任雪雯 李元文 冯蕙裳 蔡玲玲 李纬 邓宇童 肖飞

摘要 目的：探究復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。

关键词 复方紫草油;慢性剥脱性唇炎;康复新液;麻油

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

REN Xuewen1，LI Yuanwen1，FENG Huishang2，CAI Lingling1，LI Wei1，DENG Yutong1，XIAO Fei3

（1 Dongfang Hospital，Beijing University of Chinese Medicine，Beijing 100029，China; 2 Dongzhimen Hospital，Beijing University of Chinese Medicine，Beijing 100700，China; 3 Jianmin Group Children′s Drug Research Institute，Wuhan 430052，China）

Abstract 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.

Keywords Compound Oleum Lithospermi; Chronic cheilitis exfoliativa; Kangfuxin solution; Sesame oilC2D5BA86-65F2-4874-9215-7F046271D7EC

中图分类号：R275文献标识码：Adoi：10.3969/j.issn.1673-7202.2022.08.017

慢性剥脱性唇炎是慢性唇炎中最常见的一种，以唇部皮肤黏膜脱屑、干燥、疼痛、瘙痒或灼热、肿胀，可伴有渗出、结痂为主要表现[1]，初期多见于下唇红肿。病因尚不完全明确，可能与季节、干燥、烟酒刺激及不自觉的不良习惯，如舔唇、咬唇或撕破嘴唇皮肤等有关，外伤、感染亦是本病诱发因素[2]。唇部长期暴露在外，病变对颜面美观影响较为明显，同时可能伴有情绪的改变[3]，严重影响了患者的正常进食和社交生活，已成为皮肤科的慢性难治病[4]。……