芪红通络方内服联合生肌玉红膏外敷治疗下肢静脉性溃疡临床研究

Clinical Study on Oral Administration of Qihong Tongluo Prescription Combined with External Application with Shengji Yuhong Ointment for Venous Leg Ulcer

目的:观察芪红通络方内服联合生肌玉红膏外敷治疗下肢静脉溃疡(VLU)的临床疗效。方法:选取86例VLU患者按随机数字表法分为对照组与观察组各43例。对照组给予常规清创及生肌玉红膏外敷治疗。观察组在对照组基础上给予芪红通络方内服。比较2组临床疗效及不良反应发生率、创面愈合时间、肉芽组织新生时间及溃疡面积缩小率,以及治疗前后中医证候评分、创面肉芽组织生长情况、血清炎症因子[肿瘤坏死因子α(TNF-α)、细胞间黏附分子-1(ICAM-1)、白细胞介素-6(IL-6)]水平。结果:治疗后,观察组总有效率为95.35%,对照组为81.40%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组肉芽色淡、创面苍白、疼痛、周围肤色黑、肢体沉重、怠惰乏力评分均较治疗前降低(P<0.05),且观察组各项评分均低于对照组(P<0.05)。治疗后,观察组创面愈合、肉芽组织新生时间均早于对照组(P<0.05),溃疡面积缩小率大于对照组(P<0.05)。治疗前,2组创面肉芽组织生长情况比较,差异无统计学意义(P>0.05);治疗后,观察组创面肉芽生长情况优于对照组(P<0.05)。治疗后,2组血清TNF-α、ICAM-1、IL-6水平均较治疗前降低(P<0.05),且观察组3项指标水平均低于对照组(P<0.05)。2组不良反应发生率均为4.65%。结论:芪红通络方内服联合生肌玉红膏外敷治疗VLU患者疗效确切,能有效改善患者临床症状,促进创面愈合及肉芽组织生长,有效缓解机体炎症反应。

Objective:To observe the clinical effect of the therapy of oral administration of Qihong Tongluo prescription combined with external application of Jihong Yuhong Ointment on venous leg ulcer(VLU).Methods:A total of 86 VLU patients were selected and divided into the control group and the observation group,with 43 cases in each group.The control group was given routine debridement and external application of Jihong Yuhong Ointment for treatment,and the observation group was additionally treated with oral administration of Qihong Tongluo prescription based on the treatment of the control group.The clinical effects,incidence of adverse reactions,wound healing time,neogenesis time of granulation tissue and reduction rate of ulcerative area,traditional Chinese medicine syndrome scores,growth of wound granulation tissues and levels of serum inflammatory factors,including necrosis tumor factor-α(TNF-α),intercellular cell adhesion molecule-1(ICAM-1)and interleukin-6(IL-6)before and after treatment were compared between the two groups.Results:After treatment,the total effective rate was 95.35%in the observation group and 81.40%in the control group,the difference being significant(P<0.05).After treatment,the scores of light granulation,pale wound,pain,black surrounding skin,heavy limbs and sloth and lack of strength in both groups were decreased when compared with those before treatment(P<0.05),and the above scores in the observation group were lower than those in the control group(P<0.05).After treatment,the wound healing time and neogenesis time of granulation tissues in the observation group were earlier than those in the control group(P<0.05),and the reduction rate of ulcerative area was higher than that in the control group(P<0.05).Befre treatment,there was no statistically difference in the growth of wound granulation tissues between the two group(P>0.05).After treament,the growth of wound granulation tissues in the observation group was better than that in the control group(P<0.05).After treatment,the levels of serum TNF-ɑ,ICAM-1 and IL-6 in both groups were decreased when compared with those before treatment(P<0.05),and the above levels in the observation group were lower than those in the control group(P<0.05).The incidence of adverse reactions was 4.65%in both groups.Conclusion:The therapy of oral administration of Qihong Tongluo prescription combined with external application of Jihong Yuhong Ointment has a definite curative effect on VLU patients,which can effectively improve the clinical symptoms of patients,promote the wound healing and growth of granulation tissues and mitigate the inflammatory responses of the body.