外用生肌膏治疗感染性溃疡阳证患者的多中心随机对照研究

Treatment of Infective Ulcer Patients with Yang Syndrome by External Use of Shengji Ointment:a Multicenter Randomized Controlled Trial

目的评价外用生肌膏对感染性溃疡阳证患者的有效性及安全性。方法采用多中心、分层分段、随机对照的方法,分5个中心,按3∶1比例生成随机数字表,共计纳入感染性溃疡阳证患者440例,其中生肌膏组330例,对照组110例,对照组予扶他林等外科常规用药,生肌膏组予生肌膏外用,24 h换药1次。疗程均为21天。分别在治疗前及治疗第3、7、14、21天观察患者溃疡面积、创口深度及疼痛程度,同时监测患者的安全性指标。结果用药21天后,生肌膏组疮疡面积缩小,明显优于对照组(P=0.002)。对溃疡面积各个时点进行历时性分析,从用药第7天起,生肌膏组溃疡面积缩小值较对照组明显增大(P=0.002),且随着时间的延长,差异越明显。与对照组比较,生肌膏组溃疡面积及溃疡深度的愈合率及疼痛消失率等疗效指标均明显改善(均P<0.01),两组均无不良事件发生。结论外用生肌膏治疗感染性溃疡阳证患者,可加速创面愈合,且有较好镇痛作用。

Objective To evaluate the safety and effectiveness of Shengji Ointment（ SO）（ by external use） in treating infective ulcer patients with yang syndrome（ YS）. Methods A multicenter,stratified,randomized controlled clinical study was used in this study. A random digit table was formed in the ratio of 3∶ 1,440 infective ulcer patients of YS from5 centers were recruited,330 in the treatment group（ external use of SO,exchange once every 24 h） and 110 in the control group（ external use of Votalin,exchange once every 24 h）. The therapeutic course consisted of 21 days. The ulcer area,wound depth,pain degree were observed before treatment at day 3,7,14,and 21,and safety indices monitored at the same time. Results The ulcer area was significantly reduced in the treatment group after 21-day medication,obviously superior to that of the control group（P = 0. 002）. Ulcer areas at different time points were analyzed. From the 7th day of medication the reduced area was obviously less in the treatment than in the control group（P = 0. 002）. Besides,the longer the more obvious difference. Compared with the control group,the healing rate of ulcer area,the pain disappearance rate,and the healing rate of ulcer depth were all obviously improved in the treatment group（ all P〈0. 01）. No adverse event occurred in the two groups. Conclusions External use of SO was safe and effective in treating infective ulcer patients with YS. It could accelerate wound healing with better analgesic effect.