活血祛斑汤联合皙毓黄褐斑贴敷料治疗女性黄褐斑气滞血瘀证的临床研究

Clinical study on the treatment of chloasma and qi stagnation and blood stasis by Huoxue Quban Decoction combining with Xiyu chloasma patch

目的评价活血祛斑汤联合皙毓黄褐斑贴敷料治疗女性黄褐斑的临床疗效。方法随机对照试验研究。选择2021年1月-2022年3月本院皮肤科126例黄褐斑患者作为观察对象,采用随机数字表法分为2组,每组63例。对照组给予皙毓黄褐斑贴敷料治疗,观察组在对照组基础上服用活血祛斑汤。2组均连续治疗12周。分别于治疗前后进行中医证候评分,采用黄褐斑面积和严重指数(MASI)评估皮损严重程度,黄褐斑生活质量(MELASQOL)量表评估生活质量;采用酶速率法检测血清SOD水平,微量法检测MDA水平,比色法检测GSH-Px水平,记录治疗期间不良反应,评价临床疗效。结果观察组总有效率为90.48%(57/63)、对照组为71.43%(45/63),2组比较差异有统计学意义(χ2=7.41,P=0.006)。观察组治疗后中医证候积分(Z=8.13)及MASI(Z=8.92)、MELASQOL量表(t=11.52)评分低于对照组(P<0.01)。观察组治疗后血清SOD[(203.07±25.24)g/L比(176.24±33.98)g/L,t=5.03]、GSH-Px[(8.28±1.27)U/L比(7.33±1.28)U/L,t=4.18]水平高于对照组(P<0.01);MDA[(3.36±1.17)μmol/L比(5.20±1.23)μmol/L,t=8.62]水平低于对照组(P<0.01)。2组治疗期间未发生明显不良反应。结论活血祛斑汤联合皙毓黄褐斑贴敷料可有效改善黄褐斑患者皮损颜色、面积和生活质量,减轻氧化应激反应,且安全有效。

Objective To investigate the clinical efficacy of Huoxue Quban Decoction combined with Xiyu chloasma patch in the treatment of chloasma.Methods Randomized controlled trial.A total of 126 chloasma patients were selected and divided into two groups according to the random number table method,63 in each group.The control group were treated with Xiyu chloasma patch,and the observation group received Huoxue Quban Decoction combined with Xiyu chloasma patch.Both groups were treated continuously for 12 weeks.TCM syndrome scores were performed before and after treatment,and the severity of skin lesions was evaluated by the Melasma Area and Severity Index(MASI).Quality of life was evaluated by the Melasma Quality of Life(MELASQOL)scale.Serum SOD levels were measured by enzyme rate method,MDA levels were measured by micro method,and GSH-Px levels were measured by colorimetric method.Adverse reactions during treatment were recorded and clinical efficacy was evaluated Results The total effective rate of the observation group was 90.48%(57/63),while the control group was 71.43%(45/63).The difference between the two groups was statistically significant(χ2=7.41,P=0.006).After treatment,the scores of traditional Chinese medicine syndrome scores(Z=8.13),MASI(Z=8.92),and MELASQOL(t=11.52)in the observation group were significantly lower than those in the control group(P<0.01).After treatment,the serum SOD[(203.07±25.24)g/L vs.(176.24±33.98)g/L,t=5.03]and GSH-Px[(8.28±1.27)U/L vs.(7.33±1.28)U/L,t=4.18]levels in the observation group were significantly higher than those in the control group(P<0.01);MDA[(3.36±1.17)μmol/L vs.(5.20±1.23)μmol/L,t=8.62]was significantly lower than that of the control group(P<0.01).No significant adverse reactions occurred during the treatment period in both groups.Conclusion The Huoxue Quban Decoction combined with Xiyu chloasma patch can improve the color,area and quality of life of chloasma lesions and reduce oxidative stress with high safety.