祛风止痒汤联合肤痔清软膏治疗慢性肛周湿疹的临床研究

Clinical study on the treatment of chronic perianal eczema with Qufeng Zhiyang Decoction and Fuzhiqing Ointment

目的评价祛风止痒汤联合肤痔清软膏治疗慢性肛周湿疹的疗效。方法随机对照试验研究。选取2020年1月-2021年5月眉山市人民医院122例慢性肛周湿疹患者作为观察对象,按随机数字表法分为2组,每组61例。常规组外涂肤痔清软膏,研究组在常规组基础上服用祛风止痒汤。2组均连续治疗2周。分别于治疗前后进行中医症状评分,采用湿疹面积及严重程度指数(EASI)评估皮损程度,皮肤病生活质量指数(DLQI)评价生活质量;采用流式细胞仪检测Treg细胞及Th17细胞数量,计算Th17/Treg细胞比值;采用ELISA法检测血清TNF-α、IL-10、IL-6水平;记录治疗期间的不良反应,评价临床疗效;随访3个月,记录复发情况。结果研究组总有效率为86.89%(53/61)、常规组为72.13%(44/61),2组比较差异有统计学意义(χ^(2)=4.08,P=0.044)。治疗后,研究组瘙痒、滋水、红疹灼热、心烦口渴、尿黄便干积分低于常规组(t值分别为19.64、49.13、19.64、33.14、24.61,P<0.01);EASI、DLQI评分低于常规组(t值分别为-6.52、-29.33,P<0.01)。治疗后,研究组Treg细胞[(6.58±0.78)%比(5.49±0.81)%,t=7.57]高于常规组(P<0.01),Th17细胞[(1.03±0.28)%比(1.27±0.39)%,t=-3.90]及Th17/Treg细胞比值[(0.15±0.07)比(0.23±0.05),t=7.68]低于常规组(P<0.01)。治疗后,研究组血清IL-10水平高于常规组(t=-16.97,P<0.01),IL-6、TNF-α水平低于常规组(t值分别为-21.48、-25.59,P<0.01)。治疗期间,研究组不良反应发生率为6.56%(4/61)、常规组为9.84%(6/61),2组比较差异无统计学意义(χ^(2)=0.44,P=0.509)。随访期间,研究组复发率为15.09%(8/53)、常规组为50.00%(22/44),2组比较差异有统计学意义(χ^(2)=14.55,P<0.01)。结论祛风止痒汤联合肤痔清软膏可降低慢性肛周湿疹患者炎症因子水平,维持Th17/Treg细胞免疫平衡、提高临床疗效且复发率低。

Objective To evaluate the efficacy of Qufeng Zhiyang Decoction combined with Fuzhiqing Ointment in the treatment of chronic perianal eczema.Methods Randomized controlled trial.A total of 122 patients with chronic perianal eczema in Meishan People's Hospital from January 2020 to May 2021 were selected as the observation objects and divided into 2 groups according to random number table method,with 61 cases in each group.The conventional group was treated with Fuzhiqing Ointment.The study group was treated with Qufeng Zhiyang Decoction.The treatment for both groups lasted for two weeks.TCM symptom score was recored before and after treatment;the degree of skin lesions was evaluated by the area and Eczema Area and Severity Index(EASI);the quality of life of patients was evaluated by the quality of life index of dermatosis(DLQI);the number of Treg and Th17 cells was measured by flow cytometry;the ratio of Th17/Treg cells was calculated;the levels of TNF-α,IL-10 and IL-6 were detected by ELISA.The adverse reactions were recorded and the clinical efficacy was evaluated.The patients were followed up for 3 months and the recurrence was recorded.Results The total effective rate of the study group was 86.89%(53/61)and that of the conventional group was 72.13%(44/61),with statistical significance(χ^(2)=4.08,P=0.044).After treatment,the scores of pruritus,spurt water,erythema and burning,upset and thirsty,yellow urine and dry urine in the study group were lower than those in the conventional group(t values were 19.64,49.13,19.64,33.14,24.61,P<0.01);EASI and DLQI scores were lower than those in the conventional group(t values were-6.52 and-29.33,P<0.01).After treatment,Treg cells[(6.58±0.78)%vs.(5.49±0.81)%,t=7.57]in the study group was higher than that of the conventional group(P<0.01),Th17 cells[(1.03±0.28)%vs.(1.27±0.39)%,t=-3.90]and Th17/Treg ratio[(0.15±0.07)vs.(0.23±0.05),t=7.68]were lower than those in the conventional group(P<0.01).After treatment,the level of IL-10 in the study group was higher than that of the conventional group(t=-16.97,P<0.01),and the levels of IL-6 and TNF-αwere lower than those in the conventional group(t values were-21.48 and-25.59,P<0.01).During treatment,the incidence of adverse reactions was 6.56%(4/61)in the study group and 9.84%(6/61)in the conventional group,without statistical significance in the incidence of adverse reactions between the two groups(χ^(2)=0.44,P=0.509).During the follow-up period,the recurrence rate was 15.09%(8/53)in the study group and 50.00%(22/44)in the conventional group,with statistical significance in the recurrence rate between the two groups(χ^(2)=14.55,P<0.01).Conclusion Qufeng Zhiyang Decoction combined with Fuzhiqing Ointment can reduce the levels of inflammatory factors in patients with chronic perianal eczema,maintain Th17/Treg cell immune balance,improve clinical efficacy,and have a low recurrence rate.