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

中华皮肤科杂志 ›› 2016, Vol. 49 ›› Issue (8): 541-546.

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

陈旭¹,鞠梅²,俞晨³,耿龙⁴,陈俊帆⁵,梁思⁶,黄琴斯⁷,王刚⁸,高兴华⁹,许爱娥¹⁰,白彦平¹¹,陈柳青¹²,顾恒¹

1. 中国医学科学院北京协和医学院皮肤病研究所
2. 南京中国医学科学院北京协和医学院皮肤病医院
3. 第四军医大学西京医院
4. 中国医科大学附属第一临床医院皮肤科
5. 杭州市第三人民医院皮肤科
6. 卫计委中日医院皮肤科
7. 武汉市第一医院
8. 第四军医大学西京医院皮肤科
9. 沈阳中国医科大学附属第一医院皮肤科
10. 安徽医科大学附属杭州市第三人民医院皮肤科
11. 中日友好医院中医皮肤科 100029
12. 武汉市第一医院皮肤科

收稿日期:2015-08-19 修回日期:2016-04-20 发布日期:2016-08-05
通讯作者: 顾恒 E-mail:guheng@aliyun.com

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

Received:2015-08-19 Revised:2016-04-20 Published:2016-08-05

摘要/Abstract

摘要：

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3 h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7 d（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 < 0.000 1），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。

Abstract:

Chen Xu, Ju Mei, Yu Chen, Geng Long, Chen Junfan, Li Ruohong, Liang Si, Huang Qinsi, Wang Gang, Gao Xinghua, Xu Ai′e, Bai Yanping, Chen Liuqing, Gu Heng Department of Physical Therapy, Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College; Jiangsu Key Laboratory of Molecular Biology for Skin Diseases and STIs, Nanjing 210042, China （Chen X, Ju M, Gu H）; Department of Dermatology, Xijing Hospital, the Fourth Military Medical University, Xi′an 710032, China （Yu C, Wang G）; Department of Dermatology, the First Hospital of China Medical University, Shenyang 110001, China （Geng L, Gao XH）; Department of Dermatology, Hangzhou Third People′s Hospital, Hangzhou 310009, China （Chen JF, Xu AE）; Department of Dermatology, China?Japan Friendship Hospital, Beijing 100029, China （Li RH, Liang S, Bai YP）; Department of Dermatology, Wuhan No.1 Hospital, Wuhan 430022, China （Huang QS, Chen LQ） Corresponding author: Gu Heng, Email: guheng@aliyun.com 【Abstract】 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.

陈旭鞠梅俞晨耿龙陈俊帆梁思黄琴斯王刚高兴华许爱娥白彦平陈柳青顾恒. 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[J]. 中华皮肤科杂志, 2016,49(8):541-546. doi:

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