复方多黏菌素B软膏治疗细菌性皮肤病临床实验研究

Clinic Study of Bacterial Infected Skin Diseases Treated by Polymyxin B Plus Ointment

目的评价复方多黏菌素B软膏与环丙沙星软膏治疗细菌性皮肤病1周的疗效和安全性。方法入组包括脓疱疮、毛囊炎、甲沟炎、伤口感染等细菌性皮肤病48例,采用随机、双盲、平行组对比研究。受试者3次/d外用患处,疗程1周。结果治疗1周,试验组靶皮损总积分(TSS)由治疗前15.67±2.28降至3.25±3.90,症状体征改善率为(79.90±24.21)%;对照组总积分由治疗前14.71±2.90降至3.38±2.62,改善率为(76.44±19.40)%。临床有效率试验组和对照组分别为83.33%和75.00%。细菌学清除率试验组为83.33%,对照组为91.67%。临床和细菌学综合疗效评价显示,试验组总有效率为75.00%,对照组为70.83%。两组在临床疗效、细菌学疗效和总体疗效的比较差异均无统计学意义。结论复方多黏菌素B软膏与环丙沙星软膏相似,治疗细菌性皮肤病安全有效。

Objective To assess the effect and safety of polymyxin B plus ointment versus ciprofloxacin ointment in 1-week treatment on bacterial infected skin diseases. Methods 48 cases with bacterial infected skin diseases including impetigo,folliculitis, paranychia ,were recruited. The ointment was applied three times a day for 1-week. A randomized ,double-blind, parallel grouping trial was conducted. Results TSS of test group improved was decreased from 15.67 ± 2.28 to 3.25 ± 3.90, improving rat was （79.90 ± 24.21 ） % , TSS of control group improved was decreased from 14.71 ± 2.90 to 3.38 ± 2.62,improving rat was （76.44 ± 19.40） %. Clinical response rate in test group and control group were 83.33% ,75.00% respectively. Bacteria eradication rate in test group and control group were 83.33% and 91.67% The combined assess of clinic and bacterial efficacy showed the total response rate were 75.00% in test group and 70.83% in control group. There was no significant difference in all of these aspects between two groups. Conclusion Polymyxin B plus ointment, which had similar clinical, bacterial, and general efficacy with ciprofloxacin ointment,is safe and effective to treat bacterial infected skin diseases.