组，制定下肢创面标准化临床路径，记录患者创面脓腐分泌物临床量化积分变化数据及创面面积，数据由临床研究人员传输至第三方数据管理机构。结果 揭盲后显示2组患者治疗前在性别构成比、病程、病因、发病部位及创面面积大小各方面分布均衡一致；创面坏死脓腐组织脱落比较，实验组积分均明显低于对照组，结束时对照组达实验组的1.4倍（P<0.01）；创面渗出液的形质、色泽、气味、性状及渗液量积分改善，实验组优于对照组，治疗后第14天，P<0.05，第21天，P<0.01；实验组患者疼痛程度显著改善（P<0.01）;实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）；治疗第3天起实验组创面愈合率显著高于对照组（P<0.01），治疗结束时，实验组创面平均愈合了80%左右，对照组平均愈合了30%。结论 生肌玉红膏通过祛腐生肌作用良性干预下肢慢性创面的炎症反应而促进愈合。Abstract: OBJECTIVE To evaluate the function of Shengji Yuhong Plaster treating on the wound surface necrosis secret of chronic ulcer of leg by double blind， random and contrast research. METHODS 257 chronic-ulcer-of-leg patients were divided into experimental group and control group noncentral-random-doubled. Standard clinical pathway of leg wound surface was made， and the clinical quantified integral change data of the pus rot secretion and the wound area were recorded. The data were transported to the third party data authority by clinical researcher. RESULTS Uncover the blind random grouping， the result shows the two groups were divided fairly on the parts of sex， course of disease， pathogen， location and wound area. Compare the necrotic tissue dropping off， the experimental group are much lower than the contrast group， and from the 14d till the end， the treatment effect of the experimental group could reach 1.4 times of the contrast group(P<0.01).The improvement of the experimental group's texture， color， odor， nature and amount of the wound secretion are better than the contrast group. The release of the pain of the experimental group patients are much better(P<0.01). The wound surface infection of pesudomonas aeruginosa and other unclassified bacteria of the experimental group are substantial reduced(P<0.05). Three days after treatment， the wound healing rate of the experimental group is much higher than the contrast group(P<0.01). At the end of the treatment， the average healing rate of the experimental group is around 80%， and the contrast group is about 30%. CONCLUSION Shengji Yuhong Plaster can improve the healing of the wound by the function of eliminating necrotic tissues and promoting granulation.
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