复方紫草油治疗慢性剥脱性唇炎的临床疗效及安全性

Clinical Efficacy and Safety of Compound Oleum Lithospermi in the Treatment of Chronic Cheilitis Exfoliativa

目的:探究复方紫草油外治慢性剥脱性唇炎客观皮损症状及自觉疼痛/瘙痒症状程度的治疗疗效及安全性。方法:选取2019年2月至2020年12月北京中医药大学东方医院皮肤科门诊收治的慢性剥脱性唇炎患者128例为研究对象,采用随机数字表法将受试者按照2∶2∶1的比例分组,经病例脱落后,最终纳入观察组(n=52)、对照组(n=48)和安慰剂组(n=24),共计124例。观察组给予外涂复方紫草油,对照组给予外涂康复新液,安慰剂组给予外涂普通麻油,观察受试者的客观皮损症状(面积、灼热、糜烂、鳞屑、结痂、皲裂)和主观疼痛/瘙痒症状视觉模拟评分法(VAS)评分,记录受试者的不良反应。结果:对于客观皮损症状,观察组总有效率为94.20%,高于对照组的58.40%和安慰剂组的37.50%(P<0.05)。对于主观疼痛/瘙痒症状,观察组有效率为80.80%,高于对照组的60.40%和安慰剂组的66.6%(P>0.05)。结论:复方紫草油可以有效改善慢性剥脱性唇炎患者的客观皮损症状和主观疼痛/瘙痒症状,且不良反应率低。

Objective:This study aims to explore the clinical efficacy and safety of Compound Oleum Lithospermi in alleviating objective skin symptoms and subjective tingling/itching of chronic cheilitis exfoliativa.Methods:A total of 124 patients with chronic cheilitis exfoliativa who were treated in the Outpatient of Dermatology Department,Dongfang Hospital,Beijing University of Chinese Medicine from February 2019 to December 2020 were randomized into experimental group(52 cases),control group(48 cases),and placebo group(24 cases)with the random number table method.The experimental group was coated with Compound Oleum Lithospermi,the control group with Kangfuxin solution,and the placebo group with ordinary sesame oil.The objective skin symptoms(area,burning sensation,erosion,scaling,crusting,fissuring)were observed and Visual Analog Scale(VAS)score of subjective tingling/itching was calculated.Adverse reactions were recorded.Results:The total effective rate for the objective skin symptoms was 94.20%in the experimental group,as compared with the 58.40%in the control group and 37.50%in the placebo group(P<0.05).As for self-perceived symptoms,the effective rate in the experimental group was 80.80%,higher than the 60.40%in the control group and 66.6%in the placebo group(P=0.078>0.05).Conclusion:Compound Oleum Lithospermi can effectively improve the objective skin symptoms and subjective tingling/itching of patients with chronic cheilitis exfoliativa,with low occurrence of adverse reactions.