生肌玉红膏促进下肢慢性溃疡肉芽生长257例的临床多中心对照研究  

Estimation of Granulation Growth by Scores System on the Treatment of 257 Cases of Chronic Lower Leg Ulcer Patients with Traditional Chinese Medicine of ShengJi Yuhong Gao:A Multicenter,Double-blinded RCT

作　　者：王江涛[1] 张晓清[1] 姚昶[1] 

机构地区：[1]江苏省中医院,江苏南京210029

出　　处：《中国医药指南》2012年第34期1-3,7,共4页Guide of China Medicine

基　　金："十一五"国家支撑计划项目"中医外治法特色疗法和外治技术示范研究"(2008BAI53B014)

摘　　要：目的采用多中心双盲、随机、对照研究,通过总体疗效判断及溃疡创面肉芽生长无创积分评估生肌玉红膏在治疗下肢慢性溃疡创面愈合的效果,为生肌玉红膏在临床上的推广应用提供临床证据。方法由第三方数据管理机构将257例下肢慢性溃疡患者随机派位实验组与对照组,通过标准化临床路径对患者进行创面清除坏死组织、外用生肌玉红膏或与其外观气味一致的凡士林油纱布,并记录患者临床观察表的各项量化数据,由临床研究人员传输至第三方数据管理机,治疗全部结束后,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个方面分布均衡一致;实验组临床痊愈率为28.46%,显效率为46.34%,均是对照组的3倍左右(P<0.0001);创面肉芽生长状况示出实验组创面颜色变化早于肉芽生长的变化,实验组治疗后14d以后实验组显著创面肉芽生长显著好于对照组(P<0.05),创面深度与肉芽覆盖的表现一致,而创面肉芽颜色改变实验组在治疗后7d即显著优于对照组(P<0.03)。结论生肌玉红膏可以通过促进肉芽生长来提高下肢慢性创面愈合率,总体疗效明显,是否能够缩短创面愈合时间,促进肉芽生长的具体机制怎样,有待今后进一步研究。Objective A multicenter, double-blinded RCT study was designed to provide the type 2 clinical evidence of Traditional Chinese Medicine of ShengJi Yuhong Gao on the treatment of chronic lower leg ulcer by total therapeutic effect judgement and lower leg measure tool scores system. Methods 257 cases of chronic lower leg ulcer patients were applied randomly on the experimental and control!ed groups by the third institute of data management, followed by the standardized clinical pathway of eliminating necrotic tissues, external applying of ShengJi Ynhong Gao or the blinded-controlled agency of petrolatum oil gauze on the wound and filled out all the records on each designed clinical report case. All results were transported to the data management through web instantly after the case finished. The data were disclosed under supervising by the third institute of data management and the results were analyzed afterwards. Results After unblinding, there are accordant distributions on the gender composition, etiology, the course, wound part and the area of wound. 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 experimental group with P value of less than 0.0001. The growing situations of wound granulation evaluated by lower leg measure tool scores system showed that the modification of wound color changed earlier than the proliferation of wound granulation. After 14 days of treatment, the proliferation scores of wound granulation in the experimental group were significant better than the results of control group with P value less than 0.05, whereas of experimental group showed better results than those of control group as early as 7 days of treatment with P value less than 0.03. Conclusion The effects of improving wound healing of chronic lower leg ulcer by way of topical applying with Shengj Yuhong Gao are significant. The medicine can enhance granulation growth effectively .Whether it c

关 键 词：生肌玉红膏 慢性创面 下肢 随机对照 双盲 肉芽生长 

分 类 号：R269[医药卫生—中西医结合]