消疹减毒方联合红霉素软膏治疗EGFR-TKI相关性皮疹的疗效观察

Clinical Efficacy of Xiaozhen Jiedu Formula Plus Erythromycin Ointment for EGFR-TKI Related Skin Rash

目的观察消疹减毒方联合红霉素软膏治疗表皮生长因子受体酪氨酸激酶抑制剂(Epidermal GrowthFactorReceptor-Tyrosine KinaseInhibitor,EGFR-TKI)相关性皮疹的疗效及安全性。方法选择60例出现EGFR-TKI相关性皮疹的非小细胞肺癌患者,随机分为中西医组、中医组和西医组,每组各20例。中西医组予消疹减毒方联合红霉素软膏治疗,中医组予单纯消疹减毒方治疗,西医组予单纯红霉素软膏治疗,均连续治疗4周。比较治疗后三组皮疹分级、皮疹治疗疗效、功能状态评分(Karnofsky PerformanceScale,KPS)、生存质量测定量表(Functional AssessmentofCancerTherapy-Lung,FACT-L)评分和安全性。结果①三组治疗前后皮疹分级和KPS评分比较,差异具有统计学意义(P<0.05),治疗后三组间的皮疹分级、KPS评分比较,差异无统计学意义(P>0.05)。②治疗后中西医组皮疹治疗疗效(总有效率)显著优于中医组和西医组,差异具有统计学意义(P<0.05)。③三组治疗前后及组间的FACT-L评分比较,差异无统计学意义(P>0.05)。④三组均未出现治疗相关严重不良事件。结论消疹减毒方联合红霉素软膏外用可有效缓解EGFR-TKI相关性皮疹,疗效优于单纯使用消疹减毒方或红霉素软膏,且安全性好,值得临床推广。

Objective To investigate the effect of Xiaozhen Jiedu Formula plus erythromycin ointment for the treatment of epidermal growth factor receptor-tyrosine kinase inhibitor(EGFR-TKI)related skin rash.Methods Sixty non-small-cell lung cancer patients with EGFR-TKI related skin rash were enrolled.The patients were equally randomized into integrative medicine group,Chinese herbal medicine group,and western medicine group,which were treated with Xiaozhen Jiedu Formula plus erythromycin ointment,Xiaozhen Jiedu Formula alone,and erythromycin ointment alone respectively.The treatment for the 3 group lasted 4 continuous weeks.The grading of skin rash,the efficacy for skin rash,Karnofsky Performance Scale(KPS)scores,Functional Assessment of Cancer Therapy-Lung(FACT-L)scores and clinical safety were observed after 4 weeks of treatment.Results①Compared with those before treatment,the grading of skin rash and KPS scores in the 3 groups were improved obviously after treatment(P<0.05).However,there were no significant differences in the grading of skin rash and KPS scores among the three groups after treatment(P>0.05).②The total effective rate in integrative medicine 20 group was significantly higher than that in the other 2 groups(P<0.05).③There were no significant difference in the FACT-L scores of the 3 groups before and after treatment and amont the 3 groups after treatment(P>0.05).④No obvious adverse events occurred in the three groups.Conclusion Xiaozhen Jiedu Formula plus erythromycin ointment exerts stronger efficacy in treating EGFR-TKI related skin rash than western medicine or Chinese herbal medicine alone.The combined therapy is safe and worth of expanding the clinical application.