基于态靶医学运用当红祛斑精华液治疗黄褐斑的临床疗效  

Clinical Study on Treatment of Melasma Using Angelica and Safflower Spot Removal Essence Based on State-target Medicine

作　　者：陈柏林 杨皓瑜 蔡锐 白彦萍[1] 陈媛媛 CHEN Bailin;YANG Haoyu;CAI Rui;BAI Yanping;CHEN Yuanyuan(Beijing University of Chinese Medicine,Beijing 100029,China;China-Japan Friendship Hospital,National Integrated Traditional Chinese and Western Medicine Medical Center,Beijing 100029,China;Beijing Traditional Chinese Medicine Hospital,Beijing 100010,China;Beijing Hospital of Integrated Traditional Chinese and Western Medicine,Beijing 100039,China)

机构地区：[1]中日友好医院,国家中西医结合医学中心,北京100029 [2]北京中医药大学,北京100029 [3]北京中医医院,北京100010 [4]北京中西医结合医院,北京100039

出　　处：《中国实验方剂学杂志》2025年第2期111-119,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金项目(82074445);国家中医药管理局2021年岐黄学者支持项目(国中医药人教函[2021]203号)。

摘　　要：目的:评价态靶结合方当红祛斑精华液治疗黄褐斑的临床疗效及安全性。方法:采用随机、双盲、安慰剂平行对照试验方法,选择2022年9月至2023年2月北京中西医结合医院皮肤科门诊就诊的气滞血瘀型黄褐斑患者,按照双盲原则,生成随机数字表,随机分成观察组(50例)和对照组(50例),观察组使用当红祛斑精华液外用,对照组使用安慰剂外用,连续治疗8周,随访1月。患者用药前、停药后第1天进行黄褐斑面积和严重指数(MASI)评分、医师整体评估(PGA)评分、患者满意度评价、VISIA图像分析,记录所有不良事件。结果:100例患者中87例纳入分析集进行疗效分析(观察组脱落5例,最终纳入45例;对照组脱落8例,最终纳入42例)。两组患者基线资料一致,差异无统计学意义。治疗后,观察组总有效率为75.56%(34/45),显著高于对照组的2.38%(1/42),差异具有统计学意义(χ^(2)=48.38,P<0.01)。与本组治疗前比较,治疗后,观察组患者MASI评分、VISIA图像斑点、棕色斑、红色区评分明显降低(P<0.05,P<0.01),对照组患者差异无统计学意义。与对照组治疗后比较,观察组患者改善更明显(P<0.05,P<0.01)。VISIA图像分析显示,治疗8周后,观察组表层斑点、深层斑点和红色区均显著改善,而对照组则不变或有加重趋势。观察组PGA评分3分及以下占42.22%(19/45),4分及以下占88.89%(40/45)。对照组PGA评分5分及以上占80.95%(34/42),两组差异有统计学意义(χ^(2)=38.26,P<0.01)。观察组1个月内的复发率和不良反应率与对照组差异无统计学意义。结论:态靶结合方当红祛斑精华液治疗黄褐斑临床疗效肯定,安全性好。Objective:To investigate the clinical efficacy and safety of state-target formula Angelica and Safflower spot removal essence in the treatment of melasma.Methods:A randomized,double-blind,placebo-controlled parallel-group trial was conducted,selecting patients with Qi stagnation and blood stasis type of melasma who visited the dermatology outpatient department of Beijing Hospital of Integrated Traditional Chinese and Western Medicine from September 2022 to February 2023.In accordance with the double-blind principle,a random number table was generated to randomly divide the patients into an experimental group(50 cases)and a control group(50 cases).The experimental group applied the Angelica and Safflower spot removal essence topically,while the control group applied a placebo topically,with continuous treatment for 8 weeks and a follow-up of 1 month.Melasma Area and Severity Index(MASI),Physician Global Assessment(PGA),patient self-assessment scoring,VISIA detection and scoring were performed before medication and on the first day after stopping medication,and all adverse events were recorded.Results:In a study involving 100 patients,87 cases were included in the analysis.The experimental group consisted of 45 cases,with 5 dropouts,and the control group had 42 cases,with 8 dropouts.The baseline data of the patients in both groups were consistent,with no statistically significant differences.After treatment,the total effective rate of the experimental group was 75.56%(34/45),significantly higher than the control group's 2.38%(1/42),and the difference was statistically significant(χ^(2)=48.38,P<0.01).Compared with before treatment,after treatment,the MASI score,VISIA image spot,brown spot,and red area score of the experimental group patients were significantly reduced(P<0.05,P<0.01),while there was no statistically significant difference in the control group patients.Compared with the control group after treatment,the experimental group showed more significant improvement(P<0.05,P<0.01).VISIA image analysis showed

关 键 词：中医 态靶医学 当红祛斑精华液 黄褐斑 随机对照试验 

分 类 号：R275[医药卫生—中医皮科] R816.95[医药卫生—中医学] R758.42