生肌玉红膏促进下肢慢性创面愈合257例随机对照多中心临床研究  

Effect of Shengji Yuhong Paste on Chronic Leg Ulcers Healing of 257 Cases:A Randomize-Controlled and Multi-Centered Clinical Study

作　　者：张晶[1] 姚昶[2] 尹恒[1] 周勇[3] 李晨[1] 邵大畏[1] 曹东阳[1] 郭檬檬[1] 

机构地区：[1]南京中医药大学第一临床医学院 [2]江苏省中医院 [3]淮安市中医院

出　　处：《中医杂志》2013年第1期35-38,共4页Journal of Traditional Chinese Medicine

基　　金："十一五"国家科技支撑计划项目(2008BAI53B014);康缘中医药科技创新基金项目(HZ1009KY);江苏省中医药领军人才项目(LJ2009002)

摘　　要：目的观察生肌玉红膏促进下肢慢性创面愈合的疗效及作用机制。方法将257例下肢慢性溃疡患者随机分为试验组127例和对照组130例。试验组用生肌玉红膏油纱布1片覆盖创面,对照组用凡士林纱布1片覆盖创面,两组均隔日换药,4周为1个疗程。分别于治疗第3、7、14、21、28天观察创面面积减小率,计算创面愈合时间,观察创面肉芽生长状况,测定创面肉芽组织内羟脯氨酸及血红蛋白水平,治疗后评价综合疗效。结果试验组总有效率为99.21%,对照组为70.77%,试验组显著优于对照组(P<0.01)。试验组在治疗第3、7、14、21、28天创面面积减小率均显著高于对照组(P<0.01)。两组患者下肢慢性溃疡创面愈合时间差异无统计学意义(P>0.05)。试验组治疗后第7、14、21、28天溃疡深度、肉芽颜色、覆盖面积评分均较治疗前显著下降(P<0.05);试验组治疗后溃疡深度评分第14、21、28天较对照组显著改善(P<0.05),肉芽颜色评分第7、14、21、28天较对照组显著改善(P<0.05),覆盖面积评分第21、28天较对照组显著改善(P<0.05)。两组患者治疗后创面肉芽组织内羟脯氨酸和血红蛋白水平均较治疗前显著升高(P<0.01),且试验组较对照组升高显著(P<0.01)。结论生肌玉红膏治疗下肢慢性创面安全有效,可以通过提高创面肉芽组织内羟脯氨酸和血红蛋白水平及促进肉芽生长来提高下肢慢性创面愈合率。Objective To observe the therapeutic effect and mechanism of Shengji Yuhong Paste（Flesh-Engendering Jade and Red Paste）for chronic leg ulcers.Methods Totally 257 cases of chronic leg ulcers were randomized into test group of 127 cases and control group of 130 cases.The test group was externally applied with gauze of Shengji Yuhong Paste and the control group with Vaseline gauze every other day.One treatment course lasted for 4 weeks.The reducing rates of wound area,wound healing time,granulation growth,level of hydroxyproline and hemoglobin were observed on the 3rd,7th,14th,21st and 28th day of treatment,and the general efficacy was evaluated after treatment.Results The total effective rate of the test group and the control group was 99.21% and 70.77% respectively,with significant dfference between groups（P0.01）.The reducing rate of wound area in the test group was significantly higher than that in the control group on the 3rd,7th,14th,21st and 28th day of treatment（P0.01）.There was no significant difference between groups in the wound healing time（P0.05）.The scores of ulcer depth,granulation color and covering area were significantly decreased in the test group on the 7th,14th,21st and 28th day of treatment（P0.05）.Comparing with the control group,the scores of ulcer depth were significantly decreased in the test group on the 14th,21st and 28th day of treatment（P0.05）,the scores of granulation color were significantly decreased on the 7th,14th,21st and 28th day of treatment（P0.05）,and the scores of covering area were significantly decreased on the 21st and 28th day of treatment（P0.05）.The content of hydroxyproline and hemoglobin was significantly increased in both groups after treatment（P0.01）,especially in the test group（P0.01）. Conclusion Shengji Yuhong Paste is effective and safe for chronic leg ulcers.It can improve the healing rate of chronic leg ulcers by increasing the content of hydroxyproline and hemoglobin and promote the growth of granulation.

关 键 词：生肌玉红膏 慢性创面 羟脯氨酸 血红蛋白 创面愈合 随机对照试验 

分 类 号：R285[医药卫生—中药学]