复方多粘菌素B软膏联合地奈德乳膏治疗亚急性/慢性湿疹的多中心、随机、双盲、平行对照临床研究

Compound polymyxin B ointment combined with desonide cream for the treatment of subacute or chronic ;eczema：a multicenter, randomized, double-blind, parallel-group, controlled clinical study

目的探讨复方多粘菌素B软膏联合地奈德乳膏治疗亚急性/慢性湿疹的临床疗效和安全性。方法采用多中心、随机、双盲、平行对照临床研究，入选亚急性湿疹患者144例（试验组72例，对照组72例），慢性湿疹患者144例（试验组72例，对照组72例）。试验组与对照组分别外用复方多粘菌素B软膏和复方多粘菌素B软膏基质，隔3h后两组均使用地奈德乳膏，每日交替使用各2次。记录患者的症状/体征（包括瘙痒程度、炎症程度、糜烂/渗出程度、浸润/肥厚程度及靶皮损面积）和时间指标（瘙痒减轻起效时间、瘙痒减轻缓解时间）。分析两组的疗效，评估安全性。结果试验组和对照组的症状/体征总分在用药7d（亚急性湿疹：试验组6.09±2.78，对照组8.26±3.17；慢性湿疹：试验组6.56±2.68，对照组8.84±2.90）和14 d（亚急性湿疹：试验组3.68±3.18，对照组5.28±4.05；慢性湿疹：试验组4.38±3.27，对照组6.25±3.78）均较基线水平（亚急性湿疹：试验组13.44±1.66，对照组13.60±1.75；慢性湿疹：试验组12.96±1.16，对照组12.64±1.18）有不同程度的下降。试验组亚急性、慢性湿疹患者在用药7、14 d后的症状/体征均较相应的对照组低，差异有统计学意义（均P〈0.05）。亚急性湿疹患者中，试验组瘙痒和浸润肥厚评分的下降幅度均显著高于对照组（均P〈0.01）；慢性湿疹患者中，试验组瘙痒、浸润肥厚和靶皮损面积评分的下降幅度均显著高于对照组（均P〈0.05）。亚急性湿疹患者试验组瘙痒减轻起效时间短于对照组，但瘙痒减轻缓解时间长于对照组（均P〈0.05）；慢性湿疹患者试验组瘙痒减轻起效时间短于对照组（P〈0.0001），但瘙痒减轻缓解时间与对照组差异无统计学意义。试验组医生和患者对治疗效果的满意度均高于对照组（均P〈0.05）。结论外用复方多粘菌素B软膏可增强外用地奈德乳膏治疗亚急性和慢性湿疹的疗效，且对亚急性湿疹的效果更为显著。复方多粘菌素B软膏还能较好地控制湿疹患者的瘙痒症状和浸润肥厚。

Objective To evaluate the clinical efficacy and safety of compound polymyxin B ointment combined with desonide cream for the treatment of subacute or chronic eczema. Methods A multicenter, randomized, double？blind, parallel？group, controlled clinical study was conducted. Totally, 144 patients with subacute eczema and 144 patients with chronic eczema were enrolled into this study, and both randomly and equally divided into the test group and control group. The test group and control group firstly topically applied compound polymyxin B ointment and its vehicle respectively, then both topically applied desonide cream 3 hours later. The drugs or vehicle were applied twice a day in all the patients. Patients′ symptoms and signs （including degree of itching, inflammation, erosion/exudation and infiltration/thickening, as well as area of target lesions） were evaluated, and the time to onset and duration of itching？alleviating effect were recorded. The clinical efficacy and safety of treatments were analyzed and compared between the test group and control group. Results The total symptom and sign scores significantly decreased to different extents on days 7 and 14 in the test group（subacute eczema patients：6.09 ± 2.78 and 3.68 ± 3.18 vs. 13.44 ± 1.66; chronic eczema patients： 6.56 ± 2.68 and 4.38 ± 3.27 vs. 12.96 ± 1.16）and control group（subacute eczema patients：8.26 ± 3.17 and 5.28 ± 4.05 vs. 13.60 ± 1.75;chronic eczema patients： 8.84 ± 2.90 and 6.25 ± 3.78 and vs. 12.64 ± 1.18）compared with those at baseline. Moreover, the total symptom and sign score of patients with subacute or chronic eczema was significantly lower in the test group than in the control group on days 7 and 14（all P〈0.05）. A significant increment was observed in the degree of decrease in scores for itch, infiltration/thickening in patients with subacute eczema in the test group compared with that in the control group（all P〈0.01）, as well as in scores for itch, infiltration/thickening and area of target lesions in patients with chronic eczema in the test group compared with those in the control group （all P 〈 0.05）. In addition, patients with subacute eczema in the test group showed significantly shorter onset and longer duration of itching？alleviating effect than those in the control group（both P〈0.05）. The time to onset of itching？alleviating effect was also significantly shorter in patients with chronic eczema in the test group than in those in the control group（P〈0.000 1）, but there was no significant difference in the duration of it between the two groups of patients with chronic eczema. Clinicians and patients were both more satisfied with therapeutic effects in the test group than in the control group（all P〈0.05）. Conclusions Topical compound polymyxin B ointment can increase the efficacy of topical desonide cream for the treatment of subacute or chronic eczema, especially subacute eczema. Compound polymyxin B ointment also shows a favorable therapeutic effect on itching and infiltration/thickening in patients with eczema.