止痒平肤液治疗表皮生长因子受体抑制剂相关皮肤不良反应的临床观察  

Treatment of EGFRIs-related Skin Adverse Reactions by Zhiyang Pingfu Lotion

作　　者：彭艳梅[1] 崔慧娟[2] 刘喆[3] 井方方[4] 初玉平[5] 白彦平[6] 刘戴维 宋亚中 段桦[1] 邱钰芹[1] 

机构地区：[1]北京中医药大学中日友好临床医学院,北京100029 [2]中日友好医院中西医结合肿瘤科,北京100029 [3]北京胸科医院肿瘤内科,北京101100 [4]解放军总医院肿瘤内科,北京100853 [5]北京朝阳医院肿瘤科,北京100016 [6]中日友好医院皮肤与性病科,北京100029

出　　处：《中国中西医结合杂志》2017年第2期149-154,共6页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：北京市科技计划首都临床特色应用研究项目(No.Z15110700400000)

摘　　要：目的观察外用止痒平肤液治疗表皮生长因子受体抑制剂(epidermal growth factor receptor inhibitors,EGFRIs)相关痤疮样皮疹、皮肤瘙痒、皮肤干燥、指甲改变的疗效,并评价药物的安全性、患者的满意度。方法选择经病理学诊断明确的、应用EGFRIs后出现痤疮样皮疹患者201例,采用随机数字表法分为试验组和对照组。试验组(131例)在西医标准处理原则基础上加用自拟中药止痒平肤液,对照组(70例)外用空白药物及西医标准处理原则,连续14天。观察治疗前后2组患者皮疹分级、皮肤瘙痒、皮肤干燥、指甲改变的变化以及血常规、肝肾功等安全性指标,并随访无进展生存期(progression-free survival,PFS)。结果 185例完成临床观察,试验组脱落10例,对照组6例。试验组治疗皮疹分级、皮肤瘙痒、皮肤干燥、指甲改变的有效率分别为90.1%(109/121)、57.9%(70/121)、57.9%(70/121)、16.5%(20/121);对照组分别为14.1%(9/64)、6.3%(4/64)、1.6%(1/64)、0.0%(0/64)。两组比较皮疹分级、皮肤瘙痒、皮肤干燥的差异有统计学意义(χ2分别为105.1022,51.3312,59.1777,P<0.05)。临床观察过程中未出现与药物相关的严重不良事件,安全性较好,试验组与对照组患者满意度分别为95.4%(125/131)、57.1%(40/70)。两组无进展生存期比较,差异无统计学意义(χ2=2.006,P>0.05)。结论止痒平肤液治疗EGFRIs相关皮肤不良反应的疗效显著,且无明显的不良反应,但仍需要更多的随机对照试验进一步加以证实。Objective To observe the curative effect of Zhiyang Pingfu Lotion（ ZPL） for its external application in treatment of epidermal growth factor receptor inhibitors（ EGFRIs）-related acneiform rash,cutaneous pruritus,xerosis cutis,and nail changes,as well as to evaluate its safety and patients＇ satisfaction.Methods Recruited were 201 patients with confirmed pathological diagnosis,who had acneiform rash after using EGFRIs. They were assigned to the treatment group（ 131 cases） and the control group（ 70 cases） by random digit table. Patients in the treatment group were externally applied with self-formulated ZPL based onprinciples of Western medical standards,while those in the control group were externally applied with blank drugs plus conventional Western medicine standard. The therapeutic course for all was 14 days. Changes in rash degree,cutaneous pruritus,xerosis cutis,and nails were observed in both groups before and after treatment. Blood routines as well as liver and kidney function tests were performed in both groups before and after treatment. Follow-up visit was also conducted during progression-free survival（ PFS）. Results A total of 185 patients finished this clinical trial. Ten dropped out in the treatment group and 6 in the control group. The effective rates of rash degree,cutaneous pruritus,xerosis cutis,and nail changes were 90. 1%（ 109 /121）,57. 9%（ 70 /121）,57. 9%（70 /121）,and 16. 5%（20 /121） in the treatment group,respectively. They were 14. 1%（9 /64）,6. 3%（4 /64）,1. 6%（1 /64）,and 0（0 /64） in the control group,respectively. Significant difference existed in all these indices between the two groups（χ^2= 105. 1022,51. 3312,59. 1777;P〈0. 05）. No serious drug-related adverse events occurred during clinical observation,with relatively better safety. The satisfaction was 95. 40%（125 /131）in the treatment group and 57. 1%（40 /70） in the control group. No statistical difference in PFS was observed between the two groups（χ^2= 2. 006,P〉0.

关 键 词：表皮生长因子受体抑制剂 皮肤不良反应 止痒平肤液 

分 类 号：R285.6[医药卫生—中药学]