生肌玉红膏干预下肢慢性溃疡创面炎症反应的临床研究

Clinical Study on Intervention of ShengJi YuHongGao to Wound Inflammatory Reaction of Leg with Chronic Ulcer

目的: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:通过双盲、随机、对照研究,由第三方数据管理机构将257例下肢慢性溃疡患者随机派往试验组与对照组,通过标准化临床路径对患者进行下肢创面临床治疗,记录患者创面坏死脓腐分泌物各项量化数据,由临床研究人员传输至第三方数据管理机构,治疗结束后,由第三方数据管理机构在监察员监督下揭盲,并分析结果。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积分试验组明显低于对照组(P<0.01);创面渗出液的形质、色泽、气味、性状及渗液量试验组以色泽鲜明、无气味或气味淡腥血清样渗出液为主,对照组以色泽黄白或鲜明,部分黄浊,气味淡腥,血清及浆液样为主,部分有臭秽,治疗14天后试验组明显优于对照组(P<0.05),21天时P<0.01。临床痊愈率试验组为28.46%,对照组为10.16%;显效率试验组为46.34%,对照组为15.62%(P<0.01)。结论:生肌玉红膏可通过干预下肢慢性创面的炎症反应而促进愈合。

Objective： To evaluate the effects of ShengJi YuHongGao on wound exudates of legs with chronic ulcer. Method： All 257 patients were randomly divided into the experimental group and the control group with a double-blinded, randomized and controlled trial by the third institute of data management. The patients were given with lower leg standardized treatment through clinical pathway and different quantized data of exudates was recorded, sent to the third institute of data management instantly when the experiment finished, the data was disclosed under the supervise and the results were analyzed. Result： The results revealed that there were uniform in gender composition, the course, etiology, the location and the area before treating of both groups; the experimental group was lower than the control group remarkably in wound necrotic tissue scale （P〈0.01）; as for the shape and texture, color and sheen, odor, property and the amount of exudates, the experimental group oozed bright colored, odorless or light fishy exudates like serum mainly, the control group mainly revealed yellow and white or bright colored, part ofexudates yellow and turbid, light fishy exudates like serum or serosity, part was foul, after treating 14 days the experimental group was superior to the control group remarkably（P〈0.05）, the differences after treating for 21 days showed P〈0.01. The cure rates of the experimental group and the control group were 28.46% and 10.16%; excellence rates of both groups were 46.34% and 15.62% （P〈0.01）. Conclusion： ShengJi YuHongC, ao can intervene the inflammatory reaction of chronic ulcer to promote the healing.