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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 efficacy and safety of topical myogenic cream for patients with infectious ulcer Yang syndrome. Methods A multicenter, stratified and randomized controlled trial was conducted in 5 centers. Random number tables were generated according to a ratio of 3: 1. A total of 440 patients with infectious ulcer Yang syndrome were included, of whom 330 were Sheng-sheng cream group. Group 110 cases, the control group Fufarin and other surgical routine, raw myogenic plasminogen group external application, 24 h dressing 1 time. The course of treatment is 21 days. The ulcer area, depth of wound and degree of pain were observed before treatment and on the 3rd, 7th, 14th and 21st day of treatment respectively. At the same time, the safety indexes of the patients were monitored. Results After 21 days of treatment, SJA group had a smaller area of sore, which was significantly better than that of the control group (P = 0.002). The duration of ulcer area was analyzed at different time points. From the 7th day after administration, the area of ulcer in Shengangi Ointment group was significantly larger than that in control group (P = 0.002). The more obvious the difference was with time. Compared with the control group, the healing index and the disappearance rate of the ulcer area and the depth of the ulcer were significantly improved (all P <0.01), and no adverse events occurred in both groups. Conclusion External myogenic cream treatment of patients with infectious ulcer yang card can speed up the wound healing, and has a good analgesic effect.