Effect Of Kuiyangning Dressing In Patients With Chronic Venous Leg Ulcer

Objective:This study was to systematically evaluate the efficacy and safety of Kuiyangningdressing in patients with chronic leg ulcer. This randomized controlled trial was toexplore new theoretical basis and method for the treatment of chronic leg ulcer.Methods:According to the diagnosis criterion of chronic leg ulcer,30cases were enrolledin this study, and then randomly divided into two groups: the test group (n=15) andthe control group (n=15). The test group was made the dressing external applicationof Kuiyangning Dressing, and the control groups received the dressing externalapplication of Vaseline. Patients in the two groups changed dressing daily, or/andchanged if necessary. There were2weeks in a treatment circle, and2treatmentcircles were observed in current study. Curative effects, scab area and wound healingrate in the two groups were evaluated and compared at the second week and thefourth week. Wound healing time and healing speed were also observed andcompared between the two groups at the end of this research. All analyses wereperformed using SPSS （IBM SPSS Statistics20.0）statistical analysis software.Biochemical parameters and adverse reactions were closely monitored during thewhole process of therapy.Results:1. After treatment of2weeks, the wound of11patients’ healed, that of3patientsreached the standard of marked improvement, and the ulcer of1patient satisfied thestandard of improvement in treatment group. Meanwhile, in control group,5patients’wound healed,6markedly improved,3improved and2with no effect. Mann-Whitney rank-sum test was used to compare the efficacy of the two groups with theresult that the efficacy in treatment group was significantly better than that in controlgroup（Z=-2.243，P=0.025）. The mean rank of treatment group was18.77, and themean rank of control group was12.23. Moreover, the wound size in treatment group （0.26±0.48cm~2）was significantly smaller than control group（0.95±0.98cm~2）（t=-2.435，P=0.024）. Wound healing rate of treatment group was93.7%, which wassignificantly higher than that in control group(76.4%)(P＜0.01).2. After4weeks treatment, in treatment group,12patients’ ulcer healed,2patients markedly improved and1patient reached the standard of improvement.Meanwhile,6patients’ wound healed,5markedly improved and4improved in thecontrol group. Mann-Whitney rank-sum test was also conducted to compare theefficacy of the two groups. It was found that the efficacy in treatment group wassignificantly better than that in control group（Z=-2.202，P=0.028）. The mean rankof treatment group was18.60, and the mean rank of control group was12.40. Woundsize of treatment group was0.09±0.26cm~2, which was significantly smaller than thatin control group(0.77±0.88cm~2)(t=-2.839，P=0.012). Wound healing rate in treatmentgroup(97.7%) was higher than that in control group(77.3%)(P＜0.01).3. In treatment procedure, granulation tissue grew relatively fast and healthily intreatment group, while, the development of granulation tissue began later in controlgroup. The average cure time of the ulcer in the test group（17.40±8.19d）wassignificantly shorter than that in the control group（27.07±10.64d）（t=-2.788，P=0.009）. Wound healing speed in control group(0.17±0.13㎝2/d）was also slowerthan that in treatment group(0.28±0.14㎝2/d)(t=2.118，P=0.043).4. No patients were lost or withdrawn from the study during follow-up. In theprocess of using drugs, no patients experienced local skin redness, bubble andulceration around the wound. No malignant events, such as the expanding, fester andnecrosis of ulcer wound, happened to the patients.Conclusion:1. The current randomized controlled trial suggested that Kuiyangning dressingcan control infection, promote regeneration of granulation tissue and skin, acceleratewound healing, and prevent relapse in relatively short time, compared with Vaselinedressing.2. Kuiyangning dressing can be used to curse chronic leg ulcer safely.3. Kuiyangning dressing has a broad space of application.