实用临床医药杂志2026，Vol.30Issue(8)：29-34,6.DOI:10.7619/jcmp.20252469
含铜盐复方制剂联合多黏菌素B治疗脂溢性皮炎:一项随机对照试验
Combination therapy of copper-containing compound preparation and polymyxin B for seborrheic dermatitis:a randomized controlled trial
摘要
Abstract
Objective To verify the clinical efficacy of a copper salt-containing compound prep-aration(copper gluconate,zinc gluconate and Phellodendron chinense extract)combined with com-pound polymyxin B ointment in the treatment of seborrheic dermatitis,and to explore preliminary clini-cal evidence for the hypothesis that"heavy metal ions inhibit bacterial enzyme activity".Methods A total of 120 outpatient cases were selected as the study subjects.They were randomly divided into ob-servation group and control group using a random number table method,with 60 cases in each group.A positive control group(n=60)was also established.The treatment course lasted for 4 weeks.In the first week,the observation group received topical application of the copper salt-containing preparation twice daily,while the control group received topical application of 2％ketoconazole shampoo twice daily(with a unified intervention frequency).After 1 week,both groups used compound polymyxin B ointment as an adjunctfor localized perifollicular inflammation.The positive control group was treated with 2％zinc pyrithione shampoo twice daily.Results The treatment success rate was 79.31％in the observation group,59.65％in the control group,and 62.07％in the positive control group.There were statistically significant differences in the treatment success rates between the observation group and the control group,as well as between the observation group and the positive control group(P＜0.05).The 12-week follow-up results showed that the recurrence rate in the observation group was 15.22％,which was lower than that in the control group(32.35％)and the positive control group(30.56％),with statistically significant differences(P＜0.05).At 4 weeks of treatment,the improvement rate of pruritus symptoms in the observation group(100.00％)was higher than that in the control group(87.72％)and the positive control group(89.66％),with statistically significant differences(P＜0.012 5).The median time for pruritus symptoms to disappear in the observation group(2.3 days)was shorter than that in the control group(6.8 days)and the positive control group(6.5 days),with statistically significant differences(P＜0.012 5).No serious ad-verse reactions occurred in any of the three groups during the treatment period.A small number of patients in the observation group reported transient skin stinging sensations after using the copper salt-containing preparation(4 cases,6.90％),which was attributed to the weak acidity of the prep-aration irritating damaged skin.Mild skin dryness occurred in the control group(3 cases,5.26％)and the positive control group(3cases,5.17％),respectively.Conclusion The combination ther-apy of a copper salt-containing compound preparation and compound polymyxin B ointment is effec-tive in treating seborrheic dermatitis.The mechanism may be related to the inhibition of bacterial u-rease and lipase activities by copper salts,as well as their antibacterial and anti-inflammatory effects.Further experimental verification is required for the hypothesis that"heavy metal ions inhibit bacterial enzyme activity".This preparation has a lower recurrence rate compared to the existing standard therapy(zinc pyrithione).关键词
脂溢性皮炎/铜盐/酮康唑/翠云散/头皮屑增多/瘙痒/复方多黏菌素B软膏/抗菌Key words
seborrheic dermatitis/copper salts/ketoconazole/Cuiyun powder/increased dan-druff/pruritus/compound polymyxin B ointment/antibacterial property分类
医药卫生引用本文复制引用
周洁,陈敏,王莉,张慈安..含铜盐复方制剂联合多黏菌素B治疗脂溢性皮炎:一项随机对照试验[J].实用临床医药杂志,2026,30(8):29-34,6.基金项目
浦东新区"国家中医药发展综合改革试验区"建设中西医结合高级人才培养项目(PDZY-2024-0715) （PDZY-2024-0715）
