康复新液治疗慢性皮肤溃疡多中心随机对照临床研究

A Multi-center,Randomize-Controlled Clinical Trial of Kangfuxin Solution (康复新液) for Patients with Chronic Skin Ulcer

目的探讨康复新液治疗慢性皮肤溃疡的临床疗效及安全性。方法将176例慢性皮肤溃疡患者随机分为康复新液外组59例,康复新液内服+外用组59例,贝复济外用组58例。各组均常规清创,康复新液或贝复济采用湿敷或外喷,然后无菌纱布包扎,均每日更换敷料1次。康复新液内服+外用组同时口服康复新液每次10 ml,每日3次。各组共治疗4周。治疗前后观察皮损面积和溃疡深度,进行溃疡色泽、分泌物、新生肉芽组织评分,并判定临床疗效,观察不良反应。结果各组治疗后皮损面积、溃疡深度、色泽积分、分泌物积分均较本组治疗前明显下降,新生肉芽组织积分较本组治疗前明显升高(P <0. 05);治疗后康复新液内服+外用组皮损面积、色泽积分较康复新液外用组、贝复济外用组明显下降(P <0. 05)。康复新液外用组、康复新液内服+外用组、贝复济外用组临床疗效总有效率分别为94. 83%、96. 61%、92. 98%,各组比较差异无统计学意义(P> 0. 05)。治疗过程中各组患者均未见疼痛、瘙痒、过敏等不良事件。结论康复新液内服联合外用治疗慢性皮肤溃疡临床疗效肯定,在缩小皮损面积和改善色泽方面优于单纯外用,且无明显不良反应。

Objective To evaluate the therapeutic effects and safety of Kangfuxin Solution(康复新液)on chronic skin ulcer.Methods A total of 176 patients with chronic skin ulcer were randomly divided into an external application group(external application of Kangfuxin Solution)of 59 cases,an oral administration and external application group(oral administration and external application of Kangfuxin Solution)of 59 cases,a basic fibroblast growth factor(bFGF)group(external application)of 58 cases.All groups received conventional debridement,and wound area was applied hydropathic compress or external spray of Kangfuxin Solution or b FGF.The wounds were dressed with sterile gauze,and dressings were changed once a day,with 4 weeks as a treatment course.The oral administration and external application group was given oral administration of Kangfuxin Solution,10 ml each time,3 times a day.All groups were treated for 4 weeks.The ulcer area,depth,color,exudate and granulation tissue score before and after treatment were observed to evaluate the clinical efficacy,and the adverse actions were observed.Results The ulcer area,depth,color score,exudate scores were significantly reduced after treatment(P<0.05),and granulation score was increased significantly(P<0.05).After treatment,the average wound area and color score in the oral administration and external application group were significantly reduced than the external application group and the bFGF group(P<0.05).The total effective rate of the 3 groups was 94.83%,96.61%and 92.98%,respectively.And there was no significant difference among groups(P>0.05).Adverse events including pain,itching and allergy were not observed during the treatment.Conclusion The combination of oral use and external application of Kangfuxin Solution is effective and safe in treating chronic skin ulcer,which is better than external application alone in shortening the wound area and improving color,and without significant adverse effects.