溃疡油在糖尿病足溃疡治疗中的应用效果及安全性观察  

Observation on the application effect and safety of ulcer oil in the treatment of diabetic foot ulcer

作　　者：王杰 袁泉 王玥琦[1] 乔佳君 谭春丽 夏仲元[1] 刘守尧[1] Wang Jie;Yuan Quan;Wang Yueqi;Qiao Jiajun;Tan Chunli;Xia Zhongyuan;Liu Shouyao(Department of Surgery of Traditional Chinese Medicine,China-Japan Friendship Hospital,Beijing 100029,China)

机构地区：[1]中日友好医院中医外科,北京100029

出　　处：《中华损伤与修复杂志（电子版）》2024年第6期480-484,共5页Chinese Journal of Injury Repair and Wound Healing(Electronic Edition)

基　　金：北京市中医药科技发展资金项目(JJ-2020-89);中日友好医院中央高水平医院临床业务费专项项目(2023-NHLHCRF-YYPPLC-ZR-15)。

摘　　要：目的观察溃疡油对糖尿病足溃疡的治疗效果及安全性。方法选择中日友好医院中医外科2020年9月至2023年9月收治的糖尿病足溃疡患者100例,按照随机数字表法分为观察组及对照组各50例。2组患者均接受糖尿病基础治疗,足部创面常规清创并每周换药2~3次。观察组在常规治疗基础上外敷溃疡油,对照组在常规治疗基础上外敷外用重组人表皮生长因子溶液,2组疗程均为12周。治疗6、12周,比较2组创面面积、创面愈合率及创面愈合患者比例,计算2组患者中医证候积分。治疗前及治疗结束时,检测2组患者血常规及肝肾功能指标。观察2组患者在治疗过程中是否出现感染加重、过敏反应等不良事件。结果治疗6、12周,2组在创面面积、创面愈合率、创面愈合患者比例及中医证候疗效评定总有效率方面差异均无统计学意义(P>0.05);观察组治疗后白细胞计数、红细胞计数、血红蛋白、血小板计数、谷丙转氨酶、谷草转氨酶、总胆红素、尿素、血肌酐及血糖水平与治疗前相比,差异均无统计学意义(P>0.05);观察组治疗后红细胞计数及血红蛋白水平高于对照组[(4.20±0.91)×10^(12)/L比(3.48±0.68)×10^(12)/L、(123.07±19.29)g/L比(102.56±19.68)g/L],差异有统计学意义(t=5.873、5.724,P<0.001)。2组患者在治疗过程中均未出现不良事件。结论溃疡油能有效促进糖尿病足溃疡愈合,改善患者临床症状,且安全性良好。Objective To observe the effect and safety of ulcer oil in the treatment of diabetic foot ulcer.Methods A total of 100 patients with diabetic foot who were admitted to the Department of Surgery of Traditional Chinese Medicine,China-Japan Friendship Hospital from September 2020 to September 2023 were enrolled and divided into observation group and control group randomly according to the random number table method,with 50 patients in each group.Both groups received standard treatment for diabetes mellitus,and the foot wounds were cleaned and treated with weekly dressing changes,which were performed two to three times.The observation group applied a topical ulcer oil in addition to the conventional treatment,while the control group applied a topical recombinant human epidermal growth factor in addition to the conventional treatment.The course of treatment for both groups was 12 weeks.At the 6th and 12th weeks of treatment,a comparison was made between the two groups in respect of the wound area,wound healing rate and proportion of patients with wound healing,traditional Chinese medicine syndrome score of the patients were calculated.Prior to and at the conclusion of the treatment period,the blood routine,liver and kidney function indexes of the two groups were evaluated.It was also necessary to observe whether any adverse events,such as an exacerbation of infection or an allergic reaction,occurred during the course of treatment in either group.Results Following the 6th and 12th weeks of treatment,no statistically significant differences were observed between the two groups in terms of wound area,wound healing rate,proportion of patients with wound healing,and total effective rate,as assessed by the efficacy of traditional Chinese medicine evidence(P>0.05).The observed differences in the levels of white blood cell count,red blood cell count,haemoglobin,platelet count,alanine transaminase,aspartate aminotransferase,total bilirubin,urea,blood glucose,and creatinine in the observation group were not statistically signif

关 键 词：糖尿病足 溃疡 安全性 临床疗效 

分 类 号：R587.1[医药卫生—内分泌]