中药石香膏促进慢性难愈合创面修复的随机对照临床研究

Treating Chronic Ulcer with Shixiang Plaster:A Randomized Controlled Trial

目的:探讨中药石香膏促进慢性难愈合创面修复的临床疗效。方法:60例慢性难愈合创面患者通过随机入实验组与对照组,实验组36例采用石香膏换药治疗,对照组24例采用康复新液换药治疗。记录两组患者第3、7、14、21天创面愈合率、治疗前及治疗后创面疼痛评分、创面愈合时间以及临床综合疗效评价。结果:两组患者治疗前在性别构成比、年龄、病程方面分布均衡一致。1创面愈合率,治疗3天两组创面愈合率无统计学差异[(20.8±8.4)cm2,(18.7±5.7)cm2,t=1.186,P=0.240],治疗7天两组创面愈合率无统计学差异[(38.2±9.1)cm2,(35.6±7.7)cm2,t=1.147,P=0.256],治疗14天两组创面愈合率有统计学意义[(68.3±12.3)cm2,(60.2±9.8)cm2,t=2.709,P=0.009],治疗21天两组创面愈合率统计学差异显著[(87.7±8.5)cm2,(80.4±7.7)cm2,t=3.361,P=0.001]。2创面疼痛评分,治疗前两组疼痛评分无统计学差异[(6.0±1.5),(5.91±1.5),t=0.319,P=0.751],治疗后实验组疼痛评分明显小于对照组[(1.5±0.7),(2.1±0.9),t=-2.778,P=0.007]。3创面愈合时间,实验组创面愈合时间明显短于对照组[(22.9±3.3)d,(27.9±2.8)d,t=-5.976,P=0.000]。4临床综合疗效,实验组治愈3例,显效30例,好转3例共36例,对照组显效27例,好转7例共24例,实验组临床综合疗效优于对照组(R实验组=27.29,R对照组=35.31,Z=-2.429,P=0.015)。结论:中药石香膏过祛腐生肌作用良性干预慢性难愈合创面的炎症反应而促进修复,疗效优于康复新。

Objective：To observe the clinical effect of Shixiang Plaster in treating on chronic ulcer.Methods：Sixty patients with chronic ulcer were randomly divided into experimental group and control group.36 cases in experimental group were treated with Shixiang Plaster while the others in the control group were treated with Kangfu New Liquid.The wound healing rate,healing time and visual analogue scale were recorded.Results：The result showed the two groups were divided fairly on the sex,age and course of disease.The wound healing rate showed there were no statistic differences in 3 days [（20.8 ± 8.4） cm^2,（18.7 ± 5.7） cm^2,t =1.186,P = 0.240] and 7 days [（38.2 ± 9.1） cm^2,（35.6 ± 7.7） cm^2,t = 1.147,P = 0.256]and there were statistic differences in 14 days [（68.3 ± 12.3） cm^2,（60.2 ± 9.8） cm^2,t = 2.709,P = 0.009]and 21days[（87.7 ± 8.5） cm^2,（80.4 ± 7.7） cm^2,t =3.361,P = 0.001].There were no statistic differences in visual analogue scale before treatment [（6.0 ± 1.5）,（5.91 ± 1.5）,t= 0.319,P = 0.751] while the visual analogue scale in experimental group decreased more significantly after treatment compared with that of the control group[（1.5 ± 0.7）,（2.1 ± 0.9）,t =-2.778,P = 0.007].The healing time of the experimental group was much lower than that of the control group[（22.9 ± 3.3） d,（27.9 ± 2.8） d,t =-5.976,P = 0.000].3 patients recovered and 30 patients got a significantly effective improvement and 3 patients were effective in the experimental group while none recoveried and 17 patients got a significantly effective improvement and 7 patients were effective in the control group.The experimental group was superior to the control group in the total curative effect（？ R experimental group = 27.29,R control group = 35.31,Z=-2.429,P = 0.015）.Conclusion：Shixiang Plaster can improve the healing of the wound by the function of eliminating necrotic tissues and promoting granulation and it has better effects on treating chronic ulcer compared with Kangfu New Liquid.